In the pharmaceutical world, regulation is of prime importance. It is quite possible that in the run for billions of dollars worth of business, lack of regulation could spell rampant profiteering and Drug Company related malpractices that could well jeopardize the lives of millions of innocent patients around the world. There is indeed no wonder that in the best interests of humanity and life preservation, pharmaceutical regulator compliance is a science that closely regulates and monitors the pharma industry.
Drugs and pharmaceutical products have to be approved by competent authority before they are released into the market with possible impact on patients in the US and other nations. There are a host of companies that now deal specifically with the area of pharmaceutical regulatory compliances as it is vitally important to regulate and be compliant with stringent rules and regulations set for monitoring drug quality and prevention of side effects. Some of the primary efforts here are in the realm of wherein it is sought to be proven that implementation of a certain pharmaceutical process will consistently and invariably produce a particular end result in terms of the products of a designated quality and as per the defined standards.
Aspects like calibration, process and product , global regulation and quality assurance are some aspects of pharmaceutical regulatory compliance that are in vogue and in great demand also among students around the world who aspire to take a profession in the related field. You can also avail of pharmaceutical regulatory compliance software that integrates the business aspects of pharmaceutical industry and the regulatory framework that governs as well as monitors it from close quarters.
In short, pharmaceutical regulatory compliance can be called a conduit through the regulatory terrain that every new drug belonging to the pharmaceutical industry should traverse in its life cycle.
Wednesday, November 25, 2009
Concept of Process Validation For Pharmaceutical Industry
Concept of Validation
According to GMP definition Validation is "Establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes."
Appropriate and complete documentation is recognized as being crucial to the validation effort. Standard Operating Procedures (SOPs), manufacturing formulae, detailed batch documentation, change control systems, investigational reporting systems, analytical documentation, development reports, validation protocols and reports are integral components of the validation philosophy. The validation documentation provides a source of information for the ongoing operation of the facility and is a resource that is used in subsequent process development or modification activities.
All validation activities will incorporate a level of Impact Assessment to ensure that systems, services and products directly influenced by the testing have been identified.
A revalidation program should be implemented based on routine equipment revalidation requirements and on the Change Control Policy.
Types of Validation
Prospective validation
Establishing documented evidence that a piece of equipment/process or system will do what it purports to do, based upon a pre-planned series of scientific tests as defined in the Validation Plan.
Concurrent validation
Is employed when an existing process can be shown to be in a state of control by applying tests on samples at strategic points throughout a process; and at the end of the process. All data is collected concurrently with the implementation of the process until sufficient information is available to demonstrate process reproducibility.
Retrospective validation
Establishing documented evidence that a process does what it purports to do, based on review and analysis of historical data.
Design Qualification (DQ)
The intent of the DQ is met during the design and commissioning process by a number of mechanisms, which include:
- Generation of User Requirement Specifications
- Verification that design meets relevant user requirement specifications.
- Supplier Assessment /Audits
- Challenge of the design by GMP review audits
- Product Quality Impact Assessment
- Specifying Validation documentation requirements from equipment suppliers
- Agreement with suppliers on the performance objectives
- Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT) & commissioning procedures
- Defining construction and installation documentation to assist with Installation Qualification (IQ).
Installation Qualification (IQ)
IQ provides documented evidence that the equipment or system has been developed, supplied and installed in accordance with design drawings, the supplier's recommendations and In-house requirements. Furthermore, IQ ensures that a record of the principal features of the equipment or system, as installed, is available and that it is supported by sufficient adequate documentation to enable satisfactory operation, maintenance and change control to be implemented.
Operational Qualification (OQ)
OQ provides documented evidence that the equipment operates as intended throughout the specified design, operational or approved acceptance range of the equipment, as applicable. In cases where process steps are tested, a suitable placebo batch will be used to demonstrate equipment functionality.
All new equipment should be fully commissioned prior to commencing OQ to ensure that as a minimum the equipment is safe to operate, all mechanical assembly and pre-qualification checks have been completed, that the equipment is fully functional and that documentation is complete.
Performance Qualification (PQ)
The purpose of PQ is to provide documented evidence that the equipment can consistently achieve and maintain its performance specifications over a prolonged operating period at a defined operating point to produce a product of pre-determined quality. The performance specification will reference process parameters, in-process and product specifications. PQ requires three product batches to meet all acceptance criteria for in-process and product testing. For utility systems, PQ requires the utility medium to meet all specifications over a prolonged sampling period.
The PQ documentation should reference standard manufacturing procedures and batch records and describe the methodology of sampling and testing to be used.
What Gets Validated
General
All process steps, production equipment, systems and environment, directly used for the manufacture of sterile and non sterile products must be formally validated.
All major packaging equipment and processes should be validated. This validation is less comprehensive.
All ancillary systems that do not directly impact on product quality should be qualified by means of a technical documentation of the extent of the system and how it operates.
Facility
- Manufacturing Area Design.
- Personnel and material flow etc.
Process and Equipment Design
Process steps and equipment description. i.e. Dispensing, Formulating, Packaging, Equipment washing
and cleaning. etc
Utility Systems Design
Raw/purified steam, Purified water, Compressed Air, Air conditioning system, Vacuum, Power supply, Lighting, Cooling water, Waste etc
Computerized Systems Design
Information system, Laboratory automated equipments, Manufacturing automated equipments, Electronic records etc
Cleaning Validation (CV)
CV provides documented evidence that a cleaning procedure is effective in reducing to pre-defined maximum allowable limits, all chemical and microbiological contamination from an item of equipment or a manufacturing area following processing. The means of evaluating the effectiveness of cleaning involves sampling cleaned and sanitized surfaces and verifying the level of product residues, cleaning residues and bacterial contamination.
The term CV is to be used to describe the analytical investigation of a cleaning procedure or cycle. The validation protocols should reference background documentation relating to the rationale for "worst case" testing, where this is proposed. It should also explain the development of the acceptance criteria, including chemical and microbial specifications, limits of detection and the selection of sampling methods.
Method Validation (MV)
MV provides documented evidence that internally developed test methods are accurate, robust, effective, reproducible and repeatable. The validation protocols should reference background documentation relating to the rationale for the determination of limits of detection and method sensitivity.
Computer Validation
Computer Validation provides documented evidence to assure systems will consistently function according to their pre-determined specifications and quality attributes, throughout their lifecycle. Important aspects of this validation approach are the formal management of design (through a specification process); system-quality (through systematic review and testing); risk (through identification and assessment of novelty and critical functionality) and lifecycle (through sustained change control).
Where equipment is controlled by embedded computer systems, elements of computer validation may be performed as part of the equipment IQ and OQ protocols.
General process, cleaning and methodology validation concepts are described in this article with a special view to pharmaceutical industry
Validation master plan
The Validation Master Plan also referenced as "VMP" is one of the key documents in the GMP (Good manufacturing practice) regulated pharmaceutical industry. Even though it is not mandatory it is the document that outlines the principles involved in the qualification of a facility, defining the areas and systems to be validated and to provide a written program for achieving and maintaining a qualified facility with validated processes. The VMP is the foundation for the validation program and should include process validation, facility and utility qualification and validation, equipment qualification, cleaning and computer validation.
Common topics to be cover in a Validation Master Plan: Introduction, Scope of the VMP, Responsibilities, Description of facility and design, Building and Plant Layout, Construction materials, Cleanliness Zoning and room pressure Concept, Storage Areas, Personnel, Training and Personnel Flow, Material and Waste Flow, Water and solid waste handling, Infrastructure and Utilities, Water qualities, Heating, ventilation and air-conditioning (HVAC) Clean Steam, compressed air, gases and Vacuum System, Description of Manufacturing Equipment, Building management systems, Products to be manufactured, Qualification/validation approach, Process Validation and Cleaning validation approach, Microbiological Monitoring and Computer Validation, Calibration, Maintenance, Change Control, Suppliers Inspections, Internal audits and other key SOPs.
he pharmaceutical process development is designed to cover a wide array of procedures designed to ensure an efficient business environment. In order to reach the highest level of efficiency, many of todays pharmaceutical companies seek to outsource their services to companies that specialize in offering various pharmaceutical services. Such companies are used either as providers of, or validation for, sample storage and pharmaceutical storage, drug shelf life validation, stability test, humidity chamber validation or storage, environmental test chambers, and much more. The pharmaceutical validation services provided, are designed make sure that the equipment used by pharmaceutical and biotechnology specialized companies, is in line to meet the current strict environmental conditions.
Pharmaceutical validation companies, such as Pharmaceutical Stability, provide cost effective turn key effective solutions to their clients validation and compliance challenges. This US company has excellent track records in providing emergency responses to critical compliance situations that their clients encounter, as well as with setting up qualification and validation programs.
The list of services being offered by such companies include, but are not limited to, project management, design qualification, start-up and commissioning, protocol execution, final report development, customized validation master plan development, protocol execution, performance qualification, and many more. Aside from services such as pharmaceutical storage, pharmaceutical validation, and other direct services, the list of services provided by Pharmaceutical Stability are meant to ensure their customers achieve maximum productivity through discovering any potential problems and errors in the process development.
In terms of pharmaceutical validation services, Pharmaceutical Stability provides comprehensible and exhaustive directions and instructions meant to be easy to implement. When pharmaceutical companies use correct strategies for every section of its activities such as research, product development, and operational management, they maximize their profits and operations. For example, long term and short term validated stability storage services for pharmaceutical products and biotechnology products are now being offered by numerous outsourcing companies. Pharmaceutical Stability provides professional pharmaceutical storage environments that are Q1A compliant and meet all the ICH strict operational guidelines.
Specialized companies which offer pharmaceutical validation, pharmaceutical storage, and drug shelf life validation services, are using the latest in pharma storage equipment. They are able to help client companies improve numerous aspects of their business from product development, drug shelf life, and even production capacity, plus overall productivity. By employing the services of such pharmaceutical validation companies, client companies are able to profit from state-of-the-art technology without having to make any of the large investments that are normally needed to access such services. The process development testing services cover a range of numerous services including pharmaceutical validation services, process mapping, product and operational analysis, etc.
Pharmaceutical validation companies, such as Pharmaceutical Stability, provide cost effective turn key effective solutions to their clients validation and compliance challenges. This US company has excellent track records in providing emergency responses to critical compliance situations that their clients encounter, as well as with setting up qualification and validation programs.
The list of services being offered by such companies include, but are not limited to, project management, design qualification, start-up and commissioning, protocol execution, final report development, customized validation master plan development, protocol execution, performance qualification, and many more. Aside from services such as pharmaceutical storage, pharmaceutical validation, and other direct services, the list of services provided by Pharmaceutical Stability are meant to ensure their customers achieve maximum productivity through discovering any potential problems and errors in the process development.
In terms of pharmaceutical validation services, Pharmaceutical Stability provides comprehensible and exhaustive directions and instructions meant to be easy to implement. When pharmaceutical companies use correct strategies for every section of its activities such as research, product development, and operational management, they maximize their profits and operations. For example, long term and short term validated stability storage services for pharmaceutical products and biotechnology products are now being offered by numerous outsourcing companies. Pharmaceutical Stability provides professional pharmaceutical storage environments that are Q1A compliant and meet all the ICH strict operational guidelines.
Specialized companies which offer pharmaceutical validation, pharmaceutical storage, and drug shelf life validation services, are using the latest in pharma storage equipment. They are able to help client companies improve numerous aspects of their business from product development, drug shelf life, and even production capacity, plus overall productivity. By employing the services of such pharmaceutical validation companies, client companies are able to profit from state-of-the-art technology without having to make any of the large investments that are normally needed to access such services. The process development testing services cover a range of numerous services including pharmaceutical validation services, process mapping, product and operational analysis, etc.
Method For Counting And Validating Articles, In Particular Pharmaceutical
Inventors: Giuseppe MONTI
Agents: WILLIAM J. SAPONE;COLEMAN SUDOL SAPONE P.C.
Assignees: MARCHESINI GROUP S.P.A.
Origin: BRIDGE PORT, CT US
IPC8 Class: AB07C500FI
USPC Class: 209528
Claims:
1). A method for counting and validating discrete articles to be introduced into containers, comprising a stage as follows:a. distancing the articles from one another;wherein the method further comprises the following stages:b. making each article of the articles pass through at least a detection zone such as to induce a consequent reactance variation in at least a variable reactance sensor, according to which reactance variation, an output signal of the variable reactance sensor takes on a specific waveform;c. sending the output signal from the variable reactance sensor to an input of a processing unit;d. providing, in output from the processing unit, data relating to a number of the articles which have passed through the at least a detection zone, a state of wholeness of the articles as well as a passage of objects of a different nature from the articles into the at least a detection zone.
2). The method of claim 1, wherein during stage a) the articles are made to follow a non-horizontal trajectory, such that they are subject to a non-null component of force of gravity.
3). The method of claim 2, wherein the articles follow the non-horizontal trajectory, freely descending along a non-horizontal support.
4). The method of claim 1, wherein it comprises initial stages a', b' and c', respectively corresponding to actuation of stages a, b and c applied to a predetermined multiplicity of sample objects, which multiplicity comprises whole articles, variously non-whole articles, and articles which are of a different nature to the articles, and wherein the method comprises a further stage of:programming the processing unit such that once all signals relating to each sample article have been received, the processing unit subdivides respective waveforms into classes, on a basis of a predetermined function of similarity, specially associating the articles to the classes, to which articles stages a, b, c and d are successively applied in order to qualify them either as whole articles or as non-whole articles or else as articles of a different nature to a nature of the articles.
5). An apparatus for counting and validating discrete articles, especially pharmaceutical articles, destined to be introduced into containers, especially bottles, comprising a thinning-out section which receives the articles from supply means and distances the articles from one another, the apparatus wherein the thinning-out section is such that each article crosses at least a detection zone, which comprises electronic components included in at least a variable reactance sensor, a reactance of which varies according to specific articles passing through the detection zone; wherein the apparatus further comprises: at least a processing unit, connected to the variable reactance sensor in order to receive in input an output signal from the variable reactance sensor and analyze the waveform of the output signal, which waveform is a function of the reactance variation, such that in output the processing unit provides data relating to a number of the articles which have passed through the detection zone, a state of wholeness of the articles and whether articles of a different nature from the articles have passed through the detection zone.
6). The apparatus of claim 5, wherein the thinning-out section causes each article to cross the detection zone singly.
7). The apparatus of claim 5, wherein the thinning-out section comprises a non-horizontal thinning-out support on which the articles freely descend, being subject to a non-null force of gravity component.
8). The apparatus of claim 5, wherein the detection zone is comprised in the thinning-out section.
9). The apparatus of claim 5, wherein the variable reactance sensors are capacitive sensors and wherein the electronic components are armatures of at least a condenser.
10). The apparatus of claims 5, wherein: the thinning-out section comprises a non-horizontal thinning-out support on which the articles freely descend, being subject to a non-null force of gravity component; the detection zone is comprised in the thinning-out section; the variable reactance sensors are capacitive sensors and the electronic components are armatures of at least a condenser; and the thinning-out support comprises a multiplicity of grooves conformed such as to have a V-shaped transversal section, a surface of a concavity of which is covered with an electrically-insulating material, and wherein the detection zones are located in a specific position along the grooves and are laterally defined by the armatures of the condensers, the armatures being non-parallel to one another and being each located on a parallel plane to one of two planes on which surfaces defining the concavity are located.
11). The apparatus of claim 10, wherein the armatures of the condensers are located at the surfaces which define the concavity of the grooves and are covered by the electrically-insulating material.
12). The apparatus of claim 10, wherein the armatures of the condensers are located at a predetermined distance from the surfaces defining the concavity of the grooves, internally of the convex zone of the thinning-out support.
13). The apparatus of claim 7, wherein any longitudinal section of at least a portion of the thinning-out section is flat and inclined by about 30.degree. with respect to an ideal horizontal plane crossing it.
14). The apparatus of claim 5, wherein it comprises a directing section, arranged downstream of the thinning-out section, such that the transiting articles fall into the directing section, which comprises deflector means for directing the articles crossing the directing section alternatively to the container, if the articles are whole articles, or to an outflow channel, if the articles are non-whole articles or articles of a different nature to the articles.
15). The apparatus of claim 10, wherein the armatures of the condenser are conformed in a regular isosceles trapeze shape with a smallest base thereof positioned in proximity of the vertex X of the respective groove.Description:
BACKGROUND OF THE INVENTION
[0001]The invention relates to the technical sector of article counting and validating machines, in particular pharmaceutical articles, such as, though not limited to, lozenges, pills, tablets, capsules, pastilles or similar products.
[0002]In particular, the present invention relates to a method for counting and validating articles and an apparatus for actuating the method.
[0003]Various type of medicines are marketed, contained in bottles, with the aim of maintaining the integrity and preserving the sterility thereof, the filling of which is realized by special automated machines. Should the medicines be in the form of discrete articles and thus not in liquid or gassy form such as syrups or aerosols, the problem of having to count them arises, in order to control the quantity introduced into the respective bottles, and make sure the articles are singly whole.
[0004]The critical aspect of this problem is obvious on considering that the adoption of automated machines has the aim of rendering the above-described filling process not only more efficient but especially faster.
[0005]Typically, machines for filling the bottles with pharmaceutical articles comprise feeders constituted by linear vibrators which transport the articles towards a filling station, comprised in the machine, in which the bottles the pharmaceutical articles are destined for are located.
[0006]These feeders can be, for example, conformed such as to exhibit a multiplicity of conveying grooves, each having a substantially V-shaped transversal section for housing the loose articles, which advance along the grooves without piling up, thanks to the linear vibration.
[0007]It is clear that a section of the machine that is at the same time downstream of the feeder and immediately upstream of or positioned at the filling section is the best location for an article counting and validation device.
[0008]A known method for counting and validating single pharmaceutical articles to be sold in bottles and a device for performing the task are described in patent document EP 1251073.
[0009]In this method the articles borne by the feeders, once having reached the filling section, are left to fall by force of gravity, for subsequent introduction into the bottles. The articles, not being piled one on another, fall one at a time; this means that each of them, thanks to the acceleration impressed on them by the force of gravity, is distanced from the next at the moment of dropping.
[0010]A TV camera is located downstream of the feeder, at a certain point in the trajectory of the fall, and in proximity of the articles.
[0011]The camera is associated to a control unit, which has the function of comparing the profile of each falling article framed by the camera, with the profile provided to the camera as an example of a whole article. If the control unit detects, on a profile of one of the falling articles, a difference with respect to the whole article defined as meaningful on the basis of given parameters, the article is defined as non-whole.
[0012]The stage of comparison is made possible by a distancing between the falling articles, as mentioned above.
[0013]Before the articles enter the bottle, and in a zone of the machine which is upstream of the bottles themselves, the articles are counted by special optical sensor organs, such as for example photovoltaic cells, a functioning of which is assumed to be known.
[0014]An effective validation of the articles in the prior art can be done only by obtaining a considerable optical contrast between the articles themselves and that which constitutes the background in the frame captured by the camera.
[0015]Given the velocity at which the bottles have to be filled, in order to obtain good machine performance, the only adjustments possible for improving the contrast are:
[0016]placing a special contrast surface, for example for achieving a chromatic contrast with the articles to be validated, in an position (in relation to the camera) opposite the fall trajectory, and
[0017]using light sources for illuminating the fall trajectory, at the same height as the camera, positioning side-lighting with respect to the contrast surface, such that the shadows of the falling articles project thereon.
[0018]With these adjustments, there is a discontinuity between the luminosity of the article to be validated and the luminosity of the contrast surface, and this is accentuated around the edge of the profile thereof, which from the point of observation of the camera appears to be at least partly surrounded by shadows.
[0019]From the above description it can be seen that the solution of the prior art can be effective in counting completely opaque pharmaceutical articles and in obtaining a correct validation but, since only an optical technology is used, it cannot in any way achieve the technical aims of counting and validating pharmaceutical articles which are entirely or partly translucent or transparent (a representative example is that of drugs contained in a gelatin capsule).
[0020]A second considerable limitation which hinders the efficacy of the above-described solution consists in the fact that it does not make available any means or process which can prevent an object of a different nature from those of the specific pharmaceutical articles from reaching a bottle. By way of example, though not exhaustive, reference is made to a case of a pharmaceutical product which is inadvertently arranged on the conveyor groove of the feeder in which other specific pharmaceutical articles are arranged, destined for specific bottles, exhibiting the same shape, for example because they are contained in a same type of capsule but having a totally different formula. The dangers correlated to an eventuality of this type are, as will be anticipated, of considerable entity; let it suffice to think of what risks a person runs when unknowingly ingesting a pharmaceutical product comprising an active ingredient which is totally different from that of the prescribed medicine.
SUMMARY OF THE INVENTION
[0021]The above-described drawbacks and others besides are obviated by a method, as described in claim 1, for counting and validating discrete articles destined to be introduced into containers and by an apparatus for actuating the method, as described in claim 6, for counting and validating the discrete articles, especially pharmaceutical articles destined to be introduced in the container, in particular bottles.
[0022]The method comprises the following stages:
[0023]a. distancing the articles from one another;
[0024]b. making each article pass through at least a detection zone such as to induce a consequent reactance variation in at least a variable reactance sensor, according to which variation, an output signal of the sensor takes on a specific waveform
[0025]c. sending the output signal from the variable reactance sensor to the input of a processing unit;
[0026]d. providing, in output from the processing unit, data relating to the number of discrete articles which have passed through the detection zone, the wholeness thereof and the passage into the detection zone of objects of a different nature from the articles themselves.
[0027]The apparatus comprises:
[0028]a thinning-out section which receives the articles from feeding means, which section distances the articles from one another and causes each article to cross at least a detection zone, which involves electronic components comprised in the variable reactance sensor, a reactance of which changes according to the specific articles which pass there-through, and
[0029]a processing unit, connected to the variable reactance sensor and receiving in input the signal in output from the variable reactance sensor and analyze a waveform thereof, which waveform is a function of the reactance variation, such that the processing unit provides, in output, data relating to the number of articles which have passed through the detecting zone, the wholeness of the articles and the crossing of the detection zone on the part of objects of a different nature to that of the articles.
[0030]As the method and apparatus of the present invention include each discrete pharmaceutical article to be introduced in the respective bottle alters the sensor's reactance, the count and validation of the articles is obtained simply and reliably by detecting and processing not only how many times the alteration occurs, but also the type and degree of the alteration (by means of special details, a preferred embodiment of which will be better explained herein below).
[0031]Consequently, the proposed technical solution enables, on the contrary to the prior art, counting and validating discrete pharmaceutical articles destined for introduction into bottles, independently of the fact that they are opaque, translucent or transparent, since the invention does not use methods or means of an optical nature for realizing the technical aims.
[0032]Further, as mentioned, in the method of the invention, the stages of which are actuated in specific aspects of the apparatus, detection is made when and if objects of a different nature to that of the articles to be counted and validated pass through the detection zone, thus preventing the risk that these might fall into the bottles to which the articles are destined. Herein below a more detailed description will be made of which details are preferably included in the present invention in order to reach the advantageous above-described technical aim.
[0033]Before the above-mentioned stages a, b, c, and d, the apparatus has to undergo a self-learning process which actuates the method of the invention; in detail, at first stages a', b' and c' are performed, which respectively correspond to performance of stages a, b and c applied to a predetermined multiplicity of sample objects, such as whole articles, variously non-whole articles and objects of a different nature from the articles themselves.
[0034]Before or after performing stages a', b' and c', the processing unit is programmed such that once all the signals relating to each sample object have been received, the processing unit subdivides the respective waveforms into classes on the basis of a predetermined similarity function, by associating the articles to the classes, to which stages a, b, c and d are successively applied, in order to qualify the articles either as whole articles or non-whole articles, or objects of a different nature to that of the articles registered.
[0035]As the above makes clear, the invention provides a method and a relative apparatus for counting and validating pharmaceutical articles destined to be introduced into bottles, destined also to be applied to machines for filling the bottles designed to fill with the very best performance possible; the counting and validation are done without interrupting the flow of articles from the feeder to the bottles, without intervening mechanically on the flow and, especially, without slowing the flow due to technological limitations such as those imposed by the maximization of the optical contrast in the solution of the prior art.
[0036]Further, the user of a machine for filling the bottles with pharmaceutical products in which the present method and apparatus have been used can provide, for each filled bottle, not only a certification of the fact that the bottle contains the correct and predetermined number of pharmaceutical articles and that they are all perfectly whole, but also, and advantageously, that no bottle has received any object of a different nature to the correct articles.
BRIEF DESCRIPTION OF THE DRAWINGS
[0037]The characteristics of the invention which do not emerge from the above will be better detailed in the following, according to what is set out in the claims and with the aid of the accompanying figures of the drawings, in which:
[0038]FIG. 1 is a schematic view in longitudinal section of a part of the apparatus of the invention;
[0039]FIG. 2 is a schematic transversal section view of FIG. 1, performed along direction II-II;
[0040]FIG. 3A schematically illustrates a portion of a detection zone of the apparatus;
[0041]FIG. 3B, with reference to FIG. 3A, illustrates the variation of the capacity of the capacitive sensor used by the apparatus, cause by the transit of an article through the detection zone;
[0042]FIG. 4 is the circuit diagram of an oscillator circuit;
[0043]FIG. 5A is the illustration of FIG. 3A in considerably more detail, while FIG. 5B is a graph illustrating, with reference to FIG. 5A, the change in frequency due to the change in capacity of the sensor shown in FIG. 3B;
[0044]FIG. 6 shows some types of articles;
[0045]FIG. 7 is a table reporting experimental data;
[0046]FIGS. 8A, 8B show graphs obtained following the use of samples in the process of self-learning carried out by the apparatus actuating the method of the invention.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0047]With reference to the figures of the drawings, 1 denotes an apparatus for counting and validating discrete articles 2, especially pharmaceutical articles 2, destined to be introduced into container 10, especially bottles 10, comprising:
[0048]a thinning-out section 3 for receiving the articles 2 from feeding means 4, which distances the articles 2 from one another, and which makes each article 2 cross at least a detection zone 5, in which electronic components 6 comprised in at least a variable reactance sensor 7 (see FIG. 2) operate, the reactance of which varies according to the specific articles 2 which pass through it;
[0049]at least a processing unit 8 (see FIG. 2) connected to the variable reactance sensor 7 for receiving in input an output signal from the variable reactance sensor 7 and analyzing the waveform thereof, which waveform is a function of the reactance variation, in such a way that the processing unit 8 provides in output data relating to the number of articles 2 which have passed in the detection zone 5, to the wholeness of the articles 2 and to the presence of objects of a different nature to the articles 2 which have passed through the detection zone 5.
[0050]Preferably, as can clearly be seen in the figures, the variable reactance sensors 7 are capacitive sensors and the electronic components 6 are the armatures of at least a condenser; further, and again preferably, the detection zone 5 is comprised in the thinning-out section 3, which is shaped and sized such that the articles 2 cross the detection zone 5 in single file.
[0051]Note that in the accompanying tables, it is not explicitly illustrated, as it is well known to an expert in the field, that the feeding means 4 can comprise, for example, a linear vibrator which has the function of transporting the articles 2 towards the thinning-out section 3, without their piling up one on top of another.
[0052]In the illustrated example, the thinning-out section 3 comprises a non-horizontal thinning-out support 31 on which the articles 2 freely descend, as they are subject to a non-null force of gravity.
[0053]In more detail, the thinning-out support 31 comprises a multiplicity 32 of grooves conformed such as to have a V-shaped transversal section (see FIG. 2), the surface of a concavity of which is covered by an electrically insulating material, of any type as long as it is suited to the aim and not illustrated inasmuch as it is obvious.
[0054]As illustrated in FIG. 1, the detection zones 5 are located in a specific position along the grooves and are laterally defined by the condenser 6 armatures.
[0055]The armatures 6 are not parallel to one another and are each located on a parallel plane to one of the two planes on which the surfaces defining the concavity are located; this can be realized in two different ways, as described in the following.
[0056]The first way, represented in FIGS. 1 and 2, consists in placing the armatures 6 of the condensers on the surfaces which define the concavity of the grooves and covering them with the electrically insulating material.
[0057]The second way not illustrated as it is deducible by its difference from the first detail, consists in placing the armatures 6 of the condensers at a predetermined distance from the surfaces which define the concavity of the grooves, internally of the convex zone of the thinning-out support 31.
[0058]In a special version of the apparatus of the present invention, any longitudinal section of at least a portion of the thinning-out section 3 is flat and inclined by roughly 34° with respect to an ideal horizontal plane crossing it.
[0059]With reference to FIG. 3A, W denotes the sensitive zone comprised in each detection zone 5.
[0060]An article 2 crossing the sensitive zone W causes a variation in the dielectric constant of the dielectric interposed between the armatures of the condenser 6, with a consequent variation ΔC in the capacity thereof; this is illustrated in the graph of FIG. 3B with reference to the various positions of the article in the sensitive zone W.
[0061]The condenser 6 is inserted in an oscillator circuit Y, for example the one shown in FIG. 4; it follows that the variation ΔC in the condenser 6 capacity leads to a consequent variation ΔF of the frequency of the signal S in outlet from the oscillator circuit Y; the signal is sent to the processing unit 8.
[0062]FIG. 5A illustrates various positions of an article 2 which crosses the sensitive zone; correspondingly to these positions there is the variation of the characteristic frequency of oscillation of the oscillator circuit Y, as shown in the graph of FIG. 5B.
[0063]The change of frequency is compared with a threshold counter value SC determining, or not, an advance in a counter, not shown, included in the processing unit 8; the threshold is extrapolated a priori on a statistical basis for each type of article 2, by analyzing the mean variations of frequency associated to the various formats of articles 2.
[0064]With reference to the formats of the articles T1 (pastilles), T2 (capsules), T3 (pastilles) illustrated in FIG. 6, the Applicant has performed various experiments using various geometries of the capacitive sensor, and more precisely rectangular armatures (sides L, H), differently position (value D) with respect to the vertex X of the V-profile of the detection zone 5; see, in this regard, the inset in the table of FIG. 7. The table of FIG. 7 reports the value of capacity C0 (empty) of the condenser, the value of capacity Cp caused by the passage of the article, the variation of capacity ΔC in absolute value and ΔC/C0% in percentage value, all according to the geometry of the armatures of the condenser and the positioning of the armatures with respect to the vertex X.
[0065]The armatures of the condenser of the experiments shown in the table of FIG. 7 are rectangular: experiments were carried out, especially concerning the self-learning of the apparatus actuating the present method, using armatures having regular isosceles trapezoid geometry, with the smallest side positioned in proximity of the vertex X of the detection zone 5.
[0066]The applicant has performed a multiplicity of experiments, with reference to whole articles, variously non-whole articles, and articles which are of a different nature to the predetermined ones. As for the "variously non-whole articles", experiments were made using, as samples, half-pastilles and quarters of pastilles; as for the "different to the predetermined" articles, empty capsules were used, i.e. such as capsules not containing the relative product.
[0067]FIG. 8A illustrates the graphs relating to the self-learning process, with samples of pastilles T1 (see FIG. 6), more precisely whole pastilles (graph α1), half-pastilles (graph α2), and quarters of pastilles (graph α3).
[0068]The values of the graphs, more precisely the Gaussian distributions of the variation of frequency caused, for example, by about a thousand samples, are stored in the processing unit 8 and used to actuate the present method. The deviations of frequency produced by whole, half and quarter pastilles are clearly distinguishable from one another; this means that the processing unit can detect the whole pastilles from the "variously non-whole articles" and the "different to the predetermined" ones. FIG. 8A also reports the counting threshold SC which enables the unit 8 to count any type of pastille which crosses the detection zone 5.
[0069]FIG. 8B includes two graphs obtained using article T2 (FIG. 6): more precisely graph β1 relates to full capsules, while graph β2 relates to empty capsules, i.e. not containing the product.
[0070]The frequency deviations caused by full capsules and empty capsules are certainly distinguishable from each other: this enables the processing unit to detect, with certainty, full capsules from empty ones.
[0071]Clearly it would be possible to use partially-full capsules as samples such as to store, in the processing unit 8, the relative data in order to distinguish them from the full ones and therefore detect them.
[0072]With the present method and the apparatus actuating it, following the self-learning process, whole articles can be distinguished from the "variously non-whole articles" or others (e.g. empty capsules) different from the predetermined articles; at the same tie it is possible to count both the totality of the articles transiting through the detection zone 5 and, advantageously, the whole articles from among the totality.
[0073]In a more specific aspect, the present invention further comprises a directing section 11, arranged downstream of the thinning-out section 3, such that the objects that have transited through the directing section 11 fall into the directing section 11 which comprises deflector means (not illustrated as they can be of any type from among known types in the technical sector the invention belongs to), which direct the articles crossing them alternatively to the container 10 (in the illustrated example a bottle), if the articles 2 are whole, or to an outflow channel 9 if the articles 2 are not whole or of a different nature to the articles 2 (see FIG. 1). Note also that even if in FIG. 1 the articles directed to and introduced in the outflow channel 9 have a graphic appearance which is similar to the whole articles 2, directed to and introduced into the bottle 10, this is exclusively for the sake of simplicity in illustration, and in no way should it be interpreted in the sense that the whole articles 2 can be destined to end up in the outflow channel 9 or more in general, that the functioning of the apparatus 1 of the present invention is in an way different to what is described herein.
[0074]The objects deflected into the outflow channel 9 are destined, for example, to be placed in reject collection elements.
[0075]The deflector means can be connected to and controlled by the processing unit 8 which, by way of non-limiting example, calculates the number of whole articles 2 by difference, i.e. subtracting from the total number of objects that have passed through the detection zone 5 the number of non-whole articles 2 and the articles having a different nature from the articles 2.
[0076]The above is intended purely by way of non-limiting example, and any variants of a practical-applicational nature are understood to fall within the ambit of protection of the invention as described herein above and as set out in the following claims
Agents: WILLIAM J. SAPONE;COLEMAN SUDOL SAPONE P.C.
Assignees: MARCHESINI GROUP S.P.A.
Origin: BRIDGE PORT, CT US
IPC8 Class: AB07C500FI
USPC Class: 209528
Claims:
1). A method for counting and validating discrete articles to be introduced into containers, comprising a stage as follows:a. distancing the articles from one another;wherein the method further comprises the following stages:b. making each article of the articles pass through at least a detection zone such as to induce a consequent reactance variation in at least a variable reactance sensor, according to which reactance variation, an output signal of the variable reactance sensor takes on a specific waveform;c. sending the output signal from the variable reactance sensor to an input of a processing unit;d. providing, in output from the processing unit, data relating to a number of the articles which have passed through the at least a detection zone, a state of wholeness of the articles as well as a passage of objects of a different nature from the articles into the at least a detection zone.2). The method of claim 1, wherein during stage a) the articles are made to follow a non-horizontal trajectory, such that they are subject to a non-null component of force of gravity.
3). The method of claim 2, wherein the articles follow the non-horizontal trajectory, freely descending along a non-horizontal support.
4). The method of claim 1, wherein it comprises initial stages a', b' and c', respectively corresponding to actuation of stages a, b and c applied to a predetermined multiplicity of sample objects, which multiplicity comprises whole articles, variously non-whole articles, and articles which are of a different nature to the articles, and wherein the method comprises a further stage of:programming the processing unit such that once all signals relating to each sample article have been received, the processing unit subdivides respective waveforms into classes, on a basis of a predetermined function of similarity, specially associating the articles to the classes, to which articles stages a, b, c and d are successively applied in order to qualify them either as whole articles or as non-whole articles or else as articles of a different nature to a nature of the articles.
5). An apparatus for counting and validating discrete articles, especially pharmaceutical articles, destined to be introduced into containers, especially bottles, comprising a thinning-out section which receives the articles from supply means and distances the articles from one another, the apparatus wherein the thinning-out section is such that each article crosses at least a detection zone, which comprises electronic components included in at least a variable reactance sensor, a reactance of which varies according to specific articles passing through the detection zone; wherein the apparatus further comprises: at least a processing unit, connected to the variable reactance sensor in order to receive in input an output signal from the variable reactance sensor and analyze the waveform of the output signal, which waveform is a function of the reactance variation, such that in output the processing unit provides data relating to a number of the articles which have passed through the detection zone, a state of wholeness of the articles and whether articles of a different nature from the articles have passed through the detection zone.
6). The apparatus of claim 5, wherein the thinning-out section causes each article to cross the detection zone singly.
7). The apparatus of claim 5, wherein the thinning-out section comprises a non-horizontal thinning-out support on which the articles freely descend, being subject to a non-null force of gravity component.
8). The apparatus of claim 5, wherein the detection zone is comprised in the thinning-out section.
9). The apparatus of claim 5, wherein the variable reactance sensors are capacitive sensors and wherein the electronic components are armatures of at least a condenser.
10). The apparatus of claims 5, wherein: the thinning-out section comprises a non-horizontal thinning-out support on which the articles freely descend, being subject to a non-null force of gravity component; the detection zone is comprised in the thinning-out section; the variable reactance sensors are capacitive sensors and the electronic components are armatures of at least a condenser; and the thinning-out support comprises a multiplicity of grooves conformed such as to have a V-shaped transversal section, a surface of a concavity of which is covered with an electrically-insulating material, and wherein the detection zones are located in a specific position along the grooves and are laterally defined by the armatures of the condensers, the armatures being non-parallel to one another and being each located on a parallel plane to one of two planes on which surfaces defining the concavity are located.
11). The apparatus of claim 10, wherein the armatures of the condensers are located at the surfaces which define the concavity of the grooves and are covered by the electrically-insulating material.
12). The apparatus of claim 10, wherein the armatures of the condensers are located at a predetermined distance from the surfaces defining the concavity of the grooves, internally of the convex zone of the thinning-out support.
13). The apparatus of claim 7, wherein any longitudinal section of at least a portion of the thinning-out section is flat and inclined by about 30.degree. with respect to an ideal horizontal plane crossing it.
14). The apparatus of claim 5, wherein it comprises a directing section, arranged downstream of the thinning-out section, such that the transiting articles fall into the directing section, which comprises deflector means for directing the articles crossing the directing section alternatively to the container, if the articles are whole articles, or to an outflow channel, if the articles are non-whole articles or articles of a different nature to the articles.
15). The apparatus of claim 10, wherein the armatures of the condenser are conformed in a regular isosceles trapeze shape with a smallest base thereof positioned in proximity of the vertex X of the respective groove.
Description:
BACKGROUND OF THE INVENTION[0001]The invention relates to the technical sector of article counting and validating machines, in particular pharmaceutical articles, such as, though not limited to, lozenges, pills, tablets, capsules, pastilles or similar products.
[0002]In particular, the present invention relates to a method for counting and validating articles and an apparatus for actuating the method.
[0003]Various type of medicines are marketed, contained in bottles, with the aim of maintaining the integrity and preserving the sterility thereof, the filling of which is realized by special automated machines. Should the medicines be in the form of discrete articles and thus not in liquid or gassy form such as syrups or aerosols, the problem of having to count them arises, in order to control the quantity introduced into the respective bottles, and make sure the articles are singly whole.
[0004]The critical aspect of this problem is obvious on considering that the adoption of automated machines has the aim of rendering the above-described filling process not only more efficient but especially faster.
[0005]Typically, machines for filling the bottles with pharmaceutical articles comprise feeders constituted by linear vibrators which transport the articles towards a filling station, comprised in the machine, in which the bottles the pharmaceutical articles are destined for are located.
[0006]These feeders can be, for example, conformed such as to exhibit a multiplicity of conveying grooves, each having a substantially V-shaped transversal section for housing the loose articles, which advance along the grooves without piling up, thanks to the linear vibration.
[0007]It is clear that a section of the machine that is at the same time downstream of the feeder and immediately upstream of or positioned at the filling section is the best location for an article counting and validation device.
[0008]A known method for counting and validating single pharmaceutical articles to be sold in bottles and a device for performing the task are described in patent document EP 1251073.
[0009]In this method the articles borne by the feeders, once having reached the filling section, are left to fall by force of gravity, for subsequent introduction into the bottles. The articles, not being piled one on another, fall one at a time; this means that each of them, thanks to the acceleration impressed on them by the force of gravity, is distanced from the next at the moment of dropping.
[0010]A TV camera is located downstream of the feeder, at a certain point in the trajectory of the fall, and in proximity of the articles.
[0011]The camera is associated to a control unit, which has the function of comparing the profile of each falling article framed by the camera, with the profile provided to the camera as an example of a whole article. If the control unit detects, on a profile of one of the falling articles, a difference with respect to the whole article defined as meaningful on the basis of given parameters, the article is defined as non-whole.
[0012]The stage of comparison is made possible by a distancing between the falling articles, as mentioned above.
[0013]Before the articles enter the bottle, and in a zone of the machine which is upstream of the bottles themselves, the articles are counted by special optical sensor organs, such as for example photovoltaic cells, a functioning of which is assumed to be known.
[0014]An effective validation of the articles in the prior art can be done only by obtaining a considerable optical contrast between the articles themselves and that which constitutes the background in the frame captured by the camera.
[0015]Given the velocity at which the bottles have to be filled, in order to obtain good machine performance, the only adjustments possible for improving the contrast are:
[0016]placing a special contrast surface, for example for achieving a chromatic contrast with the articles to be validated, in an position (in relation to the camera) opposite the fall trajectory, and
[0017]using light sources for illuminating the fall trajectory, at the same height as the camera, positioning side-lighting with respect to the contrast surface, such that the shadows of the falling articles project thereon.
[0018]With these adjustments, there is a discontinuity between the luminosity of the article to be validated and the luminosity of the contrast surface, and this is accentuated around the edge of the profile thereof, which from the point of observation of the camera appears to be at least partly surrounded by shadows.
[0019]From the above description it can be seen that the solution of the prior art can be effective in counting completely opaque pharmaceutical articles and in obtaining a correct validation but, since only an optical technology is used, it cannot in any way achieve the technical aims of counting and validating pharmaceutical articles which are entirely or partly translucent or transparent (a representative example is that of drugs contained in a gelatin capsule).
[0020]A second considerable limitation which hinders the efficacy of the above-described solution consists in the fact that it does not make available any means or process which can prevent an object of a different nature from those of the specific pharmaceutical articles from reaching a bottle. By way of example, though not exhaustive, reference is made to a case of a pharmaceutical product which is inadvertently arranged on the conveyor groove of the feeder in which other specific pharmaceutical articles are arranged, destined for specific bottles, exhibiting the same shape, for example because they are contained in a same type of capsule but having a totally different formula. The dangers correlated to an eventuality of this type are, as will be anticipated, of considerable entity; let it suffice to think of what risks a person runs when unknowingly ingesting a pharmaceutical product comprising an active ingredient which is totally different from that of the prescribed medicine.
SUMMARY OF THE INVENTION
[0021]The above-described drawbacks and others besides are obviated by a method, as described in claim 1, for counting and validating discrete articles destined to be introduced into containers and by an apparatus for actuating the method, as described in claim 6, for counting and validating the discrete articles, especially pharmaceutical articles destined to be introduced in the container, in particular bottles.
[0022]The method comprises the following stages:
[0023]a. distancing the articles from one another;
[0024]b. making each article pass through at least a detection zone such as to induce a consequent reactance variation in at least a variable reactance sensor, according to which variation, an output signal of the sensor takes on a specific waveform
[0025]c. sending the output signal from the variable reactance sensor to the input of a processing unit;
[0026]d. providing, in output from the processing unit, data relating to the number of discrete articles which have passed through the detection zone, the wholeness thereof and the passage into the detection zone of objects of a different nature from the articles themselves.
[0027]The apparatus comprises:
[0028]a thinning-out section which receives the articles from feeding means, which section distances the articles from one another and causes each article to cross at least a detection zone, which involves electronic components comprised in the variable reactance sensor, a reactance of which changes according to the specific articles which pass there-through, and
[0029]a processing unit, connected to the variable reactance sensor and receiving in input the signal in output from the variable reactance sensor and analyze a waveform thereof, which waveform is a function of the reactance variation, such that the processing unit provides, in output, data relating to the number of articles which have passed through the detecting zone, the wholeness of the articles and the crossing of the detection zone on the part of objects of a different nature to that of the articles.
[0030]As the method and apparatus of the present invention include each discrete pharmaceutical article to be introduced in the respective bottle alters the sensor's reactance, the count and validation of the articles is obtained simply and reliably by detecting and processing not only how many times the alteration occurs, but also the type and degree of the alteration (by means of special details, a preferred embodiment of which will be better explained herein below).
[0031]Consequently, the proposed technical solution enables, on the contrary to the prior art, counting and validating discrete pharmaceutical articles destined for introduction into bottles, independently of the fact that they are opaque, translucent or transparent, since the invention does not use methods or means of an optical nature for realizing the technical aims.
[0032]Further, as mentioned, in the method of the invention, the stages of which are actuated in specific aspects of the apparatus, detection is made when and if objects of a different nature to that of the articles to be counted and validated pass through the detection zone, thus preventing the risk that these might fall into the bottles to which the articles are destined. Herein below a more detailed description will be made of which details are preferably included in the present invention in order to reach the advantageous above-described technical aim.
[0033]Before the above-mentioned stages a, b, c, and d, the apparatus has to undergo a self-learning process which actuates the method of the invention; in detail, at first stages a', b' and c' are performed, which respectively correspond to performance of stages a, b and c applied to a predetermined multiplicity of sample objects, such as whole articles, variously non-whole articles and objects of a different nature from the articles themselves.
[0034]Before or after performing stages a', b' and c', the processing unit is programmed such that once all the signals relating to each sample object have been received, the processing unit subdivides the respective waveforms into classes on the basis of a predetermined similarity function, by associating the articles to the classes, to which stages a, b, c and d are successively applied, in order to qualify the articles either as whole articles or non-whole articles, or objects of a different nature to that of the articles registered.
[0035]As the above makes clear, the invention provides a method and a relative apparatus for counting and validating pharmaceutical articles destined to be introduced into bottles, destined also to be applied to machines for filling the bottles designed to fill with the very best performance possible; the counting and validation are done without interrupting the flow of articles from the feeder to the bottles, without intervening mechanically on the flow and, especially, without slowing the flow due to technological limitations such as those imposed by the maximization of the optical contrast in the solution of the prior art.
[0036]Further, the user of a machine for filling the bottles with pharmaceutical products in which the present method and apparatus have been used can provide, for each filled bottle, not only a certification of the fact that the bottle contains the correct and predetermined number of pharmaceutical articles and that they are all perfectly whole, but also, and advantageously, that no bottle has received any object of a different nature to the correct articles.
BRIEF DESCRIPTION OF THE DRAWINGS
[0037]The characteristics of the invention which do not emerge from the above will be better detailed in the following, according to what is set out in the claims and with the aid of the accompanying figures of the drawings, in which:
[0038]FIG. 1 is a schematic view in longitudinal section of a part of the apparatus of the invention;
[0039]FIG. 2 is a schematic transversal section view of FIG. 1, performed along direction II-II;
[0040]FIG. 3A schematically illustrates a portion of a detection zone of the apparatus;
[0041]FIG. 3B, with reference to FIG. 3A, illustrates the variation of the capacity of the capacitive sensor used by the apparatus, cause by the transit of an article through the detection zone;
[0042]FIG. 4 is the circuit diagram of an oscillator circuit;
[0043]FIG. 5A is the illustration of FIG. 3A in considerably more detail, while FIG. 5B is a graph illustrating, with reference to FIG. 5A, the change in frequency due to the change in capacity of the sensor shown in FIG. 3B;
[0044]FIG. 6 shows some types of articles;
[0045]FIG. 7 is a table reporting experimental data;
[0046]FIGS. 8A, 8B show graphs obtained following the use of samples in the process of self-learning carried out by the apparatus actuating the method of the invention.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0047]With reference to the figures of the drawings, 1 denotes an apparatus for counting and validating discrete articles 2, especially pharmaceutical articles 2, destined to be introduced into container 10, especially bottles 10, comprising:
[0048]a thinning-out section 3 for receiving the articles 2 from feeding means 4, which distances the articles 2 from one another, and which makes each article 2 cross at least a detection zone 5, in which electronic components 6 comprised in at least a variable reactance sensor 7 (see FIG. 2) operate, the reactance of which varies according to the specific articles 2 which pass through it;
[0049]at least a processing unit 8 (see FIG. 2) connected to the variable reactance sensor 7 for receiving in input an output signal from the variable reactance sensor 7 and analyzing the waveform thereof, which waveform is a function of the reactance variation, in such a way that the processing unit 8 provides in output data relating to the number of articles 2 which have passed in the detection zone 5, to the wholeness of the articles 2 and to the presence of objects of a different nature to the articles 2 which have passed through the detection zone 5.
[0050]Preferably, as can clearly be seen in the figures, the variable reactance sensors 7 are capacitive sensors and the electronic components 6 are the armatures of at least a condenser; further, and again preferably, the detection zone 5 is comprised in the thinning-out section 3, which is shaped and sized such that the articles 2 cross the detection zone 5 in single file.
[0051]Note that in the accompanying tables, it is not explicitly illustrated, as it is well known to an expert in the field, that the feeding means 4 can comprise, for example, a linear vibrator which has the function of transporting the articles 2 towards the thinning-out section 3, without their piling up one on top of another.
[0052]In the illustrated example, the thinning-out section 3 comprises a non-horizontal thinning-out support 31 on which the articles 2 freely descend, as they are subject to a non-null force of gravity.
[0053]In more detail, the thinning-out support 31 comprises a multiplicity 32 of grooves conformed such as to have a V-shaped transversal section (see FIG. 2), the surface of a concavity of which is covered by an electrically insulating material, of any type as long as it is suited to the aim and not illustrated inasmuch as it is obvious.
[0054]As illustrated in FIG. 1, the detection zones 5 are located in a specific position along the grooves and are laterally defined by the condenser 6 armatures.
[0055]The armatures 6 are not parallel to one another and are each located on a parallel plane to one of the two planes on which the surfaces defining the concavity are located; this can be realized in two different ways, as described in the following.
[0056]The first way, represented in FIGS. 1 and 2, consists in placing the armatures 6 of the condensers on the surfaces which define the concavity of the grooves and covering them with the electrically insulating material.
[0057]The second way not illustrated as it is deducible by its difference from the first detail, consists in placing the armatures 6 of the condensers at a predetermined distance from the surfaces which define the concavity of the grooves, internally of the convex zone of the thinning-out support 31.
[0058]In a special version of the apparatus of the present invention, any longitudinal section of at least a portion of the thinning-out section 3 is flat and inclined by roughly 34° with respect to an ideal horizontal plane crossing it.
[0059]With reference to FIG. 3A, W denotes the sensitive zone comprised in each detection zone 5.
[0060]An article 2 crossing the sensitive zone W causes a variation in the dielectric constant of the dielectric interposed between the armatures of the condenser 6, with a consequent variation ΔC in the capacity thereof; this is illustrated in the graph of FIG. 3B with reference to the various positions of the article in the sensitive zone W.
[0061]The condenser 6 is inserted in an oscillator circuit Y, for example the one shown in FIG. 4; it follows that the variation ΔC in the condenser 6 capacity leads to a consequent variation ΔF of the frequency of the signal S in outlet from the oscillator circuit Y; the signal is sent to the processing unit 8.
[0062]FIG. 5A illustrates various positions of an article 2 which crosses the sensitive zone; correspondingly to these positions there is the variation of the characteristic frequency of oscillation of the oscillator circuit Y, as shown in the graph of FIG. 5B.
[0063]The change of frequency is compared with a threshold counter value SC determining, or not, an advance in a counter, not shown, included in the processing unit 8; the threshold is extrapolated a priori on a statistical basis for each type of article 2, by analyzing the mean variations of frequency associated to the various formats of articles 2.
[0064]With reference to the formats of the articles T1 (pastilles), T2 (capsules), T3 (pastilles) illustrated in FIG. 6, the Applicant has performed various experiments using various geometries of the capacitive sensor, and more precisely rectangular armatures (sides L, H), differently position (value D) with respect to the vertex X of the V-profile of the detection zone 5; see, in this regard, the inset in the table of FIG. 7. The table of FIG. 7 reports the value of capacity C0 (empty) of the condenser, the value of capacity Cp caused by the passage of the article, the variation of capacity ΔC in absolute value and ΔC/C0% in percentage value, all according to the geometry of the armatures of the condenser and the positioning of the armatures with respect to the vertex X.
[0065]The armatures of the condenser of the experiments shown in the table of FIG. 7 are rectangular: experiments were carried out, especially concerning the self-learning of the apparatus actuating the present method, using armatures having regular isosceles trapezoid geometry, with the smallest side positioned in proximity of the vertex X of the detection zone 5.
[0066]The applicant has performed a multiplicity of experiments, with reference to whole articles, variously non-whole articles, and articles which are of a different nature to the predetermined ones. As for the "variously non-whole articles", experiments were made using, as samples, half-pastilles and quarters of pastilles; as for the "different to the predetermined" articles, empty capsules were used, i.e. such as capsules not containing the relative product.
[0067]FIG. 8A illustrates the graphs relating to the self-learning process, with samples of pastilles T1 (see FIG. 6), more precisely whole pastilles (graph α1), half-pastilles (graph α2), and quarters of pastilles (graph α3).
[0068]The values of the graphs, more precisely the Gaussian distributions of the variation of frequency caused, for example, by about a thousand samples, are stored in the processing unit 8 and used to actuate the present method. The deviations of frequency produced by whole, half and quarter pastilles are clearly distinguishable from one another; this means that the processing unit can detect the whole pastilles from the "variously non-whole articles" and the "different to the predetermined" ones. FIG. 8A also reports the counting threshold SC which enables the unit 8 to count any type of pastille which crosses the detection zone 5.
[0069]FIG. 8B includes two graphs obtained using article T2 (FIG. 6): more precisely graph β1 relates to full capsules, while graph β2 relates to empty capsules, i.e. not containing the product.
[0070]The frequency deviations caused by full capsules and empty capsules are certainly distinguishable from each other: this enables the processing unit to detect, with certainty, full capsules from empty ones.
[0071]Clearly it would be possible to use partially-full capsules as samples such as to store, in the processing unit 8, the relative data in order to distinguish them from the full ones and therefore detect them.
[0072]With the present method and the apparatus actuating it, following the self-learning process, whole articles can be distinguished from the "variously non-whole articles" or others (e.g. empty capsules) different from the predetermined articles; at the same tie it is possible to count both the totality of the articles transiting through the detection zone 5 and, advantageously, the whole articles from among the totality.
[0073]In a more specific aspect, the present invention further comprises a directing section 11, arranged downstream of the thinning-out section 3, such that the objects that have transited through the directing section 11 fall into the directing section 11 which comprises deflector means (not illustrated as they can be of any type from among known types in the technical sector the invention belongs to), which direct the articles crossing them alternatively to the container 10 (in the illustrated example a bottle), if the articles 2 are whole, or to an outflow channel 9 if the articles 2 are not whole or of a different nature to the articles 2 (see FIG. 1). Note also that even if in FIG. 1 the articles directed to and introduced in the outflow channel 9 have a graphic appearance which is similar to the whole articles 2, directed to and introduced into the bottle 10, this is exclusively for the sake of simplicity in illustration, and in no way should it be interpreted in the sense that the whole articles 2 can be destined to end up in the outflow channel 9 or more in general, that the functioning of the apparatus 1 of the present invention is in an way different to what is described herein.
[0074]The objects deflected into the outflow channel 9 are destined, for example, to be placed in reject collection elements.
[0075]The deflector means can be connected to and controlled by the processing unit 8 which, by way of non-limiting example, calculates the number of whole articles 2 by difference, i.e. subtracting from the total number of objects that have passed through the detection zone 5 the number of non-whole articles 2 and the articles having a different nature from the articles 2.
[0076]The above is intended purely by way of non-limiting example, and any variants of a practical-applicational nature are understood to fall within the ambit of protection of the invention as described herein above and as set out in the following claims
Validating Pharmaceutical Systems
Validating pharmaceutical systems; good computer practice in life science manufacturing.
Ed. by John Andrews.
Taylor & Francis
2006
549 pages
$249.95
Hardcover
RS122
Andrews, an experienced engineer in pharmaceuticals, compiles 20 essays and a glossary by an international group of contributors in the pharmaceutical industry. They discuss automated systems validation and regulations for drug development, production, and distribution; and they analyze the inspection, risk assessment and management, planning, reporting, auditing, specifications, documentation, testing, and calibration of validations systems. In addition, the authors explain GCP, GLP See gateway location protocol. , and GMP GMP (guanosine monophosphate): see guanine.
..... Click the link for more information. regulatory requirements, manufacturing education systems (MES (Manufacturing Execution Software) Software that provides real time access to plant activities that include equipment, labor, orders and inventory. An MES integrates the data with enterprise resource planning (ERP) systems so that management has complete control of ), and include case studies of SCADA (System Control and Data Acquisition) systems, the LIMS system (Laboratory Information Management System), GAMP 4 (Good Automated Manufacturing Practice Good Automated Manufacturing Practice (GAMP) is a technical sub-committee of the International Society of Pharmaceutical Engineering (ISPE). The goal of the committee is to promote the understanding of the regulation and use of automated systems within the pharmaceutical ), and validation in Central and Eastern Europe The term "Central and Eastern Europe" came into wide spread use, replacing "Eastern bloc", to describe former Communist countries in Europe, after the collapse of the Iron Curtain in 1989/90.
..... Click the link for more information..
Ed. by John Andrews.
Taylor & Francis
2006
549 pages
$249.95
Hardcover
RS122
Andrews, an experienced engineer in pharmaceuticals, compiles 20 essays and a glossary by an international group of contributors in the pharmaceutical industry. They discuss automated systems validation and regulations for drug development, production, and distribution; and they analyze the inspection, risk assessment and management, planning, reporting, auditing, specifications, documentation, testing, and calibration of validations systems. In addition, the authors explain GCP, GLP See gateway location protocol. , and GMP GMP (guanosine monophosphate): see guanine.
..... Click the link for more information. regulatory requirements, manufacturing education systems (MES (Manufacturing Execution Software) Software that provides real time access to plant activities that include equipment, labor, orders and inventory. An MES integrates the data with enterprise resource planning (ERP) systems so that management has complete control of ), and include case studies of SCADA (System Control and Data Acquisition) systems, the LIMS system (Laboratory Information Management System), GAMP 4 (Good Automated Manufacturing Practice Good Automated Manufacturing Practice (GAMP) is a technical sub-committee of the International Society of Pharmaceutical Engineering (ISPE). The goal of the committee is to promote the understanding of the regulation and use of automated systems within the pharmaceutical ), and validation in Central and Eastern Europe The term "Central and Eastern Europe" came into wide spread use, replacing "Eastern bloc", to describe former Communist countries in Europe, after the collapse of the Iron Curtain in 1989/90.
..... Click the link for more information..
Drug Target Validation
DUBLIN, Ireland -- Research and Markets (http://www.researchandmarkets.com/reports/c31977) has announced the addition of Strategies for Drug Target Identification and Validation See validate.
validation - The stage in the software life-cycle at the end of the development process where software is evaluated to ensure that it complies with the requirements. to their offering.
Target-based drug discovery has become the prevailing paradigm used by pharmaceutical and biotechnology companies Top 100 Biotechnology Companies
The following is a list of the top 100 biotechnology companies ranked by revenue. The first nine companies qualify for the list of the top 50 pharmaceutical companies.
..... Click the link for more information.. This approach is appealing because it holds the promise of identifying more-efficacious compounds with fewer undesirable side effects Side effects
Effects of a proposed project on other parts of the firm.
..... Click the link for more information.. Companies have therefore invested significant resources in acquiring and developing technologies for identifying and validating new drug targets. This report explores both state-of-the-art and emerging target identification and validation technologies and methods. We consider the limitations of these technologies and their impact on drug discovery, examine relevant business models, and profile selected companies with novel target identification and validation technologies.
Business Implications
--Target-based drug discovery has become the prevailing paradigm used by pharmaceutical and biotechnology companies. This approach is appealing because it holds the promise of identifying more-efficacious compounds with fewer undesirable side effects. Companies have therefore invested significant resources in acquiring and developing technologies for identifying and validating new drug targets.
--A wide array of target identification technologies is available, including genomics, gene expression profiling Microarray technology is often used for gene expression profiling. It makes use of the sequence resources created by the genome sequencing projects and other sequencing efforts to answer the question, , and proteomics pro·te·o·mics
n.
The analysis of the expression, localization, functions, and interactions of the proteins produced by the genes of an organism.
..... Click the link for more information.. Biomarkers and metabolomic profiling are emerging tools for monitoring the biological effects of manipulating a potential drug target. Technologies such as gene knockouts This article or section is in need of attention from an expert on the subject.
Please help recruit one or [ improve this article] yourself. See the talk page for details. , RNA interference RNA interference
n.
A process in which the introduction of double-stranded RNA into a cell inhibits the expression of genes.
..... Click the link for more information. (RNAi), and protein inhibition provide researchers with a multipronged mul·ti·pronged
adj.
1. Having many prongs.
2. Involving several different directions, aspects, or elements: a multipronged attack; a multipronged tax bill. approach to validating new targets. The most successful approaches combine several technologies to provide a detailed understanding of the biological effects of altering the activity of a single target.
--Target identification and validation technologies form a critical foundation for modern drug discovery. These approaches provide a rich source of intellectual property and can be valuable competitive differentiators for companies seeking proprietary positions for drugs that act through novel mechanisms. Emerging technologies such as RNAi and metabolic met·a·bol·ic
adj.
Of, relating to, or resulting from metabolism.
Metabolic
Refers to the chemical processes of an organ or organism. profiling hold a great deal of promise for improving the efficiency and efficacy of drug target validation.
Topics Covered
--Introduction
--Drug Target Identification
--Target Validation Technologies
--Impact of New Targets on Drug Discovery
--Corporate Highlights
--Outlook
Companies mentioned in this report include:
--ActivX
--Alnylam Pharmaceuticals
--Ambion
--Amphora Discovery
--Archemix
--Atugen Biotechnology
--Cenix BioScience
--Cubist Pharmaceuticals
--CuraGen
--Deltagen
--DeveloGen
--DevGen
--Dharmacon
--EpiGenesis Pharmaceuticals
--Exelixis
--GeneData
--genOway
--Icoria
--Ingenium Pharmaceuticals
--Isis Pharmaceuticals
--Lexicon Genetics
--Metabolon
--Phenomenome Discoveries
--Quark Biotech bi·o·tech
n. Informal
Biotechnology.
biotech
Noun
short for biotechnology
Noun 1.
--Rigel
--Xenogen
--Xenon Genetics
--Zygogen
For more information visit http://www.researchandmarkets.com/reports/c31977
Source: Decision Resources
validation - The stage in the software life-cycle at the end of the development process where software is evaluated to ensure that it complies with the requirements. to their offering.
Target-based drug discovery has become the prevailing paradigm used by pharmaceutical and biotechnology companies Top 100 Biotechnology Companies
The following is a list of the top 100 biotechnology companies ranked by revenue. The first nine companies qualify for the list of the top 50 pharmaceutical companies.
..... Click the link for more information.. This approach is appealing because it holds the promise of identifying more-efficacious compounds with fewer undesirable side effects Side effects
Effects of a proposed project on other parts of the firm.
..... Click the link for more information.. Companies have therefore invested significant resources in acquiring and developing technologies for identifying and validating new drug targets. This report explores both state-of-the-art and emerging target identification and validation technologies and methods. We consider the limitations of these technologies and their impact on drug discovery, examine relevant business models, and profile selected companies with novel target identification and validation technologies.
Business Implications
--Target-based drug discovery has become the prevailing paradigm used by pharmaceutical and biotechnology companies. This approach is appealing because it holds the promise of identifying more-efficacious compounds with fewer undesirable side effects. Companies have therefore invested significant resources in acquiring and developing technologies for identifying and validating new drug targets.
--A wide array of target identification technologies is available, including genomics, gene expression profiling Microarray technology is often used for gene expression profiling. It makes use of the sequence resources created by the genome sequencing projects and other sequencing efforts to answer the question, , and proteomics pro·te·o·mics
n.
The analysis of the expression, localization, functions, and interactions of the proteins produced by the genes of an organism.
..... Click the link for more information.. Biomarkers and metabolomic profiling are emerging tools for monitoring the biological effects of manipulating a potential drug target. Technologies such as gene knockouts This article or section is in need of attention from an expert on the subject.
Please help recruit one or [ improve this article] yourself. See the talk page for details. , RNA interference RNA interference
n.
A process in which the introduction of double-stranded RNA into a cell inhibits the expression of genes.
..... Click the link for more information. (RNAi), and protein inhibition provide researchers with a multipronged mul·ti·pronged
adj.
1. Having many prongs.
2. Involving several different directions, aspects, or elements: a multipronged attack; a multipronged tax bill. approach to validating new targets. The most successful approaches combine several technologies to provide a detailed understanding of the biological effects of altering the activity of a single target.
--Target identification and validation technologies form a critical foundation for modern drug discovery. These approaches provide a rich source of intellectual property and can be valuable competitive differentiators for companies seeking proprietary positions for drugs that act through novel mechanisms. Emerging technologies such as RNAi and metabolic met·a·bol·ic
adj.
Of, relating to, or resulting from metabolism.
Metabolic
Refers to the chemical processes of an organ or organism. profiling hold a great deal of promise for improving the efficiency and efficacy of drug target validation.
Topics Covered
--Introduction
--Drug Target Identification
--Target Validation Technologies
--Impact of New Targets on Drug Discovery
--Corporate Highlights
--Outlook
Companies mentioned in this report include:
--ActivX
--Alnylam Pharmaceuticals
--Ambion
--Amphora Discovery
--Archemix
--Atugen Biotechnology
--Cenix BioScience
--Cubist Pharmaceuticals
--CuraGen
--Deltagen
--DeveloGen
--DevGen
--Dharmacon
--EpiGenesis Pharmaceuticals
--Exelixis
--GeneData
--genOway
--Icoria
--Ingenium Pharmaceuticals
--Isis Pharmaceuticals
--Lexicon Genetics
--Metabolon
--Phenomenome Discoveries
--Quark Biotech bi·o·tech
n. Informal
Biotechnology.
biotech
Noun
short for biotechnology
Noun 1.
--Rigel
--Xenogen
--Xenon Genetics
--Zygogen
For more information visit http://www.researchandmarkets.com/reports/c31977
Source: Decision Resources
Subscribe to:
Posts (Atom)
-
K. Dashora, D. Singh, Swarnlata Saraf and S. Saraf *. Institute of Pharmacy, Pt.RavishankarShuklaUniversity, Raipur 492 010. *Author for ...
-
Cold storage is a relatively simple cold room that is commonly used to store material between 2[degrees] to 8[degrees]C. Such cold rooms a...
-
Validation of the Autoclave is classified into the following 1.0 OQ – Operational Qualification 2.0 PQ – Performance Qualification The valid...
