The Active Pharmaceutical Ingredient Industry involves (in general) the manufacture of
Active Pharmaceutical Ingredients by both chemical and physical means through a
series of multiple step processes. Plants or individual pieces of equipment, including
ancillary equipment, may be used in multi-product manufacture or dedicated to
individual products.
The result of inadequate cleaning procedures is that any of a number of contaminants
may be present in the next batch manufactured on the equipment such as:
1. Precursors to the Active Pharmaceutical Ingredient
2. By-products and/or degradation products of the Active Pharmaceutical
Ingredient
3. The previous product
4. Solvents and other materials employed during the manufacturing process.
5. Micro-organisms
This is particularly the case where microbial growth may be sustained by the
product.
6. Cleaning agents themselves and lubricants
Thursday, March 26, 2009
Keep Your Products off the 2009 Recall List
In late December, Stryker announced that its Custom Cranial Implant Kits from its craniomaxillofacial (CMF) business unit were subject to a Class I recall. The company had originally initiated a voluntary recall in October after determining that the sterilization of the product was not performed according to appropriate standards, Stryker CMF reported on its Web site. The kits “could pose an imminent hazard to health,” the firm reported. “Because the company could not assure the sterility of the product, implantation could result in serious health problems including infection (e.g., meningitis), intracranial abscess, wound infection, sepsis. . . . Death can occur if an infection is not diagnosed quickly.”
These frightening scenarios brought to mind some conversations I had last year. A few industry experts worried aloud that some medical device manufacturers (MDMs) may not be doing all they should to validate their packaging and processes, let alone their package testing methods.
Granted, Stryker’s situation involved sterilization, not packaging . But given the crucial role of a primary package—i.e., the sterile barrier system—couldn’t inadequate packaging s pose similar health risks?
I asked PMP News editorial advisory board member Tim Early, who spent 24 years working for MDMs and now provides packaging consultation and testing services, to describe package activity in the industry. Early is the director of business development for Packaging MD (www.packagingmd.com), a division of Atlas Box & Crating (Sutton, MA). Early did not want to reveal any company names, but he did say that in many small- to medium-sized MDMs, packaging is not a core competency. “An R&D or manufacturing engineer is balancing packaging duties with other responsibilities. Companies that treat packaging as a core competency and have integrated packaging design, development, and into their product development process are in the minority,” Early says.
Corners may be cut when it comes to ISO 11607 compliance. Calling the standard comprehensive, Early says it details “all the requirements necessary to provide a validated sterile barrier system. No longer can a company simply seal, sterilize, and ship with no testing because they have been doing so for years with no history of complaints,” he says.
The risk these companies take is significant. Questionably sterile packages risk product safety and efficacy and patient health. “Also, when FDA issues a regulatory warning letter, it takes a few years before the MDM obtains clearance that the quality system’s deficiencies have been addressed and they can then move PMA submissions forward. Often, the time frame required to adequately address these issues results in product launch delays that cripple even the largest firms,” says Early.
In an era when Medicare is eliminating coverage of most hospital-acquired infections, perhaps the importance of the sterile barrier system—and validating that system—will take center stage in your company. If you can force packaging into the spotlight, you could keep your company from issuing packaging-related recalls, saving lives and money.
Sealers Offer More Control Than Ever
Touch screen controls and validatable systems make the packager's job easier.
A continuous dual-heat band sealer handles difficult-to-seal materials. The Model VBS-DH-3/8-10-V is designed for sealing medical devices in pouches. Its temperature, speed, sealing, and cooling-bar pressure can be validated. The unit can seal Tyvek/Mylar, nylon, polyethylene, polypropylene, laminates, Kraft/polyethylene, and foil. Seals are achieved with special heavy-duty, wear-resistant laminated Teflon bands. All Packaging Machinery Corp., Ronkonkoma, NY.
A fixed-speed, continuous hot-air sealer meets the requirements of FDA process guidelines. The medical sealer does not use Teflon-coated bands, which means less replacement cost and a decrease in downtime. The absence of bands also means fewer particulates in the cleanroom. The sealing temperature is fully PID controlled, and the seal pressure is air regulated, allowing for complete system calibration of the dynamic parameters that affect the seal integrity. O/K International Corp., Marlborough, MA.
Heat sealers are designed primarily for the medical and pharmaceutical industries. The Models PW5200 and PW3600 precision sealers produce consistent seals and can be validated. The heat-seal band is also the temperature sensor, which ensures accuracy and repeatability. Time, temperature, and pressure are monitored with the RES-470 controller. Failure to meet the preset parameters will activate an alarm and shut the machine down. Packworld USA, Nazareth, PA.
Sealers for midrange volumes are available in models ranging from rotary tables to shuttle tables. The Series KST shuttle table features a dual servomotor press and shuttle action, which is suitable for a cleanroom environment. The KST allows for RF or thermocontact sealing and cutting, or a combination of both, allowing the sealing of a wide range of materials. Three sizes are available. A complete line of automatic standard and custom in-line machines is available for the packaging industry. Kiefel Technologies, Hampton, NH.
A tabletop heat sealer is designed specifically for medical device and pharmaceutical packaging. The Z-Med features a single-sided, aluminum roller shuttle tray with tool-locating pins to utilize quick-change-style seal tools. The standard machine includes controls and components to ensure that protocols can be established and seals can be consistent. The 15-TM dual-shuttle heat sealer features a color touch screen that stores data from the previous 25 cycles. The 15-TM is also equipped with pressure and temperature monitors, a scratch-resistant Teflon-coated hot plate, greaseless bearings, a low-pressure shutoff alarm, and a coalescing exhaust filter. Zed Industries Inc., Vandalia, OH.
A continuous dual-heat band sealer handles difficult-to-seal materials. The Model VBS-DH-3/8-10-V is designed for sealing medical devices in pouches. Its temperature, speed, sealing, and cooling-bar pressure can be validated. The unit can seal Tyvek/Mylar, nylon, polyethylene, polypropylene, laminates, Kraft/polyethylene, and foil. Seals are achieved with special heavy-duty, wear-resistant laminated Teflon bands. All Packaging Machinery Corp., Ronkonkoma, NY.
Validation and other process controls: Prioritizing remediation activities for on-market products
Donald M. Powers
Over the past few years, warning letter trends and other regulatory actions have signaled that FDA is increasingly targeting IVD companies for failure to meet contemporary validation standards. Ronald M. Johnson, executive vice president of Quintiles Consulting (Rockville, MD), contends that companies that have not kept up with evolving validation standards place themselves and FDA in a difficult position. "The agency cannot ignore potential threats to the public health," said Johnson at a recent seminar sponsored by the Institute for Validation Technology. "Companies that fail to identify and remediate these threats place themselves and the FDA in an untenable situation. FDA is forced to act." Johnson initiated numerous regulatory actions against device firms while he was director of the Office of Compliance at FDA's Center for Devices and Radiological Health (CDRH).
Manufacturing processes and test methods for products introduced since 1997, when FDA implemented design control requirements as part of its quality system regulation, should already be in compliance with the current validation standards. However, chances are good that products that have been on the market for many years have suffered from neglect.
In this regard IVD manufacturers are no different from the rest of the medical device industry. Companies already under FDA scrutiny, or whose quality metrics have raised warning flags about its process controls, or who treated validation as a perfunctory, one-time exercise, are likely skating on thin regulatory ice. To compound the situation for IVD manufacturers, the deadline for mandatory CE marking of IVD products is now less than two years away, and some company official will shortly have to sign a declaration that the company's products and manufacturing processes conform to the requirements of the European Union's IVD Directive.1
Companies should recognize that substandard validations and other inadequate process controls place them in a precarious compliance position. To avoid risking the consequences of a regulatory action, such companies need to know how to begin a remedial compliance program.
Remediation Approaches
When executing a remedial compliance program, device companies commonly use one of two approaches. The first is to assemble a team of product and process experts who can draw upon their extensive experience and knowledge to determine what needs to be fixed. Such a brainstorming session can often develop a compliance plan within a few hours. To execute the plan, the company will then spend the next year involved in an impressive (and costly) flurry of activity. In the end, the most obvious compliance gaps will have been closed.
A second approach is to assemble the same team of experts, but with a different goal in mind. In this case, the team is asked to map out the company's manufacturing processes, to examine them in detail, and to answer the following two questions.
- Where is it possible for the company's processes to fail in a hazardous way?
- What controls are required to ensure that the company's finished products meet specifications?
In this approach, the team uses recognized risk-assessment tools and actual experience (e.g., failure data) to guide its expert judgment. With the data provided by such tools, the team then identifies the essential control points, determines whether the right controls are in place, and evaluates whether the processes (including process verification methods and controls) are validated to contemporary standards. The deliverable product of this approach is documented evidence that the company's processes are in control and assurance that its products are safe and effective.
Although each of these two approaches probably requires about the same commitment of time and resources, why would a management team select the first approach? That method may enable a company to address obvious compliance problems, but it will not generate documentation sufficient to assure FDA that the company's processes are in control or that its products are safe and effective. Nevertheless, "brainstorming the compliance gaps" is precisely the approach that most companies in trouble choose to adopt.
Emphasizing the Essential
Ultimately, manufacturing must be in full compliance—which means that all processes must be either validated or fully verified. But if a company has been skating close to the edge of a compliance cliff, there simply isn't enough time to examine every process, test method, and software validation, and remediate them to today's standards. The next inspection could begin at any moment, and firms that are unable to demonstrate adequate control are in a precarious position. So the manufacturer's first priority must be to compile documented evidence that all its essential processes are in control—and that its products can therefore be considered safe and effective.
An effective approach to achieving this end is the risk-based product assessment and traceability (PAT) process developed by Quintiles Consulting.2 A cross-functional team is formed with representatives from the scientific, engineering, and clinical disciplines necessary to evaluate the product and associated manufacturing processes. The collective knowledge of the cross-functional team makes this a powerful approach. The process begins with identification of the essential user requirements for a safe and effective diagnostic assay, which are typically described in the product's labeling. Hazards to the patient are defined as failures to meet the essential user requirements, such as accuracy, precision, and other performance characteristics. The corresponding hazards would be inaccurate results, imprecise results, and so on.
To determine the essential control points associated with each process, the cross-functional team performs a top-down hazard analysis, such as fault tree analysis, and a bottom-up analysis, such as failure mode effects and criticality analysis (FMECA).3,4 By combining the use of these analytical tools, the PAT process minimizes the possibility that an important failure will be missed and helps to focus FMECA on the most important potential failures. To lend objectivity and credibility to the process, the team agrees on criteria for hazard severity, probability of occurrence, and detectability before starting the hazard analysis. Each point in the process that exceeds the predetermined risk criteria is defined as an essential control point. The essential control points identified in this way are traceable back to the product's essential user requirements.
To be complete, the risk assessments must consider all of the following elements of the manufacturing process.
- Raw materials.
- Production and control equipment.
- Manual and automated processes.
- Control and monitoring systems.
- Test methods.
- Product storage.
- Distribution systems.
- Operators.
The risk assessments should also encompass all elements of the diagnostic system, including reagents, calibrators, control solutions, instruments, accessories, and the end-user. Since the primary focus is on demonstrating that production processes are in control, product design issues might be considered outside the scope of the risk assessment for the moment. Nevertheless, adequate design validation is important to demonstrate that the product is safe and effective.
In its emphasis on risk analysis and essential control points, the PAT process resembles FDA's hazard analysis and critical control points (HACCP) method. In fact, the process borrows from HACCP principles and methodology.5 In the end, risk analysis and risk management simply represent common sense.
Although the design control sections of FDA's quality system regulation require manufacturers to perform risk analyses, design controls do not apply to products on the U.S. market if no design or process changes have been made since mid-1997, when the quality system regulation became effective. As time goes on, however, products exempt from design control requirements will be increasingly rare.
Perhaps more pressing is the timeline for full implementation of the European Union's IVD Directive, which has no grandfather provision for products already on the market. In contrast to FDA's quality system regulation, the IVD Directive requires manufacturers to conduct a formally documented risk assessment for all products sold in the EU after December 2003.1,6
Analysis of Essential Control Points
Once the essential control points have been identified, the cross-functional product assessment team then determines which quality attributes are critical to the manufacturing process and must be well controlled to prevent unacceptable failures from occurring. These are termed critical quality attributes (CQAs). For an IVD assay, examples of such quality attributes might be clarity, uniformity, solubility, stability, accuracy, specificity, homogeneity, precision, bioburden level, and so on.
At this point, the team is ready to examine existing process controls and determine whether they are sufficient to control the process's specified CQAs. In this part of the PAT process, the most important activity is systematically assessing existing process validations and verification activities associated with each essential control point, including test method validations, software validations, and equipment qualifications.
To ensure consistency among those doing the assessments, the PAT process uses objective compliance checklists. The completed checklists also provide documented evidence of compliance or remediation requirements. Checklist questions are based primarily on FDA and Global Harmonization Task Force (GHTF) guidance documents on process validation, the quality system compendium published by the Association for the Advancement of Medical Instrumentation, and current industry practices.7–9
Typical checklist questions address such validation requirements as whether acceptance criteria were predetermined, study designs were based on statistical rationale, worst-case conditions were challenged, protocols were approved prior to execution, instruments and equipment were qualified, the CQA was adequately addressed, documentation is complete, and other requirements were met. The assessor notes deficiencies along with recommended remediation activities.
During the risk assessment process, test methods used for product release are almost always identified as essential control points. If not, it is a good idea to consider release tests as such. Validation requirements for test methods in the medical device industry have not been defined as clearly as other process validation requirements. Although CDRH has not published guidelines for the validation of test methods, both the Center for Biologicals Evaluation and Research and the Center for Drug Evaluation and Research have endorsed the guidelines of the International Conference on Harmonization (ICH), which were designed for the validation of analytical test methods in the pharmaceutical industry.10,11 Since the same analytical performance characteristics and scientific principles generally apply to all analytical test methods used in the IVD industry, it makes sense for IVD manufacturers to adapt the ICH guidelines for their test methods.
Written operating procedures and work instructions are also important process controls. In the PAT process, checklists based on regulatory requirements and guidelines enable consistent and objective assessment of compliance. Questions address common deficiencies stemming from lack of such necessary elements as clear, unambiguous instructions; defined responsibilities; completeness; criteria for satisfactory completion of a task; and so on. Other controls, such as reference materials and standards, engineering drawings, blueprints, test fixtures, inspection and evaluation methods, and operator certification, are evaluated for their adequacy in controlling CQAs.
In addition to process controls and monitoring systems, product and process specifications should be reviewed against requirements and performance data to determine if a detailed specification assessment is warranted.
The Remediation Phase
Identifying essential control points provides a defensible rationale for giving higher priority to activities associated with their remediation, and for deferring remediation of less-essential process controls. But having defined an essential control point in a process, it is important to remediate any deficiencies with due urgency. After all, if an essential control point is not adequately controlled, what can be concluded about the safety and effectiveness of the product made by that process?
Most companies can expect to identify some deficiencies that must be remediated. The amount of required remediation work depends on the number of essential control points and the nature of the deficiencies.
A detailed remediation plan should include timelines, milestones, resources, and assigned responsibilities. At the same time, manufacturers should remember to take into account other quality system requirements—particularly those for corrective and preventive actions (CAPA) and design control. Since the deficiencies being addressed are quality system nonconformities, the remediation plan must tie in to the manufacturer's CAPA system in such a way as to comply with company procedures, ensure that potential consequences are adequately assessed, and receive active management oversight. And, of course, any significant changes to a product or its manufacturing processes must follow the established design control procedures.
Documentation
Following a logical assessment and remediation process enables the company to systematically document its conclusions, decisions, and rationale. Such a process provides complete documentation about the selection of the essential control points. And perhaps more importantly, it documents the reasons that other control points are not considered essential for ensuring safe and effective product. The latter requirement is often overlooked.
The documentation produced by the product assessment team becomes part of the product's design history file, subject to review by FDA investigators and European competent authorities. It is therefore important that the completed project files document all of the following elements.
- Credentials and participation of PAT team members.
- Approved procedural instructions followed by the team.
- Essential user requirements and corresponding hazards.
- Predetermined hazard assessment criteria.
- Hazard analysis results.
- Quality data used to support the assessment.
- Events that may have affected the team's assessment.
- All issues identified and resolved by the team.
- Evaluation of existing controls.
- Remediation plan.
- Remediation activities.
A set of integrated worksheets facilitates capturing all relevant information as it is developed, so that in the end a controlled product assessment file is compiled to tell the entire story. A complete file should exist for each product that was developed prior to design control requirements.
Achieving Full Compliance
Once essential control points are identified and remediated, companies may be tempted to stop. Although the GHTF guidance document allows a company leeway to decide whether a process requires validation based on risk, FDA has not accepted this strategy. Instead, agency officials have maintained that the quality system regulation requires all processes that cannot be fully verified to be validated.
For this reason, manufacturers should establish a plan to evaluate and remediate all other process validations to bring them into compliance. This plan can be carried out on a less-urgent basis, once the essential control points have been addressed.
Going forward, having a well documented product risk assessment will make it easier for companies to evaluate changes to manufacturing processes. Any change that modifies the validated design must be implemented under design controls. Once a firm has conducted and documented a baseline assessment for its existing products, each change can be evaluated for its effect on the state of control, using the FMECA scoring rules and risk criteria already developed. Following this procedure will provide the firm with solid evidence that its manufacturing processes remain in control after each change.
References
1. "Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on In Vitro Diagnostic Medical Devices," Official Journal of the European Communities L331 (1998): 1–37.
2. Product Assessment and Tracebaility Process Training Manual (Rockville, MD: Quintiles Consulting, 2001).
3. WE Veseley et al., Fault Tree Handbook, NUREG-0492 (Washington, DC: U.S. Nuclear Regulatory Commission, 1981).
4. Analysis Techniques for System Reliability—Procedure for Failure Mode and Effects Analysis (FMEA), IEC Standard Pub. 60812 (Geneva: International Electrotechnical Commission, 1985).
5. HACCP for Medical Devices [on-line] (Rockville, MD: FDA, Center for Devices and Radiological Health, 1997 [cited 12 February 2002]); available from Internet: http://www.fda.gov/cdrh/gmp/haccp2.html.
6. "Quality System Regulation," Code of Federal Regulations, 21 CFR 820.
7. A Shaw, Guideline on General Principles of Process Validation (East Brunswick, NJ: Center for Professional Advancement, May 1987) reprint in CDER Home Page [on-line] (Rockville, MD: FDA, Center for Drug Evaluation and Research, 1993 [cited 12 February 2002]); available from Internet: http://www.fda.gov/cder/guidance/pv.htm.
8. "Process Validation Guidance," in GHTF Home Page [on-line] (Rockville, MD: Global Harmonization Task Force, Study Group 3, 1999 [cited January 2002]); available from Internet: http://www.ghtf.org/sg3/sg3-final.html.
9. AAMI Quality System Compendium: GMP Requirements and Industry Practice (Arlington, VA: Association for the Advancement of Medical Instrumentation, 1998).
10. "Guideline for Industry: Text on Analytical Method Validation, Q2A," in CDER Home Page [on-line] (Rockville, MD: FDA, Center for Drug Evaluation and Research, 1995 [cited 12 February 2002]); available from Internet: http://www.fda.gov/cder/guidance/ichq2a.pdf.
11. "Guidance for Industry: Q2B Validation of Analytical Procedures," in CDER Home Page [on-line] (Rockville, MD: FDA, Center for Drug Evaluation and Research, 1996 [cited 12 February 2002]); available from Internet: http://www.fda.gov/cder/guidance/1320fnl.pdf.
Donald M. Powers, PhD, is president of Powers Consulting Services (Rochester, NY), an independent IVD regulatory and quality consulting firm.Tamper-Evident Thermoformed Packaging
Users can reap the benefits of tamper-evident packaging without compromising sterilization quality.
by Pete Colburn, technical manager,
Cyro Industries (Rockaway, NJ)
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| Figure 1. Tensile elongation after E-beam sterilization |
Medical device manufacturers can incur significant costs due to package failure. Additional loss is incurred when someone other than the intended user opens packaging to illegally retrieve valuable medical products.
Such tampering is not always apparent. External seals can be opened, removed, and discarded without trace evidence. Some materials can be cut open or punctured with little noticeable evidence of failure. As a result, tamper-evident packaging has become an important component of the medical and pharmaceutical industries.
Supplying Tamper Evidence
Alexis Swan, corporate contract coordinator for Yale–New Haven Hospital in New Haven, CT, deals with packaging-integrity issues with medical and surgical supplies. “One of the biggest issues of healthcare providers is the ability and need to maintain a sterile field,” she says. “You want to be able to open a package and introduce the product into a sterile field, making sterilization reliability very important. We assume that the package has an appropriate level of integrity, so it is important that if a package fails, the failure is obvious. The people handling packages in a hospital inspect them to ensure that the sterile barrier in the package has not been compromised. We must be able to see any type of failure in the package immediately.”
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| Figure 2. Notched izod impact strength after EtO sterilization |
There are materials available that have been designed to show evidence of failure instantly, so that the judgment of sterile reliability can be made quickly and easily. Engineered compounds such as some acrylic-based multipolymer extrusion compounds are formulated to show that tampering with the rigid package is readily apparent.
Such compounds present strong evidence of tampering in two ways. First, if the rigid tray itself is tampered with, by tearing or cutting into it with a knife or even by sticking a needle through the sidewall, the material turns from a transparent blue tint to a highly visible, opaque white where the breach occurred. Second, once sealed, if the lidding stock is separated from the tray, the optical properties of the thermoformed compound make that seal separation evident by an apparent color change, even with the lidding stock laying against the tray edge. This is because the seal provides a certain amount of color depth when viewed through a specialized packaging compound.
Questions have been raised about whether such tamper-evident features could lead to packages being falsely identified as having had their integrity compromised, for example, after being knocked around during shipping. This is unlikely to happen. To activate the tamper-evident features, the package must be struck fairly hard. And if they are triggered, this should be a signal to check the package, not to dismiss it automatically as compromised.
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Heat sealing forms strong visible bonds with rigid tamper-evident acrylic-based trays. A range of lid-stock substrates can be used to seal the trays, including coated Tyvek, manufactured by DuPont Medical Packaging (Wilmington, DE). The adhesive used with coated Tyvek is activated at 250°–265°F. When sealing with coated Tyvek, it is important to use a rigid material, such as a tamper-evident acrylic-based compound, with a thermoforming temperature well below this.
Streamlined Sterilization
Packaging materials should not yellow or become brittle after the sterilization process. Some materials may show some yellowing depending on thickness. Tamper-evident acrylic-based compounds may slightly yellow in packages 0.040 in. thick, but thinner gauges that are typical for packages (0.010–0.020 in.) will show very little color change, if any.
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Ethylene oxide (EtO) sterilization temperatures can deform the shape of some packages but will not warp acrylic-based thermoformed trays. Acrylic-based products such as XT polymer can be used in packaging applications that are EtO sterilized without concern about package deformation due to the temperatures used in that process. EtO sterilization is generally done at temperatures in the range of 145º–165ºF. With a DTL (deflection temperature under load) of 192ºF, XT polymer is not affected by EtO sterilization temperatures. PETG products, however, have DTL values in the range of 145º–149ºF, and can therefore become deformed in the sterilization process if the temperature exceeds the DTL value.
Radiation sterilization can affect the mechanical properties of plastic compounds, but again, acrylic compounds exhibit no changes in mechanical properties up to 5 Mrd or 50 kGy of radiation. With gamma radiation, a material is considered to be significantly affected when it loses about 25% of its tensile elongation. This will occur with XT 375TE, the tamper-evident brand of XT polymer, at about 7 Mrd of radiation. Typical sterilization levels are 2.5 to 5 Mrd. When subjected to E-beam radiation, XT polymer retains its strength properties at radiation levels up to 75 kGy (Figure 1).
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| . |
XT polymer shows significant impact strength and resistance to crack initiation and propagation both before and after EtO and E-beam sterilization. This resistance to cracking further demonstrates the ability of acrylic-based materials to maintain the integrity of the package when impacted in handling. While PETG materials exhibit high tensile elongation properties, their resistance to cracking is about 25% of that of XT polymer before and after EtO sterilization (Figure 2), and about 30% of XT polymer’s impact strength after high E-beam sterilization doses of 75 kGy.
An additional benefit associated with tamper-evident acrylic-based compounds is postpackaging sterilization. Once thermoformed, acrylic-based polymer trays can be filled and sealed before final sterilization of the contents and the package. A sealed acrylic-based package can be sterilized using gamma, E-beam, or EtO sterilization methods. This method of sealed-package sterilization ensures both the contents and the packaging are free of contamination, and avoids numerous component sterilizations and the need for a sterile packaging line. Final validation testing is required to ensure the medical components are sterilized effectively inside the package. Manufacturers looking to streamline their packaging operation and provide effective tamper-evident packaging can take advantage of this.
Improving Package Design
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The ability of some compounds to be thermoformed over a wide temperature range allows the flexibility to use higher temperatures in order to obtain good definition on intricate parts without losing melt strength. Thermoformed rigid trays with deep-draw designs require a material with relatively high melt strength. Where deep draws can be limited with polyesters or crystalline materials due to their low melt strength, tamper-evident acrylic-based compounds can easily be thermoformed to draw ratios of 7:1 with good quality.
Package decoration can be an important component of design and validation. Decorating techniques can be used for a number of identification, information, or instructional purposes on thermoformed trays. Some thermoforming compounds contain lubricants that may interfere with decorating processes. Compounds such as acrylic possess excellent denesting properties and will not require silicone or lubricants to denest trays and prevent blocking. So lubricant interference with the decorating process is not a factor. Standard pad printing, screen-printing, and hot stamping techniques can be used with many extruded plastics. Acrylic-based inks are recommended for sharp graphics and vibrant color printing on acrylic-based substrates. Manufacturers seeking brand distinction or eye appeal in consumer arenas can use foil embossing decorating methods with rigid packaging trays.
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A major trend that has taken root in the medical device and pharmaceutical industries is brand distinction. Acrylic-based thermoformed compounds offer manufacturers the advantage of embossing an anticounterfeiting holographic stamp into the packaging. The holographic embossing offers a clear visual anticounterfeiting validation for medical and pharmaceutical devices without adversely affecting the material’s tamper-evident or sterilization properties.
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