Calibration of Lyophilization Pressure Gauges

Gary Osborn and Steve Hansen
Pharmaceutical Technology JUNE 2002 ISO 9000 and FDA requirements mandate that any measurement be traceable to national standards. Calibration of equipment is necessary to ensure traceability, performance, and reliability.This article explains the proper method for the in situ, o­n-site, or off-site calibration of lyophilizer pressure gauges and offers some important guidelines to ensure the accuracy of a capacitance manometer.For full article Click Here

Development of an In Situ Spectroscopic Method for Cleaning Validation

Narinder K. Mehta, Javier Goenaga-Polo, Samuel P. Hernandez-Rivera, David Hernandez, Peter J. Melling, and Mary A. Thomson, Remspec Corporation
BioPharm International, May 2002 A fiber-optic, mid-IR spectroscopy probe combined with a grazing-angle reflectance sampling head can be used as a solvent-free in situ method for validating cleanliness with substantial improvement in accuracy.

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Implementing Total Organic Carbon Analysis for Cleaning Validation

Pharmaceutical Technology, May 1, 2004
Total organic carbon (TOC) analysis is a fast and effective analytical technique for cleaning validation. Understanding the various types of TOC technologies is essential for choosing the best solution.


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Pharmaceutical Cleaning Validation Method References

Alconox A cleaning validation involves testing for acceptable residues o­n pharmaceutical manufacturing or medical device surfaces. The validation involves residue identification, residue detection method selection, sampling method selection, setting residue acceptance criteria, methods validation and recovery studies, and finally writing a procedure and training operators. This procedure is used to document acceptable residues 3 or more times and then a rational monitoring program to maintain a validated state is put in place. If you are changing any part of your procedure or cleaner, first clean the new way, collect data and then clean the old way before using any equipment while you are in the process of validating the new procedure.


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Total Organic Carbon Analysis for Cleaning Validation in Pharmaceutical Manufact

Karen A. Clark, Product Manager, Anatel Corporation
ISPE, October 2000 In the pharmaceutical industry, Good Manufacturing Practices (GMPs) require that the cleaning of drug manufacturing equipment be validated.1 Many different validation techniques can demonstrate that the manufacturing equipment is cleaned and essentially free from residual active drug substances and all cleaning agents.Common analytical techniques in the validation process include HPLC, spectrophotometry (UV/Vis), and TOC. HPLC and UV/Vis are classified as specific methods that identify and measure appropriate active and substances. TOC is classified as a non-specific method and is ideal for detecting all carbon-containing compounds including active species, excipients, and cleaning agent(s). 2,3,4,5.

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Defining Three “Consecutive” Runs

Destin A. LeBlanc,Cleaning Validation Technologies,Technical Consulting ServicesCleaning Memo for MARCH 2004 Another question I commonly get is “What constitutes three consecutive runs for cleaning validation protocol purposes?” The basic approach to answering this question is to use the same principles o­ne uses for process validation. If I am validating a blending process in a certain manufacturing vessel, do the three validation runs have to be o­ne after the other, with no intervening product being processed? Or, in between the three manufacturing processes for the validation, am I allowed to blend other products? Most people would agree that the latter is appropriate for process validation.


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Cleaning Verification Case Studies

David DeLucia,
ISPE , January 1997 Creative BioMolecules operates a cGMP plant with 1000L mammalian cell and 1000 L bacterial fermentation capacity. The plant is used for contract manufacturing as well as for CBM’s proprietary products. These case studies will review five campaigns of five products over the last three years. In each case, the goal was to demonstrate that the equipment was properly cleaned and ready for the next campaign.


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Cleaning validation in active pharmaceutical plants – guidance, 2000

APIC Guide to Cleaning Validation in API plants This Guideline has been produced by the Active Pharmaceutical Ingredients Committee(APIC) Working group.Different organizations will be influenced by their companies and the markets that theyserve in the approaches that they take and the policies that they have with respect tothe subject.It is also valuable to bear in mind that this is an area that is changing rapidly and whatwas considered as being acceptable 2-5 years ago is now not adequate. Therefore,companies should be aware of the need to continuously update themselves o­n currentregulatory requirements.


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College of American Pathologists (CAP) Residue Detection Method

Detergent Residue Testing using a pH Meter, pH Indicator, or Test Kit The following test procedures are suitable for detecting detergent residues resulting from improper rinsing and can be used to meet laboratory accreditation guidelines and questionnaires such as the College of American Pathologist program of State water lab accreditation programs.


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