Standardization of single use components' extractable studies for industry

Pharmaceutical Engineering

Volumn 32, Issue 3, 2012, Pages 54-56

  Mahajan, Ekta ^a   Ray Chaudhuri, Trishna ^a   Vogel, James Dean ^b  

^a GENENTECH INC   (United States)

^b BioProcess Institute   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CHEMICAL COMPOUND; ELASTOMER; PLASTIC; STAINLESS STEEL; VOLATILE ORGANIC COMPOUND;

ANALYTIC METHOD; DRUG FORMULATION; DRUG INDUSTRY; DRUG MANUFACTURE; LIQUID CHROMATOGRAPHY; MASS SPECTROMETRY; MEDICAL TECHNOLOGY; PH; SHORT SURVEY; STANDARDIZATION; TOTAL ORGANIC CARBON; VALIDATION PROCESS;

EID: 84866261636     PISSN: 02738139     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Short Survey

References (10)

1. Coltan et al. (Extractables and Leachables Sub-Committee of the Bio-Process Systems Alliance, Recommendations for Extractables and Leachables Testing Part 1: Introduction, Regulatory Issues, and Risk Assessment, Bio-Process International, December, 2007.
2. Markovic, I., "Risk Management Strategies for Safety Qualifications of Extractable and Leachable Substances in Therapeutic Biologic Protein Products," American Pharmaceutical Review, May/June 2009.
3. Markovic, I., "Challenges Associated with Extractable and/ or Leachable Substances in Therapeutic Biologic Protein Products," American Pharmaceutical Review, Sept/Oct. 2006.
4. Wallin, R.F., "A Practical Guide to ISO 10993-12: Sample Preparation and Reference Materials," MDDI Medical Device and Diagnostic Industry News Products and Suppliers, Dec. 1, 1998.
5. BPSA, "Bio-Process Systems Alliance Component Quality Test Matrices," BioProcess International, April/May 2007.
6. Ding, W. and Martin,J., "Implementing Single-Use Technology in Biopharmaceutical Manufacturing," BioProcess International, October 2008.
7. Hemmerich, K.J.,, "Accelerated Aging General Aging Theory and Simplified Protocol for Accelerated Aging of Medical Devices," Medical Plastics and Biomaterials Magazine MPB Article Index, July 1998.
8. Scott, K., "Extractables and Leachables Testing of Polymer Device Components," Processing Pharmaceutical Polymers, June 2007.
9. ICH Guidelines for Residual Solvents Q3(R5) (Current Step 4 version, dated February 4, 2011).
10. See European Pharmacopeia monographs specific to the chosen material, such as E.P. 3.1.13. "Plastic additives, E.P. 3.1.5, Polyethylene with additives for containers for preparations for parenteral use and for ophthalmic preparation" or E.P. 3.1.9. "Silicone elastomer for closures and tubing" etc. European Directorate for the Quality of Medicines, Strasbourg, France.