Extractables and Leachables: An Overview of Emerging Challenges - Pharmaceutical Technology

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Extractables and Leachables: An Overview of Emerging Challenges
Extractables and leachables are a growing concern for pharmaceutical manufacturers and regulatory bodies.


Pharmaceutical Technology
Volume 32, Issue 8

References

1. S.J. Carter, "Packaging" in Tutorial pharmacy, (CBS publishers and distributers, New Delhi, 6th edition, 2005), pp.133-141.

2. L. Lachman, P. deluca and M.J. Akers, "Kinetic principles and stability testing" in Theory and practice of industrial pharmacy, Lachman, L. & Liberman, A.H. (Varghese publishing house, Bombay, 3rd edition, 1991), pp. 795-802.

3. M. Kochman, "How to avoid leachables, extractables and other hazards in parenteral packaging", Biopharm bulletin, June, 27 2006. http://biopharminternational.findpharma.com/biopharm/News/How-to-Avoid-Leachables-Extractables-and-Other-Haz/ArticleStandard/Article/detail/340419

4. E. Swain, "Parentral packages need specific tests for extractables", Pharmaceutical and Medical Packaging News, March 2000. http://www.devicelink.com/pmpn/archive/00/03/004.html

5. Frances. L. Degrazio, "The importance of leachables and extractables testing for a successful product launch", Controlled Environments Magazine, Feb. 2007. http://www.samedanltd.com/members/archivers/pmps/summer2002/francesdegrazio.htm

6. Extractables and Leachables, West Analytical Services. http://www.westpharma.com/na/en/services/Pages/ExtractablesLeachables.aspx

7. D. E. Albert, "(Testing) evaluating pharmaceutical container closure systems", Pharmaceutical and Medical Packaging News, March 2004.
http://www.devicelink.com/pmpn/archive/04/03/010.html

8. F. L., Degrazio, "As biotech grows, so does the need for effective packaging", West pharmaceutical services Inc. http://www.accessmylibrary.com/coms2/summary_0286-31808939_ITM/

9. Guidance for Industry: Container Closure System for Packaging Human Drugs and Biologics (US Food and Drug Administration, Rockville, MD, May 1994) pp. 1-56.

10. J. S. Kauffman, "Identification and risk-assessment of extractables and leachables", Pharm. Tech. primer, Jan 2006. http://pharmtech.findpharma.com/pharmtech/Validation+and+compliance/Identification-and-Risk-Assessment-of-Extractables/ArticleStandard/Article/detail/309314

11. J. S. Kauffman, "Identification and risk assessment of extractables and leachables—Nondestructive analytical methods, Pharm. Tech., (2006).

12. Code of Federal Regulations, Title 21, Food and Drugs (Office of Federal Register, Washington, DC, April 2005), part 211.94, pp. 128.

13. USP 25 "Packaging—containers for injections" in Guide to General Chapters (US Pharmacopoieal Convention, Rockville, MD, 2002) pp. 1834-1835

14. "Extractables and Leachables" in Extractables and Leachables brochure, (Toxicon leaders in life science and technology, Aug-Sep 2005). http://www.toxikon.com/800386002729328402540534533/Link.htm

15. Y. G. Roth, "Extractables & leachables- regulatory pressures fuel method development", Contact Pharma (Rodman publishing, April 2005). http://www.contactpharma.com/articles/2005/04/extractables-leachables-25k

16. " Leachables and Extractables testing- points to consider", A response to the FDA guidance for industry, (Inhalation technology focus group of AAPS and international aerosol consortium on regulation & science (ITFC/IPAC-RS) Collaboration CMC Leachables and extractables technical team, March 27, 2001). http://www.ipacrs.com/PDFs/Points_to_Consider_FINAL.PDF

17. J. S. Kauffman, "Determination of extractables, leachables, residual solvents and unknowns by mass spectrometry", Pharm. Tech." Aug. 2003. http://www.lancasterlabs.com/News/PT6268e.pdf

18. J. Buss, "Extractables and Leachables", in proceedings of American Pharmaceutical review conference(West Pharmaceutical services, Hilton Alexandria Mark Centre, Alexandria, VA, USA, Oct. 16-18, 2006). http://www.intertechusa.com/conferences/conferenceDetail.aspx?displayDetail=overview&WCID=164

19. F. Qiu, and , D.L. Norwood, "Identification of pharmaceutical impurities", Journal of Liquid Chromatography & Related Technologies, 30, (2007), pp. 877-935.

20. "Extractables and Leachables testing", Lancaster Labs. http://www.lancasterlabs.com/literature/pharm-biopharmlit/extractables_leachables.pdf

21."Extractables and Leachables contamination a growing concern", lancasterlabs.com. http://www.lancasterlabs.com/pharmaceutical/Presentations/pt0206supp_014-022kauf.pdf

22. B.P. Jeneviene, "The evaluation of parenteral drug packaging," (Drug Safety Institute). http://www.drugsafetyinstitute.com/drugpackaging.asp

23. J. Ganser and D. Eikens, "Quality Control Testing for Evaluating Packaging Materials, Application of Modern Analytical Technologies to the Identification of Extractables and Leachables, Strategies for Testing and Qualifying Polymeric Articles Used in the Pharmaceutical Industry, Establishing Acceptance Criteria for Extractables", in proceedings of conference reviewer of Minnesota Chromatography Forum, (MCF retention times, 20, Philadelphia, PA, Sept. 15-16. 2003).

24. "Helovet pharma focus on reliable rubber', Packaging - Gateway, com (SPG Media Ltd, 6 April 2006).http://www.packaging-gateway.com/features/feature143/

25. F. L. Degrazio, "Parentral packaging concern for biotech drugs", in Bioprocess International, pharmalicensing.com. http://pharmalicensing.com/public/articles/view/1145955294_444de3de046d6/

26. G. Reckzugel and M. Schafers, "FDA-/GMP-compliant extract-ables and leachables testing", in proceeding of conference (Prague Czech Republic, September 26-28, 2006). http://www.gmp-compliance.org/daten/training/ECA_Extractables_06.pdf

27."Extractables / Leachables", (Cynta- drug development services). http://www.cyanta.com/Services/ExtractablesandLeachables/tabid/64/Default.aspx

28. FDA-Guidance for Industry. Metered dose inhaler (MDI) and dry powder inhaler (DPI) drug products (draft FDA, Rockville,MD, oct. 1998), pp.1-65.

29. D. M. Paskiet, "Regulation for extractables in materials/components used in OINDP" in proceeding of IPAC-RS symposium on extractables in material for OINDP, (West monarch Laboratories, Feb. 13, 2007) http://www.ipacrs.com/PDFs/February%202007%20Workshops/Review%20Guidance%20on%20Extractables%2 0for%20MaterialsComponents%20used%20in%20OINDP%20-%20Tools%20for%20Suppliers-Diane%20Paskiet.pdf

30. D. Twede and T.W. Downes, "Economics of Packaging" in "The Wiley Encyclopedia of Packaging Technology", Edited by A.L. Brody and K.S. Marsh (John Wiley & Sons, Inc., New York, Second Edition), pp 325-331.

31. D.V. Rosato, "Additives, Plastics" in "The Wiley Encyclopedia of Packaging Technology", Edited by A.L. Brody and K.S. Marsh (John Wiley & Sons, Inc., New York, Second Edition), pp 8-13.

32. F.J. Kraus and G.J. Tarulis, "Cans, Steel", in "The Wiley Encyclopedia of Packaging Technology", Edited by A.L. Brody and K.S. Marsh (John Wiley & Sons, Inc., New York, Second Edition), pp 144-155.

33. A. L. Schroeder, "Leachables and Extractables in OINDP—An FDA perspective" in proceedings of PQRI L/E workshop, Dec. 5-6, 2005.

34. M.L. Roony, "Active Packaging", in "The Wiley Encyclopedia of Packaging Technology", Edited by A.L. Brody and K.S. Marsh (John Wiley & Sons, Inc., New York, Second Edition), pp 2-8.


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