Biopharmaceutical Facility Cleaning Validation Using the Total Organic Carbon Test - Case studies show TOC is effective for cleaning validation. - BioPharm International

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Biopharmaceutical Facility Cleaning Validation Using the Total Organic Carbon Test
Case studies show TOC is effective for cleaning validation.


BioPharm International
Volume 23, Issue 6

REFERENCES

1. The US Food and Drug Administration. Mid-Atlantic region inspection guide: cleaning validation. Rockville, MD; 1993 Jul. Available from: http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074922.htm.

2. Mark AS, Terry LS, Brett TF, Avinash LL. Total organic carbon analysis of swab samples for the cleaning validation of bioprocess fermentation equipment. BioPharm Intl. 1996;9(4):42–5.

3. Clark K. How to develop and validate a total organic carbon method for cleaning applications. J Pharm Sci Technol. 2001;55(5):290–94.

4. Glover C. Validation of the total organic carbon (TOC) swab sampling and test method. J Pharm Sci Technol. 2006;60(5):284–90.

5. Mollah AH. Cleaning validation for pharmaceutical manufacturing at Genentech—Part 2. BioPharm Intl. 2008;22(3):68–75.

6. McCormick D. FDA's Evans reviews causes of warning and recall. Pharm Technol. 2005 Oct. Available from: http://www.pharmtech.com/pharmatch/content/printContentPopus.jsp?id=190230and?id=383878.x/

7. McCormick D. Poor OOS Review leads causes of FDA citations. Pharm Technol. 2006 Nov. Available from: http://www.pharmtech.com/pharmatch/content/printContentPopus.jsp??id=383878/.

8. ASTM international standard. Available from: http://www.astm.org/Standards/D6317.htm.

9. ICH Q2 (R1) Validation of analytical procedures: Text and methodology. Available from: http://www.ich.org/LOB/media/MEDIA417.pdf.

10. George Verghese. Cleaning agents for biopharma manufacturing. Gen Eng News. 2003;23(6):46–52.

11. IT 60.602 Preparation and application of API to chromatographic systems for cleaning validation in campaign changes.

12. IT 60.201 Preparation and application to Fermentors of biomass used in the cleaning validation in campaign changes.

13. PVL-005 Procedure of parenteral Epidermal Growth Factor manufacturing equipment cleaning validation.

14. Working Party on Control of medicine and inspections. Qualification and validation. Annex 15 to the EU guide to good manufacturing practice. European commission: Brussels, Belgium, July 2001. Available from: http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-4/pdfs-en/v4an15.pdf.

15. US Food and Drug Administration. Current good manufacturing practice regulations; 21 CFR 211.194 (a) (2), 2005.

16. United States Pharmacopeia. USP 31–NF 26, USP <643> Total Organic Carbon. 2007 Nov.

17. European Pharmacopeia Method 2.2.44 – total organic carbon in water for pharmaceutical use, European Pharmacopoeia Commission; 6th ed, 2009.

18. Lombard S, Inampudi P, Scotton A, Ruezinsky G, Rupp R, Nigam S. Development of surface swabbing procedures for a cleaning validation program in a biopharmaceutical manufacturing facility. Biotechnol Bioeng. 1995;48:513–519.


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