Biomedical Engineering Reference
In-Depth Information
REFERENCES
1. Ball CO. Thermal Process Time for Canned Food. Washington (DC): National
Research Council, Bulletin No 37; 1923.
2. PDA, Technical Report #1, Validation of Moist Heat Sterilization, 2007.
3. Evans K, Sterilization Options. Presentation to OPS Advisory Committee, 10/22/02.
Available at http://www.fda.gov/ohrms/dockets/ac/02/slides/3900S2_10_Evans.ppt.
Accessed 2010 May 27.
4. Agalloco J, Akers J. Aseptic Processing for Dosage Form Manufacture: Organiza-
tion & Validation. In: Agalloco J, Carleton FJ, editors. Validation of Pharmaceutical
Processes. 3rd ed. New York, USA: Informa; 2007. pp. 317-326.
5. USP, 1116, Microbiological Control And Monitoring Of Aseptic Processing Environ-
ments.
6. EMEA, Annex 1, Sterile Medicinal Products, 2008.
7. Reinmuller B. Dispersion and Risk Assessment of Airborne Contaminants in Pharma-
ceutical Clean Rooms. Stockholm, Sweden: Royal Institute of Technology, Building
Services Engineering, Bulletin No. 56; 2001. p 38.
8. Agalloco J, Akers J. Validation of aseptic processing. In: Agalloco J, Carleton FJ,
editors. Validation of Pharmaceutical Processes. 3rd ed. New York, USA: Informa;
2007.
9. Akers J, Agalloco J. A critical look at sterility assurance. Eur J Pharm Sci 2002;7(4):
97-103.
10. Akers J, Agalloco J, Madsen R. What is advanced aseptic processing? Pharm Manuf
2006;4(2):25-27.
11. World Health Organization, Technical Report Series, No. 530, 1977.
12. FDA, Guideline on Sterile Drug Products Produced by Aseptic Processing, 1987.
13. ISO 13408, Aseptic Processing Of Health Care Products-Part 1: General Require-
ments, 1992 draft.
14. PDA, Process Simulation Testing for Aseptically Filled Products, PDA Technical
Report #22, PDA J Pharm Sci Technol 1996;50(6), supplement.
15. Agalloco J, Gordon B. Current practices in the use of media fills in the validation of
aseptic processing. J Parenter Sci Technol 1987;41(4):128-141.
16. PDA, TR# 36, Current practices in the validation of aseptic processing-2001. PDA
J Pharm Sci Technol 2002; 56(3).
17. PDA, TR#34, Design and validation of isolator systems for the manufacturing and
testing of health care products, PDA Technical Report #34. PDA J Pharm Sci Technol
2001;55(5), supplement.
18. ISO 14644-7, Separative Devices.
19. Agalloco J, Akers J, Madsen R. Current practices in the validation of aseptic
processing-2001. PDA J Pharm Sci Technol 2002;56(3) PDA Technical Report #36.
20. http://en.wikipedia.org
21. FDA, Pharmaceutical CGMPs For The 21st Century-A Risk-Based Approach,
September 2004.
22. FDA, Guideline on Sterile Drug Products Produced by Aseptic Processing, 2004.
23. International Conference on Harmonization, Quality Risk Management, 2006 June.
Search WWH ::




Custom Search