Design of Barrier Isolators for Aseptic Processing: A GMP Perspective

Pharmaceutical Engineering

Volumn 18, Issue 2, 1998, Pages 28-36

  Friedman, Richard L ^a,b,c,d  

^a Office of Biotechnology Products   (United States)

^b New Jersey District Office   (United States)

^c CDER's Div of Mfg and Prod Qual   (United States)

^d CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 0002301179     PISSN: 02738139     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (20)

1. James C. Lyda, "Regulatory Aspects of Isolation/Barrier Technology," PDA Journal of Pharmaceutical Science & Technology, Vol. 49, No. 6, N/D, 1995.
2. M. Gerald Lee, "Barrier Technology for TPN Compounding: Advantages and Limitations," Nutrition, Vol. 13, No. 3, 1997.
3. Michael Porter, "Merck Barrier Isolator Cost Analysis Revisited," Barrier Isolation Technology Conference, June 1-3, 1997.
4. Ed. Gerald M. Lee and Brian Midcalf, "Isolators for Pharmaceutical Applications," HMSO, 1994.
5. Implementing Isolation Technology Meeting, J. Agalloco and J. Akers, Philadelphia, November 6, 7, 1997.
6. U.S. CGMPs, Section 211.
7. PDA/ISPE Barrier Technology Conference, Paul Hargreaves, January 17-18. 1995, Atlanta, GA.
8. Paul J. Haas, "Engineering Design Considerations for Barrier Isolator Systems," Pharmaceutical Technology, February, 1995.
9. Merck Index, 11th Edition.
10. 2 Vapor Concentration During Vapor Hydrogen Peroxide (VHP) Sterilization," Pharmaceutical Research, Vol. 14, No. 3, March, 1997.
11. 1987 "Guideline on Sterile Drug Products Produced by Aseptic Processing," U.S. Food & Drug Administration.
12. November 21, 1995 Parenteral Drug Association Comments on "EU Guide to Good Manufacturing Practice, Annex on the Manufacture of Sterile Medicinal Products," Draft 4.
13. Gordon Farquharson, "Developments in Isolators and Barrier Technology for the Healthcare Industry," 2nd European Parenteral Conference, Malmo, Sweden, May, 1997.
14. Kenneth Muhvich, PDA Letter, March 1995.
15. PDA Technical Report #23, "Industry Survey on Current Sterile Filtration Practices," 1997, Supplement, Vol. 51.
16. J. Levchuk and A. Lord, "Personnel Issues in Aseptic Processing," Biopharm, September, 1989.
17. Paul D'Eramo and R. Friedman, ISPE Conference, Zurich, Switzerland, October 1-2, 1997.
18. R. Friedman, 1997 PDA Annual Meeting, Philadelphia, PA, November 10-12, 1997.
19. ISPE Barrier Isolation Technology Conference, Rockville, MD, June 1-3, 1997.
20. PDA Technical Report No. 22, "Process Simulation Testing for Aseptically Filled Products," 1996, Supplement, Vol. 50.