Cleaning: Multiuse facility issues

Process Validation in Manufacturing of Biopharmaceuticals: Guidelines, Current Practices, and Industrial Case Studies

Volumn , Issue , 2000, Pages 228-242

  Sherwood, David ^a  

^a Lanza Biologics plc   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 84882097853     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1201/9780849398582     Document Type: Chapter

References (9)

1. D Hill, M Beatrice. Facility requirements for biotech plants. Pharm Eng 9(4):35-41, 1989.
2. FG Bader, A Blum, BD Garfinkle, D MacFarlane, T Massa, TL Copmann. Multiuse manufacturing facilities for biologicals. BioPharm, September 1992, pp 32-40.
3. MN Hamers. Multiuse biopharmaceutical manufacturing. Biotechnology 11:561-570, 1993.
4. PDA. Cleaning and Cleaning Validation: A Biotechnology Perspective. Bethesda, MD: Parenteral Drug Association, 1996.
5. D Sherwood, D. Fisher, J Clifford, S Slade. Experiences with clean-in-place validation in a multiproduct biopharmaceutical manufacturing facility. Eur J Parenter Sci 1(2):35-41, 1996.
6. J Agalloco. “Points to consider” in the validation of equipment cleaning procedures. Parenter Sci Technol 46(5):163-168, 1992.
7. GL Fourman, MV Mullen. Determining cleaning validation acceptance limits for pharmaceutical manufacturing operations. Pharm Technol 17:54-60, 1993.
8. AO Zeller. Cleaning validation and residue limits: A contribution to current discussions. Pharm Technol Eur, November 1993, pp 18-27.
9. HJ Baseman. SIP validation. Pharm Eng 12(2):37-46, 1992.