Microbiological environmental controls / The requirements of the new version of the 1. Supplementary guide for the production of sterile pharmaceuticals and their realisation;Mikrobiologische Umgebungskontrollen / Anforderungen der Neufassung der 1. Erganzenden Leitlinie zur Herstellung steriler Arzneimittel und deren Umsetzung

Pharmazeutische Industrie

Volumn 60, Issue 1, 1998, Pages 54-63

  Seyfarth, Hanfried ^a,b   Häusler, Heribert ^a  

^a Abt Qualitatskontrolle/M

^b BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG   (Germany)

Author keywords

Documentation; GMP; Limite; Methoden; Sterile Arzneimittel; Umgebungskontrollen

Indexed keywords

ARTICLE; DRUG MANUFACTURE; DRUG PURITY; FOOD AND DRUG ADMINISTRATION; HYGIENE; MICROBIAL GROWTH;

EID: 0031919285     PISSN: 0031711X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (17)

1. European Commission, Directorate-General III: Revision of the Annex I to the EU Guide to Good Manufacturing Practice: Manufacture of Sterile Medicinal Products, Brussels, 9 September 1996
2. European Pharmacopoeia, Third Edition, Council of Europe, Strasbourg (1996)
3. ISO/DIS 13408-1, "Aseptic processing of healthcare products, Part 1: General requirements", Entwurf (Februar 1997)
4. ISO/CD 14698-1, "Cleanroom technology - Biocontamination control - General principles", Entwurf (Oktober 1996)
5. ISO/CD 14698-2, "Cleanroom technology - Biocontamination control - Evaluation and interpretation of biocontamination data", Entwurf (Oktober 1996)
6. ISO/CD 14698-3, "Cleanroom technology - Biocontamination control - Methodology for measuring the efficiency of processes of cleaning and (or) disinfection of inert surfaces bearing biocontaminated wet soiling or biofilms". Entwurf (Oktober 1996)
7. <1116> Microbiological Evaluation of Clean Rooms and Other Controlled Environments; Pharmacopeial Forum 23, 3494 (1997)
8. EG-Leitfaden einer Guten Herstellpraxis für Arzneimittel. S. 73-85, zsgst. und hrsg. von G. Auterhoff, ECV · Editio Cantor Verlag, Aulendorf (1995)
9. Seyfarth, H., Häusler, H., Pharm. Ind. 58, 1135 (1996)
10. Dony, J., Davison, A. L., Devleeschouwer. J. J. et al., Pharm. Ind. 52, 1001 (1990)
11. Guideline on sterile drug products produced by aseptic processing, US Food and Drug Administration (1987)
12. 2.6.12. Microbial Contamination of Products Not Required to Comply with the Test for Sterility (Total Viable Aerobic Count) in European Pharmacopeia, Third Edition, Council of Europe. Strasbourg (1996)
13. Christiansen, B., Die physiologische Hautflora und ihre stufenweise Verminderung durch Wasch- und Desinfektionsmittel, IV. Internationales Ulmer Hygienesymposium, Ulm, 21.-23. September (1988)
14. Haberer, K., Identification of microorganism by GC Analysis for Fatty Acid Spectrum, International Congress on The Future-Visions for Parenterals Manufacture, 2.-4. März, München (1997)
15. EG-Leitfaden einer Guten Herstellpraxis für Arzneimittel, S. 33, zsgst. und hrsg. von G. Auterhoff, ECV · Editio Cantor Verlag, Aulendorf (1995)
16. Seyfarth, H., Pharm. Ind. 54, 58 (1992)
17. Seyfarth, H., Pharm. Ind. 54, 163 (1992)