7. Glossary
Aérosol microbien; microbial aerosol
Biological agents suspended in a gaseous medium. It may contain several biological contaminants: living micro-organisms (bacteria, viruses, yeasts, fungal spores), antigenic microbial fragments, toxins and/or other volatile substances of microbial origin.)
Polymerase Chain Reaction or PCR
A method for identifying micro-organisms by analyzing their genome, based on the amplification, by successive replications, of a target DNA sequence using specific primers. Quantitative analysis (determination of the number of copies of the desired gene in the sample) is possible thanks to real-time quantitative PCR techniques.
ATP Bioluminescence; ATP Bioluminescence Assay
Technique for measuring adenosine triphosphate (ATP) by measuring the...
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Bibliography
Standards and norms
- Cleanrooms and related controlled environments. Biocontamination control – Part 1: General principles and methods - NF EN ISO 14698-1 - 03-04
- Health care facilities – Controlled environment zones. Requirements for airborne contamination control - NF S90-351 - 04-13
- Indoor air – Part 16: Mould detection and enumeration – Filtration sampling - NF ISO 16000-16 - 2009
- Indoor air – Part 17: Mould detection...
Regulations
European Good Manufacturing Practice (EuGMP). Specific guideline: LD.1 Manufacture of sterile medicinal products
European Pharmacopoeia 0169. 8th edition. Specifications for water for injections
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