4. Conclusion
Isolator technology has mainly been developed and used in the pharmaceutical industry to improve product quality, increase sterility assurance levels (SAL), reduce costs compared with cleanrooms, and improve safety for operators and the environment when handling toxic products (production of cytotoxic anti-cancer drugs).
In the agri-food sector, this technology is used for activities requiring protection against contamination from the product's environment, and for those involving the handling of products hazardous to humans or the environment (e.g. laboratory handling of pathogenic bacteria). The isolator's watertightness also makes it possible to work under specific conditions (anaerobiosis, modified atmosphere, etc.).
The isolator is positioned as close as possible to the product. It facilitates control and management of the work area,...
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The Ultimate Scientific and Technical Reference
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Conclusion
Bibliography
References
Regulations
Council Directive 93/43/EEC of June 14, 1993 on the hygiene of foodstuffs.
Standardization
- Sûreté des transports de matières radioactives. Contrôle d'étanchéité des colis. - ISO 12807 - 09-96
- Sterilization of healthcare products – Biological indicators – General guidelines for the selection, use and interpretation of results. - ISO 14161 - 10-00
- Biological systems for sterilizer testing and sterilization processes – Part 1: General requirements. - NF EN 866-1 - 06-97
- Biological systems for...
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