Autoclaves
The revised Annex 1 of the GMP Guidelines for Medicinal Products describes in chapter 8 (Aseptic Preparation and Processing) new requirements for regularly recurring air removal assurance during moist heat sterilisation and the corresponding need for documentation of the results.
Lautenschläger*) autoclaves equipped with an inline steam analyser (DMA) fulfil these requirements. The proven steam analyser detects steam penetration failures caused by leaks, insufficient air removal and non-condensable gases entering the autoclave chamber together with the steam. The results are documented in cycle reports compliant with 21 CFR part 11. The system can also be used to perform an electronic Bowie & Dick test according to EN ISO 11140-4 on a daily basis. Thus, process reliability increases, and documentation efforts are reduced.
Lautenschläger autoclaves meet Annex 1 requirements for moist heat sterilisation.
Verweise
| *) | F. & M. Lautenschläger GmbH & Co.KG Zum Engelshof 1 50996 Köln |