Environmental Monitoring in Aseptic Manufacturing

Rubrik: Analytik

(Treffer aus pharmind, Nr. 02, Seite 146 (2026))

Krebsbach T | Isken J | Schönenberger M

Environmental Monitoring in Aseptic Manufacturing / Krebsbach et al. | Environmental Monitoring · Krebsbach T, Isken J, Schönenberger M · SKAN AG und Novartis Pharma und MBV
Annex 1 Contamination Control Strategy Biofluorescence Isolator Rapid Microbiological Methods The product safety of drugs and medical devices has always been the top priority throughout the entire life cycle of pharmaceutical products. For this reason, strict requirements are imposed – adapted to the method of administration (e.g., topical, oral, parenteral) – with regards to microbiological and particulate purity. This inevitably means that, from a microbiological point of view, qualified cleanrooms are necessary for the manufacture of sterile or microbiologically critical dosage forms [ 1 ]. These cleanliness zones are designed and operated in such a way that they meet defined physical ...

Proof of a successful decontamination with H2O2

Rubrik: Analytik

(Treffer aus pharmind, Nr. 09, Seite 846 (2025))

Krebsbach T | Isken J | Novák M

Proof of a successful decontamination with H2O2 / Krebsbach et al. | Proof of a successful decontamination · Krebsbach T, Isken J, Novák M · SKAN AG und Novartis Pharma AG und SKAN AG
Isolator Aseptic Processing Decontamination Indicators Annex 1 The use of isolators in the manufacture and quality control of sterile medicinal products has been a trend for years and has become even more popular with the entry into force of the current version of Annex 1 of the EC GMP guidelines [ 3 ]. Isolators make a significant contribution to drug safety as they provide effective and efficient protection against contamination. Fully automatic decontamination is the core process of the isolator. This process is therefore expected to be reliable, safe, robust and reproducible at all times. Decontamination can be carried out using various ...