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 ...

Aseptic Transfer Systems

Rubrik: Technik

(Treffer aus pharmind, Nr. 11, Seite 1034 (2025))

Krebsbach T | Lehmann F

Aseptic Transfer Systems / For Isolator and RABS · Krebsbach T, Lehmann F · SKAN
Isolator Aseptic Processing Annex 1 Material Transfer Aseptic Transfer Advisor (ATA) Over the past 2 decades, isolator technology has deservedly positioned itself at the forefront of the safest production environments in the pharmaceutical industry [ 1 ], both in the manufacturing and quality control of sterile medicinal products. This is also reflected in Annex 1 of the EC GMP Guide published in Aug. 2022, which explicitly recommends the use of barrier technology, as it significantly increases product protection against potential contamination in the form of endotoxins/pyrogens, particulate matter, and microbial contaminants caused, e.g. by personnel, materials, or the environment [ 2 ]. Consequently, ...

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 ...

Fertigspritzen | 2. Auflage

(Treffer aus Büchern)

Fertigspritzen gewinnen in der modernen Medizin und Pharmazie zunehmend an Bedeutung und verändern die Entwicklung, Herstellung und Anwendung von Arzneimitteln. Ursprünglich vor allem für Impfstoffe und Heparine genutzt, erweitern ...

Sterilherstellung in der pharmazeutischen Industrie
Aseptische Herstellung und terminale Sterilisation

(Treffer aus Büchern)

Echt (Königs)klasse Für die Herstellung steriler Produkte werden die technisch ausgefeiltesten Lösungen entwickelt, die – ganz im Sinne der Patientensicherheit – zur Königsklasse zählen. So robust wie sachlich nüchtern ...

Reinigung und Desinfektion im pharmazeutischen Betrieb

(Treffer aus Büchern)

Vor, während und nach der Produktion – Reinigung und Desinfektion auf höchstem Niveau. Klare, gesicherte Aussagen, wertvolle Hinweise für Problemlösungen und Praxistipps, die Sie bei Ihrer täglichen Arbeit ...