facilities containment-cleanrooms 
European Pharmaceutical Review
MARCH 11, 2024
Employing MALDI-TOF MS for microbial identification in sterile drug manufacturing Fungal contamination in pharmaceutical cleaning facilities Case study examples Mould and yeast have been reported by several previous authors in numerous pharmaceutical cleanrooms , cold rooms, and controlled areas, according to the authors.
pharmaphorum
JUNE 8, 2022
Cleanroom Managers. Implementation Strategy of Annex 1 in New or Existing Facilities. Led by: Richard Denk, Senior Consultant Aseptic Processing & Containment, Skan AG. Led by: Richard Denk, Senior Consultant Aseptic Processing & Containment, Skan AG. Leaders in Sterility Assurance. Regulatory Affairs Managers.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
ISPE
MARCH 16, 2023
In this blog, we will briefly explore the challenges and opportunities of digitalized aseptic production, fully contained and automated production and collaborative work with CMOs. CCS and QRM requirements for aseptic filling – a CDMO perspective Digitalization in cleanrooms from a hardware and Annex 1 viewpoint.
ISPE
JULY 10, 2023
For almost 20 years, it has been known that the original cleanroom ventilation rates from the last century are much higher than necessary to achieve the cleanliness standards set by regulatory agencies. It provides guidance for the design, construction, commissioning, and operation of cleanrooms. 2 ISO Standard 14644-16.
ISPE
MARCH 9, 2023
This article discusses the use of CFD for the purpose of predicting and optimizing the performance of a cleanroom facility in terms of steady-state airborne particulate levels and for estimating the recovery time to a particulate challenge per ISO 14644-3. Cleanrooms and Associated Controlled Environments—Part 3: Test Methods.”
ISPE
OCTOBER 28, 2022
the GEP GPG recognized GEP as a life-cycle approach, encompassing “all aspects of engineering related to the design, delivery, and operation of facilities and engineered systems, from conceptual design to retirement.” Aligning with the ISPE Baseline Guide Vol. 5, Commissioning & Qualification, 2 ed., Conclusion.
ISPE
MAY 1, 2023
UV 222 Booth: Far UV-C Light for Decontamination of Gowned Personnel Trudy Patterson Mon, 05/01/2023 - 06:00 Sponsored Content UV 222 Booth: Far UV-C Light for Decontamination of Gowned Personnel 1 May 2023 Contamination within pharmaceutical facilities can arise from different sources.
Expert insights. Personalized for you.
87 
Let's personalize your content