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This article expresses the opinions of a pharmaceutical microbiologist on the proposed revisions to the EU Good Manufacturing Practice Annex 1 in terms of current industry practice and future innovation in sterile product manufacturing.
Lyogistics Zero, the only freeze dryer vial automatic loading/unloading system with the ability to have CIP/SIP inside the chamber, and Lyonuc, the new vacuum nucleation induction method suitable for any type of freeze-dryer, are leading cutting-edge solutions for pharma processes…
Active pharmaceutical ingredients (APIs) have been established in the pharmaceutical industry over the course of many years. Containment technologies – ie, those strategies developed to contain the APIs – and qualification practices based on API powder containment have primarily been based on health and safety issues related to operator exposure…
Quality Assurance (QA) covers all aspects that could have an impact on the quality of prescribed pharmaceutical products. This article focuses on some of the Pharmaceutical Quality Systems in relation to QA of manufactured medicines.
This article explores how the new draft of Annex 1, Manufacture of Sterile Medicinal Products impacts environmental monitoring programmes.
Even with the rise of rapid microbiological methods, most environmental monitoring applications are undertaken using culture media, with many alternative methods also being growth-based. This makes the selection, control and release of culture media an area of great importance, given that the quality of the culture media underpins the environmental…
AdvantaPure has released three new case studies focused on fluid transfer challenges involving biopharm and pharmaceutical applications. Each Study Describes Processing Problems, Customer Goals, and Product Solutions...
This poster discusses a process for a 12-week clone development process. The process starts in silico, and progresses through screening and clone selection in 96-deepwell plates up to five liter shaker flasks...
OPTEL GROUP, a leading global provider of traceability systems for diverse industries, namely for pharmaceuticals, medical devices, healthcare, food and natural resources, announced today that it will be exhibiting an entirely serialised line at this year’s edition of Achema, from 11 - 15 June 2018, in Frankfurt, Germany, at Stand F31…
FPS has provided High Containment Integrated systems within aseptic condition...
Wickham Laboratories expands capacity for in-house media preparation...
A report released has identified a two-tier manufacturing market and forecast increased acquisitions by Indian companies...
15 June 2016 | By Cherwell Laboratories
Cherwell process validation & environmental monitoring product range on display at APDM training course...
In this free-to-view in-depth focus: How to deal with non-sterile results in aseptic processing, Risk Profiling and Proactive Response (RPPR) to Bio-contamination in GMP classified and controlled areas, Microbiology Roundtable...
12 December 2009 | By Gavin Halbert, Director, Cancer Research UK Formulation Unit, Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde
The manufacture of sterile products attracts the greatest regulatory scrutiny of all product types, since manufacturing failures can be fatal and manufacturers are required to utilise the most robust sterilisation method possible to limit the probability of this occurring. However, aseptic preparation, which is the last resort manufacturing method, continues…
