A number of desirable benefits over the traditional split butterfly valve offered by the Ezi-Flow CSV transfer system from UK-based Ezi-Dock are proving popular with pharma manufacturers throughout the world.
In August 2013, the European Medicines Agency (EMA) updated its pre-authorisation procedural advice for users of the centralised procedure to outline the most common mistakes detected by the Agency during the validation of initial marketing...
A large pharmaceutical company in Southeast Asia, PT Kalbe Farma Tbk., has successfully started up PAS-X at its headquarters in Jakarta, Indonesia. Kalbe modernised its IT and MES infrastructures and chose Werum's PAS-X to fully integrate with...
The European Medicines Agency (EMA) announced on 31 January 2013 that it had released a draft guideline to revise the agency’s current guideline on biosimilars containing low molecular weight heparins (LMWHs), a type of medical product often used...
Seidenader Maschinenbau claims to have combined visual inspection with high voltage (HV) leak detection in an automatic syringe inspection machine for the first time.
Regulatory affairs is a comparatively new profession that developed from the desire of governments to protect public health by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical...
Novozymes Biopharma, part of Novozymes A/S, announced that an ophthalmic solution made using its recombinant human albumin has been approved for Phase I/II development by the FDA.
In order to ensure that APIs meet the requirements for quality and purity that they purport or are represented to possess, the Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients (Q7) was developed by the International...
Sartorius Stedim Biotech has launched new sizes XS and S of the Clipster aseptic disconnector, in addition to the existing size L. This single-use device allows an aseptic disconnection of silicone as well as thermoplastic elastomer tubes...
With the new filling and closing machine MLF 5088, Bosch Packaging Technology offers an output of 400 vials per minute with integrated 100% in-process control (IPC). The newly developed member of the proven MLF series is able to fill and close...
Elastomers comprise a large number of different ingredients. Low-molecular weight organic compounds in particular can be dissolved out of the matrix by certain solvents and sometimes even by water. This effect, also known as leaching, is even more...
