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February 03, 2015
Aesica announced that it received continuing approvals from FDA for its bulk manufacturing and packaging operations in Germany.
November 05, 2014
FDA releases guidance specifying its preferred unique facility identifier system.
November 02, 2014
Connect 2 Cleanrooms' mobile, adjustable cleanroom filtration system, HEPA-lite, provides localized filtered air.
Using flow sensors, operators can monitor compressed-air use to help identify problems early and provides data for improving energy efficiency.
October 20, 2014
The WuXi AppTec bulk cell culture production facility, designed by Sartorius Stedim Biotech (SSB), received an honorable mention in the 2014 Facility of the Year Awards at the annual meeting of International Society for Pharmaceutical Engineering (ISPE) in Las Vegas last week.
October 02, 2014
The recovery of an occasional mold does not merit any particular concern. On the other hand, evidence of mold proliferation indicative of infection of facilities or equipment must be taken seriously and requires the prompt implementation of corrective and preventive actions.
September 16, 2014
Designed for ISO Class 4 compatibility, BioClean? 400mm (16?) gloves give 33% more coverage than the standard cleanroom glove providing exceptional comfort and offering extra personal and product protection.
September 10, 2014
Terra Universal introduced a floor-mount model of its BioSafe pass-through for cleanroom material transfer.
September 02, 2014
Flexibility, which involves the ability to quickly change product capacity or even product type to meet market demand, is increasingly important. In new construction or renovation, modular process skids and modular buildings create this flexibility. Experts discuss trends and challenges.
August 01, 2014
Innovative therapeutic approaches beyond mAbs will require new methods for future facility construction.