Aseptic/Sterile Processing

Mar 19, 2018
By Pharmaceutical Technology Editors
The CDMO’s new blow-fill-seal machinery at its Kaysersberg site is now operational.
Mar 14, 2018
A previously published article presented difficulties with the revised European guidelines on sterile manufacturing. The authors included a brief summary of the comments developed on the draft document. This article expands upon that summary, outlines the authors' rationale, and highlights the most difficult aspects of the revision draft.
Mar 13, 2018
By Pharmaceutical Technology Editors
Revisions to chapters on glass containers and elastomeric closures were canceled following review of comments.
Feb 27, 2018
Materials used in the seals of split butterfly valves for aseptic pharmaceutical manufacturing should be chosen carefully.
Feb 23, 2018
By Pharmaceutical Technology Editors
The company is voluntarily recalling three lots of Labetalol Hydrochloride Injection, USP, 100 mg/20 mL Vial and one lot of Labetalol Hydrochloride Injection, USP, Novaplus because of the potential of cracked glass at the rim of the vials.
Feb 12, 2018
By Pharmaceutical Technology Editors
FDA sent a warning letter to Celltrion detailing CGMP violations, including poor microbial contamination control.
Feb 02, 2018
By Pharmaceutical Technology Editors
The NECC supervisory pharmacist at the center of the 2012 fungal meningitis outbreak was sentenced to 8 years in prison.
Feb 01, 2018
Pharmaceutical Technology
A different perspective on controlling fixed costs of biomanufacturing, based on know-how from other industries, provides a competitive edge, says the CEO of Samsung BioLogics.
Jan 26, 2018
By Pharmaceutical Technology Editors
Meissner Filtration Products has acquired PDC Aseptic Filling Systems, a supplier of aseptic filling systems and sealers, to expand Meissner's automated platform offerings.
Jan 24, 2018
By Pharmaceutical Technology Editors
The company will invest $139 million in sterile manufacturing technology at its facility in Ballytivnan, Sligo, Ireland to support the growth of its oncology pipeline.
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