Aseptic/Sterile Processing

Mar 18, 2016
By Pharmaceutical Technology Editors
The agency cited Emcure Pharmaceuticals with CGMP violations.
Mar 16, 2016
Equipment and Processing Report
Revised versions of ISO 14644 Parts 1 and 2 introduce changes to sampling procedures and monitoring plans for cleanrooms and clean zones.
Feb 18, 2016
Equipment and Processing Report
Regular removal of residues from disinfectants and sporicidals is important for improved aesthetics and safety in cleanrooms.
Feb 18, 2016
Manufacturing of antibody drug conjugates requires high-containment solutions, such as high-performance aseptic isolators.
Feb 08, 2016
Single-use systems (SUS), also called disposable technology, can improve manufacturing efficiency by reducing the time needed for cleaning and cleaning validations. When implementing disposable technology for aseptic processing, considerations include material compatibility, material sourcing, facility layout, and training. It is important, however, to understand the challenges associated with using SUS and to have plans in place to mitigate risk. Steve Nole and Amanda Hawkins, from CMO Grand River Aseptic Manufacturing (GRAM), spoke with Pharmaceutical Technology about some of the best practices the company has implemented in using SUS.
Jan 13, 2016
By Pharmaceutical Technology Editors
Sensaphone's monitoring system provides low-cost, 24/7 remote monitoring of unattended freezers and coolers.
Jan 02, 2016
Pharmaceutical Technology
The revised USP Chapter <1207> Sterile Product Packaging—Integrity Evaluation gives best practices for obtaining reliable data in container closure integrity testing and recommends quantitative deterministic methods rather than probabilistic methods.
Jan 02, 2016
Pharmaceutical Technology
Parenteral packaging of the future will include more automated lines, ready-to-fill packaging formats, and supply-chain transparency.
Dec 16, 2015
Equipment and Processing Report
Collaboration between users and suppliers to increase understanding, clearly define user requirements, and mitigate risk is facilitating acceptance by industry and regulators.
Dec 02, 2015
Pharmaceutical Technology
All openings and potential breaches for air penetration must be considered when designing a cleanroom so that the HVAC system can maintain the desired negative or positive pressure.
native1_300x100
lorem ipsum