Aseptic/Sterile Processing

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.
Dec 02, 2015
Pharmaceutical Technology
Microorganism lethality requirements for process validation must always be balanced with the need to protect product integrity and patient safety.
Nov 02, 2015
Pharmaceutical Technology
Problems in an induction-sealing process, such as untorqued or crooked caps, can be identified and corrected in real time using dynamic thermal imaging.
Oct 02, 2015
Pharmaceutical Technology
Manufacturers of parenteral drugs face challenges to increase efficiency, control particulates, control extractables and leachables, and eliminate product/package interactions; new containers and packaging equipment offer increased options.
Sep 28, 2015
By Pharmaceutical Technology Editors
The US Pharmacopeial Convention preposts its new chapter on sterile preparations for compounding pharmacies for public review.
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