[HTML][HTML] Sterility Assurance Across-Sectors—New Paradigms and Tools
BJ Lambert, JM Hansen, TD Bryans… - Frontiers in Medical …, 2021 - frontiersin.org
The sterility assurance community is facing significant challenges. A relatively recent
challenge is the pressure on manufacturing supply chains resulting from the limited …
challenge is the pressure on manufacturing supply chains resulting from the limited …
[PDF][PDF] Sterility assurance-current & future state
EC Tidswell, JP Agalloco… - PDA Journal of …, 2021 - researchgate.net
Manufacture by aseptic processing accompanied by end product compendial sterility testing
has been the predominant means of production and disposition of therapeutics requiring the …
has been the predominant means of production and disposition of therapeutics requiring the …
The Boil Test—Strategies for Resistance Determination of Microorganisms
J Agalloco, EC Tidswell - PDA Journal of Pharmaceutical Science …, 2018 - journal.pda.org
The terminal sterilization of drugs and devices is the most appropriate means of assuring
patient safety in terms of infection prevention. Adoption of terminal sterilization processes …
patient safety in terms of infection prevention. Adoption of terminal sterilization processes …
[PDF][PDF] REDECORATING THE DECISION TREE
J Agalloco - PROCEEDINGS OF THE COUNCIL …, 2020 - councilforpharmaceuticalexcellence …
In March 2019, EMA issued the second official version of its Guidance document on the
selection of sterilization methods for pharmaceutical materials (EMA, 2019). This document …
selection of sterilization methods for pharmaceutical materials (EMA, 2019). This document …