Search results for " aseptic"
Article
Best Practices in Qualification of Single-Use Systems
The author discusses the current best practices in technical qualification of single-use systems.
By Weibing Ding, PhD
Single-use technology has been around for approximately two decades if …
Article
Fluid Handling in Biopharma Facilities
Whereas powder applications are typically handled in clean and controlled manner, fluids often need to be managed by an aseptic or validated sterile method.
BioPharm: What storage concerns are ass…
Article
Risk Assessment and Mitigation in Biopharmaceutical Manufacturing
PDA, Technical Report 44, Quality Risk Management for Aseptic Processes (PDA, 2008).
4. PDA, Technical Report 54, Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Man…
Article
A Look Ahead at BioPharma Manufacturing and Regulation
The FDA talks about the changing scope of regulatory science.
Regulatory science underpins innovation and practices in drug manufacturing. The most common definition of r…