Search results for " cross contamination"
Article
Automation Trend in Fill/Finish Reduces Contamination Risk
ABL reported that the new system uses a disposable product-contact path to limit cross contamination and is contained in a RABS to increase sterility assurance level (SAL) and reduce the risk of rando…
Article
Bioburden Control in the Biopharmaceutical Industry
Protecting against microbiological contamination over the whole manufacturing process grows increasingly important.
By Mostafa Eissa
The biopharmaceutical industry has witn…
Article
Gowning Practices Provide Clues to cGMP Compliance
•The risk of mix-up and cross contamination is heightened.
•There is an excessive amount of standard operating procedures.
•Air-handling units are not efficiently designed or operated.
Altho…
Article
Defining Risk Assessment of Aseptic Processes
The cleaning of the line after manufacturing is personnel dependent and, if done incorrectly, can put the next product manufactured on the line at risk of microbial and/or cross contamination. There a…
Article
Real Time Continuous Microbiological Monitoring
Laser-induced fluorescence, a rapid microbiology method for real-time airborne particle and microbial monitoring, enhances sterility assurance in pharmaceutical manufacturing.
By Claudio Denoya …
Article
A Plastic Pipeline for Commercial Bioprocessing?
…r times, the reduction or elimination of cleaning steps and cleaning validation, and a lower risk of cross contamination are recognized as benefits of single-use systems compared with traditional sta…
Article
Best Practices in Qualification of Single-Use Systems
…ntages:
• Flexibility
• Less up-front capital investment
• No batch-to-batch cross contamination
• No re-use cleaning validation
• Less work on scale up
• Shortened time…
Article
Using Single-Use Technologies in Downstream Processing
Mehta states that the use of SUS in downstream processing may “reduce risk of cross contamination and carryover due to inadequate cleaning steps.”
BioPharm International spoke with Nilesh Mehta ab…
Article
Strategizing for Rapid Changeovers in Biologics Manufacturing
Closed-system design and operation in and between unit operations also mitigates the potential for cross contamination, states Husain. Closed processing is essential because it provides a better respo…
Article
Maximizing the Effectiveness of Upstream Bioprocessing Through the Combination of Lab Informatics and Instrumentation
The key benefits of this approach are reduced manufacturing facility footprint and upfront investment, faster changeover between batches, reduced risk of cross contamination, and greater flexibility i…