Search results for " bioburden" in Articles / App Notes
Article
Single-Use for Downstream Chromatography: Benefit or Hindrance?
Thus, good sanitation methods and familiarity with the most likely microbial contaminant species present in the immediate environment are needed to address bioburden. Using pre-sanitized single-use co…
Article
Reducing Cross-Contamination Risks in Process Chromatography
In addition, disposable flow-paths on single-use downstream processing equipment typically come gamma irradiated, leading to better bioburden control, according to Lundström. Preparatory and post-proc…
Article
Development and Future of Protein A Chromatography Technology: Q&A with Jonathan Royce, Business Leader Chromatography Resins, Cytiva
Now, 1M NaOH can in fact be used, improving the bioburden control, and the binding capacity is now up to 80 g/L. With an increased binding capacity and new high-flow agarose bead design, the productiv…
Article
Process Chromatography Selection for Downstream Processing Applications
In order to address bioburden, one needs good sanitization methods and knowledge about likely species present in the local environment. Techniques such as closed column packing and/or the use of pre-s…
Article
Microbiological Testing: Time is of the Essence
…or ensuring sterility, determining antimicrobial effectiveness, detecting microbial contamination or bioburden levels, analyzing endotoxins, and implementing environmental monitoring programs. Growin…
Article
Aseptic Processing: Keeping it Safe
A concise environmental monitoring program can help a manufacturer assess product bioburden that may be attributable to water-derived organisms.
Operator interventions
The most common introduc…
Article
Strategizing for Rapid Changeovers in Biologics Manufacturing
“Environmental monitoring of different rooms is necessary to ensure they stay within qualified requirements (temperature, pressure, humidity, bioburden, etc.) Some sampling is manual, but where possib…
Article
Improving mAb Manufacturing Productivity by Optimizing Buffer and Media Prep Process Flow
…idelines (6), extractable and leachable profiles using BPOG guidelines on single-use components, and bioburden and endotoxin specifications on validated processes to manufacture these concentrates ar…
Article
Biopharmaceutical Process Development: 2018 Lessons and 2019 Predictions
The biopharmaceutical industry continues to expand in new and exciting ways. What might be in store for 2019, and what important lessons should process developers take from 2018? Here, we look back …
Article
Evaluating Surface Cleanliness Using a Risk-Based Approach
Conclusion
Surface cleanliness is crucial in ensuring that process residue, cleaning agent residue, and bioburden do not adversely affect the safety, quality, and potency of the drug manufactured.…