Microbe-carrying particle recovery efficacy with manual surface sampling
Three different contact plate methods were tested to determine a convenient manual surface sampling technique for microbial contamination recovery, the paper explained.
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Three different contact plate methods were tested to determine a convenient manual surface sampling technique for microbial contamination recovery, the paper explained.
The type of clothing worn in aseptic manufacturing areas may impact the number of particle and airborne bacteria detected in biosafety cabinets.
Employing an automated, alternative microbiological method (AMM) means water activity could be used as a microbial indicator for bioburden assessment in tablets and capsules, a study suggests.
According to the paper, the control strategy for rapid bioburden testing provides manufacturers with enhanced capabilities for process control.
Research suggests that to prevent common mould growth, low-dose far-UVC light could be applied as a chemical-free addition to manual cleaning of indoor surfaces.
This report is dedicated to exploring some of the latest advances in pharmaceutical environmental monitoring, covering topics from contamination control and cleanroom validation through to emerging technologies for bacterial endotoxin testing.
Research suggests the rapid detection method “will enable the timely implementation of microbiological monitoring strategies for large batches of medications”.
While fungal contamination detection in pharmaceutical manufacturing remains a challenge, preventive practices and policies must be followed, research states.
A study investigating microbial risks of the entire manufacturing process has identified MALDI-TOF MS as a promising first-line tool for pharmaceutical environmental monitoring.
Revisions for two proposed USP chapters recommend changes for rapid tests required for releasing sterile short-life products, as well as for rapid microbiological methods (RMM) for detecting contamination in these products.
Driven by a rise in infectious diseases and advancements in digital technologies, increased demand for rapid microbiology testing is set to accelerate the market’s growth.
The bacterial detection method is robust and highly sensitive over a wide concentration range and does not require DNA amplification, research suggests.
Aptamers offer a “cutting-edge approach” for identifying gram-negative bacterial pathogens, a paper suggests.
Here, Kathy Zagaroli, Senior Director of Quality Control at Kiniksa Pharmaceuticals, and Tom Bujold, Senior Director of Quality Control at REGENXBIO, discuss the challenges of bioburden and sterility testing for gene therapies and why industry must come together to drive increased harmonisation.
A new 24-hour sterility testing method combining nanopore sequencing and machine learning could revolutionise sterility assurance in biopharmaceutical manufacturing of cell therapies.