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88 training items found
Manufactured by:Particle Measuring Systems (PMS) based inNiwot, COLORADO (USA)
Control of the environment in which pharmaceutical products are manufactured is a key element of Good Manufacturing Practices (GMP). Monitoring of particles & microorganisms in manufacturing cleanrooms, Restricted-Access Barrier Systems (RABS), and isolators consists of clearly defined components. Absence of viable and non-viable contamination is considered a critical quality attribute due to ...
Manufactured by:Particle Measuring Systems (PMS) based inNiwot, COLORADO (USA)
On December 20th, 2017, the draft for a Revision of ANNEX 1 (“Manufacture of Sterile Medicinal Products”) of the EU Guideline for GOOD MANUFACTURING PRACTICE for drug products and drug substances was published. This updated guidline will set a milestone for adjustments needed within European agencies overseeing drug products regulatory applications. During the creation process, the ...
Manufactured by:Particle Measuring Systems (PMS) based inNiwot, COLORADO (USA)
ISO 14644-2:2015 is not only a new standard with which to be compliant, but is also a beneficial tool to use in achieving mature cleanroom environmental control. After the recent release of the ISO 14644-1:2015 Revision Summary and Understanding ISO 21501-4 application notes, Particle Measuring Systems continues the ISO Standards interpretation series of documents with the evaluation of the newly ...
Manufactured by:Particle Measuring Systems (PMS) based inNiwot, COLORADO (USA)
Managers need the assurance that the surfaces in their facilities are aseptic. Gaining that knowledge in a fast and accurate way that also provides results for all surfaces, even and uneven, is a challenge. This webinar helps you identify which critical surfaces you should be monitoring, and discusses and compares various solutions. A new approach to rapid microbial monitoring will also be ...
Manufactured by:Particle Measuring Systems (PMS) based inNiwot, COLORADO (USA)
Personnel pose the greatest risk of false positives in aseptic processing. Investigations are required when microbial activity is detected, costing per investigation and the risk of batch loss. The BioCapt® Single-Use eliminates false positives and costly investigations by preventing direct operator contact with the media plate. The innovative design combines the media plate and sampling head ...
Manufactured by:Particle Measuring Systems (PMS) based inNiwot, COLORADO (USA)
The current trend in Environmental Monitoring Systems (EMS) is to focus on data integrity by using an industrial automated solution instead of the older PC based approaches. PC-based Environmental Monitoring Systems were common in the late 1990 and early 2000s and were the preferred solution because they cost less upfront and have reduced installation times compared to Automated Control ...
Manufactured by:Particle Measuring Systems (PMS) based inNiwot, COLORADO (USA)
Quality by Design (QbD) is a well-known concept in the pharmaceutical industry to increase the overall quality of pharmaceutical drugs and increase patient´s safety. Controlling the quality of air inside an environmental monitoring program is a vital aspect of managing the risk towards the ...
Manufactured by:Particle Measuring Systems (PMS) based inNiwot, COLORADO (USA)
Environmental Monitoring Risk/Gap Analysis: Define or review the monitoring sampling points for your environment with a scientific and risk-based ...