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RESEARCH
Creating the Best Environment From The Start
Simply put, eliminating the risk of contamination is better than merely monitoring it. Though it is widely understood that isolators and RABS provide more sterile environments than human-scale cleanrooms, these cleanrooms have improved drastically over the last few decades, resulting in decreased “hits” in monitoring systems.2
This is not to say
that EM can or should be eliminated but, the increased introduction of automation equipment - mentioned as the single most significant factor contributing to better environments - continues to reduce the need for human contact while simultaneously decreasing the presence of biocontaminants.2
In addition, air changes per hour have drastically
increased from around 100 to approximately 800; and improved growing materials are more efficient at filtering microbial elements.2
It
is worth noting, however, that improvements to monitoring equipment and supplies are aiding here as well. Products such as Merck’s Isobag, for example, offer decreased human contact and easier system integration, both of which help decrease the introduction of biocontaminants,
while TSI’s BioTrak Real-Time Viable Particle Counter provides instant particulate detection and identification.
These improvements have been so significant that low recovery rates in monitoring systems are leading to over-analysis of data which, in turn, has lead to additional monitoring and even unnecessary panic, stemming from a lack of understanding regarding the limits of these systems. This includes the unavoidable contamination that human interaction presents.2 remain important.
Despite these improvements, EM is likely to
By controlling contamination through robust processes, evolved cGMP and the elimination of human intervention through RABS, isolators and improved cleanroom procedures, manufacturers can reduce contamination risks, but monitoring systems are critical to maintaining an acceptable Grade A, ISO 5 or other sterile environments. And, until manufacturing perfection can be reached, improved monitoring systems and methods will help to improve accuracy, offer an additional safeguard and reduce the risk of costly contamination issues.
To learn more about Nice Insight contact Emilie Branch at
Emilie@thatsnice.com or visit
www.niceinsight.com and the annual study websites: clinical services at
www.niceinsightcro.com, contract development and manufacturing at
www.niceinsightcdmo.com, phar- maceutical excipients suppliers at
www.niceinsightexcipients.com and pharmaceutical equipment (products, systems and services) at
www.niceinsightpharmaequipment.com.
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pharmoutsourcing.com | 43 | November/December 2016
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