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Manufacture Facilities, Quality & Compliance, Standards & Regulation, Small Molecules, Technology and Equipment

Keeping Fit With Age

sponsored by CRB

Like everything else, sterile manufacturing facilities age and performance deteriorates over time. Many of the first and second generation biomanufacturing facilities are now 15-20 years old, so it’s no surprise that sterility issues and product recalls are on the rise. One of the early warning signs that a facility is in need of some attention is an increase in batch failure rates – companies want batch failure to be less than 1 percent, but the Parenteral Drug Association has noted that it can be much higher: “Alarmingly, 80 percent of respondents to a survey conducted by the Parenteral Drug Association in 2016 had batch rejection rates of up to 4 percent due to a lack of sterility assurance or the potential thereof, and 15 percent of those respondents had rejection rates of 5-10 percent” (1).

Issues with facilities and equipment can lie dormant as operators or maintenance technicians make small tweaks to compensate, but in time this can lead to other problems. Increasing contamination rates in older bioreactors are one common problem, for example, and the kneejerk reaction is often to turn up the steam cycle or temperature, but this can lead to gasket or other component failures. If equipment is becoming a source of contamination or is difficult to clean, then it is likely to be outmoded and you may need to consider replacement. Also, bear in mind that older equipment designs tend not to be the most efficient anyway – they may have nooks and crannies that complicate cleaning, or may require significant manual intervention, so it’s good practice to continuously evaluate newer systems.

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