Paperless Environmental Monitoring for Aseptic Pharmaceutical Manufacturing
Air particle counting instruments used for biopharmaceutical environmental monitoring have essentially remained unchanged for many decades. However, every year millions of dollars and countless labor hours are spent on the manually intensive activities associated with paper-based methods. Reams of paper printouts, hours of cutting, taping and manually transcribing data is the norm for mainstream biopharmaceutical manufacturers. All of which result in costly inefficiencies and waste. Perhaps even more critically, these manual methods have been a significant source of human error which cause unnecessary investigations and rework. While add-on software “solutions” purporting to alleviate these problems abound, most operate in isolation from the company’s LIMS platforms and invariably provide outdated and non-21CFR part 11 file formats. This application paper describes how the MET ONE 3400 portable air particle counter, designed specifically for biopharmaceutical cleanroom applications, can save up to two operator-hours per day by eliminating the need to manually tear, tape and copy portable particle counting print-out data while also avoiding data transcription errors.