Biopharmaceutical processes demand strict levels of quality assurance and material traceability for all items that come in contact with a drug in production. Cleaning processes and maintenance regimes in these environments are rigorous and may stress the equipment and its components if they are not up to the demands of these practices. Often, we find that it is the gaskets and seals that are the weak link causing a loss of process integrity due to:
With procurement teams and process and facilities engineers under constant pressure to reduce costs, many people have assumed that all gaskets and seals are created equal. If a seal is USP Class VI certified then it must be appropriate for biopharmaceutical processes right?
USP Class VI certification is only an indication of biocompatibility, typically performed as part of an initial qualification. It does not indicate or guarantee:
The constant drive to reduce unit costs for elastomeric seals is turning a critical component into a commodity spare part. Many manufacturers, in order to meet the low prices demanded, are buying ‘off the shelf’ compounds, which are selected for their ease of manufacturing rather than operational performance. As a result, while pricing points may be achieved, operational capability is often severely compromised with the use of products unsuited to the demands of the biopharmaceutical environment.
Many of these compounds have their origins in the food, dairy, brewing or chemical processing industries. Few production processes within these industries carry levels of risk of financial loss that exists in biopharmaceutical operations.
Driving for the lowest possible unit cost on elastomer seals will have a severe and damaging impact on a facility’s ability to avoid contamination issues, investigations, leakage and downtime.
As a direct result of saving a few dollars on the cost of a seal, thousands of dollars can be incurred with increased maintenance and unscheduled downtime in addition to millions of dollars risked through product contamination.