Pharmaceutical companies are unwittingly putting production processes at risk of contamination by fitting mechanical seals which fail to comply with EU regulations. says John Smiddy, European Sales and Technical Support Director for AESSEAL. Here he explains how non-compliant seals might slip through the net and suggests how the issue can be resolved.
Contamination
The regulations relating to mechanical seals in pharmaceutical production processes couldn’t be simpler: every component in contact with an active pharmaceutical ingredient (API) must be 100% traceable and a statement of compliancy must be clearly marked on the packaging it comes in.