Laboratories

An interesting case study of medical device manufacturer who received complaints of bacterial contamination on several devices.  The root cause of the contamination was a change in specification to monitor microbial limits.  These limits were removed assuming that the end user sanitized the device prior to use.  There was also a facility modification that compromised […]

Another case study, in which facility contributed to contamination issues, was an ISO 5 classified zone in which the microbial contamination was recovered.  The product manufactured in this area was exposed to this contamination.  Additional citations were: Remediation activities included smoke studies, HEPA filter integrity testing and particulate testing to be performed. The Experts at

There were several warning letters that cited issues with aseptic processing.  The main factors contributing to microbial contamination were facility design and monitoring and personnel movements Case Study – Restricted Access Barrier Systems (RABS) A case study demonstrated the lack the fundamental designs of Restricted Access Barrier Systems (RABS).  There were no rigid wall designs