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:
- Failure to establish adequate air supply under positive pressure in aseptic processing areas.
- Failure to establish adequate systems for monitoring environmental conditions in aseptic processing areas.
Remediation activities included smoke studies, HEPA filter integrity testing and particulate testing to be performed. The Experts at Medvacon can conduct a facility assessment to ensure compliance and assess your processes and operations to assist in reducing microbial contamination.
There are other demonstrations of aseptic processing as in the case study that cited inadequate media fills and poor aseptic behavior. The injectable manufacturer failed to accurately simulate commercial operations. Manual operations were not representative of the full process and revealed poot aseptic techniques. Remediation activities included a comprehensive review of the media fill program and open a CAPA to ensure an accurate simulation, including appropriately incorporating the worst-case conditions of commercial manufacturing.