Validating & Maintaining Sterility for Aseptic Manufacturing

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sterilization validation for aseptic manufacturing

Equipment, environment, and product sterilization work synergistically to provide a clean pharmaceutical product.

  • Mesa offers a variety of product lines to assure sterility of the manufacturing and filling of vaccines, ophthalmology products, infusion treatments, injectable medicines, and IV fluid solutions.
  • In the pharmaceutical setting, all aseptic filling workflows must be sterile.
  • These spaces include process fluid distribution, water for injection, API filling, terminal sterilization of product or packaging components or equipment parts prior to filling, and VHP for depyrogenation tunnels, clean rooms, filling rooms, isolators.
  • There are cost associated risks with improper sterilization.
  • Failed validation cycles, production downtimes, audits, and recalls can occur when proper sterilization is not in place.

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We have equipment validation solutions.

Piping Installations (SIP, WFI)

Conventional issues with sterilizing piping include placing the biological indicator and thermocouple near the elbow of the piping or near potential air pockets and/or cold spots. Avoid condensation or places where there could be an impedance in the piping. 

Bioreactors, Holding Tanks, Freeze Dryers, Autoclaves

Secure without Kapton tape. No risk of loss or damage to biological indicator. Consistent placement. Easy removal / aseptic removal of the biological indicator. 

Terminal Sterilization

Terminal sterilization of equipment components: tubing, filling needles, filter assemblies, decontamination autoclaves, pumps, pass-through ovens.

Clean Rooms, Filling Rooms, Isolators, RABS, Depyrogenation Tunnels

Identifying areas where vapor hydrogen peroxide has difficulty penetrating. Monitoring disinfection of all surfaces. Consistent biological indicator performance. Proper biological indicator selection: carrier, strain, resistance, packaging.

Liquid Products

Minimal processing of sensitive products. Identifying bioburden resistance. Certainty of successful terminally sterilization. Selection of appropriate biological indicators. Avoiding off-label use of biological indicators. Easy aseptic removal of a biological indicator. 

Stoppers, Vials, Syringes

Identifying bioburden resistance. Small and difficult to reach locations. Confidence in successful terminal sterilization of components. Monitoring terminally sterilized packaged product. Selecting appropriate biological indicator. 

Contact Mesa

Product Questions

Contact Technical Support at 303-987-8000 X10042 or bi-support@mesalabs.com

Ordering Information

Contact Customer Service at 303-987-8000 X 10040 or bicustomerservice@mesalabs.com