Aseptic Processing & Fill Finish

Microtest provides flexible, customizable aseptic processing and fill finish services for all pharmaceutical producers conducting Phase 1, 2, or 3 clinical trials. Large manufacturers that don’t wish to divert high-capacity production lines find Microtest a fast, efficient, cost-effective alternative. Smaller makers that lack personnel or resources discover a partner with all the specialized knowledge, experience, and facilities they need.

Before purified, sterilized drugs received from a manufacturer can be dispensed into vials, complex preparation must occur. Our batch record establishes standard operating procedures for each specific fill process, including determination of empty vial weight, packed weight, and so on. Microtest specialists also prepare supplies and equipment to be used. Sterilization ensures contamination won’t be introduced; depyronization bakes glassware to eliminate endotoxins. Cleaning and environmental testing by our in-house environmental group releases fill and finish areas for pristine operation.

Our state-of-the-art SCADA systems provide continued environmental monitoring for the duration of all fill finish operations.

As necessary, Microtest can aseptically process the drug itself. A preliminary fill with cultured media functions as a proof of concept, incubating the result to make sure no contamination is present. Then we efficiently perform the main fill using our newly expanded, state-of-the-art fill suite. Subsequent testing determines continued sterility and lack of endotoxins, plus proper dilution and protein percentages.

The finish stage includes applying of stoppers, operation of custom crimp sealers, and particle inspection, plus labeling and label inspection.

Customers report a high level of training and expertise in Microtest personnel, including extensive experience with proper aseptic processing and fill finish techniques. And we offer an emphasis on customization not found in many other labs. We work with you to do the job the way you want it, tailoring our procedures to the way you work.

Microtest fill finish operations comply with both U.S. FDA and European EMEA guidelines, and have been inspected and passed by regulators from each organization.