Vial Integrity Testing

Microtest possesses long experience in testing the integrity of pharmaceutical product vials or medical devices.

This testing challenges the microbial barrier effectiveness of a test package by immersion in an actively growing bacterial culture. Brevundimonas diminuta (B. diminuta) is often used because it’s one of the smallest known bacteria, though customers may specify another challenge organism if desired.

Testing comprises the following steps:

1. Vials containing sterile product are immersed in a known concentration of challenge organism for a predetermined time.
2. Vials are removed and their inner contents cultured to indicate any trace of the challenge organism, according to procedures and media specified by the United States Pharmacopeia (USP).
3. Recovery testing is performed via qualitative methods to determine the extent of any bacterial penetration.

Customers should submit a minimum of 24 vials or packages — 20 for challenge testing and 4 for control samples. The reporting period for vial integrity is usually 2 weeks from setup.

Culture media are quality-controlled under our Good Manufacturing Practices program and all incubators regularly calibrated, ensuring optimal recovery of challenge organisms. Experienced Microtest regulatory microbiologists perform all testing.