Bowie-Dick Test in Pharmaceutical Sterilization: Principle, Procedure, Acceptance Criteria & Compliance
Bowie-Dick Test in Pharmaceutical Sterilization: Principle, Procedure, Acceptance Criteria & Compliance Guide The Bowie-Dick Test is a diagnostic steam sterilization performance test used to verify air removal efficiency and steam penetration in vacuum autoclaves used in pharmaceutical sterilization processes. The Bowie-Dick Test is one of the most critical quality assurance tests used in pharmaceutical sterilization. It verifies the ability of a steam sterilizer to effectively remove air and allow proper steam penetration in porous loads. In pharmaceutical manufacturing, incomplete air removal inside the autoclave chamber can lead to sterilization failure , which may compromise sterility assurance and patient safety. Therefore, regulatory agencies and industry guidelines require routine verification of air removal efficiency using the Bowie-Dick test. This comprehensive guide explains the principle, procedure, acceptance criteria, troubleshooting, regulatory expectation...