Verification of Sterilization Quality

Release time：2015-07-28

Over the more than 100 years since the introduction of steam sterilization, both the technology and the associated equipment have advanced rapidly. Practical experience has demonstrated that moist heat, with its simplicity, cost-effectiveness, reliability, and broad applicability, has become the method of choice, maintaining a stable leading position for many years. Even in today’s era of continuous emergence of new processes and methods, moist heat still accounts for over 90% of all sterilization treatments.

Currently, the primary approach to quality management of thermal equipment is validation. The GMP guidelines issued by the National Medical Products Administration contain explicit provisions and requirements for validation activities in pharmaceutical manufacturing. Validation is an essential component of GMP and must be conducted according to a predetermined protocol; the results of each validation study shall be documented and retained for audit purposes. Manufacturing processes and procedures should be based on validation and undergo periodic revalidation to ensure that they consistently deliver the intended performance. The objectives of process validation include: identifying cold spots within the process, establishing appropriate process parameters, conducting trials to verify operational reliability and reproducibility, and thereby ensuring that the final product meets a microbial contamination level of no more than one part per million.

Sterilization methods

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