3Q qualification of autoclave

For healthcare, pharmaceuticals and research sectors demanding strict hygiene safety, autoclaves faithfully protect sterile conditions.

1. GMP

GMP (Good Manufacturing Practice) is a set of internationally recognized quality and safety standards, specifically formulated to govern production processes in the pharmaceutical, food, cosmetic, medical device and other industries. It regulates the entire workflow ranging from facility design, production and packaging to storage and transportation, ensuring products comply with specified requirements for safety, purity and quality. The 3Q qualification of instruments and equipment carried out by pharmaceutical enterprises is also a key part of GMP certification and inspection.

II. 3Q qualification

A complete qualification protocol for instruments and equipment generally consists of four phases, namely 4Q:

DQ (Design Qualification) It verifies that the equipment design complies with user requirements and relevant regulatory provisions.

IQ (Installation Qualification) It is performed during on-site installation. Documentation shall be provided to prove that all specifications and parameters of the installation environment fully conform to the manufacturer’s specifications and safety requirements.

OQ (Operational Qualification) It is conducted after installation and repeated periodically thereafter at intervals recommended by the manufacturer and confirmed by the user. Relevant documentation shall be provided to demonstrate that all components and functional parameters of the equipment meet the manufacturer’s specifications and operate properly during use.

PQ (Performance Qualification) It verifies that the equipment system is fit for its intended use. Tests are generally performed with the user’s samples in accordance with the user’s established procedures.

In actual qualification practices, only IQ, OQ and PQ are commonly implemented, which are widely referred to as 3Q qualification.

III. 3Q qualification procedure

1. Pre-qualification preparation

Conduct preliminary research, confirm qualification conditions and processes, draft and coordinate the qualification protocol, perform pre-calibration of temperature probes, and complete review, approval and signing of the protocol.

2. On-site qualification activities

① Installation qualification: Verify relevant equipment information, documents and installation conditions to ensure the equipment is ready for operation.

② Operational qualification: Check whether all operational functions work properly, and confirm that all metering and counting functions comply with relevant national standards.

③ Performance qualification: Verify whether the equipment complies with specified standards under loaded operation. As the core part of 3Q qualification, it mainly consists of three tests: empty load heat distribution test, loaded heat penetration test and microbial challenge test.