Services

Validate / Qualify

Validation is not only a critical step when installing a new autoclave, it is also a recurring obligation: each year, the autoclave must be requalified to confirm it still performs to specification. Imtech-Steri delivers independent, fully documented validation and qualification for autoclaves of any brand, so your sterilization process stays compliant and audit-ready.

Four Parts of a New Autoclave Qualification

Design Qualification

A critical process that verifies a design meets all requirements and specifications before construction or implementation.

Installation Qualification

A critical process that verifies the installation is carried out according to the requirements.

Operation Qualification

To ensure that process control limits and action levels meet all predetermined requirements.

Performance Qualification

To ensure that all processes, under anticipated conditions, consistently produce a product which meets all predetermined requirements.

Why Validation Matters

In regulated environments, a sterilization process is only as trustworthy as its documented proof. Validation demonstrates, with evidence, that your autoclave consistently reaches the required conditions. It is required for every new installation and must be repeated at defined intervals, typically once a year, to keep your GMP status and pass audits.

What We Deliver

DQ, IQ, OQ and PQ protocols for new equipment
Annual requalification to keep your autoclave compliant
Steam quality checks and thermometric studies
Complete, audit-ready documentation
Brand-independent service, for any autoclave in your facility

Standards & Compliance

Our validation and qualification work is aligned with ISO 17665 and EN 285, and supports EP/USP and GMP requirements, including the principles of GMP Annex 15.