Autoclave and Sterile Tunnel Qualification Services

In the stringent regulatory framework of the pharmaceutical industry — including GMP and related standards — the qualification of autoclaves and sterile tunnels, especially for parenteral (injectable) products, is of critical importance.

Comprehensive documentation of the equipment’s performance and operational parameters must be developed to ensure compliance and product safety.

Our company offers full qualification services — Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) — for autoclaves and sterile tunnels, in accordance with DIN 12880 and all other applicable standards.

Key Service Features

• Use of nine (9) wireless autoclave sensors for accurate temperature mapping
• Complete temperature mapping under both empty and fully‑loaded conditions
• Provision of temperature profiles and pressure profiles for autoclave operating cycles
• Preparation of qualification protocols with client approval before dispatching technical experts
• Execution of additional required tests according to relevant standards
• Delivery of full, detailed documentation packages

For more details on test procedures, please complete and submit our Equipment Qualification Request Form.