Steam sterilizers for pharmaceutical products ensure safe and standards-compliant sterilization of sensitive pharmaceutical goods through controlled steam application.
Scope of Application:
The relevant standard applies to steam sterilizers with horizontal loading and a minimum nominal size of 6×6×6, used for the sterilization of pharmaceutical products. These systems use saturated steam, steam-air mixtures, or steam-hot water-air mixtures.
Definitions:
This includes definitions and descriptions of the individual process steps such as heating, evacuating, cooling, and drying.
Equipment Requirements:
Equipment requirements include specifications for the sterilization process, technical construction of the devices, performance parameters, and requirements for measurement, control, and regulation technology (MSR technology). Appropriate accompanying documentation and labeling are also required.
Acceptance Testing:
Acceptance testing includes various types of tests such as DQ (Design Qualification), IQ (Installation Qualification), OQ (Operational Qualification), testing according to DG guidelines, occupational safety checks, program validation, and product-specific validation. This also includes checklists, testing locations, scope of tests, and necessary equipment and tools.
Operation:
Operation requires proper assignment of sterilization goods to suitable procedures. Prerequisites for intended use must be met. There are also guidelines for changes, qualification and requalification of the systems, as well as their decommissioning.
Operating Resources and Structural Requirements:
This includes requirements for the operating media such as steam, water, and air. In addition, structural specifications must be followed. Forms are provided for supply and disposal documentation.
