Steam medical sterilizer

for the pharmaceutical industryfor sterilization servicesfloor-standing

Overview
Steam sterilisation uses pressurised hot steam to reliably inactivate microorganisms. This non-toxic method is widely applied in hospitals, laboratories and pharmaceutical production. These custom-built autoclaves are designed for pharmaceutical companies and medical device manufacturers requiring validated, repeatable sterilisation processes.

Construction and design

• Fully constructed in stainless steel (DIN1.4404 / 316L)
• Available with single or double sliding doors
• Chamber options: rectangular with steam heating/cooling jacket (for stainless steel parts, filters and liquids with pure steam) or cylindrical with internal heat exchangers (for prefilled syringes and bags)
• Air and steam mixing via internal blowers and baffle plates for process-specific control

Control and compliance

• All functions controlled by a programmable logic controller (PLC)
• Operator interface via HMI or supervisory computer
• Programs and supervision interfaces fully documented to meet 21 CFR Part 11 and GAMP requirements

Applications

• Sterilisation of surgical instruments
• Implantable medical devices
• Surgical linens and textiles
• Pharmaceutical production: prefilled syringes, bags, filters and stainless steel parts

Cycles

• Solid cycle
• Liquid cycle
• Air-steam cycle

Technical characteristics

• Material: Stainless steel DIN1.4404 (316L)
• Door options: Single or double sliding doors
• Chamber types: Rectangular (steam jacket) or cylindrical (internal heat exchangers)
• Steam: Standard steam or pure steam for liquid sterilisation
• Air/steam mixing: Internal blowers and baffle plates
• Control: PLC with HMI or supervisory computer
• Regulatory compliance: Programs documented for 21 CFR Part 11 and GAMP
• Typical applications: Medical devices, pharmaceuticals, prefilled syringes, bags, filters, stainless steel parts