Products / GMP Steam Sterilizers
GMP Steam Sterilizers
BMT USA GMP steam sterilizers not only meet the US FDA cGMP guidelines, but exceed industry standards for quality, reliability and serviceability. Every sterilizer is standard equipped with a 316L stainless steel chamber, PLC control system, and extensive validation documentation to meet the exacting requirements of pharmaceutical and biotech applications. BMT USA also offers sterilizer installation, start-up, testing, calibration and preventative maintenance services.
APPLICATIONS
Pharmaceutical
Steam or terminal sterilization of pharmaceutical products, packaging, materials, equipment, and glassware.
Steam or terminal sterilization of pharmaceutical products, packaging, materials, equipment, and glassware.
Biotech
Steam or terminal sterilization of biologics, packaging, materials, equipment, glassware and linens.
Steam or terminal sterilization of biologics, packaging, materials, equipment, glassware and linens.
Steripro
Vacuum Steam Sterilizers
Sterilization Cycles:
- Dry goods – vacuum drying
- Dry goods – pulsed air/vacuum drying
- Solution cycle – gravity air removal/ramped exhaust
- Solution cycle – air over-pressure/jacket water cooling
Applications:
Sterilization of hard or wrapped goods, filters, linens, rubber stoppers, hoses, porous materials, and product unaffected by vacuum.
Sterilization of hard or wrapped goods, filters, linens, rubber stoppers, hoses, porous materials, and product unaffected by vacuum.
Temperature Distribution:
Temperature distribution inside the chamber better than +/- 0.5°C
Temperature distribution inside the chamber better than +/- 0.5°C
Ventipro
Steam-Air Mixture Sterilizers
Sterilization Cycles:
- Steam-air mixture
- Product leaves the chamber dry and ready for labeling
- Faster heating and cooling times than conventional sterilization cycles
Applications:
Terminal sterilization of pressure-sensitive products and packaging, including syringes, plastic bags, and sealed or vented glass containers.
Terminal sterilization of pressure-sensitive products and packaging, including syringes, plastic bags, and sealed or vented glass containers.
Temperature Distribution:
High-performance fans intensify the streaming of the steam-air mixture through the chamber and around the load.
High-performance fans intensify the streaming of the steam-air mixture through the chamber and around the load.
Aquapro
Water Cascade Sterilizers
Sterilization Cycles:
- Hot water cascade
- No pure steam required as water is indirectly heated by plant steam
- Fast heating and cooling for gentle sterilization of heat sensitive loads
Applications:
Terminal sterilization of liquids in sealed containers.
Terminal sterilization of liquids in sealed containers.
Temperature Distribution:
A high capacity water recirculation pump and perforated trays inside the chamber evenly distribute water across the load and all chamber surfaces.
A high capacity water recirculation pump and perforated trays inside the chamber evenly distribute water across the load and all chamber surfaces.
Combipro
Combination Sterilizers
Sterilization Cycles:
- All dry good vacuum and solution cycles
- Steam-air mixture
- Hot water cascade
Applications:
Allows for contract manufacturers and process development centers to establish the optimum sterilization process for any given product or container.
Allows for contract manufacturers and process development centers to establish the optimum sterilization process for any given product or container.
Temperature Distribution:
- High-grade vacuum pumps for dry goods vacuum cycles
- High performance fans for steam-air mixture cycles
- High capacity water recirculation pump and perforated trays for water cascade cycles
GMP Steam Sterilizer FAQs
GMP stands for Good Manufacturing Practice and is regulated by the US Food and Drug Administration (FDA). To meet GMP requirements, sterilizer manufacturers must take proactive steps to ensure that their products are safe, pure, and effective by minimizing or eliminating instances of contamination and manufacturing errors.
GMP regulations also address issues including record keeping, personnel qualifications, sanitation, cleanliness, equipment verification, process validation, and complaint handling.
GMP regulations also address issues including record keeping, personnel qualifications, sanitation, cleanliness, equipment verification, process validation, and complaint handling.
The types of materials that can be sterilized will largely depend on the sterilizer model. However, in general, GMP autoclaves can be used to sterilize equipment and supplies used in the research, development, and production of pharmaceuticals and biotechnology, including dry goods, porous materials, wrapped goods, stoppers, hoses, filling machine parts, and liquids in heat-sensitive containers, such as PVC bags, plastic bottles, syringes, blister packs, and glass.
Every sterilizer is subject to rigorous pre-validation testing at BMT USA’s facility and shipped with an extensive documentation package in order to minimize the time required for on-site validation. IQ/OQ and GAMP-5 protocols, as well as on-site execution are also available as options.
In addition to meeting GMP requirements, BMT USA also utilizes UL-listed control panels for all our sterilizer control systems. Additionally, BMT USA offers options for GAMP-5 document execution and 21 CFR Part 11 compliance for electronic data storage.
BMT USA can design and build a custom chamber to fit your exact space requirements. We also offer a wide range of standard chamber sizes ranging from 8ft3 to more than 250ft3. Please contact us for further details on standard or custom chamber sizes, as well as standard or custom exterior dimensions.
Yes, we can design and build custom trays, loading racks, perforated shelves, and carts to match your specific requirements.
Yes, all our GMP sterilizers include a standard 1-year warranty on parts and labor, as well as a standard 15-year warranty for the chamber. An extended warranty for parts and labor is also available as an option.