Products / GMP Steam Sterilizers

GMP Steam Sterilizers

Suitable for Applications In:


Pharmaceutical

Biotech
BMT USA’s GMP steam sterilizers not only meet the US FDA cGMP guidelines, but exceed industry standards for quality, reliability and serviceability. We offer steam sterilizer solutions for any pharmaceutical or biotech application, and will work with you to meet your exact requirements. BMT USA also offers sterilizer installation, start-up, testing, calibration and preventative maintenance services.
Steripro GMP Vacuum Steam Sterilizer

Steripro

Vacuum Steam Sterilizers
Ventipro GMP Steam-Air Mixture Steam Sterilizer

Ventipro

Steam-Air Mixture Sterilizers
Aquapro GMP Steam Sterilizer

Aquapro

Water Cascade Sterilizers
Combipro Pharmaceutical Steam Sterilizer

Combipro

Combination Vacuum, Steam-Air Mixture, and Water Cascade Sterilizers

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.
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.