Pharmaceutical-Grade GMP Steam and Terminal Sterilizers

BMT USA GMP sterilizers deliver precise process repeatability, reliable performance, and effective decontamination to satisfy the stringent safety and quality requirements of pharmaceutical production facilities. Our pharmaceutical-grade sterilizers can be fully configured to your exact specifications for space, layout and functionality, ensuring you receive the right solution to match your requirements.

Engineered for repeatable process performance and reliable sterilization

Our tight adherence to current Good Manufacturing Practices (cGMP), combined with fully sanitary stainless steel construction, the highest quality non-proprietary components and industrial-grade PLC control systems, ensures reliable performance, precise process repeatability and effective sterilization — securing the safety of your work environment and protecting the quality of your products.

Steripro

Saturated Steam Sterilizers

Sterilization of hard or wrapped goods, filters, linens, rubber stoppers, hoses, porous materials, and product unaffected by vacuum.

Ventipro

Steam-Air Mixture Sterilizers

Terminal sterilization of liquids in sealed containers that are heat or pressure sensitive. At the end of the sterilization cycle, the load is cool, dry and ready for labeling.

Aquapro

Hot Water Cascade Sterilizers

Rapid terminal sterilization of liquids in sealed containers that are heat or pressure sensitive.

Combipro

3-in-1 Combination Sterilizers

Provides flexibility to contract manufacturers and process development centers to apply the right sterilization process for any given product or container.

GMP Sterilizer FAQs

What is GMP?

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.

What materials can I sterilize using a GMP Autoclave?

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.

Does BMT USA offer IQ/OQ validation execution?

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.

What other certifications and qualifications does BMT USA offer?

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.

Do you offer different chamber volumes?

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.

Does BMT USA offer custom loading equipment?

Yes, we can design and build custom trays, loading racks, perforated shelves, and carts to match your specific requirements.

Does BMT USA offer a warranty for GMP Autoclaves?

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.