cGMP Steam and Terminal Sterilizers

Engineered for repeatable process performance and reliable sterilization

BMT USA cGMP sterilizers deliver repeatable process performance and reliable decontamination to meet the rigorous safety and quality standards of pharmaceutical production. Each unit is fully customizable to meet your specific space, workflow, and process requirements.

Constructed with sanitary stainless steel, non-proprietary components, and industrial-grade PLC controls, our sterilizers ensure efficient operation and consistent cycles that protect product integrity and support compliance.

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.

cGMP Sterilizer FAQs

What is cGMP?

cGMP, or current Good Manufacturing Practice, refers to the FDA-enforced standards that ensure pharmaceutical products are consistently produced and controlled according to quality requirements. In relation to steam sterilizers, cGMP compliance means the equipment is designed, built, and operated to support validated sterilization processes that maintain product safety, purity, and integrity throughout production.

What materials can I sterilize using a cGMP Autoclave?

The types of materials that can be sterilized depend on the specific cGMP sterilizer model and configuration. In general, these autoclaves are designed to sterilize a wide range of items used in pharmaceutical and biotech production, including dry goods, porous and wrapped materials, stoppers, hoses, filling line components, and liquid pharmaceuticals in heat-sensitive containers such as PVC bags, plastic bottles, syringes, blister packs, glass vials, and ampoules.

Does BMT USA offer IQ/OQ validation execution?

Every sterilizer is subject to rigorous pre-validation testing at our facility and shipped with an extensive documentation package in order to minimize the time required for on-site validation. Optional IQ/OQ and GAMP-5 protocols, as well as on-site execution are also available.

What other certifications and qualifications does BMT USA offer?

In addition to meeting cGMP 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 8 ft³ to more than 250 ft³. Please contact us for further details on chamber capacities and exterior dimensions.

Does BMT USA offer sterilizer 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 cGMP Autoclaves?

Yes, all our cGMP sterilizers include a standard 1-year warranty on parts and labor, as well as a standard 15-year warranty for the chamber. An optional extended warranty for parts and labor is also available