Overview


cGMP Sterilizer Brochure
Key Features:
- US FDA cGMP compliant
- Extensive validation documentation
- 316L stainless steel chambers with complete envelope 316L stainless steel jacket
- Allen-Bradley or Siemens PLC control system
- Temperature distribution better than +/- 0.5°C
- Insulated chamber and piping reduces utility consumption
- Can be programmed with any type of sterilization cycle or combination of cycles
- Automatic pneumatic driven precision sliding doors – chamber doors are solid 316L stainless steel and secured on all four sides
- Lubricant free door gaskets
- 21 CFR part 11 compliance for secure electronic data storage
Engineered Features

Combined Sterilization Cycles
BMT USA understands that validation is a critical concern when purchasing a GMP sterilizer, so special attention has been given to the documentation and repeatability of each system. Every Combipro steam sterilizer is subject to rigorous pre-validation testing at the factory and shipped with an extensive documentation package to help minimize the time required for onsite validation. IQ/OQ protocols and on-site execution are also available as options.
BMT USA Combipro sterilizers are equipped with highly polished chambers made entirely of 316L stainless steel for superior durability. The chamber door is also made from solid plate 316L stainless steel. Precision machined door brackets for retaining the door on all four sides ensures smooth travel and improved security during the sterilization cycle. All chamber connections are sanitary clamp type and sloped to drain. Lubricant free door gaskets last longer and will eliminate particle shedding into clean rooms.
The primary use of BMT USA Combipro Steam Sterilizers is for production in pharmaceutical and biotech facilities where repeatability is an important criteria. Combipro sterilizers utilize high-grade vacuum pumps, the highest quality instrumentation, and industry-standard PLC control systems to ensure repeatable cycles regardless of changing environmental conditions. Temperature distribution within the chamber is better than +/- 0.5°C
The control system can configure and store 20 sterilizing cycles, which are accessed via a large touch screen operator interface terminal. In double door units, operator interface terminals are mounted on both the load and unload side of the sterilizer. All sterilizer functions are accessed through these screens and are secured by multi-level authentication. If electronic data storage is desired, the control system can be provided with 21 CFR part 11 compliance when connected to a PC or central computer system. The control system can also be equipped with different types of printers and recorders for data storage on paper.
Combipro Sterilization Cycles

The dry good cycle provides effective sterilization of hard goods, filters, linens, and other porous materials, wrapped goods, and products that are unaffected by vacuum. The load is preconditioned utilizing vacuum and steam pulses. The cycle then advances to heat-up and continues until it reaches the settable exposure temperature of 110°C up to 135°C. Once the exposure temperature set point is reached, the controller counts down the exposure time. After the exposure time is completed, drying begins and can be accomplished by fast exhaust and pulling a deep vacuum to remove moisture.
This cycle provides effective sterilization of rubber stoppers, hoses, and other material where trapped moisture can be difficult to remove. The load is preconditioned utilizing vacuum and steam pulses. The cycle then advances to heat-up and continues until it reaches the settable exposure temperature of 110°C up to 135°C. Once the exposure time is completed, drying begins and is accomplished by fast exhaust, vacuum, and air pulses which are highly effective at removing moisture from the load. To aid drying further, the air can be heated.

The solution cycle with gravity effectively sterilizes liquid products or items in vented or sealed glass containers. The load is preconditioned utilizing steam pulses. The cycle then advances to heat-up and continues until it reaches the settable exposure temperature of 110°C up to 135°C. Once the exposure temperature set point is reached, the controller counts down the exposure time. After the exposure time is completed, exhaust ramping gradually returns liquids to a temperature below boiling.

The solution cycle with gravity effectively sterilizes liquid products or items in vented or sealed glass containers. The load is preconditioned utilizing steam pulses. The cycle then advances to heat-up and continues until it reaches the settable exposure temperature of 110°C up to 135°C. Once the exposure temperature set point is reached, the controller counts down the exposure time. After the exposure time is completed, cooling of the product is started by injecting air at a pressure similar to that of the product to avoid breakage of the container. Cold water is introduced to the jacket of the chamber to help cool the product at a faster rate.

This cycle effectively sterilizes liquid products or items in vented or sealed containers. Heating occurs with steam while injecting compressed air to a preset differential over-pressure. The steam and air are circulated and mixed by the internal fans to ensure a rapid heat up to the user-configured exposure temperature, between 110°C and 135°C. The control of the air over-pressure is independent of the saturated steam pressure but corresponds to the temperature and pressure inside the load. Once the exposure temperature set point is reached, the controller counts down the exposure time. After the exposure countdown completes, the steam is stopped and cool air is blown across the load via the fans. During the cooling step, a preset support pressure is maintained in the chamber to prevent damage of the product containers . The load is cooled to a safe temperature and the pressure in the chamber is vented to atmosphere before the door can be opened.

The cycle begins with filling the chamber to a predetermined level with purified water. The water is circulated by a high capacity pump through an external heat exchanger that is heated by plant steam. The water is distributed through a perforation tray onto the product. Due to the efficient heat transfer of the water, the product is heated rapidly. Compressed air at an over-pressure is injected into the chamber to compensate for the rising temperature and pressure that builds inside liquid containers when heated. At the end of the exposure step, cooling begins. The circulating water is cooled by an external heat exchanger that is cooled with cooling or chilled water. The load is quickly cooled to ambient temperature by continuously being sprayed with the circulating water. This method of sterilization is the fastest method for sterilization of liquids in sealed containers.
Sterilizer Steam Source
Electric Heated Steam
Steam-to-Steam
Vertically Integrated Electric Clean Steam Generator Option
P: 360-863-2252
E: Sales@BMTUSA.com
Sterilizer Loading Equipment


Sterilizer Accessories & Options
Combipro Chamber Sizes
Model
Chamber Dimensions
Chamber Volume
Mountings
Door Slide Direction
Chamber Dimensions
508 x 508 x 965 mm
Chamber Volume
Mountings
Door Slide Direction
Chamber Dimensions
660 x 660 x 990 mm
Chamber Volume
Mountings
Door Slide Direction
Chamber Dimensions
660 x 660 x 1245 mm
Chamber Volume
Mountings
Door Slide Direction
Chamber Dimensions
660 x 915 x 990 mm
Chamber Volume
Mountings
Door Slide Direction
Chamber Dimensions
660 x 915 x 1220 mm
Chamber Volume
Mountings
Door Slide Direction
Chamber Dimensions
660 x 915 x 1524 mm
Chamber Volume
Mountings
Door Slide Direction
Chamber Dimensions
915 x 915 x 1220 mm
Chamber Volume
Mountings
Door Slide Direction
Chamber Dimensions
915 x 915 x 1524 mm
Chamber Volume
Mountings
Door Slide Direction
Chamber Dimensions
940 x 1448 x 1524 mm
Chamber Volume
Mountings
Door Slide Direction
Chamber Dimensions
940 x 1448 x 2184 mm
Chamber Volume
Mountings
Door Slide Direction
Chamber Dimensions
1219 x 1219 x 1524 mm
Chamber Volume
Mountings
Door Slide Direction
Chamber Dimensions
1219 x 1219 x 1829 mm
Chamber Volume
Mountings
Door Slide Direction
Chamber Dimensions
1219 x 1219 x 2184 mm
Chamber Volume
Mountings
Door Slide Direction
Chamber Dimensions
1219 x 1448 x 1219 mm
Chamber Volume
Mountings
Door Slide Direction
Chamber Dimensions
1219 x 1448 x 1524 mm
Chamber Volume
Mountings
Door Slide Direction
Chamber Dimensions
1219 x 1448 x 1829 mm
Chamber Volume
Mountings
Door Slide Direction
Chamber Dimensions
1219 x 1448 x 2184 mm
Chamber Volume
Mountings
Door Slide Direction
Chamber Dimensions
1219 x 1448 x 2438 mm
Chamber Volume
Mountings
Door Slide Direction
Chamber Dimensions
1219 x 2184 x 1524 mm
Chamber Volume
Mountings
Door Slide Direction
Chamber Dimensions
1219 x 2184 x 2184 mm
Chamber Volume
Mountings
Door Slide Direction
Chamber Dimensions
1371 x 2184 x 2184 mm