Products / GMP Steam Sterilizers / Combipro
Overview
Combipro Sterilizers are designed for sterilization of almost any product or container. It is equipped with a vacuum pump for effective sterilization of dry goods, a fan system for steam-air-mixture a sterilization process, and water recirculation pipework for a water cascade sterilization process. Combipro sterilizers are ideal for contract manufacturers or process development centers to establish the optimum sterilization process for any given product or container. Combipro sterilizers can also be equipped with the necessary ports and controls to utilize gas such as H₂O₂ for the sterilization of heat sensitive containers.
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
BMT USA offers a range of features that enhance the efficiency, reliability, and serviceability of our sterilizers. Vertical and horizontal precision machined sliding doors are exceptionally smooth and provide a safer environment for operators. Door gaskets that reliably operate without the need for lubrication reduce maintenance and prolong life span. The chamber jacket design utilizes a unique beam construction that provides a complete envelope around the chamber. PLC-based control systems are intuitive and simple to operate, while providing the necessary sophistication for maximum flexibility and ease of validation.
Combined Sterilization Cycles
Combipro sterilizers include high-grade vacuum pumps, high-performance steam-air mixture fans with a unique fan shaft sealing design for ease in inspection and maintenance, and perforated trays for water cascade sterilization cycles.
Validation
Chamber
Repeatability
Sanitary Piping
PLC Control System
Validation
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.
Chamber
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.
Repeatability
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
Sanitary Piping
All piping and ports in contact with the chamber are constructed of 316L stainless steel and are sloped to drain with no dead legs. Sanitary clamp fittings are used for ease in removal of components. Non-proprietary sanitary valves and components are selected for their reliability and availability to reduce machine downtime.
PLC Control System
Combipro Sterilizers are equipped with industrial-grade Allen Bradley or Siemens PLC control systems that provide superior reliability, serviceability, and repeatability of cycles. The control systems are developed under the latest GAMP (Good Automated Manufacturing Practices) guidelines to ensure reliability and ease in validation. Each system is also supported with a comprehensive documentation package.
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.
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
Combipro sterilizers can be programmed with any combination of the sterilization cycles described below with configurable parameters for each cycle phase. The programmed cycle recipe is stored in the sterilizer’s control system memory and is recalled and started with the touch of a button on the operator interface. All recipes are also protected from unauthorized changes via a multi-level authentication system.
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
BMT USA steam generators are constructed to cGMP guidelines and designed to provide pure or clean steam to meet the requirements of your sterilization application. The units can be configured as stand-alone units to be used a central source of steam for multiple units, or directly built into the sterilizer for a fully integrated solution. BMT USA steam generators utilize high grade non-proprietary components and can be electrically heated or heated by plant steam.
Electric Heated Steam
BMT USA electric clean steam generators are equipped with an ASME pressure vessel constructed from 316L stainless steel. The heating elements require three-phase voltage that can be specified at time of order. The units are equipped with an automatic blow-down system that carries impurities to drain. Feed water booster pumps are available when feed water is not available at the required pressure.
Steam-to-Steam
BMT USA steam-to-steam generators utilize plant steam as the heating source to produce clean steam. The tube and shell heat exchanger is made from 316L stainless steel and can be built in single-tube or double-tube configurations. The evaporator utilizes a wetted design that minimizes the temperature difference between the feed water and the heating steam, reducing stress on the evaporator tube sheet.
Vertically Integrated Electric Clean Steam Generator Option
In addition to vertically integrated steam-to-steam generators, BMT USA is one of the only manufacturers also offering vertically integrated electric clean and pure steam generators up to a 400lb/hr capacity with a maximum output pressure of 80 PSIG. The vertical integration offers significant space savings while maintaining the same tight steam pressure control within +/- 2 PSIG of the set point.
P: 360-863-2252
E: Sales@BMTUSA.com
Sterilizer Loading Equipment
BMT USA manufactures stainless steel loading equipment in standard or custom designs to accommodate any type of load. Our smaller chamber sizes can be equipped with wire or perforated shelves or loading racks, while large chambers can be equipped with loading carts and transfer trolleys. Large pit-mounted chamber include options for tracks and rub rails that can be designed to work with almost any type of wheel configuration on existing equipment. Carts with drop down wheels are also available for rooms with limited space.
Sterilizer Accessories & Options
Enhance your sterilizer’s functionality and maximize usable space with a range of sterilizer accessories and options, including 316L stainless steel perforated trays, steam quality sample cooler, printers, paperless videographic recorders, seismic restraint kits, additional operator interfaces, and electropolished chamber and piping finishes.
Combipro Chamber Sizes
Combipro Steam Sterilizers are offered in a range of chamber sizes and volumes. The table below contains some of our standard models; however, we can design and build a customized solution to match your exact chamber capacity, exterior dimension, and mounting requirements.
Model
Chamber Dimensions
(W X H X D)
Chamber Volume
(ft³/m³)
Mountings
Door Slide Direction
P202038
Chamber Dimensions
20″ x 20″ x 38″
508 x 508 x 965 mm
508 x 508 x 965 mm
Chamber Volume
8.8ft³/0.24m³
Mountings
Floor
Door Slide Direction
Vertical
P262639
Chamber Dimensions
26″ x 26″ x 39″
660 x 660 x 990 mm
660 x 660 x 990 mm
Chamber Volume
15.8ft³/0.44m³
Mountings
Floor
Door Slide Direction
Vertical
P262649
Chamber Dimensions
26″ x 26″ x 49″
660 x 660 x 1245 mm
660 x 660 x 1245 mm
Chamber Volume
19ft³/0.54m³
Mountings
Floor
Door Slide Direction
Vertical
P263639
Chamber Dimensions
26″ x 36″ x 39″
660 x 915 x 990 mm
660 x 915 x 990 mm
Chamber Volume
21ft³/0.59m³
Mountings
Floor
Door Slide Direction
Vertical or Horizontal
P263648
Chamber Dimensions
26″ x 36″ x 48″
660 x 915 x 1220 mm
660 x 915 x 1220 mm
Chamber Volume
25.9ft³/0.73m³
Mountings
Floor
Door Slide Direction
Vertical or Horizontal
P263660
Chamber Dimensions
26″ x 36″ x 60″
660 x 915 x 1524 mm
660 x 915 x 1524 mm
Chamber Volume
32.5ft³/0.92m³
Mountings
Floor
Door Slide Direction
Vertical or Horizontal
P363648
Chamber Dimensions
36″ x 36″ x 48″
915 x 915 x 1220 mm
915 x 915 x 1220 mm
Chamber Volume
36ft³/1.02m³
Mountings
Floor
Door Slide Direction
Horizontal
P363660
Chamber Dimensions
36″ x 36″ x 60″
915 x 915 x 1524 mm
915 x 915 x 1524 mm
Chamber Volume
45ft³/1.27m³
Mountings
Floor
Door Slide Direction
Horizontal
P375760
Chamber Dimensions
37″ x 57″ x 60″
940 x 1448 x 1524 mm
940 x 1448 x 1524 mm
Chamber Volume
73.2ft³/2.07m³
Mountings
Floor or Pit
Door Slide Direction
Horizontal
P375786
Chamber Dimensions
37″ x 57″ x 86″
940 x 1448 x 2184 mm
940 x 1448 x 2184 mm
Chamber Volume
102.4ft³/2.9m³
Mountings
Floor or Pit
Door Slide Direction
Horizontal
P484860
Chamber Dimensions
48″ x 48″ x 60″
1219 x 1219 x 1524 mm
1219 x 1219 x 1524 mm
Chamber Volume
80ft³/2.26m³
Mountings
Floor or Pit
Door Slide Direction
Horizontal
P484872
Chamber Dimensions
48″ x 48″ x 72″
1219 x 1219 x 1829 mm
1219 x 1219 x 1829 mm
Chamber Volume
96ft³/2.72m³
Mountings
Floor or Pit
Door Slide Direction
Horizontal
P484886
Chamber Dimensions
48″ x 48″ x 86″
1219 x 1219 x 2184 mm
1219 x 1219 x 2184 mm
Chamber Volume
114.5ft³/3.24m³
Mountings
Floor or Pit
Door Slide Direction
Horizontal
P495748
Chamber Dimensions
49″ x 57″ x 48″
1219 x 1448 x 1219 mm
1219 x 1448 x 1219 mm
Chamber Volume
77.5ft³/2.19m³
Mountings
Floor or Pit
Door Slide Direction
Horizontal
P495760
Chamber Dimensions
49″ x 57″ x 60″
1219 x 1448 x 1524 mm
1219 x 1448 x 1524 mm
Chamber Volume
96.9ft³/2.74m³
Mountings
Floor or Pit
Door Slide Direction
Horizontal
P495772
Chamber Dimensions
49″ x 57″ x 72″
1219 x 1448 x 1829 mm
1219 x 1448 x 1829 mm
Chamber Volume
116.3ft³/3.29m³
Mountings
Floor or Pit
Door Slide Direction
Horizontal
P495786
Chamber Dimensions
49″ x 57″ x 86″
1219 x 1448 x 2184 mm
1219 x 1448 x 2184 mm
Chamber Volume
155ft³/4.39m³
Mountings
Floor or Pit
Door Slide Direction
Horizontal
P495796
Chamber Dimensions
49″ x 57″ x 96″
1219 x 1448 x 2438 mm
1219 x 1448 x 2438 mm
Chamber Volume
8.8ft³/0.24m³
Mountings
Floor or Pit
Door Slide Direction
Horizontal
P488660
Chamber Dimensions
48″ x 86″ x 60″
1219 x 2184 x 1524 mm
1219 x 2184 x 1524 mm
Chamber Volume
143ft³/4.05m³
Mountings
Floor or Pit
Door Slide Direction
Horizontal
P488686
Chamber Dimensions
48″ x 86″ x 86″
1219 x 2184 x 2184 mm
1219 x 2184 x 2184 mm
Chamber Volume
205ft³/5.8m³
Mountings
Floor or Pit
Door Slide Direction
Horizontal
P548686
Chamber Dimensions
54″ x 86″ x 86″
1371 x 2184 x 2184 mm
1371 x 2184 x 2184 mm
Chamber Volume
230.7ft³/6.5m³
Mountings
Floor or Pit
Door Slide Direction
Horizontal