Combipro

cGMP Combination 3-in-1 Sterilizers

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.

Engineered for efficiency, reliability & serviceability

Chamber Construction

BMT USA 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 sterilization cycles. All chamber connections are sanitary clamp type and sloped to drain. Lubricant free door gaskets last longer and eliminate particle shedding into clean rooms.

Validation

Validation is a critical concern when purchasing a cGMP sterilizer, so special attention has been given to the documentation and repeatability of each system. Every BMT USA sterilizer is subjected to rigorous pre-validation testing at our facility and shipped with an extensive documentation package to help minimize the time required for onsite validation. IQ/OQ protocols and on-site execution options are also available.

Repeatability

The primary use of cGMP sterilizers is for production in pharmaceutical and biotech facilities where repeatability is critical. All BMT USA cGMP 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

Clean Steam Source

BMT USA steam generators are constructed to cGMP guidelines and designed to provide pure or clean steam to meet the requirements of sterilization in pharmaceutical production. The units can be configured as stand-alone units to be used a central source of steam for multiple units, or directly integrated into the sterilizer. BMT USA steam generators utilize high grade non-proprietary components and can be electrically heated or plant steam heated.

Vertically integrated electric steam generator

BMT USA is one of the only manufacturers that can offer 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.

Control System

Industrial-grade Allen Bradley or Siemens PLC control systems provide superior operational reliability and cycle repeatability. The control systems are developed under the latest GAMP (Good Automated Manufacturing Practices) guidelines to ensure system reliability and ease in validation. The control 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. Printers and recorders can also be equipped for physical data storage on paper.

Key Features:

Flexible Programming

Can be programmed with any type or combination of sterilization cycles – vacuum, steam-air mixture, hot water cascade.

Sanitary Stainless

The chamber, chamber door, sanitary piping and fittings are all constructed of 100% 316L stainless steel.

Regulatory Compliance

Designed and built in compliance with US FDA cGMP, Good Automated Manufacturing Practice (GAMP) and US FDA CFR 21 Part 11.

Temperature Uniformity

Temperature distribution inside the chamber better than +/- 0.5°C

Energy Efficient

The chamber and all piping are fully insulated to help reduce utility consumption.

PLC Controls

Industrial-grade Allen-Bradley or Siemens PLC-based control systems deliver repeatable operation.

Non-Proprietary

Fully constructed with high-grade non-proprietary components for improved reliability and serviceability.

Lubricant-Free Door Gasket

Lubricant-free door gaskets provide greater longevity and eliminate particle shedding into clean rooms.

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.

Dry Goods Cycle - Vacuum Drying

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.

Dry Goods Cycle - Pulsed Air/Vacuum Drying

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.

Solution Cycle - Gravity Air Removal/Ramped Exhaust

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.

Solution Cycle - Air Over-Pressure/Jacket Water Cooling

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.

Steam-Air Mixture Cycle

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.

Hot Water Cascade Cycle

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 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.

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 Volume

230.7ft³/6.5m³

Mountings

Floor or Pit

Door Slide Direction

Horizontal