Steripro steam sterilizers are designed for production in pharmaceutical and biotech facilities where repeatability is critical. By utilizing high-grade vacuum pumps, high quality instrumentation, and PLC control systems, the Steripro can consistently deliver repeatable cycles with temperature distribution within the chamber better than +/- 0.5°C. The Steripro can be configured to meet almost any size and capacity requirements, and can be equipped with a combination of programmable sterilization cycles to effectively sterilize a wide range of materials and equipment.
Engineered for efficiency, reliability & serviceability
Chamber Construction
Validation
Repeatability
Sanitary Piping
Clean Steam Source
Control System
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
Sanitary Piping
All piping and ports in contact with the chamber are constructed of 316L stainless steel and 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.
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:
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.
Automatic Doors
Automatic pneumatic driven
precision sliding chamber doors improve safety and convenience during operation.
Steripro Sterilization Cycles
Steripro 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.
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.
Steripro 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.
