BMT Ventipro - cGMP Steam-Air Mixture Terminal Sterilizers

High-Performance Fans

High performance fans intensify the streaming of the steam-air mixture through the chamber and around the load. The fan wheel and all components mounted inside the chamber are constructed of 316L stainless steel. The motor is installed outside the chamber and connected to the fan wheel with a unique sealing system that simplifies inspections and maintenance.

Chamber Construction

Ventipro 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.

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.

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 cGMP-compliant and produce pure or clean steam for pharmaceutical sterilization. The generators can either be configured as stand-alone units for use as a central steam source or directly integrated into the sterilizer. BMT USA steam generators are assembled with the highest quality non-proprietary components and are available in electric or plant steam heated models.

Vertically integrated electric steam generator

BMT USA is one of the only manufacturers offering vertically integrated electric clean and pure steam generators up to 400lbs/hr with a maximum output pressure of 80 PSIG. Our vertical integration offers significant space savings while maintaining tight steam pressure control.

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.

Custom Loading Equipment

BMT USA manufactures stainless steel loading equipment in standard or custom designs to accommodate loads of any size, shape or weight. Our smaller chamber sizes can be equipped with wire or perforated shelves and loading racks, while larger chambers can be equipped with carts and transfer trolleys.

Large pit-mounted chambers include options for tracks and rub rails that can be designed to work with the wheel configuration of your existing equipment. Carts with drop down wheels are available for rooms with limited space.

Product & Packaging Integrity

Counterpressure air is maintained throughout the process to protect the integrity and shape of products and packaging.

Rapid Heating & Cooling

Ventilation and heat exchanger systems allow for fast heating and cooling times and enables drying of the load after the sterilization phase is complete.

Simple Maintenance

Unique sealing of the fan shaft allows for greater ease in inspection and maintenance.

Sanitary Stainless

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

Non-Proprietary

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

Compliance

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

PLC Controls

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

Energy Efficient

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

The industry's most customizable cGMP sterilizers, precision-engineered for your process

Ventipro sterilizers can be configured to meet your specific process requirements with custom options for size, chamber capacity and layout, allowing for perfect placement in your facility, while maintaining optimal loads. Additional options for single-door or pass-through, floor or pit mounting, integrated or standalone steam generator, and custom process recipes further enhance the Ventipro’s functionality and versatility.

Examples of Ventipro configuration options:

• Custom chamber size and capacity.
• Right or left service area access.
• Floor or pit mounting.
• Integrated or remote controls.
• Single-door or 2-door pass-through. 
• Custom sterilization cycle recipes.
• Custom loading equipment, including carts, trolleys, shelving and trays.
• Integrated or standalone steam generator / electric or plant steam heated.

Ventipro sterilizers are programmed to perform the steam-air mixture sterilization process, with configurable parameters for each phase of the cycle to optimize performance and control. The programmed cycle recipes are securely stored in the control system memory and can be effortlessly retrieved and initiated via the operator interface’s touchscreen. Unauthorized modifications are prevented through a multi-level authentication system, ensuring recipe integrity and operational compliance.

Steam-Air Mixture

Terminal sterilization of liquids in heat or pressure-sensitive containers

Pure steam is pumped into the chamber while being injected with compressed air at a preset differential over-pressure. The steam and air are circulated and mixed by internal fans, rapidly heating up to an exposure temperature between 110°C up to 135°C. The exposure temperature is maintained for a specified period, after which the fans begin blowing cool air across the load.

During the cooling phase, a support pressure is maintained to prevent damaging the product containers. At the end of the cycle, the load leaves the chamber dry and ready for further handling or labeling.