Steripro

cGMP Saturated Steam Sterilizers

Steripro saturated steam sterilizers are designed for production in pharmaceutical and biotech facilities where repeatability is critical. Equipped with high-grade vacuum pumps, non-proprietary components, and industrial-grade PLC control systems, the Steripro produces repeatable cycles with even temperature distribution better than +/- 0.5°C. Steripro sterilizers can be configured with custom chamber sizes, mechanical layouts, and process cycles to meet your specific requirements.

Engineered for efficiency, reliability & serviceability

Chamber Construction

Highly polished 316L stainless steel chambers provide superior durability. The chamber door is also constructed with solid plate 316L stainless steel and held in place on all four sides by precision machined brackets for smooth travel and a tight seal against the chamber during the cycles. All chamber connections are sanitary clamp type and sloped to drain. Lubricant free door gaskets provide greater longevity and protect against 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 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.

Key Features:

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.

Temperature Uniformity

Temperature distribution inside the chamber better than ± 0.5°C

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.

Energy Efficient

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

PLC Controls

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

Automatic Doors

Automatic pneumatic driven precision sliding chamber doors improve safety and convenience during operation.

Lubricant-Free Door Gasket

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

Configured to your exact process requirements

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

Steripro 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 can further enhance the Steripro’s functionality and versatility.

Examples of Steripro 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.

Steripro Sterilization Cycles

Steripro sterilizers can be programmed with any combination of saturated steam and vacuum sterilization cycles, with configurable parameters for each cycle phase. The programmed cycle recipes are securely stored in the control system memory and can be effortlessly retrieved and initiated via the touchscreen operator interface. Unauthorized modifications are prevented through a multi-level authentication system, ensuring recipe integrity and operational compliance.

Dry Goods Cycle - Vacuum Drying

Effective sterilization of hard goods, filters, linens, porous materials, wrapped goods, and products that are unaffected by vacuum.

Dry Goods Cycle - Vacuum Drying with Air Pulses

Effective sterilization of rubber stoppers, hoses, and other material where trapped moisture can be difficult to remove.

The load is preconditioned with alternating vacuum and steam pulses, then heated to an exposure temperature between 110°C and 135°C. The exposure temperature is maintained for a specified period, after which drying begins by fast exhaust, vacuum and air pulses which are highly effective in removing moisture from the load. The air pulses can also be heated to further aid the drying process.

Solution Cycle - Gravity Air Removal with Ramped Exhaust

Sterilization of liquids in vented or sealed glass containers

The load is preconditioned with steam pulses before heating to an exposure temperature between 110°C up to 135°C. The exposure temperature is held for a specified time period followed by a gradual exhaust ramping to cool the load back to ambient temperature.

Solution Cycle - Air Over-Pressure with Jacket Water Cooling

Sterilization of liquids in heat or pressure-sensitive containers

The load is preconditioned with steam pulses, then heated to an exposure temperature between 110°C and 135°C. The exposure temperature is maintained for a specified period, after which the cooling phase begins by injecting air at a pressure equal to that inside the product container to prevent damage or deformation. To accelerate cooling, cold water is introduced into the chamber jacket.

Steripro Chamber Sizes

Steripro saturated 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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Chamber Volume

230.7ft³/6.5m³

Mountings

Floor or Pit

Door Slide Direction

Horizontal

Steripro

cGMP Saturated Steam Sterilizers

Engineered for efficiency, reliability & serviceability

Chamber Construction

Key Features:

Sanitary Stainless

Non-Proprietary

Temperature Uniformity

Compliance

Energy Efficient

PLC Controls

Automatic Doors

Lubricant-Free Door Gasket

Configured to your exact process requirements

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

Steripro Sterilization Cycles

Dry Goods Cycle - Vacuum Drying

Dry Goods Cycle - Vacuum Drying with Air Pulses

Solution Cycle - Gravity Air Removal with Ramped Exhaust

Solution Cycle - Air Over-Pressure with Jacket Water Cooling

Steripro Chamber Sizes

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