Aquapro

GMP Hot Water Cascade Sterilizers

Aquapro hot water cascade sterilizers use the efficient heat transfer properties of recirculating water to deliver rapid terminal sterilization cycles, while being gentle enough to prevent damaging or deforming products and packaging that may be sensitive to heat or pressure.

Rapid and gentle terminal sterilization of liquid pharmaceuticals

Sterilization Process Overview

Aquapro sterilizers are equipped with a high capacity water pump and large diameter piping to ensure high water flow rates. Recirculating water is heated and cooled by external heat exchangers. The heat exchangers are heated by plant steam and cooled by softened water. No direct contact is made with the recirculating chamber water by the plant steam or softened water. The recirculating chamber water is directed to a perforated tray where it is evenly distributed and cascades over the product. Due to the high flow rate of the cascading water, very even heat distribution is realized.

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.

Key Features:

Rapid Sterilization

The efficient heat transfer properties of water allow for rapid heating and cooling times, significantly reducing the duration of the sterilization cycle when compared to the steam-air process.

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.

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.

Aquapro Terminal Sterilization Cycles

Aquapro sterilizers are programmed with a hot water cascade sterilization cycle 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 protected from unauthorized changes via a multi-level authentication system.

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 heated by plant steam. The water is then distributed through a perforation tray over the load. Due to the efficient heat transfer of the water, the product is heated rapidly.

At the same time, 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 to prevent deformation or damage.

At the end of the exposure phase, the circulating water is cooled by an external heat exchanger using cooling or chilled water. The cooled circulating water is continuously sprayed over the load, quickly bringing the temperature back to ambient. This process is the fastest method of sterilization for liquids in sealed containers.

Configured to your exact requirements

Aquapro sterilizers can be configured to meet almost any application, space, and layout requirements. Custom options for sterilizer size, service area access, and chamber capacity allow for perfect placement in your facility, while maintaining optimal loads — even in locations with space constraints. Additional options for single-door or pass-through, floor or pit mounting, integrated or standalone steam generator, and custom process recipes further enhance functionality and versatility.

Examples of Aquapro configuration options:

Custom chamber size & capacity.

Single-door or pass-through models.

Floor or pit mounting.

Right or left service area access.

Integrated or remotely located controls cabinet.

Integrated or standalone steam generator (electric or plant steam heated).

Custom sterilization cycle recipes.

Loading equipment: shelves, trays, and trolleys.

Sterilizer Loading Equipment

BMT USA manufactures stainless steel loading equipment in standard or custom designs to accommodate any load. Our smaller chamber sizes can be equipped with wire or perforated shelves and loading racks, while large 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 existing equipment. Carts with drop down wheels are available for rooms with limited space.

Aquapro Chamber Sizes

Aquapro hot water cascade 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