cGMP WATER CASCADE STERILIZERS

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

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

The primary use of BMT USA Aquapro Steam Sterilizers is for production in pharmaceutical and biotech facilities where repeatability is an important criteria. Aquapro 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

All piping and ports in contact with the chamber are constructed of 316L stainless steel and are 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.

Aquapro Sterilizers are equipped with industrial-grade Allen Bradley or Siemens PLC control systems that provide superior reliability, serviceability, and repeatability of cycles.  The control systems are developed under the latest GAMP (Good Automated Manufacturing Practices) guidelines to ensure reliability and ease in validation. Each 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 when connected to a PC or central computer system. The control system can also be equipped with different types of printers and recorders for data storage on paper.