BMT Steripro cGMP Steam Sterilizers
Steripro cGMP Steam Sterilizers are designed not only to meet the US FDA cGMP guidelines, but to exceed industry standards. Reliability and serviceability are engineered into every unit. Validation is one of the biggest concerns in purchasing a cGMP sterilizer so special attention has been given to the documentation and repeatability of each system. Utilizing the latest 3D parametric and MRP software along with PBMT’s lean manufacturing principles allows state-of-the-art solutions, which are unsurpassed in quality and reliability without sacrificing value.
• Highly polished mirror finish chambers
• Meets and exceeds US FDA cGMP’s
• 316L stainless steel sanitary piping
• Piping sloped to drain with no dead legs
• Sanitary valves and components
• Extensive Validation documentation
• Chamber doors secured on four sides
• Solid stainless steel door—no welding
• Lubricant free door gaskets
PBMT Steripro sterilizers are equipped with highly polished chambers made entirely of 316L stainless steel for superior durability. A solid plate door without welding ensures the door will not warp over time. Precision machined door brackets for retaining the door on four sides ensure smooth door travel and safe secure doors. All chamber connections are sanitary clamp type and are slopped to drain. Lubricant free door gaskets will last longer and will reduce particle shedding into clean rooms.
SANITARY PIPING SYSTEMS
All piping and ports in contact with the chamber are constructed of 316L stainless steel and are sloped for drain ability. Easily removable sanitary clamp fittings are used to ease in removal of components. Non-proprietary sanitary valves and components are selected for their reliability and availability to reduce down time.
The primary use of PBMT Steripro steam sterilizers is for production in pharmaceutical and biotechnology facilities where repeatability is an important criterion. PBMT sterilizers are state-of-the-art in design and utilize high grade vacuum pumps, 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.
Every Steripro steam sterilizer is subject to rigorous pre-validation testing at the factory and shipped with an extensive documentation package in order to minimize the time required for on-site validation. IQ/OQ protocols as well as on-site execution are available as option.
The following documentation package is supplied with every Steripro Steam Sterilizer
• Piping and Instrumentation Diagram
• Installation Drawings
• Electrical Diagrams
• Control System Documentation
• Software Source Code Listing
• Mechanical Component Parts List
• Electrical Component Parts List
• Mechanical Component Catalog
• Electrical Component Catalog
• Material Certificates
• Welding log
• Pressure Vessel Certificates
• Calibration Certificates for Process Instruments
• Factory Acceptance Test Protocols
• Installation Manual
• Operational Manual