Sanitary Piping, Connections, and Fittings
Steam sterilizer piping systems specified in pharmaceutical processing and biotechnology applications normally consist of stainless steel tubing connected by a series of sanitary fittings. These sanitary sterilizers are designed to help end users meet required ASME-BPE and 3-A sanitary standards.
The PRIMUS registered sub-brand of sanitary sterilizers is BioPharma.
A sanitary steam sterilizer is designed to allow end users to validate their respective manufacturing processes in accordance with FDA and other industry requirements.
What is Validation?
Validation refers to establishing documented evidence that a process or system, when operated within established parameters, can perform effectively and reproducibly to produce a medicinal product meeting its pre-determined specifications and quality attributes.
The most common fitting in sanitary processing systems is the ISO 2852 sanitary clamp fitting, which consists of two flat-faced ferrules, each with a semicircular groove, an elastomeric gasket with semicircular protrusions, and an adjustable clamp to tighten the connection.
Sanitary fittings are made of heat-traceable 316L stainless steel materials and are marked with heat number(s), BPE specification, and internal surface finish. Tubular fittings are vacuum annealed to minimize the occurrence of stress corrosion cracking. The internal finish is 25 RA or less as a standard feature and can be specially ordered at 15 RA or less.
Tolerances, angularity, squareness, ovality, and polish finishes are closely monitored and measured by fitting manufacturers.
Fittings are designed to eliminate fluid holdup and improve drainability and cleanability.
Seals are required to remain leak-tight throughout the pressure-temperature ratings range.
Ferrules are thoroughly cleaned to ensure components are free of burrs, chips, loose particles, oil, grease, and other contaminants. All electropolished ferrules are passivated.
Additional PRIMUS sanitary design features
Standard PRIMUS high internal chamber polish
Clean stainless steel piping on all clean utilities (Pure or clean steam generators/Compressed air)
Control system based on Allen Bradley PLC for validated repeatability and reliability
Installation Qualification (IQ) protocols for end user execution (Sold as an Option)
Operational Qualification (OQ) protocols for end user execution (Sold as an Option)
0.2 micron sanitary filter installed in a 316L stainless steel housing
Sterilize Filter provided as a standard cycle
Precise temperature control
Water in Drain sensor provided as a standard feature
Have a question or having difficulties? Talk to Dave Schall, our PRIMUS sterilizer expert who is here to assist you anytime at 877.679.7800 extension 1212 or email at firstname.lastname@example.org.
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