Developed over the last 60 years, The Suncombe PureVessel™s are fully sanitary Sterile Pressure Vessels, available with capacities from 10 to 750 litres. Designed in a modular manner, the vessels can be equipped with top entry agitators, bottom mounted magnetic mixers, heating and cooling jackets, mounted on load cells, spray devices and instruments with the option of custom design and manufacture for your particular requirement. They are high specification units constructed from 316 stainless steel and optionally Hastelloy for chlorine resistance built to comply with ASME BPE Bioprocessing Equipment guidelines.
ASME BPE Construction, fully drainable, crevice free.
cGMP, GAMP
316L stainless steel contact parts, 304 non-contact parts
Sanitary Valves, manual and air operated
Calibrated Instruments
A range of automation levels are available, starting from entry level, through mid level PLC and HMI versions, to advanced validateable systems. All levels provide a repeatable automated cycle.
The validation ‘V’ model lifecycle approach is adopted (DQ, FDS, HDS, SDS, FAT, SAT, IQ & OQ) with validation being key to every stage of the development process, including Factory Acceptance Testing (FAT), SAT and Qualification.
All functions of the equipment would be fully wet and dry tested and test results would be documented in the ‘Pre-Factory Acceptance Test’ (FAT) protocol. Following successful completion of this protocol, the client is invited to the FAT test, where all tests can be repeated or the pre-FAT tests results can be used for leverage.
The PureVessel ™ was developed to operate with the Suncombe PureCIP™, to provide a pre-validated Cleaning In Place and Sterilising In Place cycle. The pre-validated cycles are integrated into the PureCIP™ control system and an electronic batch record, secured to 21CFR part11, would be provided following every cycle, allowing total confidence in the CIP and SIP result.
Material: Stainless steel, duplex or Hastelloy
Pressure range: full vacuum to +12 barg
Capacity: 10 – 2,000 litre
Temperature range: -200°C to +280°C
Operating Voltage: 230VAC or 400VAC (24VDC control)
Automation: ControlSuite Levels 1000 to 4000 or junction boxes for remote control
Reporting: Printed records or chart recorders