Pre-validated bioprocess vessels and CIP systems combine for hybrid single use facilities
Suncombe, the cleaning and critical process systems specialists, has announced the global release of the PureVessel™ range of systems, for sanitary and sterile liquid storage, preparation, thermal treatment and mixing. They are typically required in the biopharma sector, laboratories and research institutes.
The PureVessel range of systems, expands on a Suncombe range of vessels developed over the last 40 years and is certified to ASME and ISO/EN standards for processing biopharma products, complying with all relevant regulations. These systems have been developed to operate within the hybrid bioprocessing model, in which a bio processing facility employs a combination of single use technologies (SUT) and stainless steel multi use equipment.
One of the drivers for the transition to single use methodologies is the complexity of the clean in place (CIP) and sterilise in place (SIP) operations of stainless steel multi use equipment, to ensure that there is no cross contamination and all work is developed in a sterile state. There are many advantages in employing re-usable stainless steel equipment and in order to make this usage more practical, the company has developed a pre-validated version of PureVessels combined with its PureCIP™ or MobileCIP® equipment.
Operating with the Suncombe PureCIP or MobileCIP, to provide a pre-validated CIP/SIP cycle, every PureVessel can be individually ‘plugged’ into the automation system, allowing the CIP/SIP to recognise the PureVessel being cleaned and select the optimum cycle for each vessel. On cycle completion an electronic and/or paper batch report, secured to 21CFR part11, is generated to accompany the clean/sterile vessel, to validate the result.
Available in capacities from 10 to 300 litres, the mobile or static PureVessels are modular built and 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 specific requirements. The units are constructed from 316 stainless steel and Hastelloy for chlorine resistance.
Commenting on the release, Suncombe director Steve Overton said, “Combining the PureVessel
unit and the Suncombe PureCIP and MobileCIP, provides clients with a pre-validated system, taking
away many of issues and validation works. This simplicity of operation and ‘plug and play’ start up
makes these the ideal combination for incorporating in a hybrid model of single use (SUT)