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 ) technologies .”
Tel : + 44 ( 0 ) 208 443 3454 E-Mail : mail @ suncombe . com Web : www . suncombe . com
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