Cleaning and process system specialist Suncombe has announced the global release of its PureVessel range of systems for sanitary and sterile liquid storage, preparation, thermal treatment and mixing. The systems are designed for applications in the biopharma sector, as well as laboratories and research institutes.
The range is certified to ASME and ISO/EN standards for processing biopharma products, and has been developed to operate within the hybrid bioprocessing model, alongside a combination of single use technologies (SUT) and stainless steel multi use equipment.
One of the drivers for the transition to single use, Suncombe says, is the complexity of the clean in place (CIP) and sterilise in place (SIP) operation for multi use equipment, which is necessary to avoid cross contamination and ensure a sterile state. There are many advantages to reusable equipment however, and to make this usage more practical, the company has developed a pre-validated version of PureVessels combined with its PureCIP or MobileCIP equipment.
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 model being cleaned and select the optimum cycle for each vessel, the company says. 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 vessels 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.
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’ startup makes these the ideal combination for incorporating in a hybrid model of single use (SUT) technologies.”