New CIP System Feature Offers ‘Sterilising on the Move’
Jun 20 2017
Suncombe, one of the worldâs leading Cleaning In Place (CIP), bio-waste decontamination and hygienic process engineers, has announce the launch of a sterilising version of its well-established MobileCIPâ¢ portable CIP System.
Primarily for use in the BioPharma sector, the new range is called the MobileCIP/SIPâ¢ and has been developed in close co-ordination with major biopharma clients, which requested the ability to carry out Sterilise in Place (SIP) directly after Cleaning in Place.
As well as encompassing sector standard methodologies for validatable SIP, the new range incorporates an advanced control system, built to GAMP guidelines with 21CFR part11 compliance, offering audit trails and user access controls by passwords. With a standard SIP setting of 121.11Â°C for 30 minutes, the versatile control system allows configuration of F0 (Steam Sterilization Lethality) sterilising parameters.
Designed to comply with ASME BPE (Bioprocessing Equipment) â the international standard for the design and construction of equipment intended for use in the manufacturing of biopharmaceuticals â they include compliance with the â 2D deadlegâ rule, an area of entrapment in a vessel or piping run that could lead to contamination of the product. The system also offers full drainability, full traceability and is completely validatable
Steve Overton, Suncombe's Technical Director, comments, "Our MobileCIPâ¢ systems are very successful and are already widely in use around the world. Initially developed to be a versatile CIP system, with options and custom designs for client specific requirements, the MobileCIP/SIPâ¢ versions now offer an even more flexible solution without any loss of performance or reporting.â
They are available with the full range of CIPSuiteâ¢ control systems, both Siemens and Allen Bradley based, from the basic #1000 to SCADA based #4000, incorporating 1 to 100 individually configurable recipes with options for 21CFR11 compliant records.
Without taking up permanent floor space and avoiding pipework installation, all MobileCIPâ¢ units are ready to use, plug-in solutions for many cleaning requirements. Easily moved to different operating or storage locations, operational parameters for recipes (times, temperatures, flow rates, detergent strength) can be stored for both existing and future equipment.
Helping to minimise validation and qualification, the new MobileCIP/SIPâ¢ systems include a full validation package including risk assessment, design, manufacture, testing and qualification protocols. Fully certified, the cGMP designed systems comply with all legislative and safety standards. Available in standard or bespoke versions, they are incorporate GAMP, ASME BPE, FDA and ATEX guidelines.
In This Edition Chromatography - Achiral Supercritical Fluid Chromatography (SFC) for the Purification of Pharmaceuticals - Equivalent GC systems performance for regulatory method compliance...
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