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PureVessel ™


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PureVessel™ Sanitary - Sterile Vessel 10 to 750 Litre Capacity

Introduction

PureVesselDeveloped 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.

Typical Manufacturing Standards

  • ASME BPE Construction, fully drainable, crevice free.
  • cGMP, GAMP

Typical Equipment

  • 316L stainless steel contact parts, 304 non-contact parts
  • Sanitary Valves, manual and air operated
  • Calibrated Instruments

Automation System

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.

Equipment Lifecycle

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.

Testing

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.

Validation

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.

PureVessel™ & PureCIP™ Cleaning In Place and Sterilising In Place

PureVessel™ and PureCIP™ Cleaning In Place and Sterilising In Place

The PureVessel™ was developed to operate with the Suncombe PureCIP™ and MobileCIP®, 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.

PureVessel™ and Hybrid Single Use (SUT) Systems

The terminology Hybrid bioprocessing is typically used to describe a bio processing facility which employs a combination of single use technologies (SUT) and stainless steel repeat use equipment.

One of the main drivers for the use of single use methodologies is the complexity of the clean in place and sterilise in place operations, 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 ensure that this usage is more practical, we have developed a pre-validated combination of PureVessel™s and PureCIP™.

Pre-Validation Testing

The pre-validation of the clean in place and sterilise in place operations is demonstrated at Factory Acceptance Testing (FAT), SAT and Qualification. All functions of the In Place and Sterilising In Place 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 will be invited to the FAT test, where all tests can be repeated or the pre-FAT tests results can be used.

PureCIP™ for Bioprocessing Upstream and Downstream

The PureCIP™ has been developed to provide a single Cleaning In Place facility that can be shared by multiple CIP clients in the Bioprocessing Upstream and Downstream process. Typical clients can include:

  • PureVessel™
  • Solution Preparation
  • Media Preparation
  • Bioreactor
  • Ultrafiltration
  • DepthFiltration
  • TFF Filtration
  • Centrifuges

PureCIP™ and MobileCIP® Cleaning In Place and Sterilising In Place System

The Suncombe PureCIP™ and MobileCIP® are The Biotech, Pharma and Critical Application cGMP Validatable Total Loss Cleaning In Place System and have been supplied to many biopharma organisations around the world over the last 50 years.

Static PureCIP™

Static PureCIP™

MobileCIP®

MobileCIP®


PureCIP™ Introduction

These skid mounted systems provide a robust and repeatable method of cleaning process equipment with temperature controlled solutions and added chemicals.

Skids comprise all the necessary water storage tanks, heaters, pumps, valves, pipework and related components and instrumentation to deliver the required CIP cycle. Type, quantity and physical sizes of components are determined during the design phase of each project to suit the required application. System construction and components are suitable for sanitary use in pharmaceutical, biotech and other hygienic applications.

Systems include a user-configurable recipe based control system to suit a wide range of applications and are pre-assembled and fully tested with operating utility supplies in our works to minimise risk and optimise installation and validation time on-site.

Systems comply with all applicable regulatory standards and are accompanied by a comprehensive suite of documentation covering all aspects of installation, operation and maintenance. Extended documentation packages can be supplied to meet specific validation needs.