Biotech, Pharma and Critical Application cGMP Validatable Water Heating Skids
These skid mounted systems provide a robust and repeatable method of heating, storing and distributing hot water under cGMP auspices.
The skids comprise all the necessary water storage tanks, heaters, pumps, valves, pipework and related components and instrumentation to deliver the required hot water. 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 cGMP 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.
Constructed to cGMP, a 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. All functions of the equipment would be fully wet and dry tested and test results would be documented in the FAT protocol.
- Cold Water Heating
- Hot Water Temperature Maintenance
- Storage of temperature Controlled Water
- Distribution of Temperature Controlled Water
- and many more in Pharmaceutical, Biotech and other Critical process industries.
- Available with steam or electrical heating components
- Options for heat recovery and reclaim
- Options for inclusions of heat pump technology
- FDA approved components with no threads and triclamp connections
- ASME BPE 316L no dead legs, fully drainable, material & weld traceability
- Control and instrumentation to GAMP5
- Repeatable, validatable client configurable sequences
- Riboflavin proof of coverage