Suncombe Chemical Dilution Skids
The Biotech, Pharma and Critical Application cGMP Validatable Caustic, Base or Acid Chemical Dilution, Heated, Control and Delivery System
These skid mounted systems provide a robust and repeatable method of diluting, heating, controlling and delivering caustic, base and acid chemical solutions.
Skids comprise all the necessary water storage tanks, heaters, pumps, valves, pipework and related components and instrumentation to dilute, heat, control and delivery the solutions. 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.
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.
Applications
- Dilution
- Heating
- Control
- Delivery
- Chemical Routing
- Water Delivery
- and many more in Pharmaceutical, Biotech and other Critical process industries.
GMP Construction
- 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
Chemical Dilution Skids Datasheet
Sanitary 316L stainless steel construction and components: Caustic and chemical are maintained at the highest sanitary standards complying with ASME BPE offering guaranteed surface finishes with diaphragm valves, full material traceability, weld maps and tables and welding dossier.
Variable Duty Delivery Pump: 316L Stainless Steel Heavy Duty Sanitary Pumps with Variable Speed Drive to allow speed control to vary the delivery flowrate and pressure from the recipe, complete with PID loop and automatic impellor casing drain valve
Siemens PLC and 12” colour HMI with options for additional HMIs: Control hardware is industry standard and supported worldwide by Siemens. Ethernet interface included for transfer of critical operating variables to other systems. Designed to enable integration to third party equipment or higher level control system. Versions also available with remote I/O for control by clients control system.
Suncombe SmartCIPTM software: Control software specification has been developed and proven over many years for process applications and includes a wide range of user or administrator configurable parameters to enable customised cleaning recipes, including water flow, pressure, time, temperature, chemical concentration and many more. User passwords, Active Directory, Audit Trails, Electronic batch reports for local or network storage are possible. User interface screens and process visualisation is simple, intuitive, clear and comprehensive. Remote access options are possible if required. Software complies with FDA 21CFR and EU GMP regulations.
Vessel/s: 316L Stainless Steel Pressure vessel with heated 0.2μm Vent Filter, bursting disc, sanitary construction with riboflavin tests. Water storage or chemical make-up vessels.
Steam, hot water/oil or electric water heating options: Solutions can be heating energy may be derived from most convenient and cost-effective source available.
Heated Solution Preparation: Heated solutions can be batch made up in vessel or using In-Line Heating validated method
USP Water: 1, 2 or 3 water inlets for Soft Water, Purified Water and Water for Injection. Water can either fill vessel or bypass vessel for direct application.
Continuous monitoring of key parameters: Process is highly repeatable and validatable.
Variable chemical dosing: Delivery of 1, 2, 3 or 4 chemicals is controlled.
In-line or batch chemical dosing: Chemical solutions can be batch made up in vessel or using optional In-Line Dilution validated method with flowmeter. Option for conductivity concentration verification.
Return: Skid prepared to accept return of fluids
Plug ‘n’ Play: Fully integrated with comprehensive in-house testing to ensure fast start up on site
Caustic/Chemical Distribution: A single outlet is included. Options available for up to 10 separate outlets for feeding to different items. Each outlet can be a single or double valve for isolation. Distribution can also be via flowplate/splitter panel.
Solution Cooling: Coolers can be added for colder rinses
Air Purge: Includes air purge facility to evacuate all water from the pipework
Fully Drainable: Automatic valves to fully drain entire skid including pump casing
Instruments: Sanitary instruments of Endress and Hauser/Mettler Toledo or equivalent with full material and calibration certification.
