Ultrafiltration and Diafiltration cGMP Systems
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TechniKrom® provides pilot to production scale automated membrane filtration units using the same sanitary cGMP platform and technology base our LC system skids utilize. Units are designed to accommodate manual to fully automated operation depending upon need. Filtration optimization services are also provided.

Units accommodate the variety of customer specified membrane technologies which are available today. Flexibility is provided for use of the most appropriate filters and/or membranes for the specific application offering options beyond any one product line or manufacturer.

The same level of quality found in our system skids is assured by using the same MOC's, comparable or identical components, pumps, 21 CFR Part 11 control software and other features including but not limited to the following.

A Manual Filtration System Typically Includes:
A sanitary cGMP design, portable skid mounted filtration unit with industrial construction and full 316L stainless steel frame.
• All system tubing, fittings and diaphragm valves are traceable 316L stainless steel and electropolished on the interior with documented orbital welding as applicable. All tubing is individually PIN-stamped for full traceability. Interior surface finish is ≤ 20 μin Ra.
• Sanitary Triple Head Teflon Diaphragm Pump: Sanitary tri-clamp connections included.
• Sanitary Pressure Sensors
• Sanitary Coriolis Mass flowmeters
• Sanitary UV Sensor Sanitary Conductivity and pH Sensors
• Utilities: 3 phase, 460V (optional 230V), 60Hz power, and 90psi instrument grade air.
• Hazardous area design meets Class I, Division 1 or 2, Groups C & D as applicable.
• UL approved control panel includes all electrical starters, relays, drives, and wiring.
• Multi-Channel Chart Recorder for logging of analog signals.
• All TechniKrom® systems are built according to our SOPP's to ensure that the highest state of quality control is incorporated into each system.
• Warranty: for 1 year.

Full Automation Filtration System Options Typically Features:
• UL approved control panel includes PLC, electrical starters, relays, drives, and wiring.
• PLC: On-board industrial high speed PLC with IEC certified complaint PLC software.
• TechniKrom 21 CFR Part 11 Control Software

This Control Software package includes the following:
• 3.06 GHz or latest model Pentium IV PC (512MB RAM, 80GB HD) with Windows 2000 Professional has customized Intellution™ software with modules for pump priming, equilibration, reagent and reactant additions, recirculation and outlet control, automatic error and safety shutdown and CIP
• Provides data compilation, storage, and batch report generation capability with /Historian and SQL Server 2000.
• Data Trend Screen provides one second real-time data resolution both on screen and in batch reports (rather than 30 second data collection with simulated real time appearance)
• Methods/recipes are quickly created by linking modules together using Windows™ drop down menus.
• Automatic mode, manual mode, and manual override capabilities.
• Data trend screens allow the user to view all analog signals simultaneously as well as overlay previous "golden batches" for comparison during production runs with runtime (start at time zero) x-axis and 24 hour process time clock.
• On-line component documentation for major components provides troubleshooting guides and cut sheets by clicking on the components in the process view screen.
• Up to 10-user access levels can be created for system security.
• Control software package is fully 21 CFR Part 11 capable including electronic signature and audit trail (see details below). Note that this is full Part 11 capability, not the generic capability claimed by other suppliers. It provides all of the elements of a 21 CFR-Part 11 capable SW package which would include, but not be limited to: passwords, complete and secure electronic audit trails, locked-down databases for both analog signal data and method data, system and application level security, as well as electronic signatures, all subject to on-site conditions.

Depending upon the project we also offer flexibility in accommodating customer specific controller requirements such as DCS, A-B or Delta V integration.

Other Options Also Include:
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• Near Infrared (NIR) Sensor
• Heat Exchanger
• Jacketed Re-circulation Tank
• Non-intrusive End-of-Stream Air Sensor
• Low Dead Volume, Sanitary Fiber Optic Flow-Cell for Variable Wavelength UV