The Standard Group of Companies manufacture turnkey equipment processing solutions including full PLC and electronic control systems.
cGAMP, current good automated manufacturing practices are key in all pharmaceutical companies and the use of these systems in regulated industries is becoming more standard.
These control systems, in essence confirm that current good manufacturing automated practices are in place, can be audited routinely and support full traceability of the actual manufactured product.
These systems are built around a modular rack and rail framework and are designed to control single or multiple barrier isolators.
The monitoring of all-important performance statistics, from chamber and exhaust filter differential pressures, emissions and temperature.
The FDA's regulations for pharmaceutical, medical device, blood and biologics, and other regulated industries embrace the cGAMP principles and these regulations form the basis for cGMP and cGAMP control systems that are available today.
ISO quality standards are used by pharmaceutical manufacturers throughout the world and companies that are ruled by FDA standards and ISO standards must develop and utilise cGAMP control systems daily.
The design of these control systems includes the following attributes: -
- Full PLC control for operational reliability
- Tamper Proof - Electronics closed in lockable cabinets
- Record and retrieve the isolator operation data
- Multilevel password protection for Isolator operation, maintenance and control
Typical applications where cGAMP control systems are used include; -
- Barrier Isolator Control
- Reactor Control
- Process Equipment performance management
The major benefits of using these control systems include: -
- Stable, reliable and accurate results
- Clear visibility of system operational performance: Digital display, lights & alarms
- Operation safety
For more information click here or contact the UK and Indian offices directly.