Unique environmental conditions and clean rooms require unique safety measures. The combination of monitoring and airlock control guarantees reliable operation and protects the product and the environment from harmful influences.
The flexible programmable logic controllers in the PMC2 series, in combination with ProGrafNT, Neuberger’s powerful GMP monitoring system, handle this demanding task effortlessly. This provides users and operators with a reliable, multi-building system from a single source.
The life sciences sectors are subject to stringent regulations, which also apply to control and room conditioning. The slightest deviations in room conditions can have serious consequences in clean rooms, research facilities and laboratories. These critical areas also include the ventilation, heating and cooling systems in the primary plants.
The recording of current plant states, such as temperature, humidity, pressure and air quality, must also be taken into account in the control strategy to ensure reproducible room conditions. The flexible PMC automation system is used in conjunction with Neuberger’s powerful ProGrafNT building management system to achieve precise control of room conditions. Neuberger enables operators and users to detect deviations at an early stage and act accordingly. Central monitoring and operation as well as adjustment of limit values can be undertaken online at any time, taking account of GMP requirements. Neuberger provides freely configurable and programmable solutions in order to achieves this high quality.
Neuberger products are developed and produced in accordance with FDA specifications as per 21 CFR Part 11. For us, a lifelong spare parts guarantee for your plants is at the heart of a long-term customer relationship that has all the hallmarks of a partnership.
Proof of compliance with all production and quality specifications is the primary success factor when it comes to manufacturing highly sensitive products. Changes to parameters must be recorded and documented in full so that all events, including any violations of limit values and measured values, can be traced at all times. In order to demonstrate compliance with all specifications and ensure perfect product quality, Neuberger’s ProGrafNT monitoring system gives users and operators a range of options with plenty of evaluation and reporting functions.
For example, production-relevant data and critical events can be listed, evaluated, clearly displayed and output in a document directly from the monitoring interface. Daily, weekly or monthly reports can be generated easily with a single mouse click. The monitoring of limit and measured values can be traced in clear archive pictures. Fault messages are processed and sent immediately if defined limit values for warning and alarm thresholds are exceeded. The compilation, evaluation and output of all quality-relevant data (batch records) is also possible with the Neuberger monitoring system at any time at the click of a mouse.
The upside is that all evaluation and report functions are freely configurable. A Neuberger GMP monitoring system makes the time-consuming preparation of reports a thing of the past.