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Reference project Clean room monitoring

Monitoring with usability and foresight

To ensure that our customer’s production facilities meet the criteria of a so-called cleanroom, they require continuous monitoring. The company must also be able to prove at all times that all conditions are fully complied with – and therefore requires reliable records of all measurement results. In the past, both the determination and the recording of data were carried out manually. A huge burden of responsibility for the employees responsible and, despite all the precautions taken, a risky source of error that could cost the company huge sums of money – not to mention the immense amount of work involved for the staff concerned.

Project details

  • Audit security through the introduction of a monitoring system
  • Recording and archiving of all relevant room data
  • Compliance with all national and international regulations

Hardly any other industry is as demanding as the pharmaceutical sector. Few fields are subject to as many rules and regulations as here. Regional differences are an additional complication: in the USA, for example, completely different rules apply to drug production than in Europe or Germany. For companies that operate internationally, this is another challenge that needs to be overcome. The strict guidelines stipulate, for example, how a company’s production facilities must be designed. These include room temperature, humidity, air pressure and the presence of disruptive particles in the atmosphere. Precisely defined limit values must not be exceeded or undercut under any circumstances.

Qualification, realization and validation of the system according to GMP specifications with Wonderware System Platform

Use of the standard on-off monitoring system

Integrated alarm management with escalation reporting

Compliance with FDA 21, CFR Part 11 guidelines

One integrated solution

Around ten years ago, SpiraTec developed the first automated cleanroom monitoring solution for the pharmaceutical customer, which is now one of SpiraTec’s standard services. Components of the system that were worth preserving were retained, and parts of the customer’s existing concept were taken into account and integrated into the new system, e.g. the alarm management. This meant that no customer training was necessary. By switching from manual to automated monitoring, the pharmaceutical company is now saving costs and working time – resources that can be invested more effectively. Employees who were previously mainly occupied with monitoring the data now have time to analyze this data and intervene in the processes proactively and preventively on this basis. The company is therefore proactive rather than reactive and does not limit itself to mere compliance with standards, but instead exploits real potential.

“We are now working proactively instead of reactively.”

System operator monitoring on the customer side

Safety is the key

The established system provides the customer with a high level of security by giving timely and reliable warnings and intervening. The monitoring systems developed at the time are still in operation today, working smoothly and without incident. Even when the system was expanded – for example with new hardware components or updates to the operating system – production processes were never impaired or disrupted. The reason for the 100% reliability is the establishment of a so-called “hot standby”, an identical (“redundant”) parallel system that takes over monitoring immediately in the event of a failure – i.e. without dead time. A failure would therefore have no impact on processes or information. In the meantime, SpiraTec has become a real capacity in the pharmaceutical sector. Thanks to a wealth of experience in other projects in the industry, SpiraTec has in-depth knowledge of national and international regulations such as the Food & Drug Administration (FDA), the Code of Federal Regulations (CFR 21), Good Manufacturing Practice (GMP) and Good Documentation Practice (GDP).