Applying Predictive Maintenance Techniques to Utility Systems

Introduction Pharmaceutical production is one of the most heavily regulated industries. With such an emphasis on product quality within the industry and with such economic and health consequences due to machine failure, the maintenance team plays a crucial role in the success of the product. It is the maintenance department’s responsibility to ensure equipment is kept to its maximum operating condition. It must predict and prevent failures and repair any problems which may already have led to a failure, while adhering to the rules and procedures set out by the respective regulatory bodies. In addition, critical GMP utility systems supporting production are qualified and associated documentation is needed to prove that equipment serves its function consistently as per the design. This often leads to maintenance departments performing more work than is necessary to increase assurance of equipment reliability, even if these extra precautions do not necessarily provide any additional benefits. During the qualification of these systems, the maintenance program is developed and put in place. To change the content of maintenance after this can prove difficult as strict change control procedures often need to be followed and full documented justification needs to be provided. This can sometimes lead to maintenance programs being left as is and the opportunity for continuous improvement missed. In recent year’s, regulatory agencies such as the US Food and Drug Administration (FDA) and the Irish Medicines Board (IMB) have become more supportive of emerging modern maintenance techniques. Tools such as Reliability Centered Maintenance (RCM) and the use of the many sciences involved in Predictive Maintenance (PdM) are seen as a way of improving the maintenance function. This is allowing pharmaceutical companies to become more cost competitive while still ensuring utmost quality to the pharmaceutical products end user: the patient.