PharmSys provides consulting services to assist companies with troubleshooting of their equipment and process failures. Much of our expertise is directed at aseptic processes and lyophilization. Many of our investigations ultimately point to a common solution - the need for better preventive maintenance (PM).

In this respect, we work with our client's engineering and maintenance departments to improve the effectiveness of their maintenance activities. Some of our clients have required a comprehensive overhall of their PM system to include:

• Identification of all assets that require regular maintenance.
• Implementation and validation of a PM database system for tracking and scheduling maintenance activities.
• Organization of spare parts inventories.
• Specification and acquisition of special tools to ensure maintenance is performed properly.
• Extensive revisions to PM SOPs to ensure that all maintenance activities necessary to improve equipment reliability have been properly defined.
• Organization of PM files to facilitate quick access to items such as the historical maintenance records, equipment manufacturer's O&M manuals, engineering drawings, and technical specifications.
• Technical training for our client's maintenance and engineering personnel.

Improvements made to our client's PM system will typically result in a significant increase in their operational reliability.

We are also often requested to review and improve our client's operational SOPs in conjunction with review of their PM system. We audit the operational procedures to ensure that the manufacturing systems are being utilized within the design specifications upon which the PM activities are based. On occasion, we find that the frequency of some PM activities should be changed to minimize the risk of an equipment failure. We also assist our clients with planning their production schedules in order to optimize the downtime of critical equipment for planned maintenance.