Eoin Ó Riain of Readout, Ireland’s journal of Instrument and Controls, talked recently with Peter Larner, the Facilities Team Leader with Roche Ireland Ltd., a division of the giant Hoffman LaRoche, about their solution to problems in maintenance management using a computerised system in order to satisfy the strict regulatory controls now in force all over the world in the pharmaceutical industry.

The latter segment of the 20th century has seen a greater realization of the importance of quality and reliability in modern production processes. None more so than in the area of pharmaceutical manufacture.Strict regulatory control is exercised by a growing number of external parties such as ISO, FDA, HSA the EPA and many more besides.

Roche Ir. Ltd. (formerly known as Syntex Ir. Ltd.) a division of the Hoffman LaRoche pharmaceuticals giant commenced operations in Clarecastle Co. Clare to manufacture the ingredient for the drug “Naprosyn” a potent nonsteroidal anti inflammatory and the largest selling antiarthritic medicine in the United States. The plant has seen many changes and continued expansion and now produces several other pharmaceutical products such as the active ingredient for “Cardene” (Angina and Hypertension), “Toradol” (post operative acute pain ) “Celcept (Immune system suppressant) and others.

The vision of the Site explains why they are so dedicated to the control and understanding of their process control systems. “We will be recognized as one of the best customer oriented manufacturers of bulk pharmaceuticals in the world”

Peter Larner, Facilities Team Leader at Roche explained how his company decided to use CompuCal, a windows based computerized maintenance management solution.

“Originally we used a manual system of index cards and specification sheets. As the plant expanded and we began to install a higher level of process control automation, pressure on resources mounted. We had a midrange business computer which ran a preventive maintenance package, but unfortunately did not prove flexible enough for the more sophisticated instrumentation and automation components of our plant. It was primarily designed with mechanical equipment in mind. Several attempts were undertaken to modify the existing software package to enable us to handle the increasing number of I/E components. These were successful to one degree or another, but still did not handle all of our requirements”.

In 1992, Roche decided to investigate alternative solutions that were available in the marketplace. Their basic criteria was that:

• Documents must be readily available.
• The system must allow the writing and editing of maintenance and operating Sop’s.
• Must allow change Control. Must comply with BS 5750/5781 and ISO 9000.
• Must be user friendly and must have expansion and integration capabilities.
• They requested that Calibration due lists, calibration sheets, work orders, specification sheets, loop drawings and procedure sheets be available from the system.

After several presentations by some of the market leaders at the time it became evident that a radical redesign of their manual system would be necessary. Roche were understandably cautious of this undertaking. “Basically we had a good manual system, but were not handling our data very efficiently” said Peter.At this stage, Roche came across a new approach being marketed by Dornan Research and Development, a company they were familiar with, and having over twenty years experience in the instrumentation and control business. Dornan’s product was known as CompuCal.

Instrument technicians and engineers designed CompuCal from the bottom up. Ease of use was a top priority and the fact that many users would be at craft level was taken into account. Documentation generated by CompuCal could be tailor made to suit the specific requirements of Roche, an FDA regulated industry.

Peter had no hesitation in recommending the adoption of this solution to his management.

Roche were very impressed with the co-operation they received in tailoring the package to their own specific requirements. “An enormous benefit was that Dornans had a high level of experience in the area of Instrument Calibrations and ensured that we were on the same wavelength right from the start”

The procedure adopted by Roche was to field survey their Instrumentation, all operating ranges were checked and documented. Specification sheets were resurrected and finally when all was to hand entered to the CompuCal database. Effectively, from this stage this instrumentation was “live” on their new maintenance management solution.

This process continued over a period of approximately six months, when the existing manual system continued to operate with the growing automated system. Basically this served as a validation exercise. At the end of this process, approximately 700 loops and 2000 stand alone instruments had been field surveyed documented and set up on the CompuCal system.

At this stage, however, as maintenance personnel became familiar with the workings of CompuCal, and began to realize just how powerful a tool it really was, several enhancements were undertaken. One of the most significant modifications was the ability to run CompuCal in a fully networked environment. Craftsmen at Roche are the “owners” of their system. They generate their own work orders, carry out calibrations and enter their data. The ability of CompuCal to provide several workstations was an invaluable asset. As a further enhancement to the “Networking” feature of CompuCal, a link to the companies engineering file server was set up which enabled CompuCal to pick a copy of the master CAD drawing associated with the instrument being calibrated and print a copy of it with the work order. This feature has eliminated the need to store large quantities of drawings (sometimes out of date).

The range of management reports that were available was enhanced to include such content as:Projected workload, completed workload, graphical representation of an instrument installation’s accuracy (accuracy verses time) and many more.

Roche highlighted the reporting of an out of tolerance report as being an important function of any instrument departments operation. Dornan R. & D. came up with a novel way of accomplishing this. CompuCal calculated the error depending on results as entered by the craftsman compared with the maximum allowable uncertainty as per the original instrument setup. A deviation or “out of tolerance” report is automatically printed and an electronic copy sent to a predetermined mailing list using CC Mail.

The area of project handover from engineering to maintenance was seen as an area that had the potential to be streamlined. The problem of large volumes of information being passed from one office to another and the subsequent need to re-enter all of this information to a management system was solved using CompuCal as a tool. A project handover facility was designed. Basically, engineering personnel enter instrumentation details at construction stage. CompuCal generates a work order for the installer, and the commissioning details are re entered on completion. During this process, the maintenance content of CompuCal (Calibrations due etc.) is not visible to engineering users, likewise, the engineering data (instrumentation that is in the construction stage) is not visible to maintenance users. At project completion, maintenance use a project review facility, whereby they have the opportunity to review newly installed data, decide on a calibration interval and “accept” the handover. A recent enhancement to the system has been the inclusion of electrical drives. These have been assigned a unique test and inspection sheet which tracks such items as electrical interlocking, installed details (overload setting etc.) and even some mechanical details. As is the case for general instrumentation, these drives and their associated electrical line drawings are available on the plants internal network. CompuCal also handles the plants pressure relief valve records in a similar manner. Traditionally manufacturing plants of the complexity of Roche Irl. have availed of a two week opportunity of the annual holiday period to blitz many maintenance tasks. This is fast becoming a luxury that many organizations cannot afford, and it has evolved that maintenance must be done on the run, with annual duties staggered throughout the year. CompuCal has played a major role in managing this type of activity.

Roche presently track approximately 2500 stand-alone instruments, 1000 Instrument loops, 350 Pressure relief valves and 50 electrical drives. This is expanding almost daily. Indeed in the very near future Roche will be bringing some major capital projects to a conclusion with the subsequent addition of nearly 1000 further instruments and devices!