INSIGHT REPORT
Vol 4  #4
April
2001

INSIGHT REPORT

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As we all have learned in reading about the FDA legal actions over the past few years, validation of production equipment and production processes used in pharmaceutical and/or a medical device manufacturing sites is essential to assuring regulatory compliance as well as to the success of your business. Though you may be familiar with the process, validation protocol and testing procedures, one of the most common and often overlooked areas in performing the process of validation lies in the lack of documentation associated with the equipment. More precisely the lack of documentation associated with the equipment specifications.

The equipment specification should be a stand-alone approved document that thoroughly defines the equipment's description, functional requirements, utilities, safety and guarding features, size, output capacity and additional requirements associated with the demands of it's subsequent validation. It is not an IQ/OQ but a technical document describing the requirements of the equipment. During the entire life cycle of production equipment the equipment specification is not addressed, but is a very useful tool for the plant engineers, maintenance, and validation personnel.

The equipment specification is very similar to a design specification used to bid out and purchase equipment. Oftentimes the equipment specification is used as such and is especially essential for making purchases of identical equipment.

The equipment specification provides the functional requirements for the equipment that governs it throughout its life cycle. Once complete it provides a starting point for successive validation protocols like IQ and OQ. This document would also be useful for Design Qualifications, spare parts lists, preventive maintenance procedures, safety audits and the purchase of duplicate or second-generation machines. The beauty of the equipment specification document is that it's written in a template unique to the company. This document must be an approved document and maintained like other controlled documents - changes have to be reviewed and approved using the company's established change control procedure.

Therefore engineers who may have limited FDA experience or have not worked in a regulated environment, will quickly get lots of practice at preparing and circulating the documents across an inter-disciplinary team.

The equipment specification should be numbered using the equipment's unique control number (i.e. EQ-1234 for equipment #1234). The writing style should be concise and contain clear requirements that are measurable and tangible (i.e. Rubber durometer, Anodized coatings, safety guards/warnings). Always use the manufacturer's documentation including drawings and cutsheets as sources, even reference their separate location (equipment file located in plant maintenance or engineering).

Address any contracted maintenance and warranty requirements. This aspect is critical especially is there is no in-house capability for this. The equipment specification should address every aspect of the equipment from cradle to grave. For example if the equipment specification calls for Brand X gaskets for use in an alcohol bath then future engineers/maintenance personnel not necessarily experienced with that bath are forced to use Brand X. It is specified in the spec. for a reason: probably for its compatibility with the alcohol in the bath.

Remember that the equipment specification drives other life cycle activities like the spare parts list. Of course, a separate spare parts list and preventive maintenance procedure will be written for each piece of equipment. But with an equipment specification, most of the work is already done.

Another useful bit of information contained in the equipment specification is the size requirement for the equipment. This is especially valuable if the equipment has to be installed in a small space or must fit through a small doorway.

An often overlooked aspect of equipment during its design phase is compatibility with it's environment. A question that you may ask is, "Does the equipment require an exhaust?" If so, will the exhaust be required to be filtered and will the exhaust pass local, state or federal environmental regulations? Another question might be, "Does the equipment produce hazardous waste?" If it does then plans must be started to contract a collection service, train a spill team, and plan evacuation routes/drills. Another area of concern involving the equipment design is whether the equipment will be constructed of material compatible with the product you plan to manufacture? If the material is approved for compatibility then the equipment specification must require certificates of conformance by the vendor.

One often overlooked but critical area is whether the equipment design will meet your utility requirements. The specification must address the line voltage, frequency, amperage, phase; it must also specify where the power can be shut off and isolated in case of emergency. This information is useful for the IQ and also for Hazardous Energy Control documentation/Procedures.

What are the air requirements for the equipment? If the equipment specification requires clean dry air, then the compressed air qualification protocol must address and test the filters and desiccants in the airline. Additionally, if the equipment requires chilled water at 40ºF the plant chillers must have the capability to chill to that temperature, and validated back-ups must be on site.

The equipment specification must specify the required throughput speeds of the equipment. Is the equipment compatible with other machines in the line? The conveyor equipment specification would contain that information and can easily be made obtainable on the company Intranet.

The equipment specification essentially contains all of the information that will be used throughout the equipment life cycle including all instruments and gauges that came with the equipment. The document should specify type, accuracy, graduations, fitting size, etc. of all instruments. The instrument list for the equipment must be made part of the equipment specification and already available for the IQ/OQ phase. This information can usually be found in the owner manual for the equipment.

Another important and often overlooked specification related to the equipment cleaning requirements and cleaner compatibility. Any tooling or fixtures that have specific dimensional tolerance requirements should be listed. This is especially true for those that have direct product contact. It is recommended that it be made a requirement in the equipment specification that each tool or die be shipped with proof of mechanical inspection that proves conformance to the dimensional requirements. The equipment specification should also specify acceptance testing performed by the vendor. This critical point is another one of those areas that is often overlooked.

Factory Acceptance Testing and Commissioning reports are critical for validation protocols and are always referenced. They provide the first level of testing to ensure the equipment is built and operated according to specifications. The equipment specification should state the requirements that must be met in order to ship and install the equipment. Demand the vendor include signed originals with the equipment. Additionally state the following: The supplier must correct, prior to shipping, all defects in materials and workmanship which are discovered during Factory Acceptance Testing.

Imagine all the work that would be saved if equipment were to be debugged prior to validation.

If you want more information on equipment specifications email mdi and reference this Insight report.

Next Insight – Part II: Problems Encountered with Equipment Validation Software

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