EQUIPMENT

PRINCIPLE

Equipment used in manufacturing of pharmaceutical products should be of appropriate design and construction, adequate size, suitably located and qualified in order that the quality designed into each pharmaceutical product can be assured and reproducible on a batch-to-batch production basis and to facilitate its effective cleaning and maintenance.

DESIGN AND CONSTRUCTION

The design and construction of equipment should fulfill the following requirements:
equipment should be designed and constructed to suit its intended purpose;
equipment surfaces coming into contact with any starting material, intermediate, bulk or finished product should not be reactive, additive, or absorptive so as to alter its identity, quality or purity beyond the established limits;
materials required for specific equipment operations, such as lubricants or coolants should not come into contact with any in-process materials so as to alter the identity, quality, or purity of starting material, intermediate, bulk or the finished product;
equipment should not adversely affect the product through leaking valves, lubricant drips and the like; or through inappropriate repairs, maintenance, modifications or adaptations;
equipment should be designed so that it can be easily and thoroughly cleaned. It should be cleaned according to detailed and written procedures and stored only in a clean and dry condition;
washing and cleaning equipment should be chosen and used in order not to be a source of contamination;
equipment should not present any hazard to the products. The parts of the equipment that come into contact with the product must not be reactive, additive or absorptive to such an extent that it will affect the quality of the product and thus present any hazard;

all equipment designated for use with flammable substances or chemicals or in areas where flammable materials are used should be equipped with explosion-proof electrical parts and should be properly grounded;

balances and measuring equipment of an appropriate range and precision should be available for production and control operations. Equipment employed for weighing, measuring, testing and recording should be regularly checked for accuracy and calibrated according to an appropriate program and procedure. The result of the checking and calibration should be recorded. The records should be kept properly;

filters for liquid filtration used in the processing of products should not release fibers into such products. An asbestos containing filter with or without subsequent use of a specific non-fiber releasing filter should not be used; and

distilled, de-ionized and, where appropri-ate, other water pipes should be sanitized according to written procedures that detail the action limits for microbiological contamination and the measures to be taken.

INSTALLATION AND LOCATION

Equipment should be suitably located to minimize possible cross-contamination by substances used in the same area. Equipment should be installed in such a way as to prevent any risk of error or of contamination.

Equipment should be located at a sufficient distance from other equipment to avoid congestion and to ensure that products do not become admixed or confused with one another.

All open mechanical belts and pulleys should be equipped with safety guards.

Water, steam and pressure or vacuum and other lines should be installed so as to be easily accessible during all phases of operation. Fixed pipe work should be clearly labeled to indicate the contents and, where applicable, the direction of flow.

Each piece of major equipment should be clearly marked with an identifying number. This number will be used on all batch directions to designate the particular unit or apparatus used it that specific batch. Exception is made where a piece of equipment is solely used for one type of product.

Defective equipment should, if possible, be removed from production and quality control areas, or at least be clearly labeled as defective.

MAINTENANCE

Equipment should be maintained at appropriate intervals to prevent malfunctions or contaminations which could alter the identity, quality, or purity of the product.

Repair and maintenance operations should not present any hazard to the quality of the products.

Coolants, lubricants and other chemicals such as thermal probe solutions should be evaluated and approved by a formal process.
Written procedures should be established and followed for maintenance of equipment.

A written record of major equipment maintenance and use should be included in individual equipment logs which also identifies the date, time, product, strength and batch or lot number of each batch processed. For equipment used solely for one product the record can be included in the production batch records.