Current through Register Vol. 54, No. 24, June 15, 2024
Section 25.12 - EquipmentEquipment used for the manufacture, processing, packing, labeling, holding, testing or control of drugs shall be maintained in a clean and orderly manner and shall be of suitable design, size, construction and location to facilitate cleaning, maintenance and operation for its intended purpose. These regulations permit the use of precision automatic, mechanical or electronic equipment in the production of drugs when adequate inspection and checking procedures are used to assure proper performance. The equipment shall conform with the following:
(1) Be so constructed that all surfaces that come into contact with a drug product shall not be reactive, additive or absorptive so as to alter the safety, identity, strength, quality or purity of the drug or its components beyond the official or other established requirements.(2) Be so constructed that any substances required for operation of the equipment, such as lubricants or coolants, do not contact drug products so as to alter the safety, identity, strength, quality or purity of the drug or its components beyond the official or other established requirements.(3) Be constructed and installed to facilitate adjustment, disassembly, cleaning and maintenance to assure the reliability of control procedures, uniformity of production, and exclusion from the drugs of contaminants from previous and current operations that might affect the safety, identity, strength, quality or purity of the drug or its components beyond the official or other established requirements.(4) Be of suitable type, size and accuracy for any testing, measuring, mixing, weighing or other processing or storage operations.