NAC585.330. Maintenance, construction of equipment.

A licensee shall maintain in a clean and orderly condition all equipment used for the manufacturing, processing, packaging, labeling, holding, testing or controlling of drugs. The equipment must be of suitable design, size, construction and location to facilitate cleaning, maintenance and operation for its intended purpose. The equipment must:

     1. Be so constructed that all surfaces which come into contact with a drug or any of its components are not reactive, additive or absorptive in a way which alters the safety, identity, strength, quality or purity of the drug or any of its components.

     2. Be so constructed that any substances required for operation of the equipment, such as lubricants or coolants, do not come into contact with any drug in a way which alters the safety, identity, strength, quality or purity of the drug or any of its components.

     3. Be constructed and installed to facilitate adjustment, disassembly, cleaning and maintenance to ensure 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 any of its components.

     4. Be of suitable type, size and accuracy for any testing, measuring, mixing, weighing or other processing or storage operation.

     [Comm’r of Food & Drugs, Amygdalin and Procaine Hydrochl. §§ 3.2-3.2.4, eff. 5-15-78]