The requirements of the Good Manufacturing Practice for Pharmaceuticals for equipment:
The design, selection and installation of equipment should meet the requirements of pharmaceutical production, be easy to clean, disinfect or sterilize, facilitate production operation and repair and maintenance, and prevent errors or reduce pollution.
The surface of equipment in direct contact with drugs should be smooth, flat, without dead corners, easy to clean or disinfect, corrosion-resistant, and not chemically change with drugs or adsorb drugs.
The lubricants and coolants used in the equipment shall not cause contamination to drugs or containers. The design and installation of pipelines should avoid dead corners and blind pipes.
The scope of application and precision of instruments, meters, measuring tools, scales, etc. used for production and inspection should meet the requirements of production and inspection, have obvious qualified marks, and be regularly calibrated.
The production equipment should have obvious status marks, and be regularly repaired, maintained and verified. The operation of equipment installation, repair and maintenance must not affect the quality of the product.
Instruments and meters with special requirements should be placed in a special instrument room, and there should be facilities to prevent static electricity, vibration, moisture or other external factors.