How to take effective pollution prevention and control measures for pharmaceutical equipment during the production process?

Factors affecting drug quality

The quality of drugs is related to the safety of patient medication. To produce high-quality and qualified drugs, three elements are required: (1) qualified personnel; (2) Software that complies with GMP, such as reasonable dosage forms, prescriptions and processes, qualified raw and auxiliary materials, various specifications and management systems, etc; (3) Hardware that meets GMP standards, including a qualified production environment and conditions, as well as factories and equipment that meet the requirements.

 

The significance of pharmaceutical equipment in preventing and controlling pollution in production

From the above, it can be seen that the production environment, production conditions, and equipment are one aspect that affects the quality of drugs. In drug production, the pollution of production environment and conditions generally includes microorganisms, dust, particles, corrosion, errors, and cross contamination. The prevention and control of pollution in production by pharmaceutical equipment includes two layers: first, the equipment itself does not pollute drugs or the environment; 2、 Effective pollution control measures should be in place. For this reason, GMP has made several guiding provisions for pharmaceutical equipment directly involved in drug production, with the basic point of ensuring drug quality, preventing various possible pollution of drugs during the production process, as well as factors that may affect the environment and harm human health. Therefore, the design of pharmaceutical equipment should comply with GMP requirements, reduce pollution factors, and have good pollution prevention and control measures.

 

The design of pharmaceutical equipment complies with GMP requirements

The product design, manufacturing, technology, performance, and other aspects of pharmaceutical equipment under the specific conditions of pharmaceutical GMP should be based on the General Principles of Equipment GMP Design to promote the establishment and improvement of GMP standards for pharmaceutical equipment. The specific content is as follows:

 

(1) The design of the equipment should meet the requirements of drug production and technology, be safe, stable, reliable, easy to clean, disinfect or sterilize, facilitate production operation and maintenance, and prevent errors and cross contamination;

 

(2) The material selection of equipment should be strictly controlled. Components that come into direct contact with drugs should be made of non-toxic, non corrosive, non chemically reactive with drugs, non releasing particles or adsorbing drugs;

 

(3) The internal surfaces of devices and working parts that come into direct contact with drugs should be designed without platforms, grooves, or exposed bolt connections as much as possible. The surface should be flat, smooth, without dead corners, easy to clean and disinfect;

 

(4) The equipment should not cause pollution to the environment outside the device. Considering that the pollution caused by each type of equipment is different, relevant measures such as dust prevention, leak prevention, insulation, and noise prevention should be taken.

 

(5) Equipment used in flammable and explosive environments should use explosion-proof electrical appliances and be equipped with anti-static and safety devices;

 

(6) The filling or packaging equipment for sterile preparations should be operated in the corresponding clean room, locally using 100 level laminar clean air and positive pressure protection;

 

(7) The design of pipelines for medication, injection water, and purified compressed air should avoid blind spots and blind pipes. The material should be non-toxic and corrosion-resistant. The inner surface should be electropolished and easy to clean;

 

(8) When small amounts of foreign objects are generated due to driving friction or lubricants cannot be avoided, their components should be sealed and isolated from the workshop. The lubricants used should not cause pollution to drugs, packaging containers, etc;

 

(9) The cleaning of sterile equipment, especially the sterilization of parts and components that come into direct contact with drugs, should indicate the sterilization date, and if necessary, conduct sterile effect verification. It is recommended to equip CIP and SIP systems for equipment cleaning;

 

(10) The equipment design should meet the requirements of standardization, generalization, serialization, and mechatronics integration. The continuous sealing and automatic detection of the production process are the guarantees for implementing equipment GMP.

 

Source: Internet