Environment for Pharmaceutical Production
The drug production environment includes both the indoor and outdoor environments. The indoor environment refers to the clean indoor space, which can affect the quality of medicines, while the outdoor environment can impact the indoor environment and, in turn, the quality of the medicines.
Environmental Control Requirements for Pharmaceutical Manufacturing
1. Provide air that meets the required cleanliness level for the production processes in the plant. The number of dust particles and microorganisms in the clean air must comply with the standards.
2. The temperature and relative humidity of the clean air should be suitable for production and process requirements. Dust-producing rooms should be equipped with effective dust traps to prevent cross-contamination.
3. Separate, dedicated air-conditioning systems should be installed in production areas for penicillin, hormones, and antitumor drugs.
4. Dressing rooms, bathrooms, and toilets should not be installed in cleanrooms (or areas) or should not adversely affect them.
5. Effective dust collection equipment must be installed in rooms where dust is generated to prevent cross-contamination.
6. In auxiliary production rooms, such as warehouses, ventilation, temperature, and humidity should meet the requirements for drug production.
7. Cleanrooms should be disinfected regularly, and the disinfectants used should not contaminate equipment, materials, or finished products. Disinfectant types should be rotated regularly to prevent the development of resistant strains.
The Importance of Particle (Dust Particle) Control
1,GMP Regulations: In the preparation, refining, drying, and packaging of pharmaceutical ingredients, raw and auxiliary materials that come into direct contact with drugs must be handled in clean areas. A pharmaceutical cleanroom or area refers to a controlled environment where the construction, structure, and equipment minimize contamination and prevent the accumulation of pollutants.
2,Controlling Particles in Cleanrooms: For pharmaceutical companies, controlling dust particles in the environment is critical, as their presence directly impacts drug quality and can pose significant health risks. Clinical data show that contamination with dust particles between 7-2 μm, especially in intravenous medications, can cause thermogenic reactions, pulmonary arteritis, microthrombi, or granulomas. In severe cases, this contamination can lead to death. The harm caused by particles entering the vascular system is related to their number, size, and physical and chemical properties.
3,However, cleanliness control in pharmaceutical manufacturing is not limited to particle contamination. Pharmaceutical production environments also need to address biological pollutants such as bacteria and fungi, which have strong reproductive capacities. The State Administration of Drug Supervision (SDA) reflects the unique characteristics of pharmaceutical cleanrooms, distinguishing them from cleanrooms in other industries.
The Application of Clean Air Technology in Pharmaceutical Production
Air cleanliness is categorized into four levels, and the following measures are used to purify air conditioning systems:
1. Air Filtration: Filters effectively control the cleanliness of the air entering the room from outside. Since bacteria attach to suspended particles, filtering out particles also removes bacteria.
2. Airflow Organization and Ventilation: Proper airflow patterns and intensities are established to remove pollutants from the production area using clean air.
3. Pressure Control: Pressure control prevents outside air from entering the room through doors or leaks, maintaining a cleanroom environment.
4. Comprehensive Purification Measures: Appropriate measures should be taken for processes, equipment, and pipelines to maintain air quality and cleanliness.
The application of clean air technology in pharmaceutical production