|Environment for phamaceutical production|
Drug production environment includes indoor environment and outdoor environment. Indoor environment is referring to clean indoor environment and outdoor environment.Indoor environment is is referring to clean indoor environment.indoor environment may affect the quality of medicines, And the outdoor environment it may affect the quality of the indoor environment.
|Environmental control requirements for pharmaceutical manufacturing|
1)Providde air that reach cleanliness level required for the process production in the plant
The number of dust particles and microorganisms in the clean plant air shall meet the requirements
2)The temperature and relateve hunidity of clean plant air suitable for the production and process requirements,
Effective dust traps should be set up for dust producing rooms to prevent cross contamination of dust
3)Production areas for penicillin, hormones and antitumor drugs should set up a separate special-purpose air-conditioning system
4)Dressing rooms, bathrooms and toilets shall not be installed in clean rooms(area)or should not have adverse effects.
5) Effective dust collection equipment shall be installed in the room where dust is generated to prevent cross contamination of dust
6) For auxiliary production rooms such as warehouse, its ventilation facilities and temperature humidity should be commensurate with the requirements of drug production
7) Clean room should be disinfected regularly, disinfectants used shall not pollute equipment, materails an finished products, the disinfectant variety is chaged regularly to prevent the production of resistant strains.
|The impotance of particle(dust patticle)control|
1,GMP regulation: preparations, pharmaceutical ingredients refine, drying ,pack. The raw and auxiliaty materials used in the prepatation, the raw and auxiliary materials used for package, in dirct contact with drugs shall be carried out in clean area. A clean room or area of a pharmaceutical refers to its construction structure equipment and the use of the equipment can reduce pollutant intervention, avoid contaminant production and retention.
2,In term of controlling particles in the environment, clen rooms are also important for phamaceutical companies. particles, Especially, the existence of dust particles directly affects the quality of drugs. Endanger people's lives. Alarge amount of clinical date showed that, if the drug was contaminated with dust patticles of 7-2um, especially intravenous medications can cause a thermogenic reaction pulmanary arteritis,microthrombus or granulolma, severe cases can lead to death. The harm of particles entering the vascular system. It's related to particle number, particle size and physical and chemical properties.
3,However, pharmaceutical manufactures clean room on the cleanliness control is not limited to particles.
4, Mdicine, in view of its special role in saving lives, in the production environment, in addition to the non-life pollutant particles must be limited. it also has to deal with animated polllutants an microbes make the necessary rules, because bacteria and fungi that can be produced anywhere and have a strong reproductive capacity. Most of the microbes in companies must control both the particulates and microbes in their prodution environmentsin their cleanrooms. state administration of frug supervision (SDA)it also teflects th characteristics of the clean room of the pharmaceutical manufacture which is different from other industrial clean factories.
|The application of clean air technology in phamaceutical production|
Air cleanliness level: now it is divided into four levels
Air treatment measures to purify air conditioniang systems
1) Air filtration, filters are used to effctivesy control the cleanliness of all air entering the room from the outside, Because bacteria are attached to suspended particles, as particles are filtered .Bacteria can also filter out.
2) Airflow organization and ventilation to organize certain florms and intensities of airflow indoors, clean air is used to remove pollutants from production
3)Pressure control: prevent outside air pollution from entering the room through doors and various leakage;
4) comprehensive purification measures, appropriate measures shall be taken on the processed, equipment and pipelines;
The application of clean air technoligy in phamaceutical production