The Ventilation Requirements of Air Conditioning and the Environment Management of Dust Emissions of the GMP Clean Workshop in Pharmaceutical Factory
The Ventilation Requirements of Air Conditioning and the Environment Management of Dust Emissions of the GMP Clean Workshop in Pharmaceutical Factory
1 Ventilation design requirements for pharmaceutical plants
In order to reduce the risk of pollution and cross-contamination, plant and production facilities
The application and equipment should be rationally designed, arranged and used according to the characteristics of the manufactured drugs, process flow and corresponding cleanliness level requirements; according to the classification requirements of the characteristics of the drugs, the ventilation system is divided into two categories: (1) There are many factories, production facilities and equipment Products share the ventilation system; (2) Special-purpose ventilation systems for the production of special-type pharmaceutical plants, production facilities and equipment, such as highly allergenic drugs (such as penicillins) or biological products (such as BCG vaccines or other drugs prepared with active microorganisms) and Certain hormones, cytotoxicity, highly active chemicals, etc. The difference between the two lies in the object specificity of the ventilation system.
The clean workshop is divided into general production area and clean area according to the production process. The cleanliness is divided into four levels: A, B, C, and D. Class A clean areas refer to high-risk operation areas, such as filling areas, areas where rubber stoppers and open packaging containers are in direct contact with sterile preparations, and areas for aseptic assembly or connection operations; class B clean areas refer to aseptic The background area where the high-risk operation Class A clean area, such as preparation and filling, is located. Class C and D clean areas refer to clean areas with less important operating steps in the production of sterile drugs.
According to GMP requirements, the pressure difference between clean areas and non-clean areas, and between clean areas of different levels should not be less than 10Pa. The general ventilation process of the pharmaceutical factory is that the fresh air is processed by the medium-efficiency and high-efficiency filters from the clean high-level area to the low-level area, then from the clean area to the control area, and then to the general area. The ventilation of clean areas in Class A and B requires medium and high-efficiency filters to handle fresh air. Clean areas in Class C and D generally only require medium-efficiency filtration to meet the cleanliness requirements. In order to reduce the air-conditioning load, high-efficiency filtration only deals with the air volume required by A, B and clean areas.
2 Dust emission form of pharmaceutical factory
The dust discharge node of the pharmaceutical factory is in the steps of crushing and ingredients of the pretreatment process of the medicinal materials, drying, total mixing of the solid oral pharmaceuticals, and product packaging and other processes. The pretreatment process of medicinal materials is generally laid out in the general area of the factory building. The solid oral pharmaceuticals are dried and mixed together, and the product packaging is generally arranged in the C and D clean areas of the factory building. In the production of sterile drugs, the crushing, mixing and sub-packaging of sterile APIs will be arranged in a Class A clean area on the background of Class B of the factory.
2.1 The form of dust emission under different ventilation methods Comprehensive exhaust: The entire plant is in accordance with the requirements of the clean area.
Use the pressure difference of different clean areas, gradually ventilate, and finally discharge from the factory. Dust pollutants in the production process are discharged in the form of non-organized emissions with the ventilation system. In order to ensure the cleanliness requirements of Class A clean areas, it is not advisable to set up dust collection devices and atmospheric vents in Class A areas. The dust enters Class B clean areas with the pressure difference of the ventilation system, then to Class C, D areas, and general areas. Organizational emissions.
Local exhaust: on the basis of full emission, a dust collecting hood is added to the dust-generating node to discharge the dust-generating gas separately. The dust pollutants in the production process are mainly discharged in the form of organized discharge, and a small amount are discharged in an unorganized form.
2.2 The characteristics of different ventilation methods are more comprehensive. Full exhaust: the air conditioning load is large, and the investment of exhaust facilities is invested
Less, suitable for the production of pharmaceuticals with a small amount of dust, which can easily lead to cross-contamination and scattered dust emission points.
Local exhaust: The air-conditioning load is small. When local exhaust is required, additional ventilation equipment is needed. The capital investment is increased. It is suitable for the production of pharmaceuticals with local dust production. It is convenient for pollution prevention and control, and it is not easy to cross-contaminate.
3 Environmental management of dust emissions from pharmaceutical plants
Dust emission in the form of comprehensive air exhaust, environmental management focuses on the assessment of unorganized emissions at the plant boundary, and the dust emissions at the boundary of the pharmaceutical factory should meet the requirements of the concentration limit for the monitoring of unorganized emissions in the "Comprehensive Emission Standard for Air Pollution of GB16297-1996", namely ≤10mg/m3.
For the dust emission in the local exhaust mode, the environmental management assessment shall be organized and organized emissions separately. The discharge cylinder is generally based on a safety design. The height above the plant will not exceed 2m, and the height of the exhaust cylinder from the ground will not exceed 15m.
-1996 Comprehensive Emission Standards for Air Pollution requires organized and unorganized standards. The emission rate should be in accordance with the standards and extrapolated. The calculation result is strictly 50%. The height of the exhaust pipe needs to be higher than the surrounding buildings by 5m or more. If the height is not up to the limit, the emission rate calculated according to the corresponding height should be strictly 50%. Surrounding
Buildings within 200m include their own buildings, and their own buildings will also affect the diffusion of atmospheric dust. The assessment of unorganized emission is the same as the method of comprehensive exhaust. The dust emission from the boundary of the pharmaceutical factory should meet the requirements of the concentration limit for the monitoring of the unorganized emission of "GB16297 -1996 Comprehensive Air Pollution Standard", which is ≤1.0mg/m3.
Conclusion
The ventilation of a pharmaceutical factory is a complex control project, and there will be large differences according to the layout of the factory. Regardless of the type of ventilation used, it must meet GMP cleanliness requirements, atmospheric pollutants
The emission of dust must meet the requirements of national environmental protection standards.
