Article 11 In order to ensure the quality of preparation, the preparation room should be far away from all kinds of pollution sources. The surrounding ground, pavement and vegetation should not cause pollution to the preparation process.
Article 12 The preparation room should have effective facilities to prevent pollution, insects and other animals from entering.
Article XIII of the preparation room of the house and the area must be formulated with the preparation of dosage forms and scale. There should be staff locker room.
Article XIV of the workplace should be prepared according to the process and air cleanliness level requirements of a reasonable layout. General and clean area separate; preparation, dispensing and labeling, packaging separate; internal and external preparations separate; sterile preparations and other preparations separate.
Article XV of the various preparations should be based on the needs of the dosage form, the process of reasonable convergence, set up different operating rooms, according to the process of division of operating positions.
Article XVI of the preparation room should have with the preparation of materials, finished products and other appropriate storage, and ventilation, moisture and other facilities.
Article 17 The pre-treatment, extraction and concentration of Chinese herbal medicines must be strictly separated from their subsequent processes, and there should be effective dust removal and exhaust facilities.
Article 18 of the preparation room in the design and construction, should consider the use of easy to carry out cleaning work. Clean room of the internal surface should be flat and smooth, no cracks, tight interfaces, no particles off and can withstand cleaning and disinfection. Walls and floors and other junctions should be curved or other measures to reduce the accumulation of dust and easy to clean.
Article 19 of the clean room piping, lamps, air and other utilities in the design and installation should be avoided in parts that are not easy to clean.
Article 20 according to the preparation process requirements, divided into air cleanliness level (see Annex Table I, Table II). Clean room (area) the number of microorganisms in the air and the number of dust particles should be in line with the provisions of the regular testing and recording.
Article 21 of the clean room (area) should be sufficient illumination, the main workplace illumination should be 300 lux.
Article 22 of the windows of the clean room, technical interlayer and into the interior of the pipeline, air outlet, lamps and lanterns and walls or ceiling connection parts should be sealed.
Article 23 of the clean room (area) should maintain a certain positive pressure, and send in a certain proportion of fresh air.
Article 24 of the clean room (area) installed in the pool, the location of the floor drain should be appropriate, shall not cause contamination of the preparation. 100 clean area shall not be equipped with floor drain.
Article 25 of the laboratory animal room should be far away from the preparation room.