1、 Reasonably arrange the space area
Reasonable layout should first straighten out the process flow and avoid detours. The plane space of the studio shall be reasonable, which is not only conducive to operation, but also convenient for maintenance. No idle area and space shall be reserved. Reasonable space and area are also conducive to reasonable zoning and prevent mixed accidents. It should be noted that the larger the GMP purification workshop is, the better. The size of area and space is related to the air supply volume, determines the energy consumption of air conditioning, and affects the investment of the project. However, the space area of the purification workshop should not be too small, which may be inconvenient for operation and maintenance. Therefore, the needs of equipment operation and maintenance should be considered in the design of reasonable space area. The production area and storage area shall have a space area suitable for the production scale to place equipment and materials for easy operation and maintenance. Generally, the height of the purification workshop is controlled at 2.60M, and individual high equipment can be raised locally, rather than comprehensively raising the height of the clean area. There shall be an intermediate station for materials in the workshop, which is large enough to store materials, intermediate products, products to be inspected and finished products, and is easy to clearly divide the area, so as to reduce errors and cross pollution to a great extent
2、 Improve equipment level
The material, processing accuracy, sealing degree and management system of the equipment are related to cross pollution. Therefore, in addition to reasonable layout, improving the automation level of equipment and forming a linkage production line to reduce operators and reduce personnel activity frequency are necessary measures to prevent cross pollution.
The dust production of solid preparation workshop is large. How to prevent cross contamination in solid preparation workshop? First of all, the purchased equipment shall be equipped with protective cover and dust removal device; Secondly, isolation measures shall be taken to divide it into operation room and front room or operation room and auxiliary room. The front room generally adopts a single machine room in the plane layout, the auxiliary room can be set in the non clean area, and the access door can be set at one side of the corridor. Such separation methods can be used for tablet pressing, automatic coating, capsule sub packaging and other equipment. For some single machines without dust removal auxiliary equipment and without sealing, such as pulverizer, powder or particle packaging machine, the exhaust air in the isolation area can be filtered and then returned to the isolation area to form self circulation.
In the production process, some drugs have strong moisture absorption. When the air relative humidity is required to be lower than 50% or even 45%, it is difficult to meet the requirements for freeze dehumidification. Among many dehumidification measures, lithium chloride runner dehumidification is more suitable. The dehumidifier can be installed in the GMP purification workshop with special dehumidification requirements. The purified air is used as the low humidity protective air of the post to form a circulating system.
3、 Separate air conditioning purification system
The air conditioning purification system of the purification workshop shall be set according to different cleanliness levels. yes β- The working rooms of lactams, contraceptives, hormones, highly toxic microorganisms, anti-tumor drugs, radioactive drugs, etc. shall be equipped with air conditioning and purification system, and its exhaust outlet shall be equipped with high-efficiency filtration equipment to reduce the pollution of these drugs to a minimum. For purification workshops with different cleanliness levels, purification workshops that produce dust and harmful gases, and posts with highly toxic discharged media and flammable and explosive gases, a separate local exhaust system shall be set up. The air outlet of the purification workshop shall be equipped with anti backflow device. The opening and closing of supply air, return air and exhaust air shall be equipped with interlocking devices.
4、 Strictly control the flow of people and logistics
The GMP purification workshop shall be equipped with special pedestrian and logistics channels. Personnel shall enter according to the specified purification procedures, and the number of personnel shall be strictly controlled. The materials can be removed after removing the floating dust and sent through the buffer room or transfer cabinet. The articles in the clean area with different cleaning levels are transmitted through the transfer window. The intermediate station should be set at the center to shorten the transportation distance. No pipeline irrelevant to the post shall be set in the clean area. Make full use of the upper, lower or surrounding technical interlayer, and the main pipes of all public pipelines and process pipelines are installed in the technical interlayer. Pipelines crossing the ground and partition wall shall be as close as possible to the use point and laid with casing. The pipeline in the casing shall not have welds, and forkable sealing measures shall be taken between the pipeline and the casing. The pipes entering the purification workshop shall be made of stainless steel.