How can clean rooms prevent cross-contamination? The Code for the Design of Clean Workshops, which was implemented in 2002, clearly points out that the process layout of clean workshops should be reasonable and compact. Clean rooms or clean areas should only be equipped with necessary process equipment and working procedures and workrooms with air cleanliness requirements.
Improve equipment level
The material quality, processing accuracy, sealing degree and management system of the equipment are all related to cross-contamination. So in addition to reasonable layout, improving the automation level of equipment and forming a linkage production line to reduce the number of operators and the activity frequency of personnel are the necessary measures to prevent cross-contamination. Dust production in solid preparation workshop is large. How to prevent cross-contamination in solid preparation workshop? Firstly, the selected equipment should have protective cover and dust removal device; secondly, isolation measures should be taken to divide it into operation room and front room or operation room and auxiliary room. The front room is generally arranged in a single room, the auxiliary room can be located in a non-clean area, and the maintenance door is located on the side of the corridor. Such separation methods can be used in tablet pressing, automatic coating, capsule packing and other equipment. For some single machines without dust removal auxiliary equipment and without sealing, such as pulverizer, powder or granule packing machine, the exhaust air in the isolation area can be filtered and sent back to the isolation area, which forms self-circulation. In the production process, some medicines have strong humidity induction. When the relative humidity of air is less than 50% or even 45%, it is difficult to meet the requirement of freezing dehumidification. Among many dehumidification measures, lithium chloride runner dehumidification is more suitable. The dehumidifier can be installed in a clean room with special dehumidification requirements. The purified air is used as the low humidity protective air of the post and forms a self-contained circulating system.
Separate air conditioning and purification system
The air conditioning and purification system of clean room should be set up according to different cleanliness grades. For the studios of beta-lactams, yun-avoiding drugs, hormones, virulent microorganisms, anti-cancer drugs and radiopharmaceuticals, air conditioning and purification systems should be set up, and filters should be installed in the vents to reduce the contamination of these drugs to a minimum. For clean rooms with different cleanliness grades, clean rooms that produce dust and harmful gases and positions that discharge toxic, inflammable and explosive gases, shejv department should be separately ventilated. The air outlet of the clean room should have an anti-backfilling device. The opening and closing of supply air, return air and exhaust air should have interlocking devices.
Strict Control of Flow and Logistics
Clean rooms should be equipped with dedicated flow and logistics channels. Personnel should enter according to the prescribed purification procedure and the number of people should be strictly controlled. For materials, they can be removed and outsourced after dust removal and fed through buffer or transfer cabinet. Goods in clean areas of different cleanliness levels are transmitted through transfer windows. Intermediate stations should be located in the central position in order to shorten the transportation distance. There are no pipes unrelated to the post in the clean area. Making full use of the upper and lower technical interlayer or the surrounding technical interlayer, the main pipes of all public pipes and process pipes are installed in the technical interlayer. Pipeline passing through the ground and partition wall should be as close as possible to the use point and lay casing. There should be no weld in the pipe inside the casing, and there should be forked sealing measures between the pipe and the casing. The pipes entering the clean room shall be made of stainless steel.
Reasonable layout of space area _____________
Reasonable layout should first straighten out the process flow and avoid circuitous roundtrip. The plane space of the studio should be reasonable, which is beneficial to operation and maintenance, and should not reserve idle area and space. Reasonable space and area are also conducive to reasonable zoning and prevention of mixed accidents.
It should be noted that the cleanroom is not the bigger the better. The size of area and space is related to the amount of air supply, determines the energy consumption of air conditioning, and affects the investment of the project. But the space area of the clean room can not be too small, too small may not be easy to operate and maintain. Therefore, the design of reasonable space area should take into account the needs of equipment operation and maintenance. The production area and storage area shall have a space suitable for the scale of production to accommodate equipment and materials for easy operation and maintenance. Generally, the height of clean room is controlled at 2.60 meters. For some higher equipment, the height of clean area can be increased locally, but it is not suitable to improve the height of clean area in an all-round way. The interior of the workshop should be equipped with a material intermediate station, which is large enough to store materials, intermediate products, products to be inspected and finished products, and is convenient for definite zoning, so as to minimize errors and cross-contamination.
Attachment: Preventing errors, pollution and cross-contamination is one of the core of GMP. Cross-contamination refers to the incorporation of components of different kinds of drugs into the environment through roundtrip of personnel, transportation of tools, material transfer, air flow, equipment cleaning and disinfection, post clearance, etc. or the inappropriate flow of human beings, tools, materials and air to make the contaminants in areas with low cleanliness enter the environment clean. Highly polluted areas cause cross-contamination.
The professional technicians of Ed Purification Engineering design a reasonable plan to adapt to the production process and the cost of the project. The design technical indicators meet the national standard of clean room. The experienced construction team of the purification project is fast and efficient, and the after-sales service is perfect. To learn more about the medical purification industry, please pay attention to the Wechat Public No. Aide-188 (Ed Purification and Oxygen Supply)