How to prevent clean room pollution?
With the rapid development of social economy, people's life, work and product production process, product quality and so on put forward higher requirements, clean room purification engineering is more and more widely used.
How to use clean room reasonably and prevent mistakes, pollution and cross pollution is one of the cores of GMP. Cross contamination refers to the cross contamination caused by mixing the ingredients of different kinds of drugs through the way of personnel return, transportation, material transfer, air flow, equipment cleaning and disinfection, post clearing, etc., or by the improper flow direction of people, tools, materials, air, etc., the pollutants in the area with low cleanliness are introduced into the area with high cleanliness, resulting in cross contamination. So, how to prevent cross pollution? The code for design of clean room workshop implemented in 2002 clearly points out that the "process layout of clean workshop" should be reasonable and compact. Only necessary process equipment and working procedures and workshops with air cleanliness requirements are arranged in the clean room or clean area.
1、 Reasonable layout of space area and reasonable layout should first straighten out the technological process to avoid detours. The plane space of the studio should be reasonable, which is convenient for 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 larger the clean room is, the better. The size of the area and space is related to the amount of air supply, determines the energy consumption of the air conditioning, and affects the investment of the project. However, the space area of the clean room should not be too small, which may not be convenient for operation and maintenance. Therefore, the design of reasonable space area should take into account the needs of equipment operation and maintenance. Production area and storage area shall have space area suitable for production scale to place equipment and materials for operation and maintenance. Generally, the height of clean room shall be controlled at 2.60M, and the height of individual high equipment can be increased locally, but it is not suitable to improve the height of clean area in an all-round way. The workshop shall be equipped with an intermediate station for materials, which is large enough to store materials, intermediate products, products to be inspected and finished products, and is convenient for clear division, so as to reduce errors and cross contamination to a large extent. 2. Improve the equipment level
The material, processing accuracy, airtight degree and management system of the equipment are all related to cross contamination. Therefore, in addition to reasonable layout, it is necessary to improve the automation level of the equipment and form a linkage production line to reduce the number of operators and the frequency of personnel activities, which is a necessary measure to prevent cross contamination.
The dust production of solid preparation workshop is large. How to prevent cross contamination in the solid preparation workshop? First, the selected equipment should be equipped with protective cover and dust removal device; second, isolation measures should be taken to divide it into operation room and front room or operation room and auxiliary machine room. In general, the front room is a single room, the auxiliary room can be set in the non-clean area, and the access door is set on one side of the corridor. Such as tablet pressing, automatic coating, capsule separation and other equipment can use such separation method. 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, that is, self-circulation.
In the production process, some drugs have strong dehumidification. When the relative humidity of air is required to be lower than 50% or even 45%, it is difficult to achieve the requirements of freeze dehumidification. Among many dehumidification measures, lithium chloride wheel is more suitable. The dehumidifier can be installed in the clean room with special dehumidification requirements. The purified air is used as the low humidity protective air of the post, forming a circulation system by itself.
3、 Separate air conditioning purification system
The air conditioning and purification system of the clean room should be designed according to different cleanliness levels. Air conditioning and purification system shall be set up for workshops of β - lactams, contraceptives, hormones, virulent microorganisms, anti-tumor drugs, radioactive drugs, etc., and efficient filtering equipment shall be installed at the air outlet to reduce the pollution of these drugs to a low level. For clean rooms with different cleanliness levels, clean rooms with dust and harmful gases, and posts with highly toxic discharged media and flammable and explosive gases, local exhaust system shall be set up separately. The air outlet of clean room shall be equipped with anti-backflow device. The opening and closing of air supply, return and exhaust shall be equipped with interlocking device.
4、 Strictly control the flow of people and logistics
The clean room shall be provided with dedicated flow channels. Personnel shall enter according to the specified purification procedure, and the number of personnel shall be strictly controlled. The materials can be removed and outsourced after removing the floating dust and sent into the buffer room or transfer cabinet. Clean area items of different cleanliness levels are transmitted through the transfer window. The intermediate station should be located in the center to shorten the transportation distance. There is no pipeline irrelevant to the post in the clean area. Make full use of the upper and lower or surrounding technical mezzanine, and install the main pipes of all public pipelines and process pipelines in the technical mezzanine. The pipeline crossing the ground and partition wall shall be close to the use point as much as possible and the casing shall be laid. The pipeline in the casing shall not have welds, and there shall be forkable sealing measures between the pipeline and the casing. The pipes entering the clean room shall be made of stainless steel.