Modular Cleanroom Purification Project
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With the rapid development of society and economy, people's life, work and product production technology, product quality and other higher requirements, the use of Modular cleanroom purification projects more and more. How to use the Modular cleanroom reasonably and prevent the occurrence of errors, contamination and cross-contamination is one of the cores of GMP.
Cross-contamination refers to the mixing of ingredients of different varieties of medicines to cause contamination through personnel travel, tool transportation, material transfer, air flow, equipment cleaning and post clearing, etc. Flow direction, so that the pollutants in the areas with low cleanliness are introduced into areas with high cleanliness, resulting in cross-contamination. So, how to prevent cross-contamination?
The "Code for Design of Clean Workshops" implemented in 2002 clearly pointed out that the "process layout of clean workshops should be reasonable and compact. Only necessary process equipment and air cleanliness requirements should be arranged in Modular cleanrooms or clean areas."
1. Rational arrangement of space area
Rational arrangement must first straighten out the technological process and avoid circuitous round trips. The plane space of the studio should be reasonable, which is conducive to operation and maintenance, and should not reserve idle area and space.
Reasonable space and area are also conducive to reasonable zoning and prevent mixed accidents. It should be noted that the larger the Modular cleanroom 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 conditioner, and affects the investment of the project.
However, the space area of the Modular cleanroom should not be too small, which may be inconvenient for operation and maintenance. Therefore, the design of a reasonable space area should take into account the needs of equipment operation and maintenance. The production area and storage area should have a space suitable for the production scale to accommodate equipment and materials for easy operation and maintenance.
Generally, the height of the Modular cleanroom is controlled at 2.60 meters. For individual high equipment, it can be increased locally, but it is not suitable to increase the height of the clean area. There should be an intermediate station for materials inside the workshop, with an area sufficient to store materials, intermediate products, products to be inspected and finished products, and to facilitate clear divisions to minimize errors and cross-contamination.
2. improve the level of equipment
The material, Processing accuracy, degree of containment and management system are all related to cross-contamination. Therefore, in addition to a reasonable layout, improving the automation level of the equipment and forming a linked production line to reduce the number of operators and the frequency of personnel activities is a necessary measure to prevent cross-contamination. The solid preparation workshop produces a large amount of dust. How to prevent cross-contamination in the solid preparation workshop?
First, the purchased equipment should have a protective cover and carry a dust removal device;
secondly, isolation measures should be taken to divide it into an operation room and a front room or an operation room and an auxiliary machine room. The front room generally adopts a single machine and a single room in the layout, the auxiliary machine room can be located in the non-clean area, and the inspection door is located on the side of the corridor. Such separation methods can be used in equipment such as tableting, automatic coating, and capsule dispensing.
For some single machines without dust removal auxiliary equipment and unsealed, such as pulverizers, powder or granule packaging machines, the exhaust air in the isolation area can be filtered and then returned to the isolation area, that is, a self-circulation is formed. In the production process, some medicines are highly hygroscopic. When the relative humidity of the air is required to be lower than 50% or even 45%, it is difficult to achieve the requirement of freezing and dehumidification. Among many dehumidification measures, lithium chloride rotary dehumidification is more suitable. The dehumidifier can be installed in a Modular cleanroom with special dehumidification requirements, and the purified air can be used as a low-humidity protective air for the post, forming a self-circulating system.
3. Separate air conditioning purification system
The air-conditioning purification system of the Modular cleanroom should be divided according to different cleanliness levels. For the studios of beta-lactams, contraceptives, parabens, virulent microorganisms, anti-tumor drugs, radioactive materials, etc., an air-conditioning purification system should be set up, and the air outlet should be equipped with filtering equipment to reduce the pollution of these to Minimum.
For Modular cleanrooms of different cleanliness levels, Modular cleanrooms that generate dust and harmful gases, and posts with highly toxic media and flammable and explosive gases, a separate local exhaust system should be set up. The air outlet of the Modular cleanroom should be equipped with an anti-backflow device. The opening and closing of supply air, return air and exhaust air should have interlocking devices.
4. Strictly control the flow of people and logistics
The Modular cleanroom should be equipped with dedicated flow of people and logistics. Personnel should enter according to the prescribed purification procedures, and the number of people should be strictly controlled. For the material, it can be dismantled and outsourced after removing the dust and sent through the buffer room or transfer cabinet. Items in the clean area of different cleanliness levels are conveyed through the transfer window.
The intermediate station should be located in the central position in order to shorten the transportation distance. There are no pipes unrelated to the position in the clean area. Make full use of the upper and lower or surrounding technical interlayers, and the main pipes of all public pipes and process pipes are installed in the technical interlayers. Pipes passing through the ground and partition walls should be as close to the point of use as possible and the casing should be laid. The pipes in the casing should not have welding seams, and there should be forkable sealing measures between the pipes and the casing. Piping into the Modular cleanroom should be stainless steel.