How to prevent cross-contamination of GMP clean room?

Preventing errors, pollution and cross-contamination is one of the core of GMP clean rooms. Cross-contamination refers to the mixing of components of different varieties of drugs through pollution, such as personnel round-trip, tool transportation, material transfer, air flow, equipment cleaning and disinfection, post clearance, etc., or improper due to humans, tools, materials, air, etc. The flow direction causes contaminants in areas with low cleanliness to pass into areas with high cleanliness, causing cross-contamination. So, how to prevent cross-contamination? Wiskind proposes reasonable arrangements from four aspects.

The “Clean Factory Design Code” clearly states that the “cleaning plant” process layout should be reasonable and compact. Only the necessary process equipment and processes and workshops with air cleanliness requirements should be placed in the clean room or clean area.

1、Reasonable layout of space.

Reasonable layout must first streamline the process and avoid round trips. The plane space of the studio should be reasonable, which is beneficial to the operation and easy to repair. The unused area and space should not be reserved. Reasonable space and area are also conducive to reasonable zoning to prevent mixed accidents.

It should be noted that the clean room is not the bigger the better, the size of the area and the space are related to the amount of air supply, which determines the energy consumption of the air conditioner and affects the investment of the project. However, the space area of the clean room should not be too small, too small may not be easy to operate and maintain.

Therefore, the reasonable design of the space should take into account the needs of equipment operation and maintenance. The production area and storage area should have a space area suitable for the production scale to house equipment and materials for easy operation and maintenance. Generally, the height of the clean room is controlled at 2.60 meters, which can be locally increased for individual higher equipment, and it is not suitable to increase the height of the clean area. There should be an intermediate station for materials inside the workshop, which is large enough to store materials, intermediate products, products to be inspected and finished products, and to facilitate clear division to minimize errors and cross-contamination.

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2、Improve equipment level.

Equipment materials, processing accuracy, containment and management systems are all related to cross-contamination. Therefore, in addition to reasonable layout, improving the automation level of equipment and composing production lines to reduce operators and reduce the frequency of personnel activities is a necessary measure to prevent cross-contamination. The solid preparation workshop has a large amount of dust. How to prevent cross-contamination in the solid preparation workshop? First, the equipment should be equipped with a protective cover and carrying a dust removal device; secondly, isolation measures should be taken to divide it into an operation room and an front room or an operation room and an auxiliary machine room.

The front room is generally a single unit in the plane 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 for equipment such as tableting, automatic coating, and capsule dispensing. For some single machines that are not sealed with dust removal auxiliary equipment, such as pulverizer, powder or granule packing machine, the exhaust air in the isolation zone can be filtered and sent back to the isolation zone to form a self-circulation. In the production process, some drugs have strong wettability.

When the relative humidity of the air is required to be less than 50% or even 45%, it is difficult to achieve the requirements of freezing and dehumidification. Among many dehumidification measures, lithium chloride rotary dehumidification is more suitable. The dehumidifier can be installed in a clean room with special dehumidification requirements, and the purified air is used as a low-humidity protective air for the post. It is a self-contained circulation system.

3、Separate air conditioning purification system.

The clean room air conditioning purification system should be divided according to different cleanliness levels. For studios of β-lactams, contraceptives, hormones, virulent microorganisms, anti-tumor drugs, radioactive drugs, etc., air-conditioning purification systems should be installed, and high-efficiency filtration equipment should be installed at the exhaust vents to contaminate these drugs. To a minimum. For clean rooms with different cleanliness levels, dust-free rooms that generate dust and harmful gases, local exhaust systems should be set up in positions with high toxicity and flammable and explosive gases. The air outlet of the clean room should have an anti-backflow device. There should be interlocking devices for the opening and closing of air supply, return air and exhaust air.

4、Strictly control people flow logistics.

The clean room should have a dedicated flow of people and logistics. Personnel should enter according to the prescribed purification procedures and should strictly control the number of people. For the material, the dust can be removed and removed through the buffer room or the transfer cabinet. Items in clean areas of different cleanliness are delivered through the transfer window. The intermediate station should be located at the center to shorten the transport distance. There are no pipes in the clean area that are not related to this position.

Make full use of the technical interlayer above or below or around, the main pipes of all common pipes and process pipes are installed in the technical interlayer. Pipes that pass through the ground and partition walls should be placed as close as possible to the point of use and the casing should be laid. There should be no welds in the pipes in the casing, and there should be a sealable seal between the pipe and the casing. The pipes entering the clean room should be made of stainless steel.