Drainage measures in GMP clean areas

The task of the indoor drainage system is to quickly discharge the sewage that has been removed from the washing and sanitary appliances and production equipment, as well as the rainwater and snow water that has landed on the roof, into the outdoor drainage pipe, and the cleanliness requirements of the pharmaceutical production need to be prevented in the outdoor drainage pipe. Harmful gases, odors, and harmful insect lamps enter the room, cause microbial contamination, and provide convenient conditions for the treatment and comprehensive utilization of outdoor sewage. Therefore, the drainage system in the clean area is also extremely important.

There are three types of sewage generated by the pharmaceutical industry:

(1) Domestic sewage includes sewage discharged from sanitary ware, hand washing facilities, shower facilities, etc.;

(2) The production wastewater is the sewage and wastewater generated during the production process, including equipment and container washing water, cooling water, etc.;

(3) Rainwater includes rain on the roof and melted snow.

The indoor drainage system generally adopts the diversion system, and the domestic sewage and drainage design code (TJ13-74) must also comply with the relevant regulations of GMP. The main measures taken are:

(1) It is not advisable to install water buckets and floor drains in Class 100 clean rooms. Water tanks and floor drains should be avoided in Class 10,000 clean rooms. The number of water buckets and floor drains should be reduced to a minimum in other clean rooms.

(2) The water bend or water seal device must be installed in the following parts of the equipment for the connection between the clean room and the sewer pipe, cleaning appliances and drainage equipment;

(3) The floor drain provided in the clean room requires that the material is not easy to corrode (the inner surface is smooth, such as stainless steel), it is not easy to scale, there is a sealing cover, it is convenient to open, it can prevent the waste water from flowing back, and it is allowed to temporarily open the cover when flushing the ground. At the same time, the cover will be covered and, if necessary, disinfected and disinfected according to the product process requirements, so that the pollution can be better prevented (the new special clean floor drain of the pharmaceutical industry has been developed in China);

(4) The quality supervision department and the acid-base wastewater generated in production should also be provided with special pipelines, and PVC (plastic pipe or ABS engineering plastic pipe) should be used to lead to the acid-base treatment device.

In short, clean areas should try to avoid the installation of water buckets and sewers, and the aseptic operation area should be absolutely avoided. If it is installed, the design should be considered for its location for easy maintenance and cleaning to minimize microbial contamination.

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