The specification requires that the drug testing room should have sufficient space to meet the needs of each experiment. Each type of analytical operation shall have separate, suitable areas, preferably areas or fields with physical divisions: acceptance and storage areas for samples to be inspected; reagent and standard acceptance and storage areas; clean wash areas; Special work area; general analysis test area; data processing, data storage area; office; personnel room such as locker room or lounge. Therefore, in the design, we generally set the following main functions:
(1) Central Laboratory;
(2) Instrument room, including general instrument room, precision instrument room, balance room, etc.;
(3) Microbiological examination room, including sterile or semi-sterile room, culture room, and hygiene preparation room;
(4) Auxiliary functions such as drying room, disinfection room, reagent storage room, glass instrument storage room, gas chamber, special gas supply room and sample observation;
(5) Management functions such as quality inspection office and archives room;
In addition, it should be equipped with auxiliary rooms such as air-conditioning room, power distribution room, locker room, toilet, etc., which can be considered together with the administrative office area or set separately. If the drug testing room is a single building monomer, office, changing, distribution, and sample observation can be set on the bottom floor; if it is a combined office quality inspection building, the quality inspection part should be placed in the upper part of the administrative office. They must not pollute and interfere with each other.
Central laboratory layout
The central laboratory is a comprehensive work place for sample processing, reagent preparation, titration analysis, cleaning equipment, writing reports, etc. during various types of drug testing. It is the main analytical and testing site with a relatively large footprint. For ease of operation, it should be adjacent to the drying room, balance chamber, instrument room, etc.
Layout of a sterile room (or semi-sterile room)
A sterile room (or semi-sterile room) is an operating room for microbiological quality testing. The microbiological quality requirements of the preparation are divided into two types: sterility requirements and hygiene standards. For sterility requirements, such as injections and ophthalmic preparations, sterility requirements are established, which need to be tested in a sterile room. It is realized by setting a clean bench in a 10,000-class clean environment; it does not require a completely sterile general preparation, but does not allow the presence of certain bacteria, and limits the number of colonies allowed to exist, in this case Hygienic standards, such as: oral solid preparations, internal liquid preparations, external preparations, etc., can be tested in a semi-sterile room, and the design is implemented by setting a clean bench in a 100,000-level clean environment.
The sterile room (or semi-sterile room) is a clean area. It should be designed according to the requirements of the GMP for the clean area. The personnel should enter the dressing and buffer room. The material or items should also be buffered (or the transfer window). The medium and the medium must be sterilized before entering. The sterile room is equipped with an observation window where it can be directly observed by the outside world, which ensures the safety of the operator. The air-conditioned machine room is set up nearby, and the air return pipe is shortened. At the same time, the supporting culture room, hygiene preparation room, cleaning room, sterilization room, etc. should be set up.
The instrument room includes a balance chamber, a spectrum chamber, a microscope chamber, a general instrument room, and the like. Generally, the balance chamber should be set separately. The layers should be set on each floor. The other rooms can be set as needed. They should be as far away as possible from the vibration source and high temperature, and close to the central laboratory. The arrangement principle is: wet and dry separation is convenient for moisture-proof, heat and cold are separated to facilitate energy saving, constant temperature concentration is convenient for management, and the balance is concentrated for weighing and sampling.
The high-temperature greenhouse refers to a drying room, a disinfection room, etc., and is a place for placing a drying box, a muffle furnace or a sterilizing cabinet, etc., generally should be away from the reagent room and the freezing room, and the room is provided with a temperature-sensing smoke alarm, and a mechanical exhaust is set. .
Sample observation room
The sample observation includes the sample materials of the original auxiliary materials, packaging materials and finished products. It can be set separately or partitioned. The indoor should pay attention to ventilation and moisture proof design. If there is a cool storage requirement, a shade room should be set up. Floors placed on the second or second floor should also be accurately calculated to ensure safety.
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