Planning and DesignPlanning and design
Drug testing laboratories are the focus of QC testing in pharmaceutical factories. They usually consist of two test units: a physical and chemical analysis laboratory and a microbiology laboratory. Physical and chemical analysis Physical and chemical identification, content determination, and other inspections of raw materials, packaging materials, intermediates and recruitments to ensure that they meet legal requirements and internal quality standards of the enterprise. The microbiology laboratory runs a series of tests to understand the microbiological condition of raw materials, packaging materials, intermediates and finished products. The QC laboratory is an important part of the quality management department.
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Design drawing of drug testing laboratory
Due to the impact of factors such as the size of the enterprise, the level of equipment and testing methods, and the different management systems and operating habits of the enterprise, the layout of the factory buildings also varies. And with the development of science, new methods, new technologies and advanced instruments and equipment will be continuously introduced for the testing of drugs and data, and there will be different requirements for the layout of the laboratory. Therefore, from a design perspective, GDC recommends that it is best to use a reinforced concrete frame structure, which is convenient for reconstruction and has good seismic performance.
The layout of the experimental building is generally in the form of a rectangular middle inner corridor, which can maximize the use of natural light. The rectangular horizontal axis can be 6-8m, and the length can be set according to the needs; the longitudinal axis can be 6-9m, or 6m-2.5m-6m, and the corridor in the middle can be set according to demand. According to the design experience of GDC, the quality inspection building is generally 2-3 floors. The clear height of the laboratory can be set from 2.6m to 3.0m. The height of the technical mezzanine is determined according to the type and structure of the air conditioner.
2. Lab function room layout
A. Settings between functions
The specification requires that the drug testing room should have sufficient space to meet the needs of various experiments. Each type of analysis operation should have a separate and suitable area, preferably with a physical division or field ownership: the receiving and storage area for the samples sent; the receiving and storage area for reagents and standards; the cleaning and washing area; Special operation area; general analysis experiment area; data processing and data storage area; office; personnel room such as changing room or rest room. Therefore, in the design, we generally set the following main function rooms:
(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, hygienic preparation room.
(4) Drying room, disinfection room, reagent storage room, glass instrument storage room, poisonous gas room, special gas supply room, and auxiliary function room for sample observation.
(5) Management functions such as quality inspection office and archives room.
In addition, auxiliary rooms such as air-conditioning room, power distribution room, locker room, and toilet should be provided, which can be considered or set up separately with the administrative office area. If the drug inspection room is a separate building unit, office, changing, power distribution, and sample observation can be set on the ground floor; if it is a combined office quality inspection building, the quality inspection part should be placed on the upper part of the administrative office And must not pollute or interfere with each other.
B. The layout of the central laboratory
The central laboratory is a comprehensive work place for sample processing, reagent preparation, titration analysis, cleaning utensils, writing reports, etc. during various drug inspections. It is the main place for analysis and testing and covers a relatively large area. In order to facilitate operation, it should be adjacent to the drying room, balance room, instrument room, etc.
C. The layout of the 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 for preparations are divided into two types: aseptic requirements and hygienic standards.Aseptic requirements are required, such as injections, ophthalmic preparations, etc., aseptic requirements are formulated, which need to be tested in sterile rooms. It is realized by setting an ultra-clean workbench under a class 10,000 clean environment; general preparations that do not require complete sterility, but the presence of certain bacteria is not allowed, and the number of allowed colonies is limited, in this case , Proposed hygienic standards, such as: solid preparations for internal use, liquid preparations for internal use, external preparations, etc., can be tested in a semi-sterile room, the design uses a 100,000 clean environment to set up a clean bench to achieve.
The sterile room (or semi-sterile room) is a clean area.It should be designed according to the requirements of the GMP clean area. As shown in Figure 3, personnel need to set up changing rooms and buffer rooms, and materials or items should also be equipped with buffer (or transfer windows). ), Petri dishes, culture media, etc. need to be sterilized before entering. The sterile room is provided with an observation window in a place that can be directly observed by the outside world, which has ensured the safety of the operator. The air-conditioning machine room is set up nearby to shorten the air supply and return air pipes. At the same time, supporting cultivation rooms, hygienic preparation rooms, cleaning rooms, sterilization rooms, etc. should also be set up.
D. Instrument room
The instrument room includes a balance room, a spectrum room, a microscope room, and a general instrument room. Generally, the balance room should be set up separately, and multiple levels should be set up on each floor. Other rooms can be set up as needed. They should be as far away from the vibration source, high temperature, and close to the central laboratory as possible. Its layout principles are: dry and wet separation is convenient for moisture resistance, cold and hot separation is convenient for energy saving, constant temperature is convenient for management, balance is concentrated for weighing and sampling.
E. High greenhouse
High-temperature greenhouse refers to the drying room, disinfection room, etc., which is the place where drying boxes, muffles, or sterilization cabinets are placed. Generally, it should be far away from reagent rooms and freezing rooms. .
F. Sample retention room
Observation of samples includes retention samples of raw materials, packaging materials and finished products, which can be set separately or in partitions. Indoors should pay attention to ventilation and moisture-proof design, and shady rooms should be set up if there is a requirement for cool storage. Floors placed on the second floor or above should also accurately calculate floor loads to ensure safety.
3. Ventilation system design layout
The laboratory ventilation system is one of the largest and most influential systems in the entire laboratory design and construction process. The perfection of the ventilation system directly affects the laboratory environment, the health of laboratory personnel, and the operation and maintenance of laboratory equipment.
Excessive negative pressure in the laboratory, gas leakage from the fume hood, and laboratory noise have always been problems that puzzled laboratory staff. These problems cause serious physical and psychological injuries to personnel who have been working in the laboratory for a long time, and even management and logistics personnel working around the laboratory.
A scientific and reasonable ventilation system requires good ventilation, low noise, easy operation, energy saving, and even the indoor pressure difference and temperature and humidity can maintain human comfort.
GDC ventilation system control. According to the conditions and requirements of different drug inspection laboratories, surprise sensor automatic variable frequency control (or PLC programming control) and variable air volume system (VAV) control methods can be used to make the laboratory air meet national standards. Create a comfortable, smooth and convenient working environment for the staff of drug inspection laboratory.
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