1. Building layout
Due to the influence of factors such as the scale of the enterprise, the level of instruments and equipment, the detection methods, and the differences in enterprise management systems and operating habits, the layout of the factory buildings also varies. And with the development of science, new methods, new technologies and advanced instruments and equipment will continue to be introduced for drug and material testing, and there will be different requirements for the layout of the laboratory. Therefore, from the design perspective, it is recommended to adopt a reinforced concrete frame structure, which is convenient for transformation and has good seismic resistance.
The layout of the laboratory building is generally in the form of a rectangular middle corridor, which can maximize the use of natural light. The horizontal axis of the rectangle can be 6~8m, and the length can be set according to needs; the longitudinal axis can be 6~9m, or 6m-2.5m-6m, with an inner corridor in the middle, and the width of the corridor can be set according to needs. According to VOLAB's design experience, the quality inspection building is generally 2-3 floors, the net height of the laboratory can be set to 2.6m~3.0m, and the height of the technical mezzanine is determined by the air conditioning form and structure, generally not less than 1m.
2. Layout of laboratory functional rooms
A. Setting of functional rooms
The specification requires that the drug testing room should have sufficient space to meet the needs of various experiments. Each type of analytical operation should have a separate and appropriate area. The areas or places with physical divisions include: receiving and storing areas for samples for inspection; receiving and storing areas for reagents and standards; cleaning and washing areas; special operation areas; general analytical experimental areas; data processing and information storage areas; offices; and personnel rooms such as changing rooms or lounges. The following main functional rooms are generally set up in the design:
(1) Central laboratory.
(2) Instrument room: including ordinary instrument room, precision instrument room, balance room, etc.
(3) Microbiological inspection room: including sterile or semi-sterile room, culture room, and hygiene preparation room.
(4) Auxiliary functional rooms such as drying room, disinfection room, reagent storage room, glass instrument storage room, gas room, special gas supply room, and sample observation.
(5) Management functional rooms such as quality inspection office and archive room.
In addition, auxiliary rooms such as air-conditioning rooms, power distribution rooms, changing rooms, toilets, etc. should be equipped, which can be considered together with the administrative office area or set up separately. If the drug testing room is a separate building unit, the office, changing room, power distribution, sample observation, etc. can be set up 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 no contamination or interference should be allowed.
B. Layout of the central laboratory
The central laboratory is a comprehensive work place for sample processing, reagent preparation, titration analysis, cleaning equipment, writing reports, etc. during the inspection of various drugs. It is the main analysis and testing site and occupies a relatively large area. For the convenience of operation, it should be adjacent to the drying room, balance room, instrument room, etc.
C. Layout of sterile room (or semi-sterile room)
The sterile room (or semi-sterile room) is an operating room for microbiological quality testing. The microbiological quality requirements for preparations are divided into sterile requirements and hygienic standards. For those that require sterility, such as injections and ophthalmic preparations, sterile requirements are formulated and need to be tested in sterile rooms. The design adopts a clean bench set up in a 10,000-level clean environment to achieve this; for general preparations that do not require complete sterility, but do not allow the presence of certain bacteria, and the number of colonies allowed to exist is restricted. In this case, hygienic standards are proposed, such as: oral solid preparations, oral liquid preparations, external preparations, etc., which can be tested in a semi-sterile room. The design adopts a clean bench set up in a 100,000-level clean environment to achieve this.
The sterile room (or semi-sterile room) is a clean area and should be designed according to the GMP requirements for clean areas. Changing rooms and buffer rooms are required for personnel to enter, and buffers (or transfer windows) should also be set up for materials or items to enter. Culture dishes, culture media, etc. must be sterilized before entering. The sterile room is equipped with an observation window where it can be directly observed by the outside world to ensure the safety of the operator. The air-conditioning room is set up nearby to shorten the air supply and return ducts. At the same time, supporting culture rooms, hygiene preparation rooms, cleaning rooms, sterilization rooms, etc. should also be set up.
D. Instrument room
The instrument room includes balance room, spectrum room, microscope room, general instrument room, etc. Generally, the balance room should be set up separately. If there are many levels, each level should be set up. Other rooms can be set up as needed. They should be as far away from vibration sources and high temperatures as possible and close to the central laboratory. The layout principle is: dry and wet separation is convenient for moisture prevention, hot and cold separation is convenient for energy saving, constant temperature concentration is convenient for management, and balance concentration is convenient for weighing and sampling.
E. High temperature room
The high temperature room refers to the drying room, disinfection room, etc. It is a place where drying boxes, muffle furnaces or sterilization cabinets are placed. Generally, it should be far away from the reagent room and freezer. The room is equipped with temperature and smoke alarms and mechanical exhaust.
F. Sample observation room
Sample observation includes samples of raw materials, packaging materials and finished products. They can be set up separately or in zones. Attention should be paid to ventilation and moisture-proof design indoors. If there is a requirement for cool storage, a cool room should also be set up. If it is placed on the second floor or above, the floor load should also be accurately calculated to ensure safety.
3. Ventilation system design and 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 has a direct impact on the laboratory environment, the health of the experimenters, the operation and maintenance of the experimental equipment, etc. The ventilation system control, according to the conditions and requirements of different drug testing laboratories, can adopt the surprise sensor automatic frequency conversion control (or PLC programming control) and variable air volume system (VAV) control method to make the air in the laboratory meet the standard and create a comfortable, smooth and convenient working environment for the staff of the drug testing laboratory.
