Medical laboratory

medicineLayout plan for pharmaceutical laboratory construction:

1. Architectural layout:

Due to factors such as the size of the enterprise, the level of instruments and equipment, testing methods, as well as differences in enterprise management systems and operating habits, the layout of the factory buildings also varies. And with the development of science, new methods, technologies, and advanced instruments and equipment will be continuously introduced for drug and data testing, which will also have different requirements for laboratory layout.

The layout of the laboratory building is generally in the form of a rectangular central 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 as needed; The longitudinal axis can be 6-9m or 6m-2.5m-6m, with a corridor in the middle position, and the width of the corridor can be set according to demand.

2. Layout of laboratory functional rooms:

A. Settings between functions

The standard 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 physically partitioned area or field: the receiving and storage area for the submitted samples; Reception and storage area for reagents and standards; Clean the washing area; Special homework area; General analysis experimental area; Data processing and data storage area; office; Personnel rooms such as changing rooms or rest rooms. Therefore, in the design, we generally set the following main functional areas:

(1) Central laboratory.

(2) Instrument room, including ordinary instrument room, precision instrument room, balance room, etc.

(3) Microbial examination room, including sterile or semi sterile room, culture room, and hygiene preparation room.

(4) Drying room, disinfection room, reagent storage room, glassware storage room, gas chamber, special gas supply room, and auxiliary function rooms for sample observation.

(5) Management function rooms such as quality inspection office and archive room.

In addition, auxiliary rooms such as air conditioning rooms, distribution rooms, changing rooms, and bathrooms 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, offices, changing rooms, power distribution, sample observation, etc. can be set up on the ground floor; If it is a modular office quality inspection building, the quality inspection part should be placed on the upper part of the administrative office and should not contaminate or interfere with each other.

B. Layout of the Central Laboratory

The central laboratory is a comprehensive workplace for sample processing, reagent preparation, titration analysis, cleaning of equipment, and report writing during various drug inspections. It is the main analytical and testing site and occupies a relatively large area. For ease of operation, it should be located adjacent to drying rooms, balance rooms, instrument rooms, etc.

C. Layout of sterile room (or semi sterile room)

A sterile room (or semi sterile room) is an operating room used for microbiological quality testing. The microbiological quality requirements for formulations are divided into two types: sterile requirements and hygiene standards. For formulations that require sterility, such as injections and ophthalmic formulations, sterile requirements have been established and testing needs to be conducted in a sterile room. In the design, an ultra clean workbench is set up in a 100000 level clean environment to achieve this; For general preparations that do not require * sterility, but do not allow the presence of certain bacteria, and impose restrictions on the allowed number of bacterial colonies, hygiene standards have been proposed, such as solid preparations for oral use, liquid preparations for oral use, external preparations, etc., which can be tested in a semi sterile room. In the design, an ultra clean workbench is set up in a 100000 level clean environment to achieve this.

A sterile room (or semi sterile room) is a clean area that should be designed according to GMP requirements for clean areas, as shown in Figure 3. Personnel entering should be equipped with changing rooms and buffer rooms, and materials or items entering should also be equipped with buffers (or transfer windows). Culture dishes, culture media, etc. must be sterilized before entering. The sterile room is equipped with observation windows in a place that can be directly observed by the outside world to ensure the safety of operators. The air conditioning room should be set up nearby to shorten the supply and return air ducts. At the same time, supporting training rooms, hygiene preparation rooms, cleaning rooms, sterilization rooms, etc. should also be set up.

D. Instrument room

The instrument room includes a balance room, a spectroscopy room, a microscopy room, a general instrument room, etc. Generally, the balance room should be set up separately, and for rooms with multiple levels, it should be set up on each level. Other rooms can be set up as needed, and should be as far away from the vibration source and high temperature as possible, and close to the central laboratory. The layout principle is: separating dry and wet for moisture prevention, separating hot and cold for energy conservation, concentrating at a constant temperature for management, and concentrating the balance for weighing and sampling.

E. High temperature chamber

High temperature rooms refer to drying rooms, disinfection rooms, etc., which are places where drying ovens, muffle furnaces, sterilization cabinets, etc. are placed. Generally, they should be far away from reagent rooms and freezing rooms. The room should be equipped with temperature and smoke detectors, and mechanical ventilation should be installed.

F. Sample observation room

Sample observation includes the retention of raw materials, packaging materials, and finished products, which can be set separately or partitioned. Ventilation and moisture-proof design should be taken into account indoors, and if there are requirements for cool storage, a cool room should also be set up. For floors placed on the second floor or above, the floor load should be accurately calculated to ensure safety.

3. Ventilation system design layout:

Medical laboratoryThe ventilation system is one of the main systems in the entire laboratory design and construction process. The completeness of the ventilation system directly affects the laboratory environment, the physical health of laboratory personnel, and the operation and maintenance of experimental equipment.

Excessive negative pressure in the laboratory, gas leakage from the fume hood, and laboratory noise have always been problems that plague laboratory staff. These issues have caused serious physical and psychological harm to personnel who have been working in the laboratory for a long time, and even to management and logistics personnel working around the laboratory.

A scientific and reasonable ventilation system requires good ventilation effect, low noise, easy operation, energy conservation, and even requires indoor pressure difference and temperature and humidity to maintain human comfort.