With the upsurge of research in the life science industry and the rise of biomedicine and other industries, the importance of drug testing, quality assurance "QA" and quality control "QC" in pharmaceutical factories has become more and more prominent. How to establish a good and complete drug testing laboratory? What are the design standard parameters for the decoration design of the testing laboratory? How to do the laboratory layout? How to decorate and design the ventilation system? Xidi, a decoration design company in Shanghai testing laboratory, will answer for you.

I. The significance of the construction of testing laboratories

As an important base for QC testing in pharmaceutical factories, the drug inspection laboratory generally consists of two inspection units: a physical and chemical analysis laboratory and a microbiological laboratory. Among them, the physical and chemical analysis laboratory mainly conducts physical and chemical identification, content determination and other inspections on the raw materials, packaging materials, intermediates and finished products received to ensure that they meet the legal requirements and internal quality standards of the enterprise; the microbiology laboratory passes a series of Experiment to understand and analyze the microbiological status of raw materials, packaging materials, intermediates and finished products. QC laboratory is an important part of the quality management department.

II. the standard parameters of the decoration design of the inspection laboratory

There are 8 types of standards related to inspection and testing in my country, but there is no national standard to regulate this type of laboratory. Xidi Lab provides you with the following design data for reference based on long-term accumulation of decoration experience:

1. The layout of the laboratory building is generally rectangular + middle inner corridor.

① The horizontal axis of the rectangle is 6~8m, and the length is set according to the needs

② The longitudinal axis is 6-9m, or 6m-2.5m-6m, the corridor in the middle position, and the width of the corridor can be set according to requirements.

③ The quality inspection building is generally 2-3 floors, and the clear height of the laboratory is 2.6m~3.0m.

④ The height of the technical mezzanine is determined according to the air-conditioning form and structure, generally not less than 1m.

2. Temperature and humidity requirements: The temperature is set at 18～28℃ in summer, 16～20℃ in winter, and the humidity is preferably between 30% (winter) and 70% (summer).

III. The layout of the functional room for the decoration design of the testing laboratory

1. The drug testing laboratory mainly has these partitions: acceptance and storage area for samples submitted for inspection; acceptance and storage area for reagents and standard products; cleaning and washing area; special operation area; general analysis and experiment area; data processing and data storage area ; Office; personnel room such as dressing room or lounge.

The main functional rooms are: central laboratory; instrument room; microbiological examination room; drying room; quality inspection office, archives room and other management function rooms.

2. Central laboratory: sample processing, reagent preparation, titration analysis, cleaning utensils, writing reports, etc. during various drug inspections. In order to facilitate the daily operation of the laboratory personnel, it should be adjacent to the drying room, balance room, and instrument room.

3. Sterile room (or semi-sterile room)

The sterile room (or semi-sterile room) is a clean area and should be designed in accordance with the requirements of GMP for the clean area. Among them, the air-conditioning room should be set up nearby to shorten the return air pipeline. At the same time, it should also be equipped with a supporting culture room, a hygiene preparation room, a cleaning room, and a sterilization room.

4. Instrument room: including balance room, spectrum room, microscope room, common instrument room, etc. The layout principles of these departments are: separation of dry and wet for moisture prevention, separation of cold and heat for energy saving, centralized constant temperature for management, and centralized balance for weighing and sampling.

5. High-temperature greenhouse: Generally, it should be far away from the reagent room and the freezer. The room should be equipped with temperature and smoke alarms and mechanical exhaust.

6. Observation room for sample retention: It can be set up separately or dividedly. The indoor ventilation and moisture-proof design should be paid attention to. 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.

IV. Ventilation system for testing laboratory decoration

As an important environment for the decoration and design of a clean laboratory, the laboratory ventilation system plays an important role in the safe and healthy operation and maintenance of the experimental environment and personnel and equipment. According to the conditions and requirements of different drug testing laboratories, the ventilation system of testing laboratories often adopts two methods: surprise sensor automatic frequency conversion control (or PLC programming control) and variable air volume system (VAV) control methods, so that the air in the laboratory can reach Standards provide a comfortable, smooth and convenient working environment for the staff of the drug inspection laboratory.

V. Ceidi Testing Laboratory Decoration Case-Testing and Certification-Testing Agency

Xidi Laboratory Engineering EPC Project—Laboratory Decoration Design Project of China Testing and Certification Group Co., Ltd. The project area is 7,500 square meters. China Test Testing and Certification Group Co., Ltd. is referred to as "CTI". It is a comprehensive third-party organization integrating testing, calibration, inspection, certification and technical services, providing one-stop solutions.

The above is about the decoration design standards and case sharing of the testing laboratory. CEIDI Xidi designers have rich design experience. Most of them have worked in the Tenth Electronic Design Institute and the Eleventh Electronic Design Institute. The designers can communicate comprehensively through the Internet. Master the customer's decoration needs, design the project drawings, and then modify the drawings through face-to-face communication with the customers, and finally achieve the results of customer satisfaction, take into account the practicality and beauty, and efficiently realize the use of space area.