Pharmaceutical laboratories are laboratories that conduct pharmaceutical experiments, which mainly include drug research and development laboratories and QC laboratories. It is common in drug research and development units, testing institutions, and drug mass production factories.

I.The development prospects of the pharmaceutical industry

1.According to investigations, in the next 5 years, the global prescription drug market will grow steadily at a compound growth rate of 6.5%, reaching US$1.06 trillion in 2022, of which biological products will grow steadily, and will occupy 30% of the pharmaceutical market in 2022. 326 billion U.S. dollars. At present, my country's biomedical industry is showing explosive growth, with a compound annual growth rate of 16%. The industry expects that it will continue to grow in the future, and its development potential is huge, mainly affected by the three major aspects of policy, capital, and technological innovation.

2.The launch of relevant encouragement policies such as "Healthy China 2030" and "Policies to Promote the Accelerated Development of the Biopharmaceutical Industry" have created a good environment for my country's biomedical innovation and provided a favorable development platform for biopharmaceutical companies. In contrast, a series of rules and standards concerning the design and construction of biomedical plants have also been issued, which fully reflects the quality of the development of my country's biomedical industry.

II.Classification of medical laboratories

1.According to laboratory functions: drug research and development laboratories, quality control laboratories (QC), product control laboratories, and testing laboratories.

2.According to the laboratory scale: small-scale laboratory, pilot-scale laboratory, pilot-scale workshop, etc.

3.According to the type of drugs: chemical drug research and development laboratory, traditional Chinese medicine research and development laboratory, biopharmaceutical research and development laboratory, etc.

III. the key points of the construction of medical laboratories

1. According to different research and development topics, the planning and layout of medical laboratories are significantly different. The increase of laboratory equipment, the selection of laboratory furniture, and the configuration of ventilation and exhaust systems will bring changes to the planning and design of the laboratory. Therefore, the design of medical laboratory has certain requirements for the flexibility and forward-looking of the laboratory.

2. Pharmaceutical Quality Control Laboratory (QC), as an essential place for pharmaceutical R&D and production bases, must pass GMP certification. If it involves export, the certification of the corresponding exporting country is required. For example, the export to Europe needs to pass the EU GMP certification, and the export to the United States needs to pass the FDA certification. Different certification systems have specific requirements for laboratory construction.

3. Drug testing includes a necessary task: microbiological testing. Different types of drugs will correspond to different microbiological testing items. As a laboratory decoration design company, it needs to do a good job with the construction party and indicate the types of drugs to be tested to set up functional rooms. The common practice of Sanren is to experiment in advance. The technical staff of the laboratory construction party will do a good job of the docking and get the list of laboratory function rooms, and then the special designer and system engineer will further plan the layout. For example, non-sterile preparations require microbial limit testing and positive control experiments on packaging materials. In addition to the above two items, sterile drugs also need to undergo sterility testing, microbial identification, endotoxin testing, and antibiotic potency.

4. Special pharmaceutical preparations have special requirements for the layout of the laboratory process, such as β-lactam drugs, hormone drugs, anti-cancer drugs, etc., personnel protection, waste treatment, and airflow organization during laboratory construction All have special requirements.

IV.the decoration design of the GMP purification workshop of the pharmaceutical factory

The process design of the GMP purification workshop of the pharmaceutical factory plays a core role in the design of the solid refrigeration clean workshop. It is directly related to the GMP certification and verification of the pharmaceutical production group. Therefore, the layout design must be closely related to the GMP specification during the construction, and the technology that needs to be followed The requirements and design principles are as follows:

1. The solid preparation GMP purification workshop should be reasonably arranged in the factory area, so that the flow of people in the workshop and the logistics outlet should be as close as possible to the flow of people and logistics in the factory area, and the transportation should be convenient. Due to the large amount of dust generated by solid preparations, the location of the general map should not affect production workshops with higher cleanliness levels, such as large infusion workshops.

2. The design of the solid preparation GMP purification workshop is based on the "Pharmaceutical Production Quality Management Code" and "Clean Plant Design Code" and the national regulations on construction, fire protection, environmental protection, energy and other aspects.

3. If there are no special process requirements, the general solid preparation GMP purification workshop production category is Class C, and the fire resistance class is Class II. The clean area has a cleanliness level of 300,000, the temperature is 18~26℃, and the relative temperature is 15%~65%. The clean area is equipped with tight external lights, and a fire alarm system and emergency lighting facilities are installed in the clean area. Maintain a pressure difference of 5-10Pa between areas of different levels and set up pressure measuring devices.

4. The layout of the clean workshop should be as far as possible to separate people and logistics, with smooth process routes, short logistics routes, and no return flow under the conditions of meeting relevant standards and norms such as process production, GMP regulations, safety, and fire protection.

5. Make full use of the existing technology, equipment, site, and facilities of the construction unit: reasonably select production technology and equipment according to the scale of production and investment to improve product quality and production efficiency. The equipment layout is convenient and easy to operate, and the auxiliary area is arranged appropriately. In order to avoid contamination of medicines by external factors, only production-related equipment, facilities and material storage rooms are set up in the clean production area. Air compressor stations, dust removal rooms, air conditioning systems, power distribution and other public auxiliary facilities should be arranged in general production areas.

6. Pulverizers, rotary vibrating screens, granulators, tablet presses, and mixing granulators need to be equipped with dust removal devices, hot air circulation ovens, high-efficiency coating machines need to dissipate heat and moisture, and clean the walls, floors, and ceilings of the rooms. It is required to be anti-virus and resistant to cleaning.

7. Operators and materials entering the clean area should set up their own purification rooms or take corresponding purification measures. For example, the operator can enter the clean production area through the airlock room through the empty clean overalls (including work caps, work shoes, gloves, masks, etc.), air shower, hand washing, hand disinfection, etc. Materials can enter the clean area through the buffer room or the transfer window (cabinet) through outsourcing, exterior cleaning, disinfection, etc.: If a buffer room is used, the buffer room should be double-door interlocked, and the air conditioner should deliver clean air. The clean area should be set up in the production process to produce special outlets for environmental wastes that are prone to pollutants to avoid pollution to the raw materials and inner packaging materials.

V, the common design layout of the QC laboratory of the quality inspection center

The QC laboratory of the Quality Inspection Center is mainly used for the quality control and inspection of the drug production process. The organization is composed of central inspection room (physical and chemical analysis inspection, biological analysis inspection) and workshop laboratory. In general, when designing a medical quality inspection laboratory, CEIDI recommends that the function rooms be set as follows:

1.Clean washing area, such as clean room, disinfection room, preparation room, culture room.

2.Reagent and standard room.

3.Staff room, such as dressing room, rest room.

4.Special analysis work area, such as high temperature greenhouse, balance room, precision instrument room, poison gas room, microbial limit test room, antibiotic microbial test room, sterile inspection room.

5.General analysis experimental areas, such as chemical laboratories, packaging material inspection rooms, raw and auxiliary materials inspection rooms, finished products inspection rooms, and ordinary instruments.

6.Sample retention observation room, including accelerated stability inspection room.

7.Data storage and data processing areas, such as archives and computer rooms.

In addition, the buffer room is also very important. In the already highly clean purification workshop of the pharmaceutical factory, in order to maintain the absolute sanitation of the purification project of the pharmaceutical factory, the operator will also use the air pressure to create a buffer room to protect the clean environment of the clean room. This buffer room is located between the clean room and the corridor. There are often single and double doors. The single door is used for walking people, the double door is used for transporting materials, and the characters are separated. The air pressure of this buffer room is slightly higher than that of the clean room and corridor on both sides, and the doors leading to the clean room and corridor cannot be opened at the same time. In this way, when the air pressure is not equal, the air in the corridor and the air in the clean room will not enter the buffer room with higher air pressure because of the lower air pressure. In this way, the design of high middle and low sides avoids cross-contamination of air on both sides.

VI.CEIDI Xidi Pharmaceutical GMP laboratory decoration design case

On January 8, 2019, CEIDI Xidi and Fangda Pharmaceutical completed the design contract. The construction contract was completed on January 30, 2019, and construction started in early 2019 to fully implement the Lab+Office decoration project located in the Zhangjiang R&D Center of the Academy of Military Medical Sciences . Frontage Pharmaceuticals is an all-round integrated pharmaceutical research and development contract research organization (CRO). In 2006, Frontage Pharmaceutical Technology (Shanghai) Co., Ltd. was added. It is China's first GLP laboratory established and operated in accordance with US FDA standards.