Introduction
The goal of the GMP workshop is to ensure the establishment of a scientific and strict sterile drug production environment, process, operation and management system, to eliminate all possible and potential biological activity, dust, and pyrogen pollution to the maximum extent, and to produce high-quality, hygienic and safe drug products. The wall and ceiling panels of the purification plant are generally made of 50mm thick sandwich color steel plates, which are characterized by beautiful appearance and strong rigidity. The arc corners, doors, window frames, etc. are generally made of special anodized aluminum profiles.
Structural materials
1. The floor can be made of epoxy self-leveling floor or high-grade wear-resistant plastic floor. If there is an anti-static requirement, the anti-static type can be selected.
2. The air supply and return ducts are made of hot-dip galvanized plates, and flame-retardant PF foam plastic plates with good purification and thermal insulation effects are attached.
3. The high-efficiency air supply port uses a stainless steel frame, which is beautiful and clean, and the perforated mesh plate uses a painted aluminum plate, which is rust-free and dust-free, and easy to clean.
GMP clean room purification parameters
Ventilation times: 100000 level ≥15 times; 10000 level ≥20 times; 1000 ≥30 times. Pressure difference: main workshop to adjacent room ≥5Pa Average wind speed: 10 level, 100 level 0.3-0.5m/s; temperature: winter ＞16℃; summer ＜26℃; fluctuation ±2℃. Humidity 45-65%; humidity in GMP powder workshop is preferably around 50%; humidity in electronic workshop is slightly higher to avoid static electricity. Noise ≤65dB(A); fresh air supplement is 10%-30% of the total air supply; illumination 300LX
Sanitary management
In order to prevent cross contamination in GMP workshop, the tools for cleaning the purification workshop facilities should be used according to the product characteristics, process requirements, and air cleanliness level, and the garbage should be put into dust bags and taken out. The cleaning of the GMP workshop must be carried out before and after get off work and after the production process operation is completed; the cleaning must be carried out after the air conditioning system of the cleanroom is running; after the cleaning work is completed, the cleanroom air conditioning system must continue to operate until the specified clean level is restored, and the startup time is generally not shorter than the self-cleaning time of the GMP workshop. The disinfectant used should be replaced regularly to prevent microorganisms from developing drug resistance. When large objects are moved into the workshop, they must first be preliminarily vacuumed and purified with a vacuum cleaner in a general environment, and then allowed to enter the cleanroom and further processed with a clean room vacuum cleaner or wiping method; during the period when the purification system of the GMP workshop is stopped, large objects are not allowed to be moved into the cleanroom.
The GMP workshop must be disinfected and sterilized, and dry heat sterilization, moist heat sterilization, radiation sterilization, gas sterilization, and disinfectant disinfection can be used. Radiation sterilization is now introduced, which is mainly suitable for the sterilization of heat-sensitive substances or products, but it must be proved that the radiation is harmless to the product. Ultraviolet radiation disinfection has a certain bactericidal effect, but there are many problems in its use. Many factors such as the intensity, cleanliness, environmental humidity and distance of the ultraviolet lamp will affect the disinfection effect. In addition, its disinfection effect is not high and it is not suitable for spaces with personnel activities and airflow. These reasons make ultraviolet disinfection not accepted by foreign GMP. Ultraviolet sterilization requires long-term irradiation of the exposed object. For indoor irradiation, when the sterilization rate is required to reach 99%, the irradiation dose of general bacteria is about 10000-30000uw.S/cm. A 15W ultraviolet lamp 2m above the ground has an irradiation intensity of about 8uw/cm, which requires irradiation for about 1h. Within this 1h, the irradiated place cannot be entered, otherwise it will also damage human skin cells and have obvious carcinogenic effects.
Layout principles
1. Zoning layout
GMP purification workshops should be reasonably zoned according to different production process requirements. It can usually be divided into the receiving area for raw and auxiliary materials, the powder mixing area, the liquid mixing area, the sterilization area, the aseptic operation area, the packaging area and the finished product storage area. Through reasonable planning, each area can be made independent of each other, avoiding cross contamination and improving production efficiency.
2. Streamline layout
In the design of GMP cleanroom, streamline layout is crucial. Through scientific streamline design, the production process can be made smoother and cross interference in the process flow can be reduced. Usually, the receiving, inspection and storage areas of raw and auxiliary materials can be organically connected with the various areas corresponding to the production process to form a complete streamline from raw and auxiliary materials to finished products. At the same time, by reasonably arranging the location of equipment and the setting of channels, operators can conveniently carry out material handling and processing.
3. Air flow design
The air flow design of GMP cleanroom is the key to ensuring product quality. The methods usually adopted include the setting of positive pressure zone and negative pressure zone, air filtration and circulation system configuration. The positive pressure zone is mainly used in areas with very strict cleanliness requirements such as aseptic operation areas. The indoor air is pressurized by the outside air to flow to the outside to prevent the entry of outside air. The negative pressure zone is mainly used in areas with air pollution sources such as protection areas. The control of indoor air is achieved by exhausting and treating the internal air.
Construction steps
1. Design and construction of the raw and auxiliary material receiving area
The design and construction of the raw and auxiliary material receiving area is the starting point of the entire GMP cleanroom. First, the layout of the receiving area needs to be determined, such as the cargo receiving table, cargo inspection area, raw and auxiliary material storage area, etc. Then, the materials are purchased and the equipment is installed according to the design plan. During the construction process, protective measures should be taken to prevent dust, odor and other substances from polluting the receiving area.
2. Wall, ceiling and floor construction of GMP cleanroom
The construction of the walls, ceiling and floor of the GMP cleanroom needs to select materials that meet GMP requirements, such as easy-to-clean, dust-proof and disinfectable materials. During the construction process, attention should be paid to keeping the construction site clean to avoid dust, foreign matter and other pollution in the cleanroom.
3. Installation and commissioning of air purification equipment
Air purification equipment is the core of the GMP cleanroom and is responsible for ensuring the air quality of the workshop. During the installation and commissioning process, it is necessary to select equipment that meets industry standards, and debug and optimize according to the design plan so that the equipment can operate normally and achieve the expected purification effect.
Precautions
1. All decoration materials and equipment should comply with relevant national standards and requirements and have corresponding certificates of conformity.
2. During the construction process, relevant construction specifications and design requirements must be strictly followed to ensure construction quality.
3. During the construction period, the indoor air quality should be checked regularly to ensure that areas with strict requirements such as sterile operation areas meet GMP requirements.
4. After the construction is completed, the equipment needs to be regularly maintained and maintained to ensure the normal operation and sanitary conditions of the equipment.
FAQ
1. What standards should be met in the design of GMP purification workshops?
The design of GMP purification workshops needs to meet relevant national GMP standards. At the same time, it is also necessary to design according to different product characteristics and production processes, combined with the company’s own situation.
2. What air conditioning equipment needs to be purchased for GMP purification workshops?
The air conditioning equipment of GMP purification workshops needs to meet the following requirements: high filter efficiency, adjustable wind speed, low noise, corrosion resistance, easy cleaning, etc. Common air conditioning equipment includes air conditioning terminal equipment, fan coil units, fresh air treatment equipment, etc.
Conclusion
The design of GMP purification workshops is an important link in ensuring product quality. Reasonable layout principles, scientific construction steps and precautions are the key to designing an efficient and safe GMP cleanroom. At the same time, the design plan should comply with GMP standards and actual production requirements. During the construction process, relevant specifications and requirements must be strictly followed to ensure that the air quality and cleanliness of the workshop meet GMP requirements, thereby ensuring the quality and safety of the product.
Why Choose Us?
CNMEDITECH is dedicated to the long-term research of the medical equipment market. Our mission is “People oriented and win-win strategy,Matching the real needs of the region with a focus on human health,To be the world’s first-class medical field solution expert”.We have been manufacturing high-quality medical device products for more than ten years.
We have built our reputation on delivering quality healthcare solutions on time and on budget.All our products comply with international health and safety regulations and all products come with a warranty.
Are you still worrying about your customer’s product needs?Are you still angry that the product is expensive? We have various medical equipment and support personalized product customization.
Our company has many styles to choose from.In addition, we have high-quality pre-sales consulting guidance and professional after-sales service, all to meet your needs.
Whether it is a cost-effective or high-end product, there will always be something suitable for you.If you have any needs for products, you can ask us, our factory will meet your needs as soon as possible, and we will make every effort to provide you with solutions.Feel free to send us your inquiries.
