What is GMP Cleanroom Project
GMP, also refer to Good Manufacturing Practice , is translated into Chinese as "Production Quality Management System" or "Good Operating Practice". The GMP standard implemented in China is the key to the GMP regulations of the EU countries and the WHO for the relevant goods. At this stage, only the medical sector is subject to GMP in China, while other sectors such as food, health products and skin care products are not subject to GMP, but in the future, more and more companies will have their production standards close to GMP, and many famous food and chemical companies are now managing their production processes in accordance with GMP standards and are basically building clean rooms in accordance with GMP regulations. This may be the new orientation of the future development trend of the natural environment of manufacturing.
GMP cleanroom purification project is based on the requirements of the Food Category Drug Administration, in accordance with the requirements of sterility testing drugs, raw and auxiliary materials, biopharmaceuticals, blood products, pharmaceutical preparations of the five major production industry companies mandatory regulations in the pharmaceutical industry. In our country common GMP workshop purification project contains API workshop, tablet workshop, solid Chinese medicine preparation workshop, injection workshop, colloidal Chinese medicine preparation workshop, pharmaceutical preparation workshop, etc. GMP workshop purification project not only means its production workshop and auxiliary workshop gas cleanliness level (enterprise soot particle count). The GMP workshop purification project adheres to the design and construction standards of "safety, reasonableness and quality management" to ensure the quality assurance of drug production safety. The quality of production safety is guaranteed.
GMP standard for workshop purification engineering construction regulations
According to GMP, the essence of the workshop purification project design scheme is to avoid environmental pollution and quality transformation of goods in an aesthetically pleasing and clean basic way. Therefore, the GMP workshop purification project is different from the general workshop purification project in the level of clean windows and doors, walls, decoration ceiling, road surface, etc.
In the engineering building reasonable layout, GMP workshop purification project generally set outside the workshop ring sealing aisle, so that the clean area and the outside world have cache isolation bar, not only can avoid the outside environment pollution, but also can relatively save resources. The number of stacked layers of windows and the form of structure should take into account the sealing of gas and water. The internal windows and doors are flush with the internal and external walls and there are no balconies. To avoid condensation caused by the difference between indoor and outdoor temperatures, the gap between the windows and doors in different rooms of the clean level house is carried out closed. Window door raw material of course deformation is small, production and manufacturing deviation is small, sealing is good, appearance design is easy to clean. The road surface should be neat and seamless splicing, wear-resistant and corrosion-resistant, not easy to cause static induction. At this stage, more epoxy resin automatic outflow wood flooring, thin thickness of more than mm when the general use period of six years above. The walls should be smooth and flat, without dust. The intersection of the wall and the road should be made half through for 50 mm slant, in order to reduce the accumulation of dust, conducive to cleaning. In areas where the walls of the delivery aisle are prone to impact, bollards should be set up to avoid vibration and dust falling off the building decoration materials. To better ensure clean-up in the rooms of GMP workshop purification projects, it is important that all air ducts and lighting fixtures are in compartments. Ceiling ceilings are generally sealed with rock wool coloured steel sheets. The rock wool colour steel plate has the characteristics of light weight, comprehensive compressive strength, heat insulation, thermal insulation and dirt-proof. In addition, fire safety features should also be taken into account. gmp workshop purification project has strict management of electrical equipment wiring. Seamless steel pipes should be applied as far as possible to ensure that the cable lines do not easily become a method of fire accident spread.
According to the newly implemented GMP requirements, the temperature control of the 100-10000 level clean workshop room is 20-24℃ and the air humidity is manipulated at 45%-65%; a part of the workshop without special requirements, the ambient humidity is manipulated at 18℃-26℃ and the air humidity is manipulated at 45%-65%. Generally speaking, the exhaust air volume required for clean central air conditioning should be the large value of each delivery and exhaust air volume required for production staff should exceed 40m x 3; h. Some of the exhaust air volumes for clean air conditioning are generally large. In order to ensure the required positive pressure exhaust air volume in each house, many exhaust air volumes need to be upgraded. In the GMP workshop purification project, the air conditioning system operates for a long time, and some pharmaceutical companies do not take a break throughout the year, which prompts the clean air conditioning system to operate throughout the year. Depending on the outdoor climate, the humidity, temperature and cleanliness of the clean room environment are monitored and regulated in real time to ensure the smooth running of the pharmaceutical production.
According to the new GMP by-laws, the cleanliness of the workshop is divided into four classes - A, B, C and D. Classes A and B set up separate air conditioning systems. classes C and D should be equipped with separate air conditioning systems first. When the total area is very clockwork, it is able to use the same set of air conditioning system.
Class A: high-risk work area, single-sided flow, dynamic and static data all 100 levels, uniform exhaust air, wind 0.36-0.54m/s (conductive value). In enclosed acoustic material operators or handrail boxes, lower wind forces can be applied.
Class B: high-risk worka, mixed flow, static data class 100, dynamicity class 100 situation areas.
Class C and D: low necessity clean-up work areas. class C: mixed flow type, static data 10,000, dynamic 100,000.
Class D: mixed flow type, no static data 100000 level of dynamics specified. Non-sterile testing drugs: refer to the Class D clean zone provisions in the "Sterile Testing Drugs" by-law. Chinese herbal medicine acquisition, extraction, paste collection: when using closed system software, the actual operating natural environment can be in a non-clean area; when using open method, the actual operating natural environment should be consistent with the level of cleanliness of the Chinese medicine preparation position. Chinese medicine injection extraction and liquid preparation special processing process at least in the D level clean area.