It is very troublesome to build a GMP clean room. It not only requires zero pollution, but also many details that cannot be made wrong, which will take longer than other projects. The requirements of the client,etc will directly affect the construction period.
How long does it take to build a GMP workshop?
1. Firstly, it depends on the total area of the GMP workshop and the specific requirements for decision-making. For those with an area of around 1000 square meters and 3000 square meters, it takes about 2 months while it takes about 3-4 months for larger ones.
2. Secondly, building a GMP packaging production workshop is also difficult if you want to save costs. It is recommended to find a clean room engineering company to help you plan and design.
3. GMP workshops are used in pharmaceutical industry, food industry, skin care products and other manufacturing industries. First, all production workshops should be systematically divided according to the production flow and production regulations. Area planning should ensure that it is effective and compact to avoid interfering personnel passage and cargo passage; Plan layout according to the production flow, and reduce circuitous production flow.
- The class 10000 and class 100000 GMP clean rooms for machinery, equipment and utensils can be arranged within clean area. The higher class 100 and class 1000 clean rooms should be built outside clean area, and their clean level can be one level lower than that of the production area; The rooms for special tools cleaning, storage, and maintenance are not suitable to build within clean production areas; The clean level of clean room garment cleaning and drying rooms can generally be one level lower than that of the production area, while the clean level of the sorting and sterilization rooms of sterile testing clothes should be the same as that of the production area.
- It is not easy to build a complete GMP factory, as it not only needs to consider the size and area of the factory, but also needs to be corrected according to different environments.
How many stages are there in GMP clean room building?
1. Process equipment
There should be a sufficient total area of GMP factory available for manufacturing, and quality inspection to maintain excellent water, electricity and gas supply. According to the regulations on processing technology and quality, the clean level of the production area is generally divided into class 100, class 1000, class 10000, and class 100000. The clean area should maintain positive pressure.
2. Production requirements
(1). The building layout and spatial planning should have moderate coordination ability, and the main GMP clean room is not suitable for selecting internal and external load-bearing wall.
(2). Clean areas should be equipped with technical interlayer or alleys for layout of air ducts and various pipelines.
(3) . The decoration of clean areas should use raw materials with excellent sealing performance and minimal deformation due to temperature and environmental humidity changes.
3. Construction requirements
(1). The road surface of the GMP workshop should be comprehensive, flat, gap-free, abrasion resistant, corrosion resistant, collision resistant, not easy to accumulate electrostatic induction, and easy to remove dust.
(2) . The indoor surface decoration of exhaust ducts, return air ducts and supply air ducts should be 20% consistent with all return and supply air system software, and easy to remove dust.
(3) . When consider various indoor pipelines, lighting fixtures, air outlets and other public facilities, should avoid the position that cannot be cleaned during design and installation.
In short, the requirements for GMP workshops are higher than those of ordinary ones. In fact, each stage of construction is different, and the points involved are different. We need to complete the corresponding standards according to each step.
Post time: May-21-2023