HOW LONG DOES IT TAKE TO BUILD A GMP CLEAN ROOM?

Building a GMP clean room is very troublesome. Not only does it require zero pollution, but there are also many details that cannot be wrong. Therefore, it will take longer than other projects. The construction period and the requirements and strictness of the client will directly affect the construction period.

1. How long does it take to build a GMP clean room?

(1). First of all, it depends on the total area scale of the GMP clean room and the specific functional requirements. A workshop of about 1,000 square meters and 3,000 square meters will take about two months, and a larger one will take about three to four months.

(2). Secondly, it is difficult to build a GMP clean room if you want to save costs yourself. It is recommended to find a clean room engineering company to help you plan and design.

(3). GMP clean rooms are used in pharmaceutical, food, skin care and other manufacturing industries. First, the entire production workshop should be systematically divided according to the production process and production regulations. The regional planning should ensure efficiency and compactness, avoid the interference of manual channels and freight logistics; and be laid out in a smooth manner according to the production process to reduce the twists and turns of the production process.

 (4). For the equipment and utensils cleaning rooms of GMP clean room of class 100,000 and above, they can be arranged in this area. The clean rooms of higher-level of class 100,000 and class 1,000 should be built outside the clean area, and their cleanliness level can be one level lower than the production area; cleaning tools cleaning, storage rooms, and maintenance rooms are not suitable to be built in clean production area; the cleanliness level of the cleaning and drying rooms of clean clothes can generally be one level lower than the production area, while the cleanliness level of the combing and sterilization rooms of sterile test clothes should be the same as the production area.

(5). It is very difficult to build a complete GMP clean room. Not only the size of the plant area should be considered, but also it should be adjusted according to different environments.

2. How many stages are there in the construction of a GMP clean room?

(1). Process equipment

There should be a GMP clean room with sufficient available area for production and quality measurement and inspection, and good water, electricity and gas supply. According to the requirements of process technology and quality, the production area is divided into cleanliness levels, generally divided into class 100, 1000, 10000 and 100000. The clean area should maintain positive pressure.

(2). Production requirements

①. The building plan and space planning should have appropriate coordination. The main structure of the gmp plant is not suitable for using internal and external wall loads.

②. The clean area should be equipped with technical partitions or technical alleys for the layout of ventilation ducts and various pipes.

③. The decoration of the clean area should use materials with good sealing and small deformation under the effect of temperature and humidity changes.

(2) Construction requirements

①. The gmp plant floor should be well-rounded, flat, gap-free, wear-resistant, corrosion-resistant, impact-resistant, not prone to static electricity, and easy to clean.

②. The surface decoration of the exhaust duct, return air duct, and supply air duct should be 20% consistent with the entire return and supply air system and easy to clean.

③. Various piping, lighting fixtures, air vents, and other common facilities within the clean room must be carefully considered during design and installation to avoid areas that are difficult to access.

In general, the requirements for GMP clean room are higher than those for standard clean room. Each stage of construction is different, and the requirements vary, requiring compliance with the corresponding standards at each step.