Currently gmp pharmaceutical clean shop in China has been promoted and spread, pharmaceutical companies design and construction of the clean room is also more cautious, and our current standard purification scheme without making specific recommendations for equipment design, selection of materials, etc., construction Units often because of cost, technical and other reasons more conservative in the selection, selection, backward, and many new or lack of professional experience in this area of the transformation unit, so gmp pharmaceutical clean room built after causing short life, waste of energy, is not easy Operation and maintenance is unreasonable or can not reflect the GMP requirements of the Department.

gmp pharmaceutical clean room

gmp pharmaceutical clean room purification principle

1, the new three-level use of air purification filtration system, namely: three new air filter (coarse, medium, sub-high efficiency filter), secondary filtration, filtration is not the end of higher education. Making more scientific and reasonable airflow (increase cooler, in effect filter and high efficiency filter life of about 1O times) will purify the air conditioning system efficiency filter bags screws (not easily removable) to spring-mounted, ease of management personnel regularly dismantle wash.

2, high purity level can only be limited spatial range surrounding equipment, the use of partial purification technology, the use of laminar flow, vacuuming, dehumidification and other facilities in order to reduce the clean air conditioning load, to save energy.

gmp pharmaceutical clean room

3, for use in clean air conditioning system fan frequency control technology can save energy, not only substantially constant air volume system, the room pressure is stable, and the fan starts blowing steadily at the same time to meet the duty requirements.

4. In addition to the use of a differential pressure gauge can be directly indicative of clean room pressure values, it can also be installed at both ends of the resistance change filter, monitor filters in, namely to develop a reasonable replacement cycle filter through the filter end resistance, so that the filter replacement is more reasonable and scientific.

gmp pharmaceutical clean room

gmp pharmaceutical clean room purification parameters

ACH: 100,000 ≥15 times, ≥20 times 10,000, 1000≥30 times.

Pressure: the main workshop adjacent room ≥5Pa.

Average wind speed: 10, 100 0.3-0.5m / s.

Temperature: Winter> 16 ℃, summer <26 ℃, fluctuation ± 2 ℃.

Humidity: 45-65%, GMP powder workshop humidity around 50% is appropriate, electronic workshop slightly higher humidity to avoid static electricity.

Noise: ≤65dB (A)

Fresh air replenishment is 10% -30% of the total air volume.

Illumination: 300LX.

gmp pharmaceutical clean room

gmp pharmaceutical clean room construction materials

1, the purification plant wall, the top sheet generally use more steel plate 50mm thick sandwich of color, which is characterized by beautiful, strong rigidity. Arc corner, doors, window frames and other general uses special aluminum oxide manufacture.

2, the ground can be used epoxy artesian Ping Ping or high wear-resistant plastic flooring, anti-static requirements, the choice of anti-static type.

3, return air pipes made of hot galvanized plate, affixed purifying flame retardant insulation effect good PF foam plastic board.

4, HEPA stainless steel frame, beautiful and clean, perforated metal mesh plate with aluminum paint, no rust dust free, should be clean.
Name: Sunshine charity Medical Equipment Engineering Co., Ltd.
Contact: Mr. Wang
Phone: 0633-6862777
E-mail: 1002430909@qq.com
Unified national service hotline: 400-0633-028
Official website: http: //www.kqjhgc.com