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  • GMP pharmaceutical factory purification plant design principles

GMP pharmaceutical factory purification plant design principles

GMP pharmaceutical factory purification plant design, in the pharmaceutical bottles, ingredients, filling and other key processes using absolute shielding technology, in the original plant structure and purification system to do a greater change in the case, the use of absolute shielding technology advantages can be sufficient Meet the GMP requirements, but also greatly reduce the gmp pharmaceutical factory clean room transformation costs and maintenance costs, product quality to be more effective protection, can be expected with the technology gradually mature, will be widely used in China\'s pharmaceutical industry. Built in the South GMP purification plant integration services experts.
  • Case Introduction


First, gmp pharmaceutical factory clean the latest clean technology

1, a new "absolute shielding technology" has been the US FDA and the European Medicines Commission certification. At present, there are more than 200 international laboratories and more than 100 advanced pharmaceutical companies have begun to apply, the technology to protect the area and non-protected areas between the absolute shielding, breaking the traditional clean technology flow, the logistics separated step by step buffer, and then Local laminar flow model, at the same time to solve the traditional technology can not solve the two core issues, the interaction between human and operating environment, the impact of materials on the operating environment.

2, in the pharmaceutical bottle washing, ingredients, filling and other key processes using absolute shielding technology, the original plant structure and purification system to do a greater change in the case, the use of absolute shielding technology advantages, can fully meet the GMP requirements, while But also greatly reduce the gmp pharmaceutical factory clean shop transformation costs and maintenance costs, so that product quality can be more effective protection, can be expected with the technology gradually mature, will be widely used in China's pharmaceutical industry.


GMP药厂无尘车间

Second, gmp pharmaceutical clean room purification principle
1, the use of air filtration system of the new three-level filter, namely: fresh wind three filter (coarse, medium and sub-efficient filtration), intermediate filter, Making the air flow organization more scientific and reasonable (to increase the surface cooler, the efficiency of the filter and high efficiency filter about 10 times the life) will clean the air conditioning system in the efficiency of the filter bag screws fixed (not easy to disassemble) to compression spring fixed, To facilitate the regular removal of managers wash.
2, clean the high level of space can only be limited to the surrounding equipment, the use of local purification technology, the use of laminar, vacuum, dehumidification and other facilities to reduce the clean air conditioning load, to achieve energy saving purposes.
3, in the purification of air-conditioning system using fan control technology can be energy-saving; not only the system air volume is basically constant, the room pressure and stability, and the fan started smooth at the same time to meet duty requirements.
4, the use of differential pressure meter in addition to direct indication of the value of clean room pressure, but also can be installed at both ends of the filter to monitor the resistance of the filter changes, that is, through the filter end resistance to develop a reasonable filter replacement cycle, Replacement of more reasonable science.
Third, GMP pharmaceutical factory clean main technical parameters
1, the number of indoor ventilation: 100,000 10-15 times / hour; million 15-25 times / hour; 1000 50-52 times / hour;
2, 100 operating point section average wind speed 0.25-0.35m / s. Indoor noise: ≤ 65dB (A);
3, indoor pressure: high clean area on the adjacent low clean area ≥ 5Pa, non-clean area ≥ 10Pa;
4, indoor temperature: winter> 16 ℃ ± 2 ℃; summer <26 ℃ ± 2 ℃; (room temperature)
5, indoor relative humidity: 45-65% (RH); (special requirements)
6, indoor noise: ≤ 60dB (A);
7, indoor illumination: ≥ 300Lux; fresh air volume: the total air volume of 20% -30%.
Four, gmp pharmaceutical factory structure composed of clean
1, the current domestic pharmaceutical companies more use of sandwich color plate structure. Installation, the wall with the mouth type, and the ceiling with ordinary color steel plate, the use of new "single, double" sealed sandwich color plate supporting aluminum. Fasteners and piping in the plate concealed, this method makes the plant wall and ceiling can not see the screws and rivets, while the doors and windows closed to improve the degree and in the gmp pharmaceutical factory clean room with interlock and UV lamp device Transfer window (cabinet). It can keep the indoor positive pressure stability, to prevent pollution, to achieve GMP requirements.
2, gmp pharmaceutical factory floor, the use of more hardness, impact resistance, strong adhesion, easy to dust and hot water, acid and alkali corrosion of the self-leveling epoxy floor to improve the cleanliness and appearance of bright The
3, in the gmp pharmaceutical factory clean workshop using contactless faucet and hand sterilizer, to avoid contact with pollution, more in line with GMP health requirements.