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Solutions

SOLUTION

Background

As an important part of pharmaceutical production quality control, the HVAC system in pharmaceutical manufacturing primarily participates in control and monitoring of air temperature, humidity, airborne particles, and microorganisms in the production environment to ensure that environmental parameters meet drug quality requirements, prevent air pollution and cross-contamination, and provide a comfortable environment for operators. Additionally, the pharmaceutical HVAC system can also reduce and prevent adverse effects of drugs on personnel during production and protect the surrounding environment.

The Good Manufacturing Practices for Pharmaceutical Products (2010 Revision), as the primary design basis for cleanroom construction in the pharmaceutical industry, put forward clear requirements for the air cleanliness levels in key pharmaceutical production processes. When pharmaceutical production processes or products have special temperature and humidity requirements, these parameters should be determined based on the specific process and product requirements. When pharmaceutical production has no special temperature and humidity requirements, Grade A, B, and C cleanrooms should maintain a temperature of 20°C-24°C with 45%-60% relative humidity; Grade D cleanrooms should maintain a temperature of 18°C-26°C with 45%-65% relative humidity; and the personnel purification and living areas should maintain a temperature of 16°C-20°C in winter and 26°C-30°C in summer.

The "Good Manufacturing Practice for Pharmaceutical Products" (2010 Revision) clearly defines the requirements for air cleanliness and microbial particle concentration limits in pharmaceutical production environments, with cleanrooms classified into four grades: A, B, C, and D.


Cleanroom airborne particle standards:

Cleanliness Grade

Maximum Permitted Particles per Cubic Meter

At Rest

In Operation

≥0.5μm

≥5.0μm

≥0.5μm

≥5.0μm

Grade A

3520

20

3520

20

Grade B

3520

29

352000

2900

Grade C

352000

2900

3520000

29000

Grade D

3520000

29000

No requirement

No requirement


The dynamic microbial monitoring standards for clean areas are shown in the following table:

Cleanliness Grade

Airborne viable particles

cfu/mm³

Settle plates (ø90mm)

cfu/4 hours

Surface microorganisms

Contact plates

cfu/plate

5-finger glove

cfu/glove

Grade A

<1

<1

<1

<1

Grade B

10

5

5

5

Grade C

100

50

25

-

Grade D

200

100

50

-



SINO KING Solution for Cleanroom Air Conditioning Systems in Pharmaceutical Factories

To address pharmaceutical factories' requirements for large cooling capacity and high-frequency usage of air conditioning systems, SINO KING recommends a flooded screw chiller unit with large cooling capacity for facilities with dedicated cold source rooms, and an evaporative cooling integrated chiller unit for facilities without separate cold source rooms. The air handling side utilizes purification-type packaged air conditioning units, with fresh air purification-type DC variable frequency air-cooled direct-expansion packaged air conditioners specifically recommended for anode control laboratories. SINO KING's custom-designed evaporative cooling integrated chiller, a substitute for traditional chiller equipment, improves the utility value of factory buildings while delivering high energy efficiency ratios and reducing electricity costs. The purification-type packaged air conditioning units can be configured with various sections - fresh air section, primary filter, preheating, return air, medium efficiency filter, sub-HEPA filter, HEPA filter, surface air cooler, eliminator, heating, humidification, airflow stabilization, heat recovery, dehumidification, sterilization, sound attenuation, supply fans, and air discharge – according to different purification application scenarios to meet temperature, humidity, and cleanliness requirements for different pharmaceuticals and different production processes.





industry case

    1. Jumpcan Pharmaceutical Group Co., Ltd.

      Jumpcan Pharmaceutical Group Co., Ltd.

    1. Jiangsu Simcere Pharmaceutical Co., Ltd.

      Jiangsu Simcere Pharmaceutical Co., Ltd.

    1. CanSino Biologics Inc.

      CanSino Biologics Inc.

    1. Shandong Lukang Pharmaceutical Co., Ltd.

      Shandong Lukang Pharmaceutical Co., Ltd.

    1. Xi'an Tsinghua Deren Xi'an Xingfu Pharmaceutical Co., Ltd.

      Xi'an Tsinghua Deren Xi'an Xingfu Pharmaceutical Co., Ltd.

    1. Yangtze River Pharmaceutical Group

      Yangtze River Pharmaceutical Group