The Importance Of HEPA Box In Pharmaceutical Industry

  • 03, 09, 2021

 HEPA Box In Pharma Industry

  Pharmaceutical is an industry that applies a lot of cleanroom technologies. The function of the cleanrooms in the pharmaceutical industry is to protect the products from contamination. And the important goal of the pharmaceutical cleanroom is controlling the differential pressure and minimizing the number of airborne particles. Therefore, terminal filtration devices such as HEPA Box play a crucial role in pharmaceutical cleanrooms.

In this article, let's find out with VCR - Vietnam Cleanroom Equipment the importance of HEPA box in pharmaceutical industry.

The importance of HEPA box in pharmaceutical industry

The key technology of the pharmaceutical cleanroom is the control of particles and microorganisms. Contaminants are a primary concern of cleanroom control. Contaminants that accumulate in equipment and pipelines in clean areas of pharmaceutical plants can threaten the cleanliness of cleanroom, which can result in product contamination. Consequently, the efficiency of the products will be reduced. Therefore, there must be a set of standards like GMP for the pharmaceutical industry.

vai trò HEPA Box trong dược phẩm

Good Manufacturing Practices (GMP) set strict standards on pharmaceutical factories to maintain a clean production environment. GMP requires the manufacturing plants to control various sources of contamination right from the start and emphasizes the control of contamination during the production process.

The goal of a pharmaceutical cleanroom is to prevent contamination throughout the entire production process, while at the same time creating a sterile manufacturing environment. 

Requirements of HEPA Box in pharmaceutical cleanroom

Cleanliness requirements in pharmaceutical clean rooms

Below is a table of air cleanliness levels of pharmaceutical cleanrooms:

    Class

The maximum air particles                        The maximum number of microorganisms
          ≥ 0,5 μm
    
≥ 5 μm (cfu / mm3) (cfu / m3)
100 3500 0 5 1
10000 350000 2000 100 3
100000 3500000 20000 500 10
300000 10500000 60000 - 15

Requirements of HEPA Box in pharmaceutical cleanroom

HEPA Box in GMP pharmaceutical factory is different from HEPA Box used in conventional electronics factories.

HEPA Box used for pharmaceutical clean rooms need to meet the following requirements:

  • Hepa box consists of a static pressure box and a high-efficiency air filter (HEPA filter)
  • Static pressure box and casing are usually made of stainless steel
  • The air supply port is equipped with a ventilation surface
  • HEPA filter and the static pressure box are a total monolithic structure. The inlet connected to the duct system is equipped with a control valve to regulate the air supply.
  • The air supply port has the advantages of strong flexibility, beautiful appearance, convenient installation and replacement, simple maintenance, low investment, and high filtration efficiency.

HEPA box in pharmaceutical cleanrooms needs DOP integration. With DOP test port and spray port, a leak test can be performed in time after installation of HEPA filter box to check the tightness of gasket, frame, and filter material. For sterile workshops, HEPA filter terminal boxes need to be checked regularly. Therefore, HEPA box with integrated DOP is widely used in biopharmaceutical plants, scientific research institute, disease control centers, hospitals, scientific research universities, and other working environments with high cleanliness requirements.

HEPA box supplier in Viet Nam

VCR - Vietnam Cleanroom Equipment is a unit specializing in providing cleanroom equipment for the construction of pharmaceutical factories, medical equipment, packaging, food, electronics, etc.

If you need HEPA box as well as other cleanroom equipment, please contact us via:

VCR - Vietnam Cleanroom Equipment

Address: N03-T7 building, Diplomatic Resident, Northern Tu Liem District, Hanoi.

Phone: +84 90 123 7008

Email: info@vietnamcleanroom.com

Website: en.vietnamcleanroom.com

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