From Design to Delivery: A Comprehensive Cleanroom Solution for the Pharmaceutical Industry in Africa
- Project name: Medicine filling and sealing production line cleanroom
- Customer information: Bio-pharmaceutical industry Large-scale pharmaceutical manufacturing enterprises in Congo
- Core Demand: Build a 2,000 ㎡ clean room for medicine filling production lines, meet the production requirements of sterile preparations and biological products, and achieve compliance acceptance in line with GMP standards.
- Project Level: ISO6&ISO 7&ISO 8 cleanliness level.
- Delivery cycle: Efficient delivery, successfully completed in 2023.
customer visit
customer visit
Project Key Challenge
As we know, for pharmaceuticals, especially sterile preparations and biological products industries, it’s crucial to design a cleanroom meeting global standard. Because the medicine can directly affect patients' lives and health. Any tiny dust particles and microbial contamination may lead to risks such as contamination, microorganisms growth, and cross-infection. Therefore, a standard cleanroom is the cornerstone for enduring the safety, efficacy and consistency of medicines quality. It is the core hardware requirement of the GMP standard.
The filling and sealing production line line for customer demands, as a high-risk operation area, requires precise control of air cleanliness and airflow organization to prevent cross-contamination.
SZ-PHARMA Customized Solutions
Over the past few years, Suzhou Pharma Machinery has completed numerous cleanroom projects in Africa and the surrounding region. It’s worth mentioning that all these projects have obtained FAD certification. About the core components of cleanroom structure, we have the following conclusions.
This time the overall project is designed in accordance with the ISO 14644-1 standard, ISO7 and ISO8 cleanliness standard. The design complies with the EU GMP and Chinese GMP standards.
- Core Design Concept: Combined with the production process of the medicine filling production line, the functional zoning planning of the clean area is carried out to strictly separate the personnel flow from the material flow. The high-risk filling area is independently planned as a laminar flow operation area, forming a reasonable pressure gradient with other auxiliary areas, so as to eliminate cross-contamination while optimizing process connection.
- Key Technology Implementation: HEPA/ULPA air filters are configured at the air supply end to accurately control the air distribution forms of laminar flow (unidirectional flow) and turbulent flow (non-unidirectional flow); precise pressure difference control is achieved by adjusting the air supply and return volume, with a professional temperature and humidity control system supporting it. Meanwhile, the envelope structure adopts dust-free and easy-to-clean materials such as color steel plates and stainless steel, and the doors and windows are specially treated for airtightness.
- Compliance Adaptation: In view of the GMP sterile preparation production requirements of the biopharmaceutical industry, a dual purification process for personnel and materials is specially designed, with a standardized cleaning and disinfection SOP formulated in a supporting manner, which fully meets the sterility and cleanliness requirements of ISO14644-1, EU GMP, Chinese GMP and local FDA certification in all dimensions.
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Meeting Core Indicators
- Air handling unit(HVAC):
- Air flow:
A:Laminar flow (unidirectional flow). The air flows uniformly at a constant cross-sectional speed in a single direction, effectively removing pollutants quickly. This type is mainly used in the high-risk operation areas(such as filling line of this project)
B:Turbulence (non-unidirectional flow). The air flows in an uneven and irregular manner. The dust concentration in the room is reduced through dilution. This type is used in the areas with lower cleanliness requirement
C: Differential pressure control. By adjusting the supply and return air volumes, cleanrooms of different levels can maintain a certain pressure gradient. For example, the core area has the highest pressure, followed by the corridor; the ordinary area has the lowest pressure. This type can ensure that air can only flow from the cleanroom to the less cleanroom to prevent cross-contamination.
D: Temperature and humidity control. Provide a comfortable environment for the operators, while preventing the growth of microorganisms or the moisture absorption and deterioration of products due to inappropriate temperature and humidity.
- Building structure and material:
A: Building envelope structure: wall, ceiling, and floor should be smooth, flat, free of cracks, corrosion-resistant, easy to clean; they should not produce dust or accumulate dust. They are usually made of color steel, stainless steel material. Especially the wall should be made of fire-resistant material(it is recommended to choose those with a fire resistance limit of more than 60 minutes and equipped with a professional fire certificate).
B: Doors and windows: The structures should be tightly sealed to prevent external contaminants from seeping in.
- Personal and material purification:
A: Personal purification. All the people entering the cleanroom must undergo the strict dressing procedure, including changing shoes, washing hands, putting on the one-piece clean suit, gloves, a mask, and head covers. They must also pass through the air shower room for blowing to remove particles and microorganisms emitted by the human body.
B: Material purification. All the material, instruments, and equipment entering the cleanroom must undergo surface cleaning and disinfecting through the pass box(or an interlock device); or pass through the material airlock area.
- Strict cleaning and disinfecting procedure
Formulate and implement detailed cleaning SOP(standard operating procedure). Clean and disinfect walls, floors, equipment, and air regularly with validated disinfectants to control the microbial load.
Achieving Customer Demands
- Compliance Aspect: Successfully passed the local FDA certification, met the requirements of EU GMP, Chinese GMP and ISO14644-1 standards at the same time, and completed the all-dimensional compliance acceptance.
- Production Aspect: The 2,000 ㎡ clean room for the pharmaceutical filling production line was successfully put into place, realizing the safe production of sterile preparations and biological products. The hardware level ensures no cross-contamination and no microbial growth in the pharmaceutical production process, and guarantees the continuity and stability of pharmaceutical production.
In this project, in response to the high standards of clean production conditions demanded by the client, Suzhou Pharma provides system solutions, forming a complete chain covering early design, integration, construction and commissioning to final delivery. We transform the "complex projects" of our clients into "turnkey", by integrating resources and controlling processes of the professional team, enabling our clients to obtain reliable long-term value at a lower cost and with higher efficiency.
Suzhou Pharma Machinery Co.,Ltd.
2025/11/03
Lucy
