From Design to Delivery: A Comprehensive Cleanroom Solution for the Pharmaceutical Industry in Africa

Industry: Medicine filling and sealing production line

Location: Congo

Project SQM: 2000 square meters

Year of Execution: 2023

This 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. 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.

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.

• Air handling unit(HVAC):

(HEPA/ULPA filter). It is installed at the end of the air supply part, capable of effectively filtering particles with a size of ≥0.3 micrometers (HEPA) or ≥0.12 micrometers (ULPA), with a filtration efficiency of over 99.97%. They are crucial for ensuring air cleanliness.

• 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.

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.