Meeting GMP Standards: A Cleanroom Project in African Pharmaceutical Company
Industry: Blister packaging machine and medicine filling machine production line
Location: Morocco
Project SQM: 300 square meters
Year of Execution: 2024
In the final stage of the pharmaceutical industry, packaging and filling are the crucial factors that determine whether the medicine can safely reach to patients. Among them, blister packaging line(commonly used for tablet and capsules ) and liquid filling line(especially for sterile injection solution) have extremely strict requirements for the production environment. Their cleanroom is invisible guardian that ensures physical and microbiological quality of the medicine. Although both cleanroom, the areas servicing for these two different processes have significant differences in design requirements, cleanliness level and control priorities.
- Blister packaging machine clean area. Blister packaging seals the solid medicines between blister(plastic blister ) and an aluminum foil. This process itself doesn’t requirement absolutely sterility, but the core function of its cleanroom and prevention of contamination are of great importance.
- Core function and risk:
Main risk: particle contamination and cross-contamination.
Contaminate source: Dust generated by the operation of the machine (from the friction of tablets, the cutting of aluminum foil), particles emitted by personnel, and fibers in the environment, etc.
- Cleanliness level:
- It is usually required that the C-level and D-level systems operate in coordination with each other.
- For the areas where the products are directly exposed (such as forming, filling, heat sealing stations), we will design the local Grade A laminar flow cover to create unidirectional flow at the critical operation points, providing the highest level protection.
- Environmental control key points:
- Effective dust-proof system: The packaging machine should be equipped with dust collection device to promptly remove the powder and aluminum foil debris, preventing them from spreading into the cleanroom environment.
- Rational differential pressure and air flow: Maintain a positive pressure relative to adjacent lower-classification areas to prevent the intrusion of external contaminants.
Personal and material control: Operator must wear the standard clean cloth and go through the standard changing procedure. Packaging material(PVC hard go through) must undergo surface cleaning through a pass-through window before entry.
- Liquid filling machine cleanroom.
About liquid filling production line, especially those used for sterile preparations such as intravenous injections and eye drops, are among the most critical processes in the pharmaceutical industry. Any invasion by microorganisms can be fatal.
- Core function and risk:
Main risk: particle and microorganism contamination.
Contaminate source: air, personal, equipment surface, and vessels.
- Cleanliness level:
The core operation areas need to be designed to meet Grade A and Grade B level. These areas includes injection needles, container openings, stopper feeding systems, and product about to be sealed.
- Environmental control key points:
- Grade A level laminar flow protection: The critical operation area of filling machine must be covered by vertical laminar flow hood or a higher level isolator. They can provide continuous, uniform, and unidirectional A-level, instantly blowing away the particle and microorganisms generated by people and the environment, forming a physical barrier.
- Strict differential pressure: The Grade B area maintains a positive pressure relative to the adjacent Grade C area, which in turn maintains a positive pressure relative to the general area, establishing multi-layered protective system.
- Sterile changing room design: Personal entering B-level area must go through extremely strict changing procedure, wearing one-piece clean cloth, keep the most cautious operational guidelines, and minimize all movement and activity as much as possible.
- Aseptic transfer of materials: All components(such as Filling pump, pipelines), containers (Syringe bottles, ampoule bottles), and sealing parts(rubber plug) in contact with products must be cleaned and sterilized(such as Wet heat sterilization, dry heat sterilization), and be transferred aseptically to A-level(such through the double-door sterile cabinet or the rapid VHP pass chamber)
The smooth operation of this clean room vividly demonstrates our core capability of providing high-standard, one-stop comprehensive solutions. From the initial planing design to the final delivery, Suzhou Pharma Machinery overcomes the geographical and environmental challenge. If you are also facing similar challenges, please feel free to contact us. Let us turn your vision into an equally outstanding reality.
Suzhou Pharma Machinery Co.,Ltd.
2025/11/14
Lucy
