Meeting GMP Standards: A Cleanroom Project in African Pharmaceutical Company

• Project name: Blister packaging machine and medicine filling machine production line
• Customer information: Bio-pharmaceutical Industry Medium-sized Manufacturing Enterprise in Morocco
• Core Demand: Construction of a 300 sqm pharmaceutical cleanroom supporting the operation of blister packaging and medicine filling production lines; meeting the requirements for solid medicine packaging and filling; ensuring compliance with industry regulatory standards.
• Project Level: ISO 7&ISO 8 cleanliness level and Supporting Standards.
• Delivery cycle:Efficient delivery, successfully completed in 2024.

Project Key Challenge

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.

• 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.

• Main risk: particle and microorganism contamination.
• Contaminate source: air, personal, equipment surface, and vessels.

SZ-PHARMA Customized Solutions

• Cleanliness level:

1. It is usually required that the C-level and D-level systems operate in coordination with each other.
2. For the areas where the products are directly exposed (such as forming, filling, heat sealing stations), SZ-PHARMA will design the local Grade A laminar flow cover to create unidirectional flow at the critical operation points, providing the highest level protection.

 Liquid filling machine cleanroom. 

• 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.

Meeting Core Indicators

• Environmental control key points:

1. 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.
2. Rational differential pressure and air flow: Maintain a positive pressure relative to adjacent lower-classification areas to prevent the intrusion of external contaminants.
3. 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.

• Environmental control key points:

1. 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.
2. 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.
3. 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.
4. 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)

Achieving Customer Demands

Project Challenges Overcome

Through sophisticated airflow organization design and pressure differential gradient control within the 300 sqm space, we achieved seamless integration of multi-grade clean environments, ensuring the production setting meets stringent industry requirements.

Compliance Aspect

The design scheme aligns with GMP specifications for the pharmaceutical industry, and the cleanroom fully complies with the regulatory requirements for pharmaceutical production.

Production Aspect

We successfully realized the perfect adaptation of the 300 sqm cleanroom with blister packaging machines and pharmaceutical filling machine production lines. The setup meets the production needs of both solid pharmaceuticals and sterile liquid pharmaceuticals, effectively preventing particulate and microbial contamination and safeguarding the physical and microbiological quality of pharmaceutical products.

After-sales Support

Suzhou Pharma Machinery provides 24/7 technical response to promptly resolve various issues arising during the operation of equipment and the cleanroom.

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