Suzhou Pharma Successfully Delivers Cleanroom Turnkey Project to Africa

• Project name: Clean Room Construction Project for Syringe Assembly Industry
• Customer information: Syringe assembly industry local manufacturing enterprise
• Core Requirements: To build a 500-square-meter clean room for syringe assembly, equip with complete laboratory equipment, enable the client to complete installation independently relying on installation guidelines, and ensure the project meets local market requirements and government FDA certification standards.
• Project Level:Project Grade: Cleanliness class includes ISO5 (supporting ISO5 clean bench)&ISO 7&ISO 8; Supporting Standards: Professional HVAC design complies with local African market specifications and Nigerian government FDA certification requirements.
• Delivery cycle: Efficient delivery, being the first completed project among our many projects in Nigeria

Project Key Challenge

1. The syringe assembly industry has high requirements for the cleanliness of the production environment and strict compliance acceptance (needing to meet local FDA certification). Substandard clean environment will affect product quality and market access.

2. About clean room installation, our customer needs a solution that can be completed independently, and requires complete supporting laboratory equipment to meet production and testing needs.They not only require production workshops, but also the corresponding laboratory testing environment (sampling, weighing, microbial control). A single supplier is unable to provide a complete solution.

3.For Suzhou Pharma Machinery, there were difficulties such as cultural communication differences, and we need to ensure that the equipment arrived at the site on time and in good condition.

SZ-PHARMA Customized Solutions

Suzhou Pharma based on customer demands and in combination with the actual environment of the African market and government regulatory requirements, has tailored an industry-leading HVAC system design. This system not only meets the stable operation requirements under local climate conditions, but also has passed the FDA certification standards in line with international standards, fully demonstrating our professional strength in cleanroom technology.

It is worthy to say that Suzhou Pharma uses digital tools such as CAD drawings and 3D animation videos to provide customers with detailed installation instructions. The customer team, relying on these materials, completed the independent installation and commissioning of all equipment in a very short time, significantly reducing costs and time. The cleanroom project is also equipped with all the laboratory equipment. They include sampling booth, ISO 5 clean workbench, the Class 2 bio-safety cabinet, and the pass box, among others. All these equipment are designed in a modular manner, facilitating transportation and installation, while also ensuring efficiency and safety.

Meeting Core Indicators

Cleanliness Indicators: The background environment of the production area consistently maintains ISO Class 7/8 standards, while suspended particle counts at key assembly stations exceed ISO Class 5 requirements. The laboratory's microbiological testing environment complies with pharmacopoeia standards.

Supporting Indicators: Temperature and humidity are controlled within the optimal range for syringe production (specific values can be supplemented based on actual operational data, e.g., ±2°C / ±5% RH). Pressure differentials are rationally designed to effectively prevent the intrusion of external contaminants.

Achieving Customer Demands

The 500-square-meter clean room was completed smoothly, becoming the first delivered project among our many projects in Nigeria; relying on the CAD drawings, 3D videos and other installation guidelines provided by us, the client successfully completed the installation independently and quickly put it into syringe assembly production, realizing the landing of production needs.

After the project was delivered, the customers were full of praise for our professional capabilities and execution ability. Mr.C said: "From design to delivery, the Suzhou Pharma team has always responded to challenges with a high sense of responsibility and flexibility. Whether it's equipment performance or technical support, it has exceeded our expectations!"

Since its establishment, Suzhou Pharma Machinery Co., Ltd. has been committed to meeting global customers' needs through professional technology and customized services. The successful completion of this overseas project has verified our core competitiveness of "technology& service". In the future, we will continue to provide global customers with higher-quality and more efficient solutions.

Suzhou Pharma Machinery Co.,Ltd.

2025/08/06

Tia