Latest company case about Suzhou Lingyao Intelligent Equipment Co., Ltd. certifications

Vietnam’s pharmaceutical sector has tightened regulations in recent years, especially for ophthalmic products. Eye drops are considered high-risk sterile formulations, and many factories struggle with:

• Cleanroom facilities failing to meet ISO-5 (Class 100) requirements

• Particle spikes in the filling zone

• Lack of online monitoring equipment (particle counter, airflow monitoring, microbial sampling)

• High manual involvement leading to contamination risks

• GMP audits repeatedly pointing out insufficient sterility assurance

To overcome these challenges, the customer adopted our 10–20 ml Eye-Drop Filling, Sealing, and Packaging Line, operating at 30–40 bottles/min. The line includes:

Complete Sterile Manufacturing Architecture

• ISO 5 laminar-flow hood covering filling & sealing

• Online particle counter

• Real-time airflow monitoring

• Active air samplers for microbial inspection

• Isolator glovebox system to reduce operator intervention

• Fully automated: solution preparation → storage → sterile filling → sealing → inspection → packaging

Key Achievements for the Client

1. Sterility assurance significantly improved, meeting the strictest ophthalmic standards.

2. The line maintained stable output even during long production cycles.

3. Operator involvement minimized, reducing human-borne contamination risk.

4. The factory successfully passed GMP certification on the first attempt.

5. Overall production efficiency increased nearly 200% compared with semi-automatic operations.

During the audit, inspectors noted:
“This production line’s sterility control is fully aligned with modern ophthalmic international requirements.”