Sterile Eye-Drop Production Line Enables Vietnam Pharma Companies to Pass GMP Audits Faster

Vietnam’s pharmaceutical industry has undergone rapid modernization in recent years, especially in the ophthalmic sector where product safety and sterility standards are becoming increasingly strict. Eye-drop manufacturing is classified as a high-risk sterile formulation, and many Vietnamese factories have struggled to upgrade their production environments and equipment to meet evolving GMP requirements. Frequent audit failures, inconsistent batch quality, and insufficient environmental control have become common challenges.

Before adopting a modernized line, the client relied on a semi-automatic filling process where disinfected bottles were manually transferred into the filling area. Although procedures were in place, the production environment could not maintain the required ISO 5 cleanliness. Particle counts fluctuated, and the lack of online monitoring systems made it difficult to demonstrate compliance during GMP inspections. Additionally, the high level of operator involvement increased contamination risks, limiting the manufacturer’s ability to scale production efficiently.

To overcome these issues, the client introduced our Fully Automatic 10–20 ml Eye-Drop Filling, Sealing, and Packaging Line, operating at 30–40 bottles per minute. This turnkey solution integrates every critical step of eye-drop production, including solution preparation, sterile filtration, storage, precision filling, sealing, visual inspection, and final packaging. The line is built around a complete aseptic architecture designed specifically for ophthalmic products.

The production area is equipped with an ISO 5 laminar-flow hood, ensuring a unidirectional airflow that consistently maintains low particle levels. To support GMP compliance, the line includes a full set of online environmental monitoring devices:

• Airborne particle counter for real-time particle tracking

• Wind-speed sensor to confirm laminar flow stability

• Active air sampler for microbial monitoring

• Isolator glovebox that minimizes operator intervention

With these features, the entire filling zone remains highly controlled, greatly reducing the risk of microbial contamination and ensuring repeatable sterile conditions across all batches.

Following system installation, the factory observed dramatic improvements. Batch stability increased, contamination risks declined, and production speed became significantly more consistent. For the GMP audit, inspectors were able to see continuous environmental data, equipment qualification records (IQ/OQ/PQ), and automated log reports. This level of transparency and control helped the client successfully pass the audit on the first attempt, something they had previously struggled to achieve.

Moreover, the fully automatic line reduced reliance on manual labor, enabling the factory to operate with fewer personnel while maintaining a much higher degree of sterility assurance. The management team noted that this upgrade has not only improved compliance but also enhanced their competitiveness in Vietnam’s fast-growing ophthalmic market.

Today, the client is expanding production and preparing to introduce additional ophthalmic SKUs, confident that their upgraded sterile environment and automated line can support higher volumes and stricter quality requirements. This case reflects a broader trend in Vietnam: pharmaceutical manufacturers are increasingly recognizing the value of automation and aseptic technology in meeting global regulatory standards.