Stellapharm Pharmaceutical Joint Stock Company (Binh Duong)
Client
Stellapharm Pharmaceutical Joint Stock Company is an EU-GMP-certified pharmaceutical manufacturer specializing in the production of tablets, capsules, and injectable drugs, with products exported to more than 20 countries worldwide.
Challenges
Stellapharm’s production lines use various highly toxic active pharmaceutical ingredients (APIs). During grinding, mixing, and packaging processes, API dust is continuously generated, posing potential risks to workers’ health and increasing the risk of cross-contamination within the production area.
Therefore, the dust collection system needed to meet strict exposure control requirements while allowing filters to be replaced without releasing hazardous dust into the surrounding environment.
Air Filtech’s Solution
Air Filtech supplied a Camfil Dust Collection System integrated with BIBO (Bag-In/Bag-Out) technology, allowing filters to be replaced in a completely isolated environment.
The solution includes:
- The BIBO mechanism securely encloses the contaminated filter inside a specialized bag within the filter housing before removal, preventing API dust from being released.
- An H14 HEPA filtration system with an efficiency of ≥99.995% at MPPS.
- A fully enclosed design suitable for pharmaceutical production areas requiring strict cross-contamination control.
- Compliance with operational safety and occupational exposure control requirements in EU-GMP-compliant pharmaceutical facilities.
Results
- The system meets EU-GMP requirements for pharmaceutical production areas.
- API dust concentration in the air is controlled below 1 µg/m³, meeting occupational exposure limit (OEL) requirements.
- The filter replacement process is carried out safely, minimizing the risk of personnel exposure to pharmaceutical dust.
- Reduced equipment downtime for maintenance and improved overall system operating efficiency.
