High Potency Product Formulation
We manufacture formulation of high potency products ranging from clinical samples to pharmaceuticals
Our manufacturing environment is based on hazard assessment, exposure assessment, and implementing strict residue management.
In addition, we monitor the environment and verify the containment by measuring the exposure to workers. We target APIs with an OEL (Occupational Exposure Limit) of 1μg/m3 or less. The production scale is mainly 5 to 15 kg, and the dosage forms are granules, uncoated tablets, and coated tablets.
Based on the safety information, we evaluate the APIs and decide whether we can handle them or not, taking into account the dosage form and the manufacturing process.
- High speed agitation granulator
- Fluidized bed granulator
- Particle sizing equipment
- Tableting machine
- Mixing machine
- Coating machine
- Packing machine
High Potency Tablet Dosage Form:
Production Equipment
- Closed System
- Glove Box
- Flexible Enclosure
- Isolation Flap
- Local Exhaust Ventilation system
Production Area
- Air flow control
- Monitoring System
- Mist Shower
- Dedicated All Fresh Air condition
- Dedicated Purified Water system
Rigorous Operating Policy
- No simultaneous production with others
- Cleaning Validation
- Dedicated equipment
- Entire Cleaning procedure for Production room/auxiliary chamber
- Monitoring for residual chemicals
- Monitoring of Exposure/leakage
- Disposal equipment and wears
Pharmaceutical Manufacturing
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