High Potency Active Pharmaceutical Ingredient Plants
Handling of high potency active pharmaceutical ingredients requires an attention to product quality and to worker safety and health in the manufacturing environment. Also important are encapsulation technologies and their implementation to ensure the location of target substances is controlled.
We offer manufacturing plant solutions for high potency active pharmaceutical ingredients with a focus on three concepts of encapsulation technologies—cross-contamination prevention (to protect people taking medication), scatter prevention (to protect plant operators), and environmental discharge prevention (to protect the surrounding environment).
Examples
High potency active pharmaceutical ingredient plant: High volume production
Scope of service
- Design, equipment procurement, construction, installation, trial operation, validation
Features
- Multi-series high potency active pharmaceutical ingredient encapsulation technologies for high-variety production (OEL: <1 μg/m³)
- Risk assessment-based automatic control system
- Building designed to accommodate future expansion
High potency active pharmaceutical ingredient plant: High category pharmaceuticals
Scope of service
- Design, equipment procurement, construction, installation, trial operation, validation
Features
- Category 5 compliance (OEL: <0.2 μg/m³)
- Future Category 6 compliance (OEL: <0.1 μg/m³)
- Multi-product multi-purpose pharmaceutical plant
High potency active investigational pharmaceutical ingredient plant
Scope of service
- Design, equipment procurement, construction, installation, trial operation, validation
Features
- Conversion of existing plant to support high potency active pharmaceutical ingredients
- Small-lot multi-product manufacturing plant
- Isolators and incidental equipment engineered from the user’s perspective
