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

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

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

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
High potency active investigational pharmaceutical ingredient plant
High potency active investigational pharmaceutical ingredient plant