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Contained Roller Compaction

Roller compaction is a proven process that provides a method of granulation for materials that are heat and moisture sensitive.

The process avoids the use of granulation liquids and high temperatures associated with wet granulation and subsequent drying methods.

Roller compaction turns powder blends into densified sheets using the pressure of two compacting rollers. The resulting sheets can then be milled to any desired mesh size providing an efficient and scalable process. PCI has invested in a contained Gerteis Mini-Pactor to further expand existing contained manufacturing operations. This technology offers a patented proven design able to process highly potent molecules using effective containment technology and integrated cleaning systems.
Our investment in the Gerteis Mini-Pactor allows easy scale-up to commercial volumes, with an out-put range from 10 grams per trial to 100Kg/hr, facilitating shorter and less costly development programmes. The addition of this state-of-the-art technology to our already award-winning contained operations, ensures that PCI are able to offer the full range of processing options for the development and manufacture of highly potent molecules. Ongoing investments in our facility ensures that we continue to lead the market in contained processing.

Explore the PCI Process Phase by Phase

PRE-CLINICAL
PHASE I
PHASE II
PHASE III
COMMERCIAL

Swipe to explore the PCI Process

PRE CLINICAL

pre-clinical-icon
  • Formulation Development
  • Analytical development/characterisation

PHASE 1

PCI Phase 1
  • Formulation Development
  • Analytical Development
  • Drug in capsule/vial technology (Xcelodose)®
  • Phase I product manufacture
  • Tablets/Capsules
  • Blinding via over-encapsulation
  • Phase I packaging and labelling
  • Storage and distribution

PHASE 2

PCI Phase 2
  • Formulation Optimization
  • Dosage Form Process Validation
  • Analytical Testing and Stability Services
  • Phase II Product Manufacture
  • Tablets/Capsules
  • Blinding via over-encapsulation
  • Phase II packaging and labelling
  • Storage and distribution

PHASE 3

PCI Phase 3
  • Comparator Sourcing
  • Scale Up Studies
  • Phase III Product Manufacture
  • Tablets/Capsules
  • Blinding via over-encapsulation
  • Phase III packaging and labelling
  • Analytical testing and stability services
  • Storage and distribution

COMMERCIAL

PCI Commercial Phase
  • Scale up for commercial supply
  • Commercial product manufacture
  • Commercial packaging and labelling
  • Validation services
  • Analytical testing and stability services
  • Product release to market
  • Storage and distribution

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