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Contained Potent Drug Manufacturing, A Center of Excellence

Through the acquisition of Penn Pharma, PCI is proud of a long and successful track record in manufacturing products requiring containment resources.

Our facilities and capability for safely handling potent products enables the safe development and commercial supply of products with an OEL down to 0.01 μg/m3.

Investment in leading-edge engineered technology places us at the forefront of the industry and enables the provision of a fully comprehensive service for solid dose potent dosage forms.

The development facility created by Penn Pharma for tablets and capsules utilizes processing technologies including roller compaction, high shear granulation and fluid bed drying that are common with our larger scale production unit.

Designed from first principles to meet the growing demand for safe and compliant production of tablets and capsules containing highly potent molecules, our contained manufacturing facility

uses the latest generation contained equipment and systems and automated clean in place or wash off-line systems.

Equipped to meet the needs of development, clinical batch and commercial batch requirements, our facility is able to produce batches from development scale (1kg), through clinical scale (10kg) and up to commercial (120kg) batches of capsules or film coated tablets.

This design-for-manufacture philosophy and use of geometric scale-up ensures consistent reproducibility delivering true speed to market for our clients.

Potent drug product manufactured in specially designed contained engineering equipment including:

  • High shear granulation
  • Contained roller compactor granulation
  • Fluid bed drying
  • Milling/blending
  • Tablet compression
  • Encapsulation
  • Contained Xcelodose® drug in capsule/vial filling
  • Film coating

Contained Operations Summary

  • Capability to process multiple compounds
  • Development scale (1kg) to commercial scale(120kg) batch sizes
  • Segregated people and material flows
  • Secure access and client viewing gallery
  • Automated cleaning procedures
  • Contained engineering solutions eliminating the need for PPE
  • HVAC system with single pass air
  • Temperature and humidity controlled processing areas
  • Small and large-scale packaging options
  • Meeting global regulatory standards including the MHRA, FDA, ANVISA, Turkish Ministry of Health and Japan
  • Design-for-manufacture delivering true speed to market

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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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