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Commercial Pharmaceutical Manufacturing

PCI offers flexible and globally compliant commercial scale pharmaceutical manufacturing of tablets, capsules, semi-solid and liquid oral preparations.

Recent investments include separate suites for large volume tablet manufacture and dry granulation
for moisture sensitive formulations.

Our aim is to provide a comprehensive service from launch through to worldwide supply from an experienced production team supported by engineering and validation specialists.

 

Depending upon the hazard profile of the active pharmaceutical ingredient, PCI can utilize a number of on-site dispensing facilities including a high performance isolator for weighing highly potent actives.
From 10Litre to 600Litre processors, PCI can granulate and dry across a broad range of batch sizes to match the majority of commercial demands. Using HMI interfaced high shear mixer granulators and fluid bed driers, PCI is confident of producing reproducible, globally compliant commercial batches of granules for compression or encapsulation.

Recently acquired is PCI’s dry granulation capability utilizing roller compaction. Providing semi-continuous production, roller compaction is a robust granulation technology for moisture or heat sensitive molecules.

Granulation services offered by PCI include:

  • Single pot processing
  • High Shear granulation
  • Fluid bed drying
  • Roller compaction

For more information on Contained Roller Compaction, please click here:

With multiple machines available to compress up to 200,000 tablets per hour, PCI maintains flexibility and capacity to compress a broad range of tablets from simple normal curvature to complex embossed shapes. PCI scientists utilize instrumented tablet presses to collect batch data to support validation and routine production and are highly experienced in the transfer of existing processes into our GMP compliant facilities.

With several machine types on-hand capable of a broad range of output speeds, PCI has the technology and capacity to meet your commercial capsule demands.

Covering all the major capsule sizes, PCI can encapsulate moisture sensitive formulations, modified release multiple particulates and formulations for inhalation devices. PCI has both on-machine and off-line capsule weight checking equipment to provide a high level of confidence in the compliance of the finished batch.

Utilizing aqueous based film coating systems, PCI maintains a number of perforated pan coating machines to provide a range of batch size for coated tablets up to 350kg.

PCI has invested in the latest HMI interfaced coating machines with high performance spray systems that produce exceptional quality coated tablets. PCI specifies clean-in-place systems on all new equipment including coating machines.

Our latest generation coating machines are capable of handling tablet cores containing potent actives and are configured with contained core loading and sample collection ports.

PCI is experienced in manufacturing semisolids and oral liquids for commercial supply. With excellent scale-up technology in-house, commercial batches are produced in a range from 5L to 500L.

Several high performance processors with heated jackets, vacuum and in-line homogenization are available to provide quality formulations for tube and bottle filling. On site analytical and micro-biological laboratories support production of all oral preparations.

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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

PCI Points...

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Our global reach and localized support ensures PCI as a strategic partner remains focussed on delivering speed-to-market and the commercial success of our customers

PCI is a global company that focusses on delivering speed-to-market and the commercial success of our customers

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