High Potent Commercial Manufacturing

PCI offers flexible and globally compliant commercial scale manufacturing and packaging of multiple dosage forms including tablets, capsules, creams, gels, ointments and oral liquids for both highly potent and non-potent drug products.

Investments include separate suites for large volume tablet and liquid manufacture as well as specialist roller compaction technology for heat and moisture sensitive formulations.

A dedicated department of validation specialists ensure a seamless transition from clinical phase to commercial launch as well as supporting ongoing commercial supply through continuous process verification (CPV).

Commercial manufacturing and packaging is supported by an experienced team of Qualified Persons, a full analytical release testing laboratory and a GMP compliant temperature controlled warehouse with storage down to -20°C.

Commercial Manufacturing Operations include:

Depending upon the hazard profile of the active pharmaceutical ingredient(API), PCI is able to utilize a number of on-site dispensing facilities including a high performance isolator for weighing highly potent actives.

From 10 L to 600 L processors, PCI is able to granulate and dry across a broad range of batch sizes for commercial supply. Using HMI interfaced high shear mixer granulators and fluid bed driers, PCI is confident of delivering reproducible, globally compliant, commercial scale batches of granules for compression or encapsulation. Our dry granulation roller compaction technology provides an alternative granulation technique for moisture or heat sensitive molecules.

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 capable of a broad range of output speeds, PCI has the technology and capacity to meet your commercial capsule demands. Covering all major capsule sizes, we are able to 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, we maintain a number of perforated pan coating machines to provide a range of batch sizes for coated tablets. As part of our philosophy, we specify clean-in-place (CIP) systems for all new technologies including coating machines. Our latest generation coating equipment is capable of handling tablet cores containing potent actives, configured with contained core loading and sample collection ports.

PCI is experienced in manufacturing semi-solids and oral liquids for commercial supply. 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.

Specialized Manufacturing of Highly Potent Products

Building on 35 years in potent processing, we offer a purpose-built facility utilizing the very latest in containment technology, enabling the safe development, clinical and commercial supply of products with an occupational exposure limit (OEL) as low as 0.01µg/m3.

The facility itself has multiple levels of containment built into the design. Dispensing of API is undertaken within isolators and subsequent processes within appropriately contained equipment, ensuring operator safety and preventing cross-contamination.

Our fully integrated facility utilizes common equipment trains from development to commercial scale, with geometric scale-up delivering reproducibility and ultimately speed-to-market.

  • Multiple compound processing
  • Development to commercial scale manufacturing and packaging
  • Segregated people and material flow
  • Secure access with client viewing gallery
  • Automated cleaning procedures
  • Contained engineering eliminating the need for personal protective equipment (PPE)
  • HVAC system with single pass air
  • Purpose-built, high performance, bespoke effluent treatment facility
  • Design-for-manufacture delivering true speed-to-market
  • Meeting regulatory standards for major markets including Japan, TMoH, the MHRA, FDA and ANVISA

    Our dedicated team of specialists will be happy to discuss any of your High Potent Commercial Manufacturing needs. Contact us by email talkfuture@pciservices.com

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