Highly Potent Active Pharmaceutical Ingredients



Somerset, NJ Center Of Excellence

Catalent further expands its high potent handling platform with investment in contained oral solid manufacturing at its Somerset, NJ Headquarters.  With extensive oral solid development, clinicaland commercial manufacturing capabilities as well as integrated analytical services, Catalent Somerset can get you to market faster.

Catalent Somerset Facility
Containment & Controls
  • Categorization required prior to handling
    • All APIs assessed to the 4 band system recognized globally through Safebridge
    • Once a category is identified – appropriate control measures are applied
  • Engineering controls provide the primary containment
    • Single pass HEPA-filtered air with zero recirculation – safer processing within suites
    • Processes are designed to contain exposure at point of air borne generation
  • Administrative controls
    • Work practices and procedures designed with ease, safety and simplicity in mind
    • Highly skilled and trained staff understand the requirements
  • Personal protective equipment (PPE)
    • Various levels of respiratory equipment up to Personal Air Powered Respirators
    • Protective clothing, gloves and eyewear designed for the process and person
Fit-for-Purpose Suites

Glovebox

General Purpose Suites

  • Single pass Hepa filtered air  - zero recirculation
  • Separate gown in & gown out areas
  • Room vacuum systems & closed transfer vacuum hoppers
  • General purpose isolator – milling, sieving, blending, pack-off
  • Contained bin thieving
  • Sub-division isolator – API mixing, transfer, pack-off
  • Encapsulation and compression within disposable and dedicated isolator bags
  • Roller compactor Isolator

Fluid Bed Suites

  • Single pass Hepa filtered air  - zero recirculation
  • Separate gown in & gown out areas
  • Glatt 5L isolator – links VG50 to FBD
  • Glatt 30L isolator – provides closed transfer means
  • Closed transfer VG200 high shear granulator bin
  • Room Vacuum Systems
  • Glatt 120L and PMA 800 High Shear designed with same features
  • Wurster processing

Zydis® Suites

  • Single pass Hepa filtered air  - zero recirculation
  • Separate gown in & gown out areas
  • Dedicated washroom
  • All waste water from washroom and freeze drier wash down can be captured into potent waste tanks for safe disposal
  • Final packing stage is separated to allow safe transition of product to warehouse

Equipment

  • Split butterfly valves: Enabling closed transfers of potent powders
  • Glove Bag Isolation Technology: Investment in glove bag frames and high spec glove bags has enhanced potent compound containment at the point of processing
  • Hard Isolators: High dust operations such as milling now enclosed

Air Monitoring Studies

  • Library of processes with IH (Industrial Hygiene) studies
Development Laboratories
  • Multiple Oral Solids equipment available at scales of 100g to 8kg
    • Fluid Bed (GPCG3)
    • Coating
    • Compression
    • Encapsulation
    • Hot Melt Extrusion
    • Zydis®
    • Other Equipment trains
Case Study in Potent Handling

Activity IH Monitoring Table

Example of actual IH monitoring on engineering controlled equipment

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