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Pilot-scale Preparation Testing

Pilot-scale Preparation Testing

For oral solid preparations, we conduct laboratory-scale production and preliminary stability studies. After the determination of the formulation process, the preliminary stability of samples and identifying the proposed inner packaging materials, we prepare relevant documents and materials for pilot-scale tests.

  • Preparation of documents for pilot-scale tests
    Scheme of pilot-scale testsRecords for batch production & packaging Draft quality standard for finished productsDraft quality standard for intermediates
  • Preparation-making for pilot-scale tests
    Collection of APIsProcurement of ingredients and packaging materialsDetermination or customization of tableting, capsule filling and aluminum-plastic molds
    The preparation of documents and materials shall be made during the pre-stability period of laboratory-scale test to meet the requirements of the new drug project for the schedule and time limit.
  • The sample production for pilot-scale test includes
    Pretreatment of raw materials (mechanical crushing, airflow crushing, etc.)Mixing - box-type mixing or high shear mixingGranulating - wet granulating, dry granulating and fluidized bed granulatingDrying - fluidized bed drying and oven dryingSieving -fast sieving equipmentTableting - high-speed tablet pressCapsule filling - capsule filling machine, available for granules, powders or pellets at the same timeCoating -  efficient coating machine with digital display of key parametersPackaging - aluminum-plastic packaging and bottle packaging
    The documents for pilot-scale test shall be released after being drafted and taken into effect, and implemented under a sound management system.
    As a transition between laboratory-scale batches and clinical batches, pilot-scale batches shall be produced based on the risk control strategy in process research and the production experience of multiple drug varieties. As the equipment basically corresponds to GMP-based workshop, seamless connection with later GMP-based batches and the successful production of clinical samples can be both guaranteed.
    Samples for pilot-scale tests are mainly used for the verification of analytical methods and the research on stability.
Relevant laboratories
  • Preparation workshop
  • formulation equipment
  • Constant temperature culture vibration box
  • Transdermal diffusion tester
  • New generation medicated impactor
  • Rheometer
  • Respiratory simulator
  • Constant temperature culture vibration box
  • Formulation pilot test
  • Wet Mixing Granulator
  • Capsule Filling Machine
  • Preparation workshop
  • Preparation workshop instruments
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