Pilot-scale Preparation Testing

• 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.

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