New Product Introduction 丨FZM Series Fluid-bed Granulator: New Scenarios for Drug Development

1. Insufficient batch adaptability: Conventional equipment processing capacity starts at kilograms, which cannot meet the needs of 100g-level micro-experiments, resulting in raw material waste and a surge in R&D costs;

2. Single function and space limitation: Drying, granulation, coating and other processes require multiple equipment to cooperate, laboratory space utilization is low and operation is complicated;

3. Data traceability and compliance pressure: Traditional equipment lacks refined parameter control and data recording functions, and it is difficult to meet GMP requirements for process verification and traceability.

1. Applicable Scenarios:

• Process exploration of high-value APIs (such as ADC drugs and peptides);

• Prescription optimization and process verification in the consistency evaluation of generic drugs;

• Innovative dosage form development in universities and research institutes (such as sustained-release pellets and orodispersible films).

•Full process coverage: a single device supports key processes such as drying, granulation, and coating;

•Micro-process adaptation: fluidized air duct and atomization system designed specifically for small batches, ensuring process stability as low as 100g batches.

• Free parameter configuration: multiple sets of parameters can be set by yourself, covering variables such as temperature and injection rate;

• Real-time monitoring and traceability: built-in sensors can realize millisecond-level acquisition of key data (such as bed temperature and pressure gradient), in compliance with FDA 21 CFR Part 11 electronic record regulations;

• Cloud collaboration: optional data export function, directly connected to the LIMS system, to accelerate the transfer of knowledge from R&D to production.

• Cost optimization: micro-scale processing reduces the loss of high-value raw materials and reduces the cost of a single experiment by 70%;

• Efficiency breakthrough: module switching and parameter preset functions shorten the process development cycle;

• Compliance guarantee: fully enclosed design + SUS316L material, meeting GMP requirements for cross-contamination prevention and control and cleaning verification.