THE sealability and isolation policies comply with current regulations and requirements
It has the fully enclosed filling chamber with minimum leakage risk.
The HMI centralized visual interface is used to control the filling machine, and the well-sealed auxiliary machines and BIBO utilities are provided, which conform to the requirements of 21CFR PART11.
The all-round integrated solution ensures that materials and capsules flow in sequence, there is no dead corners for cleaning, and the high sealability is still kept even in case of emergency power outage, and stop of compressed air.
The equipment door is sealed and protected by four inflatable sealing strips.
A glove compartment is installed on the safety door to facilitate the operator to complete the operation without touching hazardous materials.
A cleaning nozzle is installed inside the chamber to allow the operator to perform an initial flush through the glove compartment before opening the safety door.
The domestic well-known brands are provided for the indexing box, featuring the high precision, good equipment stability, and long life.
All cams adopt the most advanced curve trajectory in the world, full CNC machining, high precision, smooth operation, having a certain effect on the loading accuracy.
The modular design is provided to facilitate the disassembly, cleaning and installation.
The mold is 100% interchangeable.
Yield: It is no less than 99% (the yield is related to batch quantity and material properties).
The whole machine conforms to GMP production requirements.
The filling accuracy (empty particles) : Drug powder: ≤3%; Mini-pill: ≤3%;
Liquid (anhydrous ethanol, 5μL (equal to 4mg)) : ≤5%
