Injectable Powder Dosing System
Introducing MicroDose- The complete aseptic processing for injectable Powder Dosing, stopping, and Capping with production speed up to 200 units per minute. It can be connected to the upstream washing and depyrogenation tunnel.
Features
- Full Servo Driven with Rapid changeover and minimum change part.
- Linear intermittent motion. Vials are gently transported via parallel grippers without knocking each other.
- Micro Auger Dosing technology, dosing volume can be fast and repeatability adjusted via HMI.
- 15* IPC HMI Comply to FDA 21 CFR PART 11.
- Barrier System in LAF or RABS.
- 100% weight IPC with full speed. (Optional)
- N2 gas flushing before and after. (Optional)
- Media Fill (Optional)
- Vial Loading via Turn Table via turn table. Gently pitched out by Servo Pitcher to the main indexer with full servo Electronic CAM speed synchronization.
- Main Indexer by Parallel V Grip design to securely grip and transfer the vial. No change part is requited for this main indexer plate. Changing different vial diameters or heights is programmable in the Recipe.
- Dosing system by SUS316L Precision Micro Auger driven by Servo, dosing range is wide without change part.
- A single-hopper design with multiple dosing nozzles facilitates powder handling and requires fewer parts to clean. The Vial is lifted into the dosing nozzle to ensure minimum dust is created for hygiene dosing.
- 2 Axis Robot to pick & place the stopper with the help of a vacuum.
- No vial, No Stopper.
- Stopper missing detection & auto rection are in place as standard.
- Capping Stations are partitioned from a dosing area with differential pressure for better sterility.
- Cap Sealing Depth by programmable Pilfer Roller.
- Good Vials will be unloaded to the downstream conveyor via a vacuum star wheel.
Software & Digitalization
- 15″ IPC intuitive design HMI
- Comply to FDA 21 CFR Part 11
- Electronic Batch Record
- Non-Editable Audit Trial
- Recipes
- OEE Dashboard Visualization
Machine Specification
| HFSA 60 |
HFSA 120 |
HFSA 180 |
HFSA 250 |
|
|---|---|---|---|---|
| Speed (upm) |
50 | 100 | 150 | 200 |
| Dosing Range | 0.1gm-5gm | |||
| Container | 6R-50R | |||
| Voltage | 380V-415V, 50Hz | |||
| Air | 6 Bar | |||
Precision Mirco Auger Driven By Fully Servo Motor System
Parallel V - Grip Design Sercurely Grip And Transfer Vial
Cap Sealing Depth By Programmable Pilfer Roller
Vials Are Gently Pitched Out By Servo Motor Electrical CAM Speed Synchronization
IPC Intuitive design HMI & Comply FDA 21 CFR Part 11
GMP Design, Screwless Table Top
Capping Station Partitioned From Dosing Area With Differential Pressure For Better Sterility
Auto Reject And Verification Features
Rubber Stopper Auto Missing Detection & Auto Rejection
Changing Different Vial Diameter Or Height Via Programable In Recipe
Vial Unload To Downstream Conveyor Via Vaccum Starwheel
Smooth Sorting Via SUS 316L Vibrator Sorting Bowl
Reduce Noise Via SUS 316L Vibrator Sorting Bowl
Cap Rail
Aseptic Powder Canister
Machine Layout
Frequently Asked Questions (FAQs)
How does the machine ensure precise and repeatable dosing for injectable powder to meet stringent fill accuracy demands?
The machine uses a precision micro-auger dosing system driven by a full servo motor equipped with 100% IPC weight check. The dosing volume can be adjusted via HMI and repeatability is maintained at full speed.
How does the system support rapid change-over between vial sizes or container types, to reduce downtime and increase flexibility?
This system features full servo motion with “Rapid changeover and minimum change part.” The main indexer uses a “Parallel V-Grip design” that can handle different vial diameters or heights via programmable recipes — no mechanical change parts required for differing sizes.
What sterility and containment / aseptic processing features are incorporated to satisfy injectable manufacturing requirements?
Key features include a barrier system (LAF or RABS) for aseptic environment, nitrogen -gas flushing before and after dosing (optional).
How does the machine support data integrity, digitalization and compliance with regulatory requirements such as FDA 21 CFR Part 11?
The machine includes a 15″ IPC (industrial PC) HMI with features such as electronic batch record (EBR), non-editable audit trail, recipe management, OEE dashboard visualisation — all compliant with FDA 21 CFR Part 11.
How does the design of the powder handling and vial transport minimize dust generation, cross-contamination and product waste?
The machine uses a single-hopper design with multiple dosing nozzles to reduce parts to clean. The vial is lifted into the dosing nozzle (rather than dosing the powder in) to ensure minimum dust creation. Vials are gently transported via parallel grippers for next station.
