Automatic Eye/Ear Drop Filling Line
Description
An Eye/Ear Drop Filling Line is an integrated system designed for washing, filling, inner plug inserting, capping, and labeling small-volume bottles (typically 5ml to 30ml) used for ophthalmic and optic pharmaceutical formulations. It is built to comply with cGMP, WHO, and US FDA standards, ensuring aseptic operations in sterile environments (Class 100/ISO 5 at filling area).
Features of Automatic Eye/Ear Drop Filling Line
- Complete washing, filling, plugging, capping, and labeling line for ophthalmic/otic solutions.
- Peristaltic filling technology ensures sterility and easy changeover.
- HEPA-filtered laminar airflow in critical areas.
- Quick changeover for different bottle sizes and closures.
- Optional integration with visual inspection, track-and-trace, and carton packing systems.
Automatic Eye/Ear Drop Filling Line Technical Specification
Bottle Washing Unit
| Speed: | 20 – 100 bottles/min (customizable) |
|---|---|
| Bottle Range: | 5 ml to 30 ml (HDPE/LDPE bottles) |
| Washing Media: | WFI (Water for Injection), sterile compressed air |
| Construction: | SS316L (contact parts), SS304 (non-contact parts) |
| 0.2-micron filtration for water & air | |
Bottle Unscrambler
| Speed: | upto 150 per minute |
|---|---|
| Bottle size : | 5ml to 100ml |
Sterile Liquid Filling, Plugging & Capping Machine (Eye/Ear Drop Filling & Capping Machine)
| Speed: | 20 – 100 bottles/min (depending on no. of heads) |
|---|---|
| Filling Range: | 2 ml to 30 ml |
| Filling System: | Peristaltic Pump (ideal for sterile liquids with CIP/SIP) |
| Servo-driven Piston Pump (for viscous liquids) | |
| Filling Accuracy: | ±0.5% |
| Plugging: | Automatic insertion of dropper plugs or inserts |
| Class 100 (ISO 5) laminar airflow at filling zone | |
| No bottle – no fill, no plug – no cap | |
| Optional nitrogen purging before & after filling | |
| Inline capping | |
| Speed: | Matches filling speed (20 – 100 BPM) |
| Cap Types: | Screw caps, pilfer-proof caps, CRC (child-resistant) caps |
| Torque Control: | Adjustable (servo/mechanical) |
| No bottle – no cap | |
| In-line rejection of improperly sealed caps | |
Labeling Machine
| Type: | Automatic self-adhesive wrap-around labeling (round bottles) |
|---|---|
| Speed: | Matches filling speed (up to 100 BPM) |
| Label Accuracy: | ±1 mm |
| Online batch coding (inkjet/thermal printer) | |
| Label presence detection and rejection system | |
Control & Compliance
| Automation: | PLC-based with HMI control panel |
|---|---|
| Data Compliance: | 21 CFR Part 11-ready (electronic records) |
| Validation: | Supports DQ, IQ, OQ, PQ protocols |
| Compliance: | cGMP, GAMP 5, US FDA, WHO |
Utilities Required
| Power Supply: | 415V, 3 Phase, 50/60Hz |
|---|---|
| Compressed Air: | 6 bar, dry, oil-free |
| WFI Supply: | For washing stations |
| Cleanroom Environment: | ISO 5 (Class 100) at filling, ISO 7/8 in surrounding areas |
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