Project Overview
Motionwell Automation designed and built GMP-grade filling and sealing machines (Projects P23005, P25026) for pharmaceutical manufacturers in Singapore. The machines handle liquid product filling with servo-driven volumetric accuracy and automated sealing with rotary capping heads.
GMP-Compliant Design
Material Specification
The machine frame and all product-contact components are fabricated from SUS316L stainless steel (1.4404 grade) with electropolished surfaces to Ra 0.4um or better. Non-contact structural members use SUS304 to manage material cost while maintaining corrosion resistance in washdown environments:
- All welds ground flush and passivated per ASME BPE standards for pharmaceutical equipment
- Garlock Gylon 3545 PTFE gaskets and Parker E-series EPDM O-rings at all product-contact sealing surfaces, both FDA 21 CFR 177.2600 compliant
- Clean-in-place (CIP) compatible design with spray ball ports at all dead legs and drain points sloped at minimum 3 degrees
Filling System
The filling stations use Festo EMMS-AS servo motors driving ceramic-lined piston pumps for volumetric dispensing. Each fill head operates independently, allowing per-nozzle volume calibration:
- Filling accuracy within +/-0.5% of target volume across the 5ml to 500ml range
- 8-head rotary filling configuration achieving 120 bottles per minute at 100ml fill volume
- Keyence FD-Q series flow sensors provide real-time fill volume verification as a secondary check
- No-bottle-no-fill detection using Omron E3Z retroreflective sensors at each fill position
- Anti-drip nozzles with pneumatic shut-off valves and suck-back function to prevent product stringing
Sealing System
The sealing section handles both ROPP (roll-on pilfer-proof) aluminum caps and screw-on plastic closures via quick-change capping chuck assemblies:
- Rotary capping heads driven by Mitsubishi HG-KR servo motors with torque feedback
- Programmable torque range from 0.5Nm to 5.0Nm with real-time torque curve logging
- Cap presence verified by Keyence IL-600 laser displacement sensor measuring cap height
- Automated reject station with pneumatic pusher directing improperly sealed containers to a quarantine bin
Serialization Integration
The line integrates with Cognex DataMan 370 fixed-mount readers and Domino Gx150i thermal inkjet printers for track-and-trace serialization compliant with Singapore HSA and EU FMD requirements:
- 2D DataMatrix code printing and verification at up to 150 units per minute
- Aggregation data logged to a Level 3 serialization server for parent-child relationship tracking
- Reject mechanism with Festo DSBC pneumatic cylinders for unreadable or duplicate codes
GMP Validation
Motionwell provides full IQ/OQ/PQ (Installation Qualification, Operational Qualification, Performance Qualification) documentation packages as part of the machine delivery. Factory acceptance testing (FAT) is conducted at Motionwell’s facility in Singapore prior to shipment, followed by site acceptance testing (SAT) at the customer’s cleanroom. All validation protocols follow ISPE Baseline Guide Vol. 5 for commissioning and qualification.
Technical Details
Material and Surface Finish Specification
All product-contact surfaces are fabricated from SUS304 or SUS316 stainless steel with electro-polished finishes achieving Ra <= 0.8um (surface roughness). The electro-polishing process removes the outer molecular layer of the stainless steel, creating a smooth, passive chromium-oxide surface that resists product adhesion, bacterial colonization, and corrosion from acidic or alkaline cleaning agents.
Non-contact structural components use SUS304 to balance corrosion resistance with material cost. All welds on product-contact surfaces are ground flush and passivated to match the surrounding surface finish, eliminating crevices where product residue could accumulate.
The machine enclosure is rated IP65 (dust-tight, protected against water jets from any direction), ensuring that washdown cleaning procedures do not compromise electrical components or control systems within the enclosure.
Filling System Performance
The filling stations deliver precise volumetric dispensing across a wide range:
| Parameter | Specification |
|---|---|
| Filling range | 0.1 mL to 50 mL |
| Filling accuracy | +/-0.5% of target volume |
| Configuration | Triple-head parallel filling |
| Anti-drip | Vacuum suck-back on each nozzle |
The triple-head parallel filling configuration processes three containers simultaneously per filling cycle, tripling throughput compared to single-head systems at the same cycle rate. Each fill head operates independently with its own servo motor and piston pump, allowing per-nozzle volume calibration to compensate for manufacturing tolerances between pump assemblies.
The vacuum suck-back system activates at the end of each fill stroke, creating a brief negative pressure at the nozzle tip that retracts the last drop of product back into the nozzle bore. This eliminates product dripping between fill cycles, which would otherwise cause underfilling, container exterior contamination, and cleaning burden on downstream stations.
Machine Footprint and Capacity
The complete filling and sealing machine occupies a footprint of approximately 3m (length) x 1m (width) x 2m (height), making it suitable for integration into existing cleanroom production lines where floor space is constrained. The compact footprint is achieved through vertical stacking of the filling mechanism above the container transport level and side-mounting of the pneumatic and electrical control cabinets.
The tray-based input system accommodates 500 to 1,000 pieces per tray load, depending on container size. Tray changeover is tool-free using quick-change nest plates, enabling the machine to switch between different container formats in under 5 minutes.
Inline Vision Inspection
An inline vision inspection station positioned downstream of the sealing station performs two critical quality checks on every container:
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Fill level verification: A side-view camera measures the liquid meniscus height through the transparent or translucent container wall. The vision system calculates the actual fill volume from the meniscus position using a calibrated height-to-volume lookup table specific to each container geometry. Containers with fill levels outside the programmed tolerance band are automatically rejected.
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Seal integrity inspection: A top-view camera inspects the sealed cap or closure for proper torque indicators (tamper band engagement, pilfer ring separation), cap presence, cap skew angle, and visible defects such as cross-threading or incomplete sealing. The vision algorithm checks multiple inspection criteria simultaneously and assigns a composite pass/fail result.
Rejected containers are diverted to a quarantine bin by a pneumatic pusher downstream of the vision station. Rejection data (container serial number, rejection reason, inspection image) is logged for quality review and SPC analysis.
Related
This project showcases Motionwell’s custom machine design and machine vision inspection expertise for the pharmaceutical & packaging industry.