High-Precision, Ultra-Compact Monoblock Solution for Clinical Trials, R&D Laboratories, Pilot Plant Production, and Small-Batch Bio-Pharmaceuticals

In research laboratories, pharmaceutical pilot plants, and clinical trial production, filling liquid vials requires maximum dosing precision, minimal dead-volume, and strict sterility compliance. The Harsiddh Pilot Scale Vial Filling Machine For R&D is an advanced, ultra-compact monoblock unit engineered specifically for handling small-to-medium research batches. Combining high-accuracy liquid dosing with automatic rubber stoppering on a unified rotary indexing platform, this machine bridges the gap between laboratory scale development and commercial-scale production without wasting high-value Active Pharmaceutical Ingredients (APIs).

High-Performance Engineering for R&D & Clinical Trial Batches

When working with high-cost active ingredients, monoclonal antibodies, diagnostic reagents, or experimental vaccines, traditional large-scale filling lines introduce excessive product hold-up volume and setup friction. The Pilot Scale Vial Filling Machine For R&D solves these challenges by providing a tightly controlled, highly repeatable packaging sequence on a single benchtop-friendly platform.

By positioning liquid filling nozzles and the automated rubber stoppering mechanism in close sequence, open vial exposure time is reduced to a minimum, preserving product integrity under sterile airflow.

Step-by-Step Operational Workflow & Technical Anatomy

[ In-Feed Rotary Starwheel ] → [ High-Precision Liquid Dosing ] → [ Automated Stopper Placement ] → [ Discharge Tray ]

1. In-Feed & Starwheel Indexing

Sterile glass or plastic vials are loaded onto the starwheel index wheel via the in-feed tray. The custom-machined starwheel captures each vial smoothly, moving it through filling and stoppering stations without glass-to-glass friction or risk of tipping.

2. High-Precision Liquid Dosing

The machine executes bottom-up filling using sub-surface diving nozzles to eliminate air entrapment, splashing, and foaming.

• Peristaltic Pump Configuration: Uses single-use, pre-sterilized silicone or platinum-cured tubing, ensuring the liquid never touches mechanical pump parts—ideal for biologics, protein solutions, and cell therapies.
• Volumetric Piston Pump Configuration: Mirror-polished SS 316L syringes offer high repeatability for standard liquid injectables.

3. Automated Vibratory Rubber Stoppering

Rubber stoppers are sorted via an integrated overhead vibratory bowl feeder and delivered down a precision chute. A synchronized pick-and-place mechanism inserts the stopper firmly into the vial neck immediately after dispensing.

4. Controlled Outfeed Collection

Finished vials are smoothly guided out of the starwheel onto an outfeed collection tray, ready for downstream crimp capping or inspection.

Salient Features

• Zero-Dead-Leg Fluid Pathway: Fluid contact parts feature sanitary tri-clamp fittings and polished SS 316L for rapid Cleaning-in-Place (CIP) or manual autoclaving.
• Fast Tool-Less Changeover: Change parts for different vial sizes (e.g., 2 ml, 5 ml, 10 ml, 20 ml, 30 ml) can be swapped out in under 15 minutes without specialized tools.
• Drip-Free Nozzle Cutoff: Positively driven diving nozzles ensure clean liquid cutoff, maintaining pristine vial neck surfaces for secure rubber seating.
• Variable Speed Control: AC variable drive allows effortless speed tuning based on batch size and fluid viscosity.
• Safety & Interlocks: Integrated front panel emergency stop button and transparent acrylic safety shields ensure safe laboratory operation.

Technical Specifications

Feature / Parameter	Specification
Model	HS-PVFM-RD (Pilot Scale Series)
Production Capacity	15 to 40 Vials / Minute (Depending on fill volume & operator feeding)
Filling Range	0.5 ml to 50 ml (Customizable based on pump selection)
Filling Accuracy	±0.5% to ±1%
Dosing Mechanism	Peristaltic Pump System or SS 316L Volumetric Syringes
Applicable Containers	Tubular / Molded Glass Vials & Plastic Vials
Stopper Types	Rubber Stoppers (Full Stoppering or Partial Lyophilization Stoppering)
Contact Parts Material	Stainless Steel 316L / Single-Use Silicone Tubing
Non-Contact Frame	Stainless Steel 304
Control System	PLC Controlled with Color HMI Touchscreen
Power Supply	220V, Single-Phase / 3-Phase, 50/60 Hz
Air Consumption	2 to 4 CFM @ 6 Bar Pressure
Compliance	cGMP, WHO, US-FDA Standards

Benefits of the R&D Monoblock Solution

• Minimal Product Waste: Micro-dosing capability ensures maximum yield from expensive APIs and limited experimental batches.
• Cleanroom Space Optimization: Ultra-compact footprint allows seamless integration into Grade A / Class 100 cleanrooms and LAF hoods.
• Seamless Scalability: Parameters established on this R&D pilot line easily scale to Harsiddh’s higher-speed commercial 2-head, 4-head, and 6-head filling machines.
• Full Regulatory Validation Support: Provided with complete DQ, IQ, OQ, and PQ documentation packages for laboratory and clinical compliance audits.

Frequently Asked Questions