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Dosator

This Dosator is part of 3P innovation’s Pharma Equipment Discover Range, which fully replicates commercial dosator based powder dispensing, at a laboratory scale.

  • Reduce time to market and process uncertainty
  • Lower clinical sample cost

Using the Dosator, pharmaceutical powder formulations can be screened for suitability with commercial machinery. It also automatically produces representative early phase clinical supplies.

The system can be configured to replicate the full range of dosators sizes (with or without pre-compression). When compared with manual filling with spatulas, the introduction of automation into laboratory applications reduces variability and enhances product quality.

 

Dosator

Providing Flexibility

As a laboratory scale device, the Dosator fits within small fume enclosures and operates with a very small powder bed. This is critical in the early stages of formulation and process development, when active ingredients may be scarce.

The micro dosing head version is configured to present consistent powder samples in the 1mg to 5mg range. Where this Dosator offers significant advantage is through its inherent flexibility and ability to replicate commercial processes. It can fill medical devices, inhalers, capsules or blisters under controlled laboratory conditions. The system dispenses consistent samples directly into delivery units for clinical or pharmaceutical evaluation.

Further optional enhancements include provision of bulk powder feeds to remove the need for manual powder bowl top-up, and integrated weighing head for 100% recording of all dispensed sample weights.

Supporting Quality by Design

Process understanding and Quality by Design relies on reliable process data. The Dosator provides users with live charting and recording of all critical process parameters. This includes pin height, powder bed height, pre-compression force, compression force and ejection force. Dose weight is also available via an optional high-speed weigh cell.

Reducing time to market and process uncertainty

Understanding uncertainty and minimising risk early is key to reducing time to market. The Dosator ensures that scale issues are minimised by being compatible with industry standard dosating pin and tube sets. This ensures optimised product handling parameters can be developed from the outset and in the knowledge that the same parameters can then be applied to a scaled-up commercial manufacturing process.

Lowering clinical sample cost

The cost of supplying small scale clinical trials can be significant because the volumes do not justify commercial production processes. Alternatively, manual filling of capsules, blisters or tablet presses is not a cost-effective use of laboratory staff. The Dosator offers a cost-effective alternative. It can dispense powder precisely time after time, decreasing viability, lowering sample making costs and increasing the throughput of candidate drugs.

MACHINE SPECIFICATIONS

Dosing range

Up to 600mg

Dosing resolution

Powder consistency / properties dependent

Dosing accuracy

Typically, <5% RSD (Powder consistency / properties dependent)

Dosing cycle time

450 doses an hour

Electronic records

100% of dosed samples if integrated with a weigh cell.

21CRF11 option available

Full retention of all powder handling parameters as standard

Powder bowl capacity

0.8 L

(0.7 L with an optional powder cone)

Compaction

Up to 160N

Features

Live on-screen display of process parameters

Interchangeable industry standard dosator sets (size 00 – 5)

Dosing straight to powder receptacle (vial, capsule, blister or syringe)

Quantitative data collection of pin force and pin position in real time to data file

Supports

Quality by Design

Process control and understanding

Parametric tolerance interval testing

Applications

Dosing trials of development material

Evaluate powder performance under production condition within laboratory environment