Gamlen Development Series: D500 & D1000

The first fully automated powder compaction analysis system


21CFR11 Compliant Option


Applications

  • Generate USP <1062> compaction data
  • Assess and optimise tablet lubrication
  • Fast and effective formulation development
  • Alternative supplier evaluation
  • Process or formulation change evaluation
  • Pre-formulation studies
  • Establish API intrinsic compaction properties
  • Troubleshoot manufacturing issues
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The Gamlen D-Series range represents our most advanced powder compaction analysers. These instruments allow the user to assess compaction behaviour without any prior tableting knowledge so are ideal for both compaction novices and experts alike. Portable and easy to learn, you will be generating useful results within minutes.

The D-Series powder compaction analyzers have been designed to facilitate fully automated compaction analysis. Combine it with the Gamlen Dashboard software for the worlds first automated compaction analysis system. Automated analysis prevents data entry errors while ensuring fast, consistent analysis.

The D-Series includes an integrated detachment force measurement mechanism. Detachment force is force used to detach tablets from the lower punch during manufacture. As high detachment forces are indicative of poor lubrication, detachment data is particularly useful when investigating sticking/picking issues.

Unique integrated detachment force measurement

Key benefits

  • Gamlen Dashboard software allows for fully automated compaction analysis
  • Automatically generates all USP <1062> and lubrication data
  • Complete analysis of compaction process
  • Provides compaction, detachment and ejection profiles
  • Proven to be indicative of plant behaviour
  • Software enables users to evaluate results without prior compaction experience
  • Easy comparison of different materials/formulations
  • Quick and easy to use
  • Requires minimal bench space
  • Suitable for GMP testing
  • Minimal material required to generate useful results (typically 1.5 g)
  • Suitable for use in protected or controlled GMP environment
  • Significantly less expensive than powder compaction analysis
  • Minimal training required (typically <2hr)
  • Minimal method development – test conditions unchanged 90% of the time
  • Minimal troubleshooting and maintenance
  • Compaction speed range 0.01 to 3 mm/s
  • Available in two max. operating loads 500 kg (D500) and 1000 kg (D1000)

Generate USP <1062> tablet compression characterization data

The D-Series is designed to be used with the Gamlen Dashboard software for fully automated compaction analysis. The software automatically generates all lubrication and USP <1062> compaction data (compactibility, compressibility and tabletability).  This allows you to easily rank your formulations against all standard tablet Critical Quality Attributes prior to entering into manufacture.

Complete compaction analysis in 3 easy steps

  1. Make tablets Gamlen D500/D1000 compacts the powder, detaches the die base from the tablet (equivalent to tablet take off force) then ejects the tablet from the die
  2. Measure tablets Tablets are weighted and their dimensions (thickness and diameter) measured
  3. Break Tablets Tablets are fractured with the Gamlen TTA
  • The Gamlen D-Series Analysis Suite (Gold Development Package) automatically captures all measurement data
  • Full compaction analysis is generated with minimal user input
  • Software aids data interpretation with clearly defined problem zones
  • The manual Dashboard software requires additional data entry

Measurements

  • Compaction force/displacement
  • Detachment force/displacement
  • Ejection force/displacement
  • Tablet weight
  • Tablet thickness
  • Tablet diameter
  • Tablet breaking strength
  • Estimated true density value required

Calculations

  • Compaction pressure
  • Detachment stress
  • Ejection stress
  • Tablet tensile strength
  • Tablet solid fraction
  • Tablet volume
  • Tablet density
  • Tablet elastic recovery
  • G ratio

Data Displayed

  • Compressibility
  • Tabletability
  • Compactibility
  • Detachment stress profile
  • Ejection stress profile
  • Sawai Plot
  • Elastic Recovery profile
  • G ratio profile

Gamlen D-Series packages

The Gamlen D-Series Bronze Development Package

  • Gamlen D500 or D1000

  • Manual Dashboard Software

  • GamPette Powder Dispenser

  • Gamlen Tablet Tensile Analyser (TTA)

  • Automated Micrometer

  • Automated Balance or Interface for Existing Balance

Key benefits

  • Ideally suited to users with some experience of compaction analysis
  • Data capture is not automated
  • Tablet hardness tester required
  • Generate USP <1062> data
  • Measure detachment and ejection stress
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The Gamlen D-Series Silver Development Package

  • Gamlen D500 or D1000

  • Manual Dashboard Software

  • GamPette Powder Dispenser

  • Gamlen Tablet Tensile Analyser (TTA)

  • Automated Micrometer

  • Automated Balance or Interface for Existing Balance

Key benefits

  • Avoid time consuming powder weighing
  • All the benefits of the bronze package with the addition of a GamPette precision powder pipette
  • GamPette typically dispenses powder with ±2% accuracy or better
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The Gamlen D-Series Gold Development Package

  • Gamlen D500 or D1000

  • Automated Dashboard Software

  • GamPette Powder Dispenser

  • Gamlen Tablet Tensile Analyser (TTA)

  • Automated Micrometer

  • Automated Balance or Interface for Existing Balance

Key benefits

  • Fast, fully automated compaction analysis
  • Suited to compaction experts and novices
  • Full USP <1062> and lubrication data
  • Software aids data interpretation
  • Requires minimal user input
Contact us for a quote