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
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
The patented integrated detachment mechanism consists of a rotating die and simple lever. This allows compaction, detachment and ejection operations to be carried out with no need for awkward re-configuration.
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)
USP <1062> TABLET COMPRESSION CHARACTERISATION
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.
3 STEPS TO UNDERSTANDING HOW YOUR POWDERS WILL COMPACT
STEP 1: MAKE THE TABLETS
Make the tablets using the Gamlen D1000 or D500. Maximum compaction load for the D1000 is 1000 kg and 500 kg for the D500. The D500 is recommended for minitabs.
The Gamlen D-Series compacts tablets to a set force or thickness. It then measures the force required to detach and eject the tablets.
STEP 2: MEASURE THE TABLETS
Tablet thickness and mass are measured using a micrometer and balance.
All measurements are captured automatically by the software for faster analysis. Alternatively, the system can be configured for manual data entry to use a pre-existing balance and/or micrometer.
STEP 3: BREAK THE TABLETS
The Gamlen TTA (Tablet Tensile Analyser) measures tablet diameter and breaks the tablets to measure tablet tensile fracture stress. Values are automatically captured by the software.
All calculations take tablet size and shape into account so data can be compared across different tooling types.
UNDERSTAND YOUR POWDERS
The Gamlen Dashboard software automatically captures and analyses all data. No data entry is required during testing and the
software aids result interpretation. No compaction experience or expertise is required.
- Training time <2 hr.
- Testing time ~30 min
- Typical sample mass
required <2 g
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
Optional: Gamlen CHE or Gamlen SafeTab
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
THE GAMLEN D-SERIES GOLD DEVELOPMENT PACKAGE
Optional: Gamlen CHE or Gamlen SafeTab
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
UNDERSTANDING POWDER COMPACTION ANALYSIS
Interested in learning more?
Enjoy an insightful webinar hosted by Gamlen’s Product Director, Dr. Rebecca McVicker, where you can learn more about the science and method behind effective powder compaction analysis and see our compaction analysis suite in action.