Gamlen – INOS

Gamlen Manufacturer Series | M500 | M1000

admin — Thu, 15 Feb 2024 03:46:43 +0000

The Gamlen M-SERIES Packages : A portable benchtop tablet press for the small scale manufacture of custom tablets

Application

Clinical trial and phase 1 product manufacture
Manufacture of test product batches
Formulation comparisons
Excipient compatibility studies
Generation of USP <1062> data

Quickly manufacture small batches of tablets under tightly controlled conditions

Unique Benefits Include:

Suitable for GMP manufacture
Works straight out of the box
Plug-in and go
Quick and easy to use
Can be used with tiny amounts of material (doses <10 mg possible)
No training required
Very low wastage rates, typically <1%
Requires minimal bench top space
Inexpensive
Easily used in a controlled or protected GMP environments

Using the Gamlen M series you will be able to:

Reliably manufacture high quality tablets
Quickly compare formulations
Control compaction force and speed
Investigate tableting problems
Assess final formulations prior to entering production
Improve tablet manufacturing processes
Measure tablet hardness
Save time, money and materials

Performance

Push button operated
Approx. 100-180 tablets/hour
Easily re-configured for hardness testing
Two speed settings: 1 mm/s and 4 mm/s
Available with two maximum operating loads: 500 and 1000 kg
M500 (500 kg) is ideal for mini tabs

The Gamlen M-SERIES Packages

The Gamlen M-SERIES Basic Manufacturing Packages
Gamlen M500 or M1000
Key Benefits
Ideal for fast, small scale tablet manufacture.
M500 is recommended for mintabs
Gamlen SafeTab for handling OEL 4/5 materials

The Gamlen M-SERIES Manufacturing Packages
Gamlen M500 or M1000
GamPette Powder Dispenser
Key Benefits
Ideal for fast, small scale tablet manufacture.
M500 is recommended for mintabs
GamPette typically dispenses powder with ±2% accuracy or better
Avoid time consuming powder weighing
Gamlen SafeTab for handling OEL 4/5 materials

The Gamlen M-SERIES GMP in a Box Package

Gamlen M500 or M1000
GamPette Powder Dispenser
Gamlen CHE (Controlled Humidity Environment)
Key Benefits
Ideal for small scale manufacture where controlled environmental conditions are required
Gamlen CHE provides humidity control from 0-98% relative humidty
M500 is recommended for mintabs
GamPette typically dispenses powder with ±2% accuracy or better

For more information Contact Us

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Automated Powder Compaction Analysis System | D500 & D1000

admin — Fri, 09 Feb 2024 03:45:36 +0000

The first fully automated powder compaction analysis system developed by GAMLEN. The Development Series: D500 & D1000.

The Gamlen D series includes the Gamlen Powder Compaction Analyzer and Tablet Tensile Analyzer (TTA).

21CFR11 Compliant Option

Application

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.

Find The GAMLEN D-SERIES Package That’s Right for You

For more information Contact Us

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