ANALIS- Data Acquisition, Control and Reporting System for Tabletting

Product – MEDELPHARM S.A.S
ANALIS- Data Acquisition, Control and Reporting System for Tabletting

MEDELPHARM Logo

Contact Supplier: MEDELPHARM S.A.S
Supplier Product: ANALIS- Data Acquisition, Control and Reporting System for Tabletting
Address: 12, rue des Petites Combes, Z.I. Nord, F-01700 Beynost, France
Tel: +33 478 976 213
Fax: +33 478 881 865
Website: www.medelpharm.com

ANALIS- Data Acquisition, Control and Reporting System for Tabletting

Analis

MEDELPHARM’s continuous search for innovation in powder compression and expertise in engineering applied to tablet presses has allowed us to develop advanced proprietary software to streamline Research and Development processes.

ANALIS software is optimised for use on MEDELPHARM STYL’ONE systems but can also be used with other tablet presses.

Either way, ANALIS let you use standard reporting parameters like Heckel, force hardness and others to create detailed individual analyses, working with single data points during a compression cycle or exploiting average values during batch production.

ANALIS Software comes in three complementary modules:
1. ANALIS Advanced: add two new dimensions to STYL’One Classic and Evolution machines
2. ANALIS Multilayer: upgrade STYL’One Classic and Evolution into multilayer machines
3. ANALIS GMP Production: enhanced control over clinical batches in GMP

Force Hardness

ANALIS Advanced Module
The ANALIS Advanced Module effectively turns your press into the world’s first ‘tableting robot’.

The Advanced Module adds two new dimensions to your STYL’One press:
• Full automation of research and reporting
• Ability to modify compression profiles to create an optimised individual profile

Automated Tableting Research
The STYL’One has been designed to automate your tableting research, and to explore the Research space autonomously. You simply define your design space boundaries, and then let ANALIS work and acquire data for you. Your time is free to concentrate on the interpretation and analysis.

STYL’One presses come as standard with predefined profiles optimised for the Pharma/R&D world such as saw tooth, long dwell time, and pre-main compression. The STYL’One Evolution even comes with predefined profiles simulating particular production presses (KILIAN Synthesis 500, FETTE 2090, KORSCH X400, etc.)

The advanced module allows you to use ‘blue sky’ thinking in designing completely new compression profiles to investigate (i.e. slow compression ramp up and fast decompression; multiple pre-compression, etc.). The only limit on profiles to explore is your imagination.

Heckel

Optimised Tablet Press Behaviour
If you want to test a new idea or verify some theory, the software lets you program the compression behaviour to meet your requirement.

You can extend the feeding time for badly flowing powder; perform five compressions in a row to measure in die elastic recovery; try a long, slow pre-compression coupled with very fast main compression, etc. Again, there is no limit to your creativity in optimizing production profiles.

ANALIS Multilayer Module
The ANALIS Multilayer module converts your STYL’One into a multilayer and tab in tab machine.

This allows you to produce multilayer tablets, incorporating up to five layers with three active pharmaceutical ingredients (APIs) manually or automatically. You can create these as easily as single tablets now. This software module also opens up core coating possibilities.

Hand feed can be used to produce limited pre-production samples. Once the profile is proved, simply fit the necessary feed shoes and go into continuous production.

Instant Multi-Layer
The multi-layer option allows you to fill, dose and tamp up to five layers with three APIs. Rapid final compression allows you to test the layer adhesion. Setting up the parameters uses only one tablet per layer, minimizing powder consumption to create rapidly small batches of multilayered tablets.

The feed shoes can be paddle forced feed, gravity systems or combined.

Easy to use Tab in Tab
ANALIS makes it easier than ever before to carry out Multilayer Testing and dry coating at lab scale.

You can switch to creating dry coated tablets simply by adding a special “kernel feeder” inside the enclosure.

You can also switch easily between multiple test regimes: comparisons on different format behaviour, capping tendencies or kernels’ resistance to compression and many more.

ANALIS GMP Production Module
Should you need to create a clinical batch in GMP conditions, the ANALIS GMP Production module is equivalent to having an accredited inspector on the team.

Combine Flexibility with Assurance
Built on SQL database the software rigorously controls and track your production, leaving no room for untracked parameter changes.

Fully CFR Part 11 compliant, this module allows you to perform GAMP 5 certification should you wish to do so.

R&D users retain full flexibility while production can be rigidly programmed to ensure compliance, with no chance of unauthorized or accidental tampering.

Weight Regulation and Tablet Reject
The optional good and bad tablet chutes can be used in R&D to sample only a few tablets or in some specific mode.

Coupled with the weight regulation of the production module, the chute selects only tablets that are within specification, while the software allows you to manage T1/T2 selection and to correct tablet filling accordingly.

Multiple options
One option available is a “viewer license” which allows you to view, edit, analyse your data away from the press, and always with the same ease of use.

Another option allows you to connect your STYL’One to a measurement chain in order to input your data directly without errors. Most major brands are supported.

Benefits
ANALIS software delivers the following benefits:
• Enhanced machine control
• Data capture and analysis
• User friendly interface
• Tested and optimised on MEDELPHARM machinery
• Versatile and flexible
• Adds value to your total system
• Provide new lease of life to legacy single presses
• Set and forget ‘coffee mode’
• Open source development to run on industry standard hardware (e.g. National Instruments)
• Export data to other software packages
• In-house development by MEDELPHARM for expert support

For more information on the ANALIS software and how it can benefit you and streamline your research and production processes, please contact MEDELPHARM directly.

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