In-process Control MF 1. Maximum Reliability in Tablet Production. In-process Control.

Transcription

1 In-process Control MF 1 Maximum Reliability in Tablet Production In-process Control

2 Checkmaster The quality requirements for tablet production are constantly increasing. Process equipment from Fette Compacting ensures that your production fully complies with the applicable regulations and effectively reduces the workload of your staff. Extensive automation of all process steps reduces manual intervention and provides for excellent tablet quality. Your advantages: maximum reliability, the highest quality and efficiency in tablet production. The Checkmaster makes the automated measurement of the most important tablet parameters possible: weight, thickness, hardness and diameter and completely integrates them into the in-process control concept of Fette Compacting tablet presses. Features BENEFIT + Fully automatic measurement of the four quality critical parameters: weight, hardness, thickness, diameter + Automatic feedback to Fette Compacting tablet weight control loop on the tablet press (optional: hardness control loop) + Precise control of tablet parameters within freely adjustable warning and stop limits + Documented tablet inspection results in your batch report + 21 CFR Part11 compliant operation via the operator and password management on the Fette Compacting HMI (Human Machine Interface) + GMP-compliant design + Frequent sampling for seamless batch documentation, elimination of manual laboratory tests + Easy to clean, rapid availability after a product changeover + Guided validation and calibration process + Extremely accurate and reliable weight monitoring + All common formats can be tested in standard configuration, customized star-wheels for non-standard formats available TECHNOLOGY covers all products in the tableting technology; from tablet presses, to process equipment and tableting tools. SERVICE includes all services related to machinery and equipment, such as: spare parts supply, installation, system upgrades and technical field service. COMPETENCE is the generic term for our process-related services. This includes our training programs and compression trials, as well as application and OEE consulting, and engineering.

3 In-process Control 2 3 Technical data Measurement Thickness tester Hardness tester Diameter tester Weight unit Measurement method Linear potentiometer Pressure Load Cell (DMS) Pressure Load Cell (DMS) Precision weighing cell Sartorius WZ64S Measuring unit mm or inch N mm or inch 1 mg / 0,5 mg / 0,1 mg (adjustable) Measuring range 1 17 mm N or N 3 18 mm (3 30 mm manuell) Measuring accuracy ± 0,1 mm ± 2 N (800 N ± 4 N, 50 N ± 0,2 N) 10 mg 50 g ± 1 mg in stable environment, ± 2 mg in unstable environment Dimensions W D H Weight Power supply cm 40 kg V, 50/60 Hz

4 AIO Checkmaster The flexible and modular Tablet Testing System AIO measures the weight, thickness, diameter and hardness of tablets. Features BENEFIT + Dust tight industrial design stainless steel housing + Plug-and-Play connection on the AIO deduster + Fully automatic operation or manual mode + Control with or without Fette Compacting HMI + New weighing cell less sensitive to the prodution environment + Easy validation, calibration and cleaning + Round, oval, square and rectangual shapes can be tested + No cable connection necassary Technical data Measurement Thickness tester Hardness tester Diameter tester Weight unit Measurement method Linear Potentiometer Pressure Load Cell (DMS) Pressure Load Cell (DMS) Precision weighing cell Sartorius WZ64S Measuring unit mm or inch N mm or inch 1 mg / 0,5 mg / 0,1 mg (adjustable) Measuring range 1 17 mm N or N 3 18 mm (3 30 mm manual) 10 mg 50 g Measuring accuracy ± 0,1 mm ± 2 N (800 N ± 4 N, 50 N ± 0,2 N) ± 1 mg in stable environment, ± 2 mg in unstable environment Dimensions cm (W D H) Weight Power supply 40 kg V, 50/60 Hz

5 In-process Control 4 5 Weightmaster Cost-optimized process equipment for in-process control of tablet weight. Features BENEFIT + Fully automatic measurement of tablet weight + Automatic feedback to Fette Compacting tablet weight control loop on the tablet press + Precise control of tablet parameters within freely adjustable warning and stop limits + Documented tablet inspection results in your batch report + 21 CFR Part11 compliant operation via the operator and password management on the Fette Compacting HMI (Human Machine Interface) + GMP-compliant design + Frequent sampling for seamless batch documentation, elimination of manual laboratory tests + Easy to clean, rapid availability after a product changeover + Guided validation and calibration process + Extremely accurate and reliable weight monitoring + All common formats can be tested in standard configuration, customized star-wheels for non-standard formats available Technical data Measurement method Gauge accuracy Measuring accuracy Measuring range Weight Power supply Precision weighing cell Sartorius WZ64S 1 mg / 0,5 mg / 0,1 mg (adjustable) ± 1 mg in stable environment ± 2 mg in unstable environment 10 mg 50 g 20 kg V, 50/60 Hz

6 AutoTest 4 with EasyTouch TM Tablet testing system that can fully be validated and automatically positions the tablet for measurement of weight, thickness, diameter and hardness Integrated Touch-Screen The AutoTest 4 comes standard with an integrated touch screen (EasyTouch ). Main features + Measeurements are displayed during the test + Menu guided calibration/validation incl. printing of reports + Tests can fully automatically by the tablet press or be started manually on the panel + Stand-alone tests can be activated on demand + Login function (three authorization levels): can completely disabled if CFR 21 Part 11 compliant control via Fette Compacting HMI + Printing of reports via USB or Ethernet LAN (PostScript) + Configuration of test reports BENEFIT + Automatic measuring of 4 physical parameters + Reliable handling of all tablet shapes + Full integration with tablet press for self-regulation + Stand-alone operation incl. printing of reports + Reliable tablet orientation + Stand-alone tests, can be added on request: Single Test: Quick measurement of a tablet Easy Test: Measurement of several tablets by simply entering the number of specimens Full Test: Measurement of several tablets using of programmed products (up to 100 products can be programmed) Technical data Measurement Weight Thickness Hardness Diameter Measuring range 0,1 mg 100 g 0 15 mm Standard: up to 400 N Optional: 50 N, 500 N, 800 N 0 25 mm Resolution 0,1 mg 0,01 mm 1 N 0,01 mm Power supply EU-Standard 230 V / 50 Hz US-Standard 115 V / 60 Hz

7 In-process Control 6 7 NIR-Checkmaster NIR analysis of tablets can significantly cut release times. This technology is the lever to significantly shorten time and costs on the batch release procedures. Features + Shorten Release times + Fully automatic measurement of the critical parameters during the production + Its regular use obviates the need for separate release analyses by understanding and controlling the tableting procedure in the way the FDA wants + The patented NIRCAL-Software enables a robust and extremely precise calibration BENEFIT + Higher process reliability, test cycles on production process and quality specifications + Reduction of production time and costs + Shorter release times (Real-Time-Release) + Precise positioning for reproducible results Technical data* Interferometer type (NIR-Unit) Detector type Polarization interferometer InGaAs, fitted with thermost Spectral range cm -1 (recommended cm -1 ), bzw nm (recommended nm) Resolution Dynamic photometric range 8 cm -1 (Boxcar-apodization) 0 6 AU Wave number accuracy ± 0,2 cm -1 Typical signal-noise ratio (Rms for spectral segments of 300 cm -1 in range between cm -1 ) Lamp type Laser type open beam: mean value: 2 10 (-5) AU measured with 5 mm spectralon: (-5) AU Tungsten-halogen with h working life (double lamp module) HeNe * For the NIR Checkmaster the same technical data as for the Checkmaster apply.

8 E Fette Compacting Gmbh Grabauer Strasse Schwarzenbek Germany Phone Fax tablet@fette-compacting.com Fette Compacting america, Inc. 400 Forge Way Rockaway N.J USA Phone Fax sales@fetteamerica.com Fette Compacting america latina ltda. Av. Cambacica, 1200 módulo 10 Parque Imperador CEP Campinas / SP Brazil Phone/Fax contato@fette-compacting.com.br Fette Compacting Mexico, sa de CV Adolfo Prieto No Colonia Del Valle Sur Mexico, DF Mexico Phone tablet@fette-compacting.com Fette (Nanjing) Compacting Machinery Co., ltd. 8 Phoenix Road Jiangning Development Zone Nanjing China Phone Fax fcn@fette-compacting.com Fette Compacting Machinery India Private limited Sales Office A-301/302, Citi Point Co-op Society Premises Andheri-Kurla Road, J.B Nagar Andheri East, Mumbai Phone sales@fette-compacting.in Competence Centre: Plot No S 115, Phase III B Verna Industrial Estate Verna, Goa India Phone Fette Compacting asia Pacific Pte ltd. 107 Eunos Avenue 3, #01-01 Singapore Singapore Phone Fax infoasiapacific@fette-compacting.com Fette Compacting Ibérica, sl Calle Saturno Tres Cantos Spain Phone Fax fcib@fette-compacting.com ECOPaC a Fette Compacting and uhlmann Company 1, Rue du Centre Noisy Le Grand France Phone Fax ecopac@ecopac.fr