10X – The new standardfor Tablet Hardness Testing

Precise measurement within

«In Process Control» production environment

Unique design for dust and water protection

Fast, accurate and comprehensive testing process

Quick, easy and simple cleaning

The automatic Tablet Tester 10X sets an unprecedented new standard formeasuring Weight, Thickness, Diameter and Hardness of solid forms to thePharmaceutical industry or alike. The 10X is a unique concept and designdeveloped by Dr. Schleuniger® Pharmatron AG. In contrary to other testers the10X has been specifically designed to work in the In-Process-Controlenvironment. This means the 10X is protected (up to IP65) against dust andwater permitting the user to washed-down and decontaminated the 10X withwater and recommended solvents; thus eliminating the concerns of manyPharmaceuticals companies when automatically testing tablets within IPC.

10X-LAB (Laboratory unit)The model 10X-LAB is alwaysequipped with a segregation device,which guarantees tablets aredelivered to the testing platformsindividually. Additional hardwareoptions such as, 10 magazinefeeders and a sample collector formultiple testing applications areavailable. The 10X-LAB includes auser interface (CP410) with adisplay, keyboard and communi-cation port for a printer. The com-prehensive TabStat Pro softwarepackage is also available as anoption.

10X-IPC (In-Process-Control unit)The model 10X-IPC provides acommunication port to directly linkthe 10X to a tablet press. The 10Xis then controlled via the tabletpresses software. Optional extrasare the segregation device and asample collector.

10X-FT-NIR(Combination with FT-NIR device)The model 10X-FT-NIR is anintegral part of the combined unitwith a Bruker FT-NIR system. The10X-FT-NIR can be equipped withor without a segregation device. It provides one communication port and is controlled through theTabStat Pro software only.

10X – The selected tablet testerfor the production environment

Functional DescriptionThe product specific test and feeding parameters can beprogrammed through the CP410 interface, the TabStat Prosoftware or the control software of the tablet press. The numberof measurements per parameter can be set individually.

Once the test has been initiated, the samples are automatically delivered intothe segregation* device. After the weight reading has been taken, the tablet istransported to the Thickness gauge. On its way to this station, the tablet isautomatically oriented. Thereafter the tablet is transported by means of apatented programmable paddle transport system to the diameter and hardnessstation.

* (This unit is not required for tablet presses, which deliver single tablets to the 10X).

Upon completion of the hardness test, the second paddle automatically cleansthe pressing jaws of any dust or debris. The design of the mechanical systemenables a quick, easy and simplistic cleaning of the system. All of the individualtesting stations can be easily removed for cleaning. There are only a few stepsnecessary for re-installation.

Key FeaturesThe tablet tester 10X automatically measures Weight, Thickness, Diameter andHardness of any tablet form. The number of samples per parameter may beconfigured individually.

The 10X is dust and water protected (up to IP65). Therefore appropriatecleaning for toxic, high potent and dangerous material is guaranteed.

The angle and speed of the tablet transport paddle is freely programmable. Thisassures automatic orientation of any tablet form without the need to change overany parts.

The 10X is specifically designed for the customer’s requirements in theproduction environment and fully complies with the current regulations.

Calibration /Verification The 10X is very easy to calibrate and verify. Our customers can choose fromcalibrating and verifying the 10X themselves or setting up a planned visit by oneof our trained and authorized technicians.

ValidationWe provide full validation support to the customer after installation. A specialistcan be ordered for that purpose if requested.

Warranty & SupportThe products of Dr. Schleuniger Pharmatron are reliable, long lasting and reachthe highest quality standards.

The warranty period is twelve Months. Parts that fail during the warranty perioddue to a manufacturing defect, will be replaced free of charge. Installation of thesystem at customer site can be performed upon request. This includes theIQ/OQ documentation and certificates. Customer training is also available uponrequest at any time.

DR. SCHLEUNIGER PHARMATRON AGSchöngrünstrasse 27 · CH-4501 Solothurn/ SwitzerlandPhone +41 (0)32 624 40 80 · Fax +41 (0)32 624 40 88info@pharmatron.ch · www.pharmatron.ch

DR. SCHLEUNIGER PHARMATRON INC.One Sundial Avenue, Suite 214 · Manchester, NH 03103/USAPhone +1 603 645 67 66 · Fax +1 603 645 67 26info@pharmatron.com · www.pharmatron.ch