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q-doc prolab® Software: Acquisition-Recording-Management- Analysis-Archiving

q-doc has been developed for the use in the pharmaceutical industry (R&D, laboratory and production environment). The first version, Q-Doc V1 was installed in 1998 and is, accompanied by constant development, in use in more than 100 laboratories worldwide. In the meantime Food and Cosmetics laboratories are working with this software as well.

In 2009 Q-Doc V1 was replaced by the more sophisticated q-doc prolab®. The new, more comprehensive system acquires data from laboratory equipment of various metrics and manufactu- rers, provides statistical evaluations, compares the results with the requirements, saves data in a Client/Server SQL-Database and passes the information into a log or a parent ERP-System. The scalability enables the use as a simple data acquisition and output system, but also as a laboratory-wide solution like the IPC-lab.

The comprehensive system includes: • Implementing the workflow

• Connection to LIM Systems

• Modular driver’s concept (allows adding new components, measuring equipment or PCs)

• Acquirement and collection of relevant data from various laboratory equipment and devices

• Statistical evaluations

• Comparing the results with the requirements

• Exporting of data into a file in several formats or to an overall ERP system

• Scalability enables the use as a simple data acquisition and reporting system

• Batch comparison, data trending, different types of (customizable) reports

• Archiving

Useful add-on modules, such as export and data trending module complete the q-doc prolab® range. It corresponds to the regulations of GAMP4 and complies with the rules of FDA CFR21, Part 11.

• Network capability

• Windows interface

• Microsoft SQL Server database

• Electronic Signature

• Adaptation of individual server solutions

• File-based import/export (several formats)

• Flexible reporting engine

q-doc prolab® users appreciate: • The easy operation and high level of automation

• The ability to adapt to R&D, laboratory and quality procedures

• The customization and training programs

Of course we are also offering additional services, like training and qualification support (IQ, OQ), on-site as well.

Single workstation version

Protocol printer

Disintegration (SDx)Mass

Multiple workstation solution

SQL-Server

Friability– Test

Mass Disintegration (SDx) Tab-Density

Hardness-Test

Protocol printer

LAN

Label printer

Disintegration (SDx)

SECOM GmbH · Saseler Bogen 4 a · 22393 Hamburg · Germany · Phone: +49 40 6000939-0 · Fax: +49 40 6000939-30E-Mail: contact@secom.de · Internet: www.secom.de

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SDx Disintegration Tester: efficient and innovativeWith over 20 years experience, including the development of one of the world’s first automated disintegration test basket for tablets, SECOM GmbH is regarded as the pioneer of automated tablet disintegration testers. The combined result of this expe-rience, technical development and innovation, has consolidated in the new tablet disintegration tester SDx.

SDx has been specifically designed for use within the production, the quality and the R&D departments. Tablets forms, such as standard, plain-coated and delayed release coated tablets, as well as hard gelatine capsules, can be tested whilst conforming to the European, United States and all associated Pharmacopoeia.

The SECOM vision for a new generation of disintegration tester was clear: originality in our design, ergonomic handling combined with the technical requirements of the modern day laboratory. We have accomplished this by: elimination of the water bath, reduction of the systems footprint, wireless auto-mated test baskets and touch screen technology - some of the main innovations of the SDx disintegration tester.

New generation in Disintegration Testing

Mechanics

Temperature control and monitoring

www.secom.de www.secom.de

Feature Customer benefit

No water bath Very small footprint, perfect for limited bench space in QC/IPC labs. Also eliminates the need for water tank cleaning!

Induction heater Direct heating of the test me-dium reduces time and energy effort.

Fast preparation of test media

From ambient to test tempera-ture within 5 minutes and auto-matic test start upon reaching the target temperature.

Feature Customer benefit

Stand-alone device with a modern TFT touch screen (GUI)

Modern, clean and easy to use. Reduces operator training times and human error during test setup.

Operation with PC and q-doc prolab® software, FDA CFR21, Part11 compliant

Powerful software. Interface to LIMS available.

Feature Customer benefit

Linear drive with brushless DC - Motor (BLDC). Stroke and lift movements real-ized in a single drive unit.

Maintenance-free. Reducing the risk of mechanical breakdown.

Feature Customer benefit

Independent pre-heating unit Completing the disin-tegration tester with the possibility of parallel heat-ing of the next test medium

For time conscious busy labs the SDMP will preheat the next beaker. Simple complete one test and your next is ready to go. Configurable via the SDx.

Customer benefit Customer benefit

Measurement and docu-mentation of the filling level height

Ensuring compliance with the Pharmacopoeia.

pH-measurement Automatic identification of the test medium such as Gastric Acid.

Complete monitoring and documentation of the medium temperature

Statistical recording and docu- mentation of the test process. Statistical reports such as Min, Max, s, Average and RSD are reported and exported to q-doc prolab® software.

Wireless controlled test basket

Smooth-running magnetic coupling ensures the basket its correct position. Automated detection of the basket is also integrated.

Corrosion-protected test basket

Easy industrial cleaning. Specifi-cally sourced material ensures longevity of the test basket.

6-tubes default basket or 3-tubes version (for large samples) available

Flexibility to test standard tablet forms and larger (effervescent tablets).

Monitoring the test medium Software

SDMP

Medium preparator: unique and easy to handle