Online PAT → Automatic tablet testing system → TANDEM IIIA

Leading technology for FDA-approved real-time releaseOnline FT-NIR transmission spectroscopyHigh precision measuring of physical tablet propertiesFull validation with proven USP / EP compliant protocols

TANDEM IIIAOnline Content Uniformity (CU) with NIR

Online PAT → Automatic tablet testing system → TANDEM IIIA

TANDEM IIIA

→ TANDEM IIIA Online PAT and tablet characterization with TANDEM cube and AutoTest 4

Regulatory authorities require the accurate analysis of finished pharmaceutical goods to confirm the products’ content uniformity and physical characteristics. Traditionally, content uniformity analysis has been performed offline by liquid chromatography. This time-consum-ing and operator-intensive process requires a manual collection of samples during a batch followed by laboratory analysis.

Near-infrared (NIR) transmission spectroscopy has proven to be a reliable, rapid and non-destructive alternative for routine tablet content uniformity testing along with mois-ture and excipient analysis. The TANDEM IIIA combines Bruker’s MATRIX FT-NIR spectrometer with an AutoTest 4 tablet tester by Dr. Schleuniger® Pharmatron into one fully automated tablet testing system. Whether operated stand-alone or fully integrated with a tablet press, the

system provides real-time information about a tablet’s content uniformity (CU) and physical properties such as weight, thickness, diameter/length and hardness. While collecting real-time process data helps you to improve your process understanding, the TANDEM IIIA also allows control of the tablet compression process and can be easily deployed as an integral part of your continuous manufac-turing strategy using a standardized OPC protocol.

Online PAT → Automatic tablet testing system → TANDEM IIIA

The AutoTest 4 is a key module of the TANDEM IIIA and has originally been designed for online testing in combi-nation with a tablet press. Robust design, the ability to reliably handle even difficult-to-orient tablet shapes, and proven Dr. Schleuniger® hardness measuring technology have made it a favorite in compression rooms globally.

As an integral part of the TANDEM IIIA, the unit sepa-rates tablets and measures weight and thickness before diverting samples to the TANDEM cube for NIR meas-uring. During NIR analysis, the AutoTest 4 continues to perform physical tests (weight, thickness, diameter/length, hardness) of additional tablet samples in parallel.

Real-time physical parametersThe TANDEM cube with integrated transmission FT-NIR automatically measures tablet samples that have been diverted from the AutoTest 4 module. Tablets are precisely oriented, automatically positioned under the NIR trans-mission detector head, measured, and collected in exactly the same sequence.

While conventional spectrometers can’t be exposed to the demanding requirements of a production environ-ment, the TANDEM cube is fully protected against dust and water (IP65). This ensures that the NIR components are safely contained inside the housing and that the unit can be easily cleaned – making even wash-down cleaning possible if required.

Real-time FT-NIR analysis

Operating the TANDEM IIIA is easy. Test runs can be started automatically by the tablet press via a standardized OPC protocol – without requiring any additional actions by the operator. Alternatively, TabStat™ Pro software is available to execute complete test plans with automatic sampling at predefined intervals if your tablet press does not support online NIR testing.

Regardless from where tests are started, all NIR data analysis and evaluation is performed in the background using Bruker’s standard OPUS software. This implies that operators run the system from a single controller – and that NIR methods can be easily transferred from a stand-alone laboratory MATRIX FT-NIR to the TANDEM IIIA.

Results, including complete spectra, can be sent to the tablet press or other process software platforms such as the Siemens SIPAT™.

Seamless software integrationComprehensive instrument and software validation doc-umentation – based on years of experience – are readily available for the TANDEM IIIA.

• Full 21 CFR, Part 11 compliance• Full GMP compliance• Full IQ / OQ / PQ support

Additionally, the TANDEM IIIA is designed to be easily maintained, e.g. exchange of the NIR light source. Per-manent real-time diagnostics monitor the instrument and advise the user of a failing component. Instrument performance is validated at the click of a button using Bruker’s instrument test software in conjunction with the built-in internal validation unit – assuring correct operation of the entire system.

Regulatory compliance

→ Individual sample collection in defined sequence

→ Automatic positioning under NIR detector head

→ Automatic transfer of samples to NIR

→ Measuring of up to 4 physical parameters

Online PAT → Automatic tablet testing system → TANDEM IIIA

Your local sales & service partner

Dr. Schleuniger® Pharmatron is a brand of the SOTAX Group

SOTAX AG | Nordring 1 | 4147 Aesch | Switzerland P +41 61 487 5454 | F +41 61 482 1331 | sales@sotax.com

www.pharmatron.com

MB

2002

6EN

-01_

01/0

6-20

15

Technical Specifications

Weight Measuring range Up to 100 g

Resolution 0.1 mg

Units of measure mg / g

Thickness Measuring range Up to 15 mm (0.6")

Resolution 0.01 mm (0.00039")

Units of measure mm / inch

Diameter Measuring range Up to 25 mm (1.0")

Resolution 0.01 mm (0.00039")

Units of measure mm / inch

Hardness Measuring range Standard: up to 400 N; Optional: 50 N / 500 N / 800 N

Accuracy Better than +/- 1 N

Units of measure N, Sc, Kp, programmable user-defined factor (based on N)

Power supply EU-Standard 230 V / 50 Hz

US-Standard 115 V / 60 Hz

Special (on request) 230 V / 60 Hz or 115 V / 50 Hz

Compressed air supply Pressure min. 5 bar, max. 6 bar (87 psi)

Gas flow recommended flow rate: 2’000 L/h

CE Conformity Fully compliant with all CE and EMC equipment guidelines relative to mechanical and electrical safety and electromagnetic compatibility.

AutoTest 4 TANDEM cube TANDEM trolley

Dimensions Width 438 mm 600 mm 1280 mm

Height 554 mm 580 mm 596 mm

Depth 599 mm 520 mm 725 mm