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PERFORMA D ROTARY TABLET PRESS. The commercial-scale PERFORMA D is largest size in this range of GEA rotary tablet presses.

PERFORMA D – DEPENDABLE PERFORMANCE. Designed for the reliable and cost-effective large-scale production of oral solid dosage forms, the new double- sided model combines the benefits of flexibility and robust performance for a wide range of formulations.

Scope The PERFORMA D features a large turret containing up to 106 stations, making it capable of producing up to 1,140,000 tablets per hour. It is the machine of choice for high-volume applications when minimal downtime and high quality are key.

Features • Turret enclosure concept • Multiple compression modes • Programmable dwell times at pre- compression and main compression

• Weight control by displacement or force measurement

• Maximized length of the powder feeding unit

• Bilayer production capable • Small footprint.

Benefits • Robust, flexible and reliable, high-output operation

• Fast and easy (interbatch) cleaning • Higher levels of operator protection • Enhanced tablet quality • Reduced weight variation (resulting in a more consistent drug delivery)

• Individual weight control for both layers of a bilayer tablet

• User-friendly, intuitive MC5 operating system.

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DEDICATED SOLUTIONS FOR YOUR APPLICATIONS.

BiLayer Tableting MUPS Tableting Effervescent Tableting

Combining the benefits of flexibility and robust performance, even for difficult-to-process formulations, the PERFORMA range of double-sided rotary presses can handle a wide range of tableting applications..

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The PERFORMA D has been designed to offer the smallest footprint per tablet produced in the market. This double- sided rotary tablet press from GEA is easy to maintain, clean and operate, and ensures the cost-effective and energy efficient production of both single- and bilayer tablets.

Unique to the PERFORMA D and a key differentiator from other available tablet presses is the turret enclosure. The exchangeable turret is encased in a barrier system that, compared with standard machines, provides higher levels

of operator protection, enables rapid changeovers and also supports GMP-compatible production. A further benefit is the ability to perform intermediate dry cleans during extended manufacturing campaigns.

Featuring a longer, PAT-compatible double-paddle forced powder infeed system that maximizes output, the PERFORMA D also benefits from an anti-bridging rotary valve that keeps the powder column above the paddle feeder constant, resulting in a uniform pressure and reduced weight variation.

The press comes fitted with a three- or four-way tablet chute for both manual and automated station sampling. The design is offering easy, tool-free removal that facilitates both cleaning and changeovers.

COST-EFFECTIVE COMPRESSION. Experience the high speed, high quality, high volume output of the PERFORMA D by running your own trials at our European test center.

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Key features include: • Standalone PC application (all-in-one), independent from Windows operating system

• Microsoft Windows 10 operating system • 21.5” HD multi-touch widescreen • Industrial IPC • Siemens PLC (S7-1500) for machine control • Software design and lifecycle management according to GAMP 5 and internal ISO procedures (QMS)

• Integrated help system, with user manual, machine operation manual, mechanical and electrical drawings.

MC5 CONTROL SYSTEM. The MULTI-CONTROL 5 system’s hardware and software are designed to be fully 21 CFR PART 11 compliant.

The HMI panel can be moved to either side of the unit for increased flexibility and positioning.

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Technical Data PERFORMA D Specifications

Further information GEA Pharma & Healthcare pharma@gea.com gea.com/contact

Tooling (EUR or TSM) D35 D B BB BBS A2D

Maximum tablet diameter / length1 [mm] – dies 35 25 16 (L=19 13 (L=14,3) 11 11 (A2D) Maximum tablet diameter / length [mm] – segments N/A 25 18 (L=19 N/A N/A 11 (A) Punch body diameter [mm] 35 25,4 19 19 16 12 Outside die diameter [mm] 52 38,1 30,16 24 22 38,1 Die height [mm] 23,81 23,81 22,22 22,22 22,22 23,81 Number of Punch Positions (dies/segments) 39 53 (65) 67 (80) 81 89 116 (115) Maximum fill depth [mm] 20 (25) 20 19 19 19 19 Top punch penetration [mm] 1 to 4 1 to 4 1 to 4 1 to 4 1 to 4 1 to 4 Maximum precompression force2 [kN] 10 (under extended dwell time) Maximum main compression force 100 100 100 100 100 100 Output capacity3 [tab/h] – dies 350.000 540.000 722.000 875.000 1.069.000 1.392.000 Output capacity [tab/h] – segments N/A (662.000) (862,000) N/A N/A (1.380.000)

Machine Specifications / Requirements Electrical requirements 3 phase + PE: 380–480 V 50/60Hz nominal consumption 16 kW; installed power = 32,4 kVA Compressed air requirements Clean & dry; 7-8 bar; 500Nl/min peak – 100Nl/min average  Dust extraction requirements 150 m3/h at 15 mbar (single-layer) / 230 m³/h at 50mbar (bi-layer) Operating conditions Temperature 15 – 40 °C, relative humidity < 60% Machine dimensions (doors closed) & weight W = 1450 mm x D = 1450 mm x H = 2245 mm – 5700 kg

1 In case of special tablet shapes, it is recommended to contact GEA Process Engineering nv (Halle). 2 Higher pre-compression forces are possible, please contact GEA Process Engineering nv (Halle) if required. 3 Real effective output depends on powder flow & compression characteristics and tablet specifications.

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