PERFORMA D Tablet Press

The commercial-scale PERFORMA D is the latest addition to GEA’s portfolio of rotary tablet presses. 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.

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Scope

Created for reliable, high-output operation in a competitive industry, 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.

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.

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 agitator 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.

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

Main 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

Bilayer Production: The GEA Way

The PERFORMA D manufactures bilayer tablets using a unique GEA process: it measures the weight of each layer independently to ensure the correct drug delivery profile; however, most tablet presses can only accurately assess weight when a high force is applied. High forces result in dense tablets that are difficult to bond together, making separation of the layers, or capping, almost inevitable.

GEA’s double-sided tablet presses have been specifically designed and developed for the high-speed production of quality bilayer tablets and provide

displacement weight monitoring/control for the accurate and independent weight control of the individual layers
low compression force exerted on the first layer to avoid capping and separation of the two individual layers
increased dwell time at pre-compression of both first and second layer to provide better de-aeration and defined hardness at maximum turret speed
maximum prevention of cross-contamination between the two layers
a clear visual separation between the two layers
maximized yield.

Data Collection

The MULTI-CONTROL 5 (MC5) is the latest GEA control system for rotary presses. The system’s hardware and software are designed to allow for full compliancy with the 21 CFR PART 11 guideline. It is a fully automated monitoring, control and reporting system based on a PLC/PC hardware configuration. MC5 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 and internal ISO procedures (QMS)
integrated help system, with user manual, machine operation manual, mechanical and electrical drawings.

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

Technical Specifications

The PERFORMA D is available for D35, D, B, BB, BBS and A2D tooling

Tooling (EUR or TSM)	D35	D	B	BB	BBS	A2D
Max. tablet diameter/lenght [mm]	35	25,4	16 (L=19)	13 (L=14,3)	11	11
Punch body diameter [mm]	35	25,4	19	19	19	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	39	53	67	81	89	106
Max. fill depth [mm]	20 (25)	20	19	19	19	19
Top punch penetration [mm]	1 to 4
Max. pre-compression force [kN]	10 (under extended dwell time)
Max. main compression force [kN]	100
Max. output capacity [tab/h]	350.000	540.000	722.000	875.000	1.069.000	1.272.000
Electrical requirements	3phase+PE – 380 / 400 / 415 / 460 / 480 V – 50Hz / 60Hz (nominal consumption 16 kVa; power installed 32,4 kVA)
Compressed air requirements	clean & dry - 7-8 bar - 500Nl/min peak - 100 Nl/min average
Dust extraction requirements	150 m³/h at 15 mbar (single layer) - 230 m³/h at 50 mbar (bi-layer)
Operating conditions	temperature 15 - 40 °C ; relative humidity < 60%
Machine dimensions & weight	W = 1.450 mm x D = 1.450 mm (+ max 865 extended HMI arm) x H = 2.245 m – 5.700 kg (excluding electrical cabinet: W 810 x D 510 x H 2.150 ; weight +/- 300 kg)