Common Issues on Tableting Performance 常见压片问题分析 All … · 2018-09-25 · Sticking Problems ... • Different coating manufacturing processes ... ऀ吀眀漀瘀攀爀猀椀漀渀猀

Tom Zhu

Common Issues on Tableting Performance 常见压片问题分析

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All rights reserved by Fette GmbH.

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Tableting Performance

Content

Weight Variation

Hardness Issues

Sticking Problems

Scale-Up Related Issues

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Copyright The copyright to this instruction is retained by FETTE Compacting GmbH. This instruction is intended for personnel involved in the assembly, operation or maintenance. It contains regulations and technical drawings, which must not be copied, spread to unauthorized persons or abused for competition purposes, neither completely nor partly. The copyright also extends to the data processing programs and the related program descriptions. In case of extension or change of existing programs, the user, unless otherwise agreed, undertakes to destroy all previous versions, copies and changed documentation. Transfer to third parties is prohibited. Additional information is given in the manual. This information contains important information and additional tips for the user.

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Weight Variation-Overview Top Solutions

Fill-O-Matic

Design and Set Up

Filling and Dosing Cam

Penetration Depth

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Fette Fill-O-Matic(FOM)

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Different FOM Design

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Filling Cam

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Dosing Cam

Tablet filling depth

Pull-down ledge

Starter piece

Upper edge = 0,00 mm

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Penetration Depth

• Extract the air out of the blend

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Hardness Issues- Overview Top Solutions

• Compression Station

• Tooling

• Pressing Zone

• Direct Compression

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Compression station

• The final tablet is compressed

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Punch Terminology

Key

Shaft diameter

Head flat

Dust cap ring

Overall length

Tip size

Functional length

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Head Design – Comparison Table

Head design Shaft diameter [mm] Head diameter [mm] Length [mm] Head flat [mm]

FS®12 12,00 19,00 133,60 8,00

EU19 19,00 25,27 133,60 9,60

TSM19 19,00 25,40 133,35 9,33

TSM19 domed head 19,00 25,40 133,35 9,53

FS®19 19,00 28,00 133,60 12,50

EU1“ 25,35 31,60 133,60 16,00

TSM1“ 25,35 31,75 133,35 14,60

TSM1“ domed head 25,35 31,75 133,35 15,90

EU1“-441 25,35 38,00 133,60 24,00

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Compare EU1”-441 with EU1”

• 50% longer dwell time

• higher production speeds

• less movement on the compression station

• reduced vibrations

• lower noise level

• better run behavior

•Benefits

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FE55 Direct Compression

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TCM(Traditional Chinese Medicine)

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FE75 Direct Compression

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Sticking Problem - Overview Top Solutions

Punch Coating

Coating inlays

FETTE PKB

Magnesium Stearate Spray System

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Punch Coating Tableting tools requirements:

• High surface quality is needed for a good surface of the tablet

• Coating without defects

• Low adhesion for high-viscosity and sticky materials

• High wear resistance by using crystalline powder

• Good adhesion of the coating to the punch steel

• Different coating manufacturing processes • Electroplating (galvanic) • PVD -> Physical Vapour Deposition • FCG -> Fette Coating Grate

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Coating: Table of FCG-Coatings

Coating Thickness [µm]

Hardness [HV0,03]

Color

FCG-HCP 3 – 5 1000 Silver

FCG-PCR 3 – 5 1100 Silver-blue

FCG-CRN 2,5 – 4 2000 Silver-grey

FCG-TIN 2,5 – 4 2500 Gold

FCG-TAN 2,5 – 4 3700 Grey-purple

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• For some application a coating is not advisable

• In some applications, inlays can be used for anti sticking

• An inlay is a kind of plastic or rubber plate which is fixed in the punch tip

• Silicon – transparent or red/brown color

• Teflon – white colour

• Vulculan – brown colour

• Delrin – white colour

• Adipren – white colour

Coating: Inlay

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FETTE PKB

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PKB II和PKBIII的区别 PKB II Volumetric and gravimetric dosing system Reduction of imprecision in dosage Two versions (with and without balance) Can be started manual or from a tablet press Usable by every rotary press Can be validated (only with balance) PKB III Volumetric and gravimetric dosing system Two versions (with and without balance) Can be started manual or from a tablet press Positioning of 10 m away from the tablet press is possible Can also be used as a „Stand-alone-System“ Identical unit for single and double sided rotary press

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Concentration of Mg-stearate

Internal lubrication

•0.5% to 1.0%

PKB II / PKB III

•0.02% to 0. 13%*

Results proofed by the University of Bonn /Pharmaceutical Technology (Pharmaceutical Institute)

HARMACEUTICALECHNOLOGY

PTpharmaceutical institute

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PKB 工艺问题

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Scale-Up Related Issues

Press and Tooling type

Filling Method

Compaction Time

Compression Force

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Press and Tooling Type

• Single Stroke Press

• Small Scale Rotary Tablet Press

• High Speed Rotary Tablet Press

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SingleStroke

SmallScale

1200 2090 30900

0,2

0,4

0,6

0,8

1

1,2

1,4Seconds

Filling Time Comparison

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So ideally a rotary tablet press should be used in order to achieve a very large degree of transferability from R&D results direct to solid production data and settings.

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SingleStroke

SmallScale

1200 2090 30900

0,1

0,2

0,3

0,4

0,5

0,6Seconds

Compaction Time Comparison

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SingleStroke

Small Scale 1200 2090 30900

10

20

30

40

50

60

70

80

90

100KN

Compression Force Comparison

Pre compr.Main compr.

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Thanks for your attention

Documents

Common Issues on Tableting Performance 常见压片问题分析 All … · 2018-09-25 · Sticking Problems ... • Different coating manufacturing processes ... ऀ吀眀漀 瘀攀爀猀椀漀渀猀

Common Issues on Tableting Performance 常见压片问题分析 All … · 2018-09-25 · Sticking Problems ... • Different coating manufacturing processes ... ऀ吀眀漀瘀攀爀猀椀漀渀猀