Multiple Tip Tooling. Durability, Productivity, Longevity. MKT-45 Issue 3

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Multiple Tip Tooling Durability, Productivity, Longevity. MKT-45 Issue 3 T A B L E T T I N G S C I E N C E

Contents DESCRIPTION PAGE Introduction 4 Benefits 5 Multi-Tip or Micro-Tip 6 MULTIPLE TIP CONFIGURATION Internal Cap Fixing 8 External Cap Fixing 9 Monoblock 10 Pin Fixing 11 USING MULTIPLE TIP TOOLING Tablet Press Considerations 12 Frequently Asked Questions 13-14 Additional Multi-Tip Features 15 MULTIPLE TIP REFERENCE CHARTS Matrix for Multi-Tip & Micro-Tip Tooling 17 Reference Chart 18 Typical Shaped Multi-tip Configuration 19-20 OTHER TOOLING PRODUCTS PharmaGrade Steels 21 PharmaCote Treatments & Coatings 22 MKT-45 Issue 3

Introduction As one of the worlds leading tablet tooling manufacturers I Holland has been instrumental in introducing many innovative and unique developments to the industry including the Rotating Head, Universal Seal Groove, and is author of the industry s leading global tooling standard the Eurostandard. This document is a reflection of the current designs and configurations available. I Holland Research and Development and design teams are constantly working on new solutions. For further information on our R&D activity, please contact: info@iholland.co.uk I Holland have been leading the way in the production of Multi-tip tools for over 25 years; this experience has culminated in today s impressive array of configuration options to suit many products in several industries including: Pharmaceutical; Nutraceutical; Detergent; Cosmetic; Veterinary; Confectionery and various industrial applications. I Holland understands the demand for increased productivity within modern tablet production. We are always striving to ensure that our punches and dies are at the very leading edge of tooling design, allowing our customers to retain a competitive edge. To assist our partners in their quest for increased capacity we developed our Multi-Tip and Micro-Tip range of Multiple Tip tooling. Many PharmaCote treatments & coatings and PharmaGrade steels can be used in conjunction with multipletip designs in order to create a robust tooling solution that is capable of being both incredibly productive and durable at the same time. I Holland also offers very competitive lead times on these tooling systems. 4

Benefits of Multiple Tip Tooling Increase in productivity - Number of tablets per turret rotation is multiplied by the number of tips. No large capital outlay on new tablet presses mean that higher tooling costs are easily outweighed by increased output. Reduction in press run-time per output of tablets means that less maintenance is required per batch of tablets produced. Reduction in press setup-time per output of tablets. Less tablet presses required to satisfy output therefore requiring less floor space leading to more product produced per Sq Metre. Fewer tools require less storage space leaving room for production equipment. All of these points lead to a reduction in overall plant running costs. MKT-45 Issue 3 5

Multi-Tip or Micro-Tip? Holland Multi-Tip Diameter larger than 4mm Available for round and shaped tablets Available for most tool types including IMA Comprima External Cap Fixing available Internal Cap Fixing available Pin Fixing available Monoblock available Designer shapes available Fitting Pot & Die Alignment Tools available Fitting and Assembly instructions provided on request Holland Micro-Tip Diameter less than 4mm Available for round and shaped tablets External Cap Fixing available Internal Cap Fixing available Fitting Pot & Die Alignment Tools available Fitting and Assembly Instructions provided on request 6

Multi-tip Design Solutions MKT-45 Issue 3 7

Internal Cap Fixing This design results in a seamless punch barrel as the cap is fitted inside the body. This reduces the risk of damage to the turret punch guides and oil/dust seals as well as reducing contamination concerns but does require disassembly before cleaning. The cap fixing is set to a specific torque to prevent it from working loose. Features Worn or damaged tips can be replaced individually Seamless joint eliminates risk of damage to seals and minimises contamination Floating lower tips for smooth alignment Material selection can be optimised. For example, tips and body can be of different PharmaGrade materials depending on granule characteristics and tablet design Fixing Screws Cap Individual Tips Punch Body MKT-45 Issue 3 8

External Cap Fixing Multi-tip punches are manufactured with the cap fixing fitted external to the body of the punch. In some circumstances this may allow more tips to be located on each punch. However, the risk of product contamination and damage to punch guides and seals increases with this design as does time taken to clean the punch due to requiring disassembly before cleaning. Features Worn or damaged tips can be replaced individually More tips per punch may be achieved on smaller tip sizes Material selection can be optimised. For example, tips and body can be of different PharmaGrade materials depending on granule characteristics and tablet design Cap Fixing Pin Individual Tips Punch Body 9

Monoblock This design is machined from a single piece of steel resulting in a solid monoblock multi-tip punch. Monoblock multi-tips offer benefits in reduced cleaning time within the PharmaCare 7-Step Process and a smaller risk of product contamination compared to composite designs. However, it should be considered that any damage to the monoblock punch requires the whole punch to be replaced. Features No joint eliminates risk of damage to seals No need for assembly/disassembly Reduces risk of contamination due to ease of cleaning Ideal for Wash In Place machines when appropriate materials and coatings are used. Monoblock design MKT-45 Issue 3 10

Pin Fixing The simplicity of the Pin Fixing design makes this an effective solution for users who need to change the tips regularly. With a simple pin operating as the fixing device this is a straightforward operation. The pin fixing of the tips also reduces the risk of cross contamination compared to other composite designs and is easy to clean as part of the PharmaCare 7-Step Process. Features Simple design makes changing tips easier May allow for more tips per punch depending on tablet design Fewer component parts Replacement of individual tips possible Material selection can be optimised. For example, tips and body can be of different PharmaGrade materials depending on granule characteristics and tablet design Punch Body Fixing Pins Individual Tips 11

Tablet Press Considerations The upper section of the turret must have keyways. This ensures the correct fixing of the upper punch. Modification to the feeder paddles may be required due to increased fill requirements Tablet press monitoring systems can be adjusted to monitor the multitablet outputs as standard. Calibration punch may be required for single sort rejection system (available upon request) Granulation flow must be working effectively due to the increased fill requirement The tablet press should be in good working order and critical dimensions of the turret (punch guides and die pockets) should all be within tolerance Tablet diameter below 3mm may require reinforced tips, and the press will need to be fitted with restricted fill cams MKT-45 Issue 3 12

Frequently Asked Questions Q. What is the smallest tip size available? A. The smallest tip size for round Multi-Tip tooling is 4mm and for round Micro-Tip 1.5mm. Shaped tooling must be assessed individually at the time of enquiry. Q. What happens if we break or damage a certain part of the Punch? A. Individual components of the composite fixing designs can be replaced individually. Q. How do you clean and polish Multi-Tipped punches? A. Multi-Tipped tooling should be maintained in accordance to the PharmaCare 7-Step process the same way as conventional tooling. This should be achieved using an ultrasonic cleaning bath and automated polishing which gives significant time savings and more consistent results over manual techniques. Q. How do I set up Multiple-Tipped tooling in the tablet press? A. In the same way as shaped punches. I Holland recommend the use of a Die Alignment Tool which reduces tooling damage and set up time. Q. What is a Universal Seal Groove? A. The Universal Seal Groove gives the ability to use all types of Drip Cup or I Holland Bellows which form a flexible seal between the Turret and the Punch, reducing the risk of oil contamination from the machine s lubrication system. 13

Frequently Asked Questions Q. Are bellows and drip cups available for Multi-Tipped punches? A. Yes, I Holland offer the Universal Seal Groove which can accommodate both the bellow and drip cup. Alternatively the drip cup can be fitted to the undercut of the tip. Please note the use of a seal groove could limit the maximum number of tips available. Q. Do I have to assemble Multi-Tipped tooling? A. No, all I Holland Multi-Tipped tooling is delivered assembled. Q. Can Multi-Tipped tooling be repaired/refurbshed? A. Yes, this service can be provided by I Holland following assessment of the tooling condition. Damage to the tips of monoblock tooling will usually result in the punch having to be replaced. Q. Can PharmaCote treatments and coatings be applied to Multi-Tip tooling? A. Yes coatings from our PharmaCote range are suitable for application to our Multi-Tipped tooling. Q. What is the maximum force that I can apply to Multi-Tipped tooling? A. In theory the force rating for a single tip can be multiplied by the number of tips on the punch. For example: A multi 3 punch maximum force would be calculated as follows (No of tips (3) x Maximum force for tablet design (kn)) In addition to the above example we would recommend that the calculated force is reduced by a safety factor of 30% at least for the initial press start up. MKT-45 Issue 3 14

Additional Features Available For All Multi-tip Designs Die Segments I Holland are experienced in supplying and fitting multi-tip tools compatible with die segments Rotating Head Rotahead punches allow the head to rotate independently to the punch body, providing a bearing between the punch head and cams. The punch head can be manufactured from a harder, more wear resistant material optimising metallurgical characteristics of the punch assembly, and providing extended tooling life. Die Alignment tools The die alignment tool is used in conjunction with multi-tipped tools. The die alignment tool aligns the die bores relative to the keyways in the turret guides; this allows all dies to be fitted rapidly and accurately with just one special tool. WIP Keys Designed with Wash In Place (WIP) solutions in mind, this coated key is extremely resistant to corrosion. When partnered with the Monoblock design and appropriate PharmaGrade steel, this is the ideal tool for WIP presses. Validation punches Are provided to aid initial press set up and single sort rejection. These punches are often embossed with different marks to distinguish between tablets 15

Matrix for Round Multi-Tip Tooling Eurostandard B,BB, BBS, Pharma, Kilian 20/28 Eurostandard D, Fette 441, Kilian 25/32 Without Universal Seal Groove* With Universal Seal Groove Without Universal Seal Groove* With Universal Seal Groove Tip Size (MM) >4mm Pin Fixing Internal External Mono Pin Fixing Internal External Mono Pin Fixing Internal External Mono Pin Fixing Internal External Mono 5 4 4 3 7 2 4 3 4 8 9 5 10 6 9 5 7 6 4 4 2 4 2 3 2 3 5 7 4 7 5 7 4 7 7 2 2 2 3 2 2 2 4 5 3 7 4 5 3 5 7.5 2 2 3 2 3 4 3 5 3 4 3 5 8 2 3 4 3 4 3 4 3 4 9 2 2 3 2 3 2 3 2 3 10 2 2 3 2 3 Shaped tooling sizes on request. Please Note: Small changes in tablet diameter may result in an increase of available tips. *Can have standard seal groove. 16

Matrix for Round Micro-Tip Tooling Eurostandard B,BB, BBS, Pharma, Kilian 20/28 Eurostandard D, Fette 441, Kilian 25/32 Tip Size (MM) 4mm Without Universal Seal Groove* With Universal Seal Groove Without Universal Seal Groove* With Universal Seal Groove Internal External Mono Internal External Mono Internal External Mono Internal External Mono 1.5 16 18 12 18 26 35 24 35 2 16 18 12 18 26 35 24 35 3 7 8 6 8 14 19 12 19 4 5 6 5 6 8 14 8 14 Shaped tooling sizes on request. Please Note: Small changes in tablet diameter may result in an increase of available tips. *Can have standard seal groove. 17

Multi-Tip Reference Chart Clean assembled Replaceable tips Clean disassembled PharmaCote Material Options Internal Cap Fixing External Cap Fixing Pin Fixing Monoblock Clean Assembled I Holland recommend that this multi-tip design is cleaned in an ultrasonic bath without taking it apart. I Holland recommend that this multi-tip design is taken apart before cleaning in an ultrasonic bath. Clean Disassembled I Holland recommend that this multi-tip design is taken apart before cleaning in an ultrasonic bath. This multi-tip design cannot be disassembled but can be cleaned in an ultrasonic bath. Replaceable Tips The tips on this design are independently replaceable without scrapping the whole punch. The tips on this design cannot be replaced. Material Options Component sections of this assembly can be manufactured from complementary PharmaGrade steel types to optimise performance. This punch design is manufactured from one type of PharmaGrade steel. PharmaCote PharmaCote technology can be applied to this punch design. MKT-45 Issue 3 18

Typical Shaped Multi-Tip Configuration Impact of design selection on tip configuration These illustrations show a typical 10 x 5 capsule shaped tablet (with a flat bevelled edge) on a Eurostandard B punch and the possible configurations available on different design options with and without a universal seal groove. Monoblock Monoblock Multi 3 Monoblock Multi 3 With Universal Seal Groove External Cap Fixing Multi 2 External Cap Fixing Multi 2 External Cap Fixing With Universal Seal Groove MKT-45 Issue 3 19

Typical Shaped Multi-Tip Configuration Pin Fixing Multi 2 Pin Fixing Multi 2 Pin Fixing With Universal Seal Groove Internal Cap Fixing Multi 2 Internal Cap Fixing Multi 2 Internal Cap Fixing With Universal Seal Groove Please note that these designs are for illustrative purposes only and I Holland will always endeavour to find the best possible solution for each individual application and customer requirement. 20

PharmaGrade Steels There are thousands of steel types available but only a few meet the complex design and functional requirements of tablet tooling. Chemical composition of the steel is only one part of the overall equation, material selection must always be considered alongside good tablet design for strong punch cups and punch tip edges. Cross Sections Showing Carbide Distribution Unrefined Steel To optimise the material and its properties, other processes are required such as: Steel refinement (ESR Electro slag re-melting) Optimal heat treatment Treatments and coatings Powder Metallurgy PharmaGrade Durability, Productivity, Longevity. All PharmaGrade materials are highly refined to our own specifications and this quality is provided at no additional cost to our customers giving increased strength and wear resistance to tablet tooling. Conventional Steel Refined Steel - ESR MKT-02_Issue_3 Steel Refinement - ESR I Holland s PharmaGrade ESR material (HPG-S & HPG-P) has a homogeneous carbide structure which is distributed evenly throughout the steel. This provides benefits for the end user such as increased tool strength, extended tooling life over conventional (non-refined) steel and coating uniformity. Holland PharmaGrade HPG-S & HPG-P Holland PharmaGrade Powder Metallurgy Steels Powder Metallurgy I Holland offers two specialist powder metallurgy steels (HPG-MP & HPG- MD) each offering a uniform carbide distribution, small carbide size and extremely high wear resistance when compared to HPG-S and HPG-P. Powder Metallurgy steels are recommended for extremely abrasive products. MKT-45 Issue 3 Holland PharmaGrade Steels HPG-MP & HPG-MD 21

PharmaCote Treatments and Coatings I Holland s PharmaCote range is a suite of treatments and coatings that enhance the performance of substrate material for punches and dies. Our PharmaCote range is focused on:- PharmaCote Improving wear resistance Overcome common tooling problems with PharmaCote treatments and coatings. Includes New PharmaCote EC Improving corrosion resistance Improving anti-stick properties Our PharmaCote brochure is also available to advise on this range of treatments and coatings. COATING Tooling Type Steel Type PUNCHES DIES HPG-S HPG-P HPG-SS PharmaCote HC (Standard) PharmaCote HC (Barrel & Tip) PharmaCote HC (All Over) PharmaCote HC (Tip Only) PharmaCote HC (Head, Neck & Barrel) PharmaCote HC+ (Standard) PharmaCote HC+ (Barrel & Tip) PharmaCote HC+ (All Over) PharmaCote HC+ (Tip Only) PharmaCote EC (Standard) PharmaCote CN (Standard) PharmaCote CN (Barrel & Tip) PharmaCote CN+ (Standard) PharmaCote CN+ (Barrel & Tip) PharmaCote TN (Standard) PharmaCote TN (Barrel & Tip) PharmaCote DN (Tip Only) PharmaCote RS (Tip Only) 22

PharmaCote Durability, Productivity, Longevity. PharmaGrade Durability, Productivity, Longevity. MKT-01_Issue_7 Includes New PharmaCote EC MKT-02_Issue_3 These brochures detail materials, treatments and coatings that are currently available for I Holland tooling. The Research and Development Team is constantly working on the development of new materials. For further information on our R&D activity, please contact info@iholland.co.uk

T A B L E T T I N G S C I E N C E I Holland Limited Meadow Lane, Long Eaton, Nottingham. NG10 2GD. England Tel: +44 (0) 115 972 6153 Fax: +44 (0) 115 973 1789 Web: www.iholland.co.uk E-Mail: info@iholland.co.uk