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MKT-47_ISSUE_07

P H A R M A C A R E ®

7 S T E P P R O C E S S


01

CONTENTSINTRODUCTION

WHY USE PHARMACARE®?

STEP 01: CLEAN

STEP 02: ASSESS

STEP 03: REPAIR

STEP 04: MEASURE

STEP 05: POLISH

STEP 06: LUBRICATE

STEP 07: STORE

AUDIT & TRAINING

03

04

09

13

17

25

31

36

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45

7 S T E P P R O C E S S02

INTRODUCTION7 SIMPLE STEPS TO PROTECT YOUR INVESTMENT

It’s simply good business sense - manage, maintain and store your punches and dies correctly and you will produce a better product for longer, reduce costs and enhance profitability. I Holland's PHARMACARE® 7 Step Process is a planned, professional maintenance and storage programme which will provide a significant return on investment. When the 7 Step process is combined with I Holland's simple but comprehensive Tool Management System, the results speak for themselves.

PHARMACARE® 7 STEP PROCESS

01. CLEANTooling should be cleaned and dried to remove any oil or product residue.

02. ASSESSVisually inspect tooling for signs of obvious damage and establish if maintenanceis required.

03. REPAIRLight surface corrosion and damage can be polished out and repaired.

04. MEASUREMeasuring is essential after repair to ensure that critical tooling dimensions have stayed within tolerance.

05. POLISHPolishing should result in a smooth mirror finish.

06. LUBRICATELubrication is important to protect, preserve and aid the smooth operation of tooling.

07. STOREStorage cabinets should be specially designed to maximise security, safety and minimise potential damage.

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WHY USE PHARMACARE®?OPTIMISE MAINTENANCE & MANAGEMENT OF TABLET TOOLING

Tablet compression tools are often viewed as consumable items that can be easily replaced at relatively low cost. Maintenance therefore, can be seen as an unnecessary evil and overlooked within the tablet manufacturing industry. However, by carrying out maintenance procedures and keeping the tooling in pristine condition, costly tablet press downtime and compression problems such as sticking, capping, tablet weight and thickness variation will be reduced.

Correct maintenance and management is critical in obtaining maximum life from tooling. A high percentage of punch and die problems/damage can be conclusively traced back to poor handling and maintenance procedures. Serious issues with regulatory compliance can be pre-empted by having a planned professional procedure and carrying out audits of these on a regular basis.

I HOLLAND’S RECOMMENDED 7 STEP PHARMACARE® PROCESS:

STEP 01: CLEAN

Punch and die cleaning is essential for the removal of residue to avoid product contamination.Cleaning allows for accurate assessment of tooling condition during the inspection/assessment phase. Ultrasonic baths are recommended for cleaning as they allow for consistent cleaning results, reduced processing and operator time (cleaning times are normally 5 minutes) and reduced risk of tablet contamination. Importantly, ultrasonic cleaning allows for the whole punch to be cleaned including in and around the embossing.

| Ultrasonic cleaner | Ultrasonic punch holders

05

STEP 02: INSPECT / ASSESS

Following cleaning, punches and dies should be assessed visually to determine their general condition allowing the user to identify the repair and polishing work required, if any. Inspection and assessment can be carried out visually using an eye glass or a high magnification camera / lens. Visual inspection importantly allows for tooling life to be monitored and potential failure predicted. It also ensures that tablet detail and definition are maintained and helps to validate the cleaning and maintenance procedures.

STEP 03: REPAIR

The repair stage allows the user to rectify minor damage to the tooling before polishing. Minor damage and corrosion can be repaired using a motorised chuck. If damage is excessive, tools must be replaced. In all cases it is important to remember that repair to punches and dies should only be carried out when absolutely necessary as this can potentially change tooling dimensions resulting in other tabletting problems. Regular maintenance and repair work will help to extend tooling life, maintain tablet image and definition, optimise tooling productivity and prevent tooling breakages.

| Lens | iNSPECT 2.0 system


STEP 04: MEASURE

Measuring is essential after polishing and repair, as well as at regular intervals, to ensure that critical tooling dimensions have stayed within tolerance. The critical dimensions to measure are working length and overall length. Other key dimensions that can be checked include: head form, barrel diameter, tip diameter, die outer diameter and die bore diameter. Measurement can be carried out manually using conventional equipment such as micrometers, height gauges, go/no-go gauges. However, using digital equipment interfaced with our simple but powerful Tool Management System, the data can be captured, analysed and used to control tooling life-cycles as well as satisfy audit and regulatory requirements.

The use of digital measurement systems allow for measurements to be taken consistently, reducing the risk of manual data entry errors. Measurement is essential for validating the tooling specification and maintaining tablet weight and hardness thus avoiding non-conforming tablet production. It also allows for the proactive monitoring of the tooling inventory and the prediction of tooling replacements resulting in an improved return on investment.

| IH-TMS with measuring equipment

07

STEP 05: POLISH

Automated polishing is recommended to ensure punches are evenly polished to a consistent finish. Automated polishing ensures optimum and consistent tooling condition for maximum productivity, a reduced risk of damage compared to manual processes, reduced sticking, and saved labour costs.

Manual polishing using diamond paste or a dental motor can also be performed. However, this is an abrasive polishing method and care must be taken not to deform the tip profile and embossing causing a deviation from the tablet specification. Extensive polishing of die bores is not recommended as this can easily alter the size and geometry of the bore leading to ejection problems and incorrect tablet size, weight and dosage. Only light polishing or cleaning should be undertaken. Polishing should result in a mirror finish and smooth tooling surface.

Please Note: Re-cleaning after polishing is not required provided that a food grade polishing media and paste is used during this operation.

STEP 06: LUBRICATE

When storing tooling it is important to protect with a preservative or rust inhibitor to prevent corrosion. Prior to this, it is important to ensure that the tools are perfectly dry as any remaining moisture may be sealed in by the coating of oil. Lubrication helps to optimise the interface between the tooling and the press, reducing machine down time.

| MF40 automated polisher


STEP 07: STORE

There are many methods for storing punches and dies, from specially designed plastic storage boxes to custom designed and built storage cabinets. Correct storage facilitates good tooling management and ensures less press downtime as a result of poor handling and storage.

SUMMARYThe 7 step PHARMACARE® process, coupled with IH-TMS, is essential for maximising tooling life and producing quality tablets. Investment in the correct equipment and training will pay dividends in the long term, enabling the tablet press to be more productive and tooling life to be extended.

I Holland’s Customer Support Group is able to provide advice, training and product solutions for any aspects of punch and die maintenance, handling and storage.Please contact [email protected] for further information.

| Versatool storage cabinet | SafeStore box

STEP 01: CLEAN


A WIDE SELECTION OF TOOL CLEANING SOLUTIONS TO MEET A VARIETY OF REQUIREMENTS

ULTRASONIC CLEANERSSTEP 01: CLEAN - THE RANGE

| Holland Automated Cleaning System 'HACS'

| HCS1 | HCS2| Basic extra

ULTRASONIC CLEANING // THE KEY FACTS:

01. The most reliable method for ensuring that all deposits are removed from the tablet tooling// 02. Achieves a high degree of cleanliness from a short wash cycle // 03. All units are made of stainless steel and conform to the highest quality standards // 04. No special operator skill required // 05. Safe and highly portable // 06. Drip cups can also be cleaned in ultrasonic cleaner

| Standard extra

11

PRODUCT FEATURES:• Ultrasonic tanks made of cavitation-proof stainless steel• Slanted tank floor to facilitate the draining of the cleaning liquid• Integrated sweep mode for a continuous varying of sound field• Automatic temperature-controlled ultrasonic operation• Automatic safety switch-off after 12 hours operation, at 90°C or if liquid level drops too low• Housing made of stainless steel• Indication of set values and actual values

HACS' ADDITIONAL PRODUCT FEATURES:• 2 stage filtration assembly• Sandwich-type performance transducer systems• Two ultrasonic frequencies available: 25kHz for coarse and preliminary cleaning, and 45kHz for fine cleaning• Integrated sweep mode for a continuous varying of sound field• Pulse mode gives an intensified cleaning power for use on difficult to remove contamination• Temperature-controlled ultrasonic operation: ultrasound starts automatically when the preset temperature is reached• User-friendly operation; alternative display languages available• Housing made of V2A stainless steel• Stable, adjustable levelling feet• Drain duct on the rear of the unit, made of V2A stainless steel• Rinsing tanks with ultrasonic function• Hot air drying facility• Incorporates dosing alert system

CORE BENEFITS:• Cleans in a fraction of the time taken by conventional methods• Cleans tooling areas that are difficult to access by conventional methods (keyways etc.)• Consistent cleaning performance• No special operator skill required• Extremely safe in use• Process certified to leave no residue

HACS' ADDITIONAL CORE BENEFITS:• Fully automatic• Adds compliant process• Data logger available for 21 CFR compliance• Simplifies rinse process• Very fast warm air drying• Large cyclic capacity - up to 265 punches or 180 dies dependent upon maximum weight loading

FEATURES & BENEFITSSTEP 01: CLEAN


PRODUCT SPECIFICATIONSTEP 01: CLEAN

All units are supplied with stainless steel baskets, punch and die inserts and a supply of cleaning fluid. Punches are separated and suspended, preventing them from coming together causing damage in the cleaning process. Additional baskets and fluid can be purchased separately. If you have a requirement to clean die segments, please contact us for further details.

Part NumberMains .

Voltage+

Unit dimensionsW/D/H mm

Tank internal dimensionsW/D/H mm

Maximum tank volume

Punch capacity 'B'

Punch capacity 'D'

Die capacity

BasicK-HEUS-S180 220-240V

390/340/321 327 / 300 / 20018ltr

(4.76 US gal)1x32 1x20 25

K-HEUS-S180A 115-120V

Basic ExtraK-HEUS-BASEX 220-240V

568/340/321 505 / 300 / 20028ltr

(7.4 US gal)2x32 (64) 2x20 (40) 45

K-HEUS-BASEXA 115-120V

Standard K-HEUS-X300 220-240V 500/550/936 330 / 300/30030ltr

(7.93 US gal)1x32 1x20 25

Standard Extra*+

K-HEUS-EB550 3x400V

670/580/936 500 / 330 / 35058ltr

(15.33 US gal)2x32 (64) 2x20 (40) 45K-HEUS-EB555 3 x 200-208V

K-HEUS-EB560 220-240V

HCS1* K-HEUS-HCS1 3 x 400 / N / PE 500/940/1200 296 / 501 / 309 55ltr (14.53 US gal) 2 x 32 (64) 2 x 20 (40) 45

HCS2* K-HEUS-HCS2 3 x 400 / N / PE 1500/940/1200 296 / 501 / 309 55ltr (14.53 US gal) 2 x 32 (64) 2 x 20 (40) 45

HACS* HEUS-HACS 3 x 400 / N / PE 2743/1439/1922 296 / 201 / 309 55ltr (14.53 US gal) 2 x 32 (64) 2 x 20 (40) 45

*Also suitable for cleaning die segments + Other voltages available on request

| Insert

| Basket

ACCESSORIES

PART NUMBER OPTIONS Capacity

HEUS-BAS09 Stainless Steel Basket Basic (spare) NA

HEUS-BAS10 Stainless Steel Basket BasicExtra (spare) NA

HEUS-BAS11 Stainless Steel Basket Standard (spare) NA

HEUS-BAS12 Stainless Steel Basekt StandardExtra (spare) NA

HEUS-BAS07 B Type Holder for Ultrasonics 32 (Punches)

HEUS-BAS08 D Type Holder for Ultrasonics 20 (Punches)

HEUS-BAS13 441 Type Holder for Ultrasonics 16 (Punches)

HEUS-BAS14 25/32U Type Holder for Ultrasonics 16 (Punches)

HEUS-BAS15 25/32L Type Holder for Ultrasonics 16 (Punches)

HEUS-BAS18 Comprima Type Holder for Ultrasonics 28 (Punches)

HEUS-BAS20 FS12 Type Holder for Ultrasonics 56 (Punches)

HEUS-EB550L Stainless Steel Hinged Lid StandardExtra NA

HEUS-BAS16 Pair of Handles for Holders NA

HEUS-DIE02 Die Holder for Ultrasonics 45 (Dies)

CERT COA Certificate of Analysis NA

CLEANING SOLUTIONS

PART NUMBER OPTIONS

HEUS-CON08 Labclean Detergent (10ltr)

HEUS-CON06 KS Corrosion Inhibitor (2.5ltr)

STEP 02: ASSESS


INSPECTION EQUIPMENT STEP 02: ASSESS - THE RANGE

| iNSPECT 2.0| Mini-Cam - Optional WiFi kit available

| Scope| Eye Loupe

FOR VISUAL INSPECTION OF PUNCH TIPS AND TABLETS

NEW PRODUCT

15

FEATURES & BENEFITSSTEP 02: ASSESS

MINI-CAM

PRODUCT FEATURES:• Up to 200x magnification• LED illuminated• Protective carry case• 1.3 MP• WIFI Connectivity - optional extra

OPE

CORE BENEFITS:An easy to use low cost digital inspection system which is compatible with the I Holland Tooling Management System (IH-TMS) allows the visual assessment of tablets and tablet tooling. Mini-Cam is easily transportable in a protective carry case and has the ability to save and share images via computer.

SCOPE

PRODUCT FEATURES:• 6x magnification• LED illuminated• Universal stand

SCOPECORE BENEFITS:Allows optical (non-digital) assessment of finished tablets and entire inventory of tablet tooling, highlighting poor tablet appearance and the need to investigate production conditions or preventing costly damage to tablet presses caused by damaged and poorly maintained tooling.

iNSPECT 2.0

PRODUCT FEATURES:• Up to 300x magnification• Full HD (1080p) digital microscope• Integral 8-point LED ring light• Captures image direct to USB memory stick• Stand provides exceptional stability• Auto focus• Supplied with full HD monitor

SCOPE

CORE BENEFITS:Full HD live video imaging system. Up to 300x magnification and auto focus ensures ultra sharp images of tablet and tooling detail at all times. Compatible with or without a computer.

LOUPE

PRODUCT FEATURES:• Up to 10x magnification• Low cost• Easily transportable

SCOPECORE BENEFITS:Low cost, basic inspection tooling


PRODUCT SPECIFICATIONSTEP 02: ASSESS

MINI-CAM

PART NUMBER K-HEAP-INS53

Magnification 200x

Image Capture Yes

Connection to Computer? Yes

LED Yes

WIFI Yes (optional extra)

Image Resolution 1280 x 1024

SCOPE

PART NUMBER K-HEAP-INS39

Magnification 6x

Image Capture No

Connection to Computer? No

LED Yes

WIFI No

Image Resolution N/A

iNSPECT 2.0

PART NUMBER K-HEVI-VIS04

Magnification 300x

Image Capture Yes


LED Yes

WIFI No

Image resolution 1920 x 1080

LOUPE

PART NUMBER Various

Magnification up to 10x

Image Capture No


LED No

WIFI No

Image Resolution N/A

ASSESS // THE KEY FACTS:

01. Establishes whether the tablet production process is running well and if maintenance is required // 02. Allows for potential failure to be predicted // 03. Ensures tablet detail and definition are maintained // 04. Helps to validate ongoing maintenance procedures // 05. Images able to be saved on a computer can easily be e-mailed to I Holland for consultation

STEP 03: REPAIR

19

REPAIR EQUIPMENT STEP 03: REPAIR

DOUBLE ENDED POLISHING MOTOR

For polishing and de-burring all shaped and embossed punch tips.

MOTORISED CHUCK

A compact bench-top polishing unit for effective lapping, de-burring and general maintenance of punches and dies. The motorised chuck accepts punches and dies up to 40mm in diameter.

UC500

The UC500 electric polishing unit should be used in conjunction with the motorised chuck in order to polish plain round tips.


REPAIR KITSTEP 03: REPAIR

REPAIR KIT // THE KEY FACTS:I Holland offer a range of consumable products which can be bought separately, or as a complete maintenance kit (including the UC500, electronic polishing unit, polishing motor, comparators, motorised chuck and consumables pictured above).

A.

B.

C.

D.E.

F.

I.K.H.

G.M.

L. N.

O.J.

21

A. Precipitated chalk - removes polishing compound (e.g. Hyfin paste or diamond) residue from punch tips after polishing.B. Lappingfluid - flushes out polishing paste residue.C. Super chrome polish - used in conjunction with the double ended motor and nylon wheel brushes for polishing embossed or shaped punch tips.D. Brass polishing brushes - used to remove stains and corrosion on punch tips and to blend areas of the tip that have been repaired using the Arkansas stone.E. Radius gauges - used to determine the radius of plain concave tips and to use as a template during the shaping of felt bobs.F. Diamond polishing compound - available in fine or coarse grade, used with nylon wheel brushes for polishing punch tips.G. Nylon polishing brushes - fitted into the dental motor for polishing all embossed, flat bevelled and shaped punch tips.H. Turret brushes - for cleaning punch guides.I. Felt bobs - fitted into the hand piece of the UC500 unit to polish the tips of plain round punches. The radius gauges are used on the felt bobs to shape them when polishing plain tips.J. Bramet strips - used with the lapping sticks for removing marks and damage to punch heads and for adjusting working length of punches. A fine emery should also be used to improve the surface finish after using the coarse emery.K. Corrugated strips - ideally used on a bench top for safe handling of punches whilst polishing.L. Eye glass - used to closely examine punches and the tips.

M. Lapping sticks - used for de-burring punch tips. Abrasive strips & emery rolls are used with lapping sticks to give the emery a hard surface.N. Arkansas stone - used to remove slight damage to edges of punch tips and to remove burrs from the outside edges.O. Scotch Brite - used for the removal of any surface rust.P. Cotton wool (no image) - used to wipe away any residue fluids or polishing paste.Q. Length pot (no image) - used to hold and stabilise the punch for measurement/inspection.R. Length gauge (no image) - used for setting measuring devices when checking punch length.S. Course emery (no image) - for removing marks and damage to punch heads and for adjusting the working length of punches.T. UC500 (see page 19) - used with the motorised chuck for tip polishing of plain & concave punches, large FBE’s and die bores (includes Ua).U. Double ended polishing motor (see page 19) - used for polishing and de-burring all embossed punch tips (including breaklines) flat bevelled edge and shaped punch tips.V. Motorised chuck (see page 19) - used for general cleaning and polishing of punch heads, punch bodies, polishing plain concave punch tips and cleaning die bores.W. Bench comparator (no image) - This is used for the measurement and comparison of punch lengths. Also for checking punch tip to barrel concentricity. Used with ‘B’ & ‘D’ type punch holders (pots) and length setting gauge.


REPAIR KIT COMPONENTSSTEP 03: REPAIR

REPAIR KITS

PART NUMBER DESCRIPTION QUANTITIES

K-HEEQ-KIT01 Repair Equipment Kit 1 (240V/50Hz) 1




K-HEEQ-COM Repair Consumables Kit 1

K-HEEQ-EQT12A U Handy Kit (230V) 1

K-HEEQ-EQT12B U Handy Kit (120V) 1

REPAIR KIT CONSUMABLES

PART NUMBER IMAGE REF. DESCRIPTION QUANTITIESHEPE-CHA01 A Precipitated Chalk 500g tub

HEPE-HYP01 B Lubricating Fluid (Lapping Fluid) 2.5ltr

HEPE-SCP01 C Super Chrome Polish 250ml

HEMA-BRU01 D Brass Wheel Brushes 2” Dia. Pack of 10

HEPE-GDI01 F Polishing Diamond 3-KD-C2 Green 5g

HEMA-BRU06 G Nylon Wheel Brushes 19mm Dia. Pack of 12

HEMA-BRU02 H Turret Brush B Type (brass) 1

HEMA-BRU03 H Turret Brush D Type (brass) 1

HEMA-BRU08 H Turret Brush B Type (nylon - black) 1

HEMA-BRU09 H Turret Brush D Type (nylon - black) 1

HEMA-BRU08W H Turret Brush B Type (nylon - white) 1

HEMA-BRU09W H Turret Brush D Type (nylon - white) 1

HEPE-FB004 I Felt Bobs No.4 - 9mm Pack of 10



HEMA-GAU03 E Radius Gauge 1mm - 7mm (metric) 1

HEMA-GAU04 E Radius Gauge 7.5mm - 15mm (metric) 1

HEMA-GAU05 E Radius Gauge 15.5mm - 25mm (metric) 1

REPAIR EQUIPMENT

PART NUMBER IMAGE REF. DESCRIPTION QUANTITIESHEMA-EQT12 T UC503 Power Controller 230V 1

HEMA-EQT13 T UC500 Heavy Duty Unit UM 23 (Minitor) 1

HEMA-EQT13A T UT03 Handpiece 1

HEMA-EQT17 T UC501C Power Controller 110V 1

HEMA-EQT15 Ta 3.175mm (1/8) Collet Kp-063 for UM 23 1

HEMA-EQT01 U Double Ended Polishing Motor (240V/50Hz) 1

HEMA-EQT02 U Double Ended Polishing Motor (110V/60Hz) 1

HEME-MC012 V Motorised Chuck Unit (120V/50Hz) 1




HEMA-COM01 W Bench Comparator + Analogue Metric Dial 1

HEMA-COM02 W Bench Comparator + Analogue Imperial Dial 1

23

REPAIR KIT CONSUMABLES cont

PART NUMBER IMAGE REF. DESCRIPTION QUANTITIESHEMA-GAU01 E Radius Gauge 1/32 - 1/4 inch (imperial) 1

HEMA-GAU02 E Radius Gauge 17/64 - 1/2 inch (imperial) 1

HEMA-ABS01 J Bramet Strips 320 Grit Pack of 10

HEMA-ABS02 J Bramet Strips 600 Grit Pack of 10

HEPE-CPS01 K Corrugated Plastic Strips 1

HEPE-EYE02 L Loupe x3 Magnification (basic) 1

HEPE-LS005 M Hardwood Lapping Sticks No. 5 Pack of 10



HEMA-ABS05 N Arkansas Stone - Oblong 100x25x6mm 1

HEMA-ABS03 S Emery Roll P80 Grit - 25mm x 25mm 1

HEMA-ABS04 S Emery Roll P180 Grit - 25mm x 25mm 1

REPAIR KITS - ADDITIONAL OPTIONS

PART NUMBER DESCRIPTION QUANTITIESHEMA-EQT14 On/off footswitch for UC 500 series power controller 1

HEBR-CUP01 Bristle Cup Brushes 9mm Dia. Pack of 10



HEBR-NWB04 Bristle Wheel Brushes 19mm Pack of 10

HEBR-NWB05 Bristle Wheel Brushes 22mm Pack of 10

HEME-REA01 BB Type Die Pocket Cleaner 1

HEME-REA02 B Type Die Pocket Cleaner 1

HEME-REA03 D Type Die Pocket Cleaner 1

HEME-REA04 Killian 30 x 25 Type Die Pocket Cleaner 1

HEME-REA05 Killian 35 x 25 Type Die Pocket Cleaner 1

HECS-TRA01 TSM Manual 1

HECS-EUR02 Eurostandard Full Edition (Volumes 1 to 5) 1

HEPE-BD001 Polishing Diamond 1-KD-C2 - Blue 1

HEPE-BDI01 Polishing Diamond 14-KD-C1 - Brown 1

HEME-YDI01 Polishing Diamond 6-KD-C2 - Yellow 1

HEME-RED01 Polishing Diamond 8-KD-C2 - Red 1

HEME-MAH01 Polishing Diamond 25-KD-C2 - Mahogany 1

HEPE-WDI01 Polsihing Diamond 90-KD-C2 - White 1

HEMA-BRU14 Nylon Wheel Brushes 15mm Dia. Pack of 12

HEMA-BRU15 Nylon Wheel Brushes 21mm Dia. Pack of 12

HEMA-BRU17 Nylon Wheel Brushes 2" Dia. Pack of 10

HEPE-FB001 Felt Bobs No.1 - 20mm Pack of 10

HEPE-FB005 Felt Bobs No.5 - 7mm Pack of 10

HEMA-ABS08 Arkansas Stone - Round 4x3/8 1

HEMA-ABS09 Arkansas Stone - Square 3x3/8 1

STEP 04: MEASURE


MEASUREMENT SYSTEMSSTEP 04: MEASURE

I Holland Tool Management System (IH-TMS) with optional extras

21 CFR Part 11

COMPLIA

NT


IH-TMSSTEP 04: MEASURE

FULL TOOLING INVENTORY PROVIDING LIFE-CYCLE MANAGEMENT

OVER COMPRESSION, REPAIR AND REPLACEMENT PROMPTS, ALLOWING PLANNED TOOL MAINTENANCE

SYSTEM IS FULLY ADAPTABLE TO ANY LANGUAGE OR ANY SCRIPT (R TO L OR L TO R)

SCREEN

SCREEN

29

FEATURES & BENEFITSSTEP 04: MEASURE

KEY FEATURES:• Non-contact system for accurate length measurement• Super accurate laser displacement sensor with 0.05 micron repeatability across the tool set• Quick to identify lowest point on the punch tip cup without marking the tool face• Length measurement for any punch type including multi tip tooling• Type of laser: Displacement sensor

CORE BENEFITS:• Consistent measurements are taken time after time• Minimum tooling knowledge is required by the operator• Helps to ensure a scratch free tip face and smooth surface thereby helping to avoid problems such as sticking

KEY FEATURES:• Full tool inventory• 21 CFR part 11 compliant• Powerful management reports• Tool measurement capability with USB connectivity• 64 Bit windows based application with touch-screen• Eurostandard Educational Suite Embedded• Flexible, user definable multi-lingual dictionary• Over compression warnings and tool repair / replacement prompts

CORE BENEFITS:• Tooling life-cycle and rotation management• Gives complete audit trail• Keep track of key performance indicators, such as tablet quantities produced, yield etc.• Compatible with industry standard measuring equipment• Easy to use interface• Access drawing and tool image archives• Protect tooling with planned tool maintenance schedule• Measurements can be input using simple gauges

HNC Laser

I Holland Tool Management System

System is 21 CFR Part 11 compliant with password protection, several levels of authority, comprehensive document management and audit trail


PRODUCT SPECIFICATIONSTEP 04: MEASURE

DIGITAL COMPARATOR

PART NUMBER DESCRIPTION QUANTITIESHEAP-DAP01 Mini Processor 1

HEAP-INS06 IDF Digimatic Length Gauge Indicator 1

HEAP-INS09 Data Output Cable for IDF Indicator 1

HEAP-INS05 IDF Comparator Stand 1

HEMA-LGH11 Length Pot - B Type (nylon) 1

HEMA-LGH12 Length Pot - D Type (nylon) 1

HEMA-LGH04 Length Gauge - TSM 5.25" Stainless Steel 1

HEMA-LGH13 Length Gauge - Euronorm 133.600mm Stainless Steel 1

Standard B and D nylon length pots come with IH-TMS® as standard. Further details ofthese products are supplied with the repair kit information on page 21.

ADDITIONAL MEASUREMENT EQUIPMENT

PART NUMBER DESCRIPTION QUANTITIESK-IHTMS400 IH-TMS Handheld Instruments Kit 1

K-IHTMS500 IH-TMS Concentricity Module Kit 1

K-HEAP-INS47 HNC Laser 1

I HOLLAND TOOL MANAGEMENT SYSTEM


K-IHTMS100 IH-TMSBasic - Starter package includes compact & powerful touch screen, PC, scanner-printer, mouse,keyboard & minicam system 1

K-IHTMS200 IH-TMSContact - Full system as IH0TMSBasic plus digital comparator 1

K-IHTMS300 IH-TMSLaser - Full system as IH-TMSBasic plus I Holland non-contact laser comparator 1

VALIDATION, TRAINING & SUPPORT


IHTMS600 Validation Documentation for IH-TMSBasic 1

IHTMS610 Validation Documentation for IH-TMSContact 1

IHTMS620 Validation Documentation for IH-TMSLaser 1

IHTMS700 Installation & Training (3 Days) for IH-TMSBasic 1

IHTMS710 Installation, Training & Validation Support (4 Days) for IH-TMSContact or IH-TMSLaser 1

IHTMS800 IH-TMS Software Support (24 Months) 1

STEP 05: POLISH


AUTOMATED POLISHINGSTEP 05: POLISH

MF40 Pharma

MF80 Pharma

33

AUTOMATED POLISHING MACHINES

KEY FEATURES:• Stainless or Aluminium cabinet with door and perspex windows• Tool holding fixtures attached to drive unit• Automatic drag finishing process• Variable speed drive• Timer and safety interlock• All electrics are single phase• CE marked• Compatible with various media types• Now available with acetal, food grade punch holders

CORE BENEFITS:• Polish dull and discoloured punches to a micro-fine, high quality finish• Can polish coated punches• Reduce health and safety risks• Eliminate risk of overpolishing• Allow smoother operation and improved efficiency within the tablet press• Enable higher press speeds and increased tablet productivity• Can help overcome common tooling problems such as sticking and corrosion• Easy to use with minimum training required• Consistent results every time

Polish dull and discoloured punches to a micro-fine, high quality finish using a drag finishing process.

FEATURES & BENEFITSSTEP 05: POLISH


PRODUCT SPECIFICATIONSTEP 05: POLISH

MF POLISHER PUNCH HOLDERS AND CAPACITY

TYPE OF HOLDER ACETAL STEEL

DESCRIPTION B-TYPE D-TYPE 441 FS-12 IMA 20/28 25/32

MF403 X 17 HOLES(51 PUNCHES)K-HEPO-COM22

3 X 12 HOLES(36 PUNCHES)K-HEPO-COM23



3 X 10 HOLES(30 PUNCHES)K-HEPO-COM01/I

6 X 9 HOLES (U&L)(27 PUNCHES)K-HEPO-COM01/K


MF805 X 17 HOLES(85 PUNCHES)K-HEPO-COM30




5 X 10 HOLES(50 PUNCHES)K-HEPO-COM02/I



TECHNICAL SPECIFICATIONS

PART NUMBER MACHINE WIDTH(MM) DEPTH(MM) HEIGHT(MM) WEIGHT(KG) POWER (KVA/V)

HEPO-MF040 Microfine Polishing Machine - MF40 Pharma 1124 851 1972 350 1,2/230

HEPO-MF080 Microfine Polishing Machine - MF80 Pharma 1330 1090 2260 500 2,0/230

MF POLISHING // THE KEY FACTS:

01. Polish dull and discoloured punches to a micro-fine high quality finish using a drag finishing process // 02. The entire punch is automatically rotated through media and polishing paste // 03. Automated process saves valuable time in the tool room and ensures consistent results each and every time // 04. Means smoother operation and improved efficiency in the tablet press // 05. Can help overcome common tooling problems such as sticking and corrosion

EXTRAS

PART NUMBER DESCRIPTION QUANTITYHEPO-IQOQ IQ/OQ Documentation for MF Polisher 1

HEPO-SSMIXPAD Stainless Steel Mixing Paddle for Polishing Paste 1

HEPO-COO04 Water Cooling System for MF40 Pharma 1

HEPO-COO05 Water Cooling System for MF80 Pharma 1

MF POLISHER DIE HOLDERS AND CAPACITY

DESCRIPTION D-TYPE B-TYPE BB-TYPE BBB-TYPE BBS-TYPE

MF 35/40&70/80 10 X D DIESK-HEPO-DIE02

12 X B DIESK-HEPO-DIE03

12 X BB DIESK-HEPO-DIE04

16 X BBB DIESK-HEPO-DIE08

16 X BBS DIESK-HEPO-DIE07

MF12 4 x D DIESK-HEPO-DIE09

6 X B DIESK-HEPO-DIE05

6 X BB DIESK-HEPO-DIE06

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MF POLISHER ACCESSORIESSTEP 05: POLISH

CONSUMABLE POLISHING MEDIA AND PASTE

PLEASE NOTE: Media should be replaced after every 100 hours use and paste after every 10 hours. Failure to renew media and paste within guidelines will result in poor performance of your MF polishing machine.

POLISHING GRANULE

PART NUMBER NOTES QUANTITY

HEPO-PLA01A DFPA0/400 Plastic - Best polishing capabilities. Chiller unit recommended 25kg

HEPO-WAL01 H1/500 Walnut - Good polishing capabilities, however is not suitable for ‘nut free’ environments 25kg

HEPO-MAZ03 M1/03 Maize - Offered as ‘nut free’ alternative to the walnut media 25kg

HEPO-WAL02 Irradiated H1/500 Walnut - Goes through a radiation process(dosage of 10-30 kilogray) to kill bacteria 25kg

HEPO-MAZ02 Irradiated M1/03 Maize - Goes through a radiation process(dosage of 10-30 kilogray) to kill bacteria 25kg

POLISHING PASTE

HEPO-PLA05 P16 - For Plastic - Used to charge the media prior to use and re-charge the media after every 10 polishing hours 1kg

HEPO-PLA04 P16 - For Plastic - Used to charge the media prior to use and re-charge the media after every 10 polishing hours 7.5kg

HEPO-PAS03 P1- For Walnut & Maize - Used to re-charge the media after every 10 polishing hours 1kg

HEPO-PAS02/2 P1- For Walnut & Maize - Used to re-charge the media after every 10 polishing hours 7.5kg

Acetal Holders FDACOMPLIANT

STEP 06: LUBRICATE

37

PHARMALUBE, OIL & GREASESSTEP 06: LUBRICATE

KEY FEATURES:• Food grade and FDA compliant• Non-toxic• Appropriate selection of products for tooling applications • MSDS documents available• Product conforms to Kosher dietary laws

CORE BENEFITS:• Clean, colourless, odourless and non- staining requiring very minimal user precautions when handled• Provides and maintains a high level of product performance and security where tooling lubrication is required

THE I HOLLAND PHARMALUBE RANGE PROVIDES YOU WITH A COMPLETE SYSTEM OF NON-TOXIC, FDA COMPLIANT OILS AND GREASES AND CLEANERS. THIS RANGE CAN BE USED FOR THE CLEANING OF TABLET PRESSES AND THE SHORT OR LONG TERM STORAGE OF TABLET PUNCHES, DIES AND SEGMENTS.

Food Grade FDA

COMPLIANT


PRODUCT SPECIFICATIONSTEP 06: LUBRICATE

PHARMALUBE - OIL

PART NUMBER DESCRIPTION USAGE QUANTITY

HEOG-NTO21 Food Grade Oil - FS HYD OIL68 General lubrication and corrosion protection for tablet compression tooling

5L

HEOG-NTO22 Food Grade Oil - FS HYD OIL68 25L

PHARMALUBE - GREASE


HOEG-NTO25 Food Grade Grease - FS EXTRA Longer term storage 400g Cartridge

PHARMACLEAN


HEOG-NTO10 Food Grade Cleaner - FS Ease - Trigger Spray Food safe penetrating & cleaning lubricant, with added corrosion protection

500ml

HEOG-NTO11 Food Grade Cleaner - FS Ease 25L

PHARMALUBE // THE KEY FACTS:01. Machine component protection equal to or greater than that of conventional petroleum lubricants // 02. Lubrication performance within a wide temperature range in all operating conditions // 03. Full selection of products available for all types of applications

STEP 07: STORE

41

VERSATOOL™ MODULARRANGESTEP 07: STORE

9 DRAWERS

MODELMAXIMUM CAPACITY

B TOOLING D TOOLING WEIGHT INSERTS

9-2 864 punches432 dies

720 punches360 dies

140kg (nett)

4 x drawer


1080 punches540 dies

200kg (nett)

6 x drawer



240kg (nett)

8 x drawer

15 DRAWERS

MODELMAXIMUM CAPACITY

B TOOLING D TOOLING WEIGHT INSERTS



235kg (nett)

4 x drawer



333kg (nett)

6 x drawer



400kg (nett)

8 x drawer

CHOOSE FROM OUR MODULAR RANGE OF STORAGE UNITS TO ACCOMMODATE YOUR STANDARD TOOL SETS

MODEL 9-2

9-2 | 9-3 | 9-4

1045

mm

| 15-2 | 15-3 | 15-4

1600

mm

| Plan view of drawer & insert layout

530m

m

720mm 1030mm 1325mm


DIE SEGMENT STORAGESTEP 07: STORE

VERSATOOL UNITS CAN BE TAILORED TO INCORPORATE 3 AND 5 SEGMENT SETS FOR 1200, 2090, 3090 AND FE TABLET PRESSES. CORRESPONDING PUNCHES CAN BE HOUSED ALONGSIDE THE MATCHING DIE SEGMENTS FOR EFFICIENT STORAGE

DIE SEGMENT MODELS AND PART NUMBERS

MODEL CONFIGURATION FOR PUNCHES & SEGMENTS

PART NUMBERMAX NO OF SETS

STAINLESS STEEL MILD STEEL

6-2 6 Drawers - 6 Inserts per Drawer VERS110S VERS110M 6











MTTDStainless Versatool Segment Transportation Trolley VERS600S N/A VARIES

43

STORAGE // THE KEY FACTS:01. Storage systems for punch & die tooling incorporating a range of inserts for all tool types and die segments // 02. Made to the highest standards by quality precision sheet metal engineers // 03. All units feature anti-tilt full length lockable drawer slide mechanisms as well as optional rear wall fixing brackets for added safety

Double stacking of tooling trays possible to allow punch sets to be stored together.

FEATURES AND BENEFITSSTEP 07: STORE

KEY FEATURES:• All standard units with drawers feature anti- tilt mechanism • Units supplied with wall fixing brackets where required.• Drawers are lockable • Built in Great Britain to high engineering standards with strong under chassis• High capacity with double or triple stacking of tooling trays• Trays available for many different tool types.• Layouts can be planned and tailored to your space and requirements

CORE BENEFITS:• Keep all staff safe from heavily loaded cabinets over-balancing• Ensure valuable tooling is securely stored• Excellent build quality with ease of placement using forklift if required• Store tooling sets together in the same location • Can accommodate a variety of alternative tooling types• All space is used efficiently to make the most room you have available

http://tablettingscience.com/PDFs/Downloads/polisher-quotation-request-form.pdf


I HOLLAND SAFESTORESTEP 07: STORE

STORAGE CAPACITY

PART NUMBER / DESCRIPTION PUNCHES DIES

HECA-REM01 / ‘B’ Type SafeStore Box 72 36

HECA-REM02 / ‘D’ Type SafeStore Box 48 24

KEY FEATURES:• Holds 72 ‘B’ type punches and 36 dies• Holds 48 ‘D’ type punches and 24 dies

CORE BENEFITS:• Cost-effective method of storing punches and dies• Prevents damage to tooling during movement and maintenance• Compact stacking feature allows for efficient use of toolroom space

HOLLAND SAFESTORE // THE KEY FACTS:01. Boxes available in ‘B’ or ‘D’ type // 02. Punches and dies can be stored together // 03. Boxes nest when empty and stack together when fully loaded // 04. Produced from FDA approved moulded polyethylene in a one piece seamless mould

REVIEW YOUR CURRENT PRACTICES AND HIGHLIGHT RECOMMENDED IMPROVEMENTS

DAY 1 & 2• Audit and review of your tool maintenance procedures, methods and equipment• Introduction to 7 Step process and SOP

KEY FEATURES:• Planned, professional programme• Fully customised to your specifications• A full independent audit• Audit and training carried out at your site, to your convenience

DAY 3• Presentation of recommendations and full audit report

CORE BENEFITS:• Reduce downtime through unplanned tooling maintenance and replacement• Cover all the topics that are important to your business• Uncover the root causes to persistent problems such as sticking and corrosion

I Holland’s PharmaCare® 7 Step process is a program of professional planned maintenance and audit which has been designed to outline an appropriate method for the maintenance of tablet compression tooling, ensuring it is clean, serviceable and within specification whenever it is required.

PHARMACARE® 7-STEP AUDIT & TRAINING

www.iholland.co.ukI Holland Limited, Meadow Lane, Long Eaton, Nottingham. NG10 2GD. Englandt: +44 (0) 115 972 6153 // f: +44 (0) 115 973 1789 // e: [email protected]

pharmacare - i hollandtablettingscience.com/pdfs/downloads/7-step-pharmacare-process.pdf ·...

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