Packaging of Pharmaceutical, Home and Personal Care

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1 Packaging of Pharmaceutical, Home and Personal Care HENKIE WIBAWA April 2013

2 Agenda 1 Flexible Packaging for Pharmaceutical Products 2 Home and Personal Care Retail Packaging 3 Digital Solution for Labels

3 Market situation ethical & OTC in 2007 market share in m² (estimated) (estimated) Private Eth 51 % 51 Mio. m² Private OTC 74 % 37 Mio. m² Foreign Eth 36 % 36 Mio. m² Foreign OTC 18 % 9 Mio. m² State-own Eth 13 % 13 Mio. m² State-own OTC 8 % 4 Mio. m² Total % ~ 150 Mio. m² 3

4 4. Product Product Awareness: correctly maintained Drug Master Files traceability of our laminate and raw materials manufacturing according to GMP guidelines knowledge on the customer practices Laminate Components Process of Laminating Pharmaceutical Packaging Product Awareness Customer Service All these pillars are fundamental for being a competent partner in pharma packaging and for satisfying our customer s demands. 4

5 Raw Materials Clean Room Pharmaceutical Packaging Converting Machines Skilled Manpower 5

6 Clean Room Clean room printing, slitting and packing Class Extension of the concept to new factories and workshops

7 Blister and Strip Foil Common Pharma Flexi-Packaging Type in Indonesia Blister Foil Hard Temper AL Foil based, one or both side side printed, heatseal lacquer on one side to facilitate sealing on PVC or PVDC coated PVC Strip Foil One side printed soft temper AL Foil and extrusion coated on the other side to facilitate heat sealing

8 PolyCellonium or Strip-Foil MSAT specification SPE specification Polycellonium Laminate aluminium specification + primer adhesive 8

9 Alu-Strip-Packs a new developing concept eliminated MSAT Concept for Alu-Strip-Packs step 1) substitution and completion of the two-layers-development step 2) printing and overlacquering on the Alu-soft temper step 3) extrusion coating station on existing machine. This structure could be the alternative to manage catching up with difficult sourcing of MSAT It has to reduce cost and work together with other completion of innovative-development 9

10 ALU-STRIP SEAL

11 Formability of aluminium foil Aluminium foil of > 20µm is pinhole free => provides absolute barrier elongation of pure aluminium foil is about 20% - crystalline structure - if only one layer (of crystals/ grains) is available => premature cracking in case of defects within this layer - if more than one layer is available => defects or weak spots can be compensated

12 BLISTER : lidding AL20 or AL25 Printed one or both sides Coloured lacquers or HSL Printing on dull or bright side HSL or PVDC20

13 Folded boxes coatings Hygienically excellent High scuff and rub resistance Slippery slip angle (17-19 ) Medium slip angle (24-26 ) High gloss coatings Gloss coatings Matt coatings

14 Barrier Properties WVTR Water Vapour Transmission Rate Grams/m²*day at 23 C and 85% r.h PVC 250/40 PVC 250/60 PVC 250/80 PVC 250 PET 250

15 COC Coex Barrier Properties WVTR Water Vapour Transmission Rate Flat films according to DIN 53 g/m²/day at 38 C and 90% r.h PVC 250/40 PVC 250/60 PP/COC120/PP PP/COC240/PP PP/COC300/PP PVC/PE/PVDC90 PVC/Aclar Coldform 0

16 Packaging Machine Principle (Form-Fill-Seal) Forming Filling Sealing

17 Cold Form Blister - High Barrier Packaging for Pharmaceuticals

18 Forming technologies for blisters Bottom foil Thermoforming PVC, PVC/PVDC, PP, Aclar/PVC, PP/COC/PP,... Coldforming opa / Al / PVC (= standard ), opa/ Al/ PE, Al / opa / Al Alu+HS-lacquer If barrier is not high enough, Alu/ Plastic laminates can provide the required barrier properties

19 Packaging Machine Principle (Form-, Fill-, Seal) COLD FORMING

20 Simulation Program for the design of coldform blisters & tools Customer specifications (dimension of the product, laminate,..) Order form: Simulation Program for Coldformed Blisters Customer: Product: Design of the cavity based on experience Why using Simulation Software? g no extensive and time-consuming trials g optimal tools for high process reliability g optimisation of existing blisters and forming tools Step 2 Product geometry (capsule, tablet,..) A:...B:...H:... sample Design of cavities Certain form depth or headspace required? Information on blister card: Formation of cavities on blister card? Outlining here Simulation study Number of units per blister:... Maximum size of blister card? A...B Information on packaging machine: Machine manufacturer/ type of machine: Forming cycles/ minute?... Size of forming station? A...B... Type of laminate: (from outer to inner layer) 25µm OPA / 45µm Al / 60µm PVC punch material: (if known) PTFE (Teflon) POM S-green (PE-HMG) others: further details of customer's request: (maximum size of blister card,..) Forming Limit Curve CAD-Plot for tool manufacturing Forming Curve

21 Anti-Counterfeiting with VISIBLE DEVICE : Special Ink photochromic ink optical colour change when exposing to sunlight thermochromic ink temperature colour change, when spec. temp. is reached interference ink optical delicately shimmering pastel shades fluorescent ink UV-light high colour strength - intensively fluorescent luminescent ink UV-light colour strength, when exposed to UV-light coin ink rubbing rubbing a certain spot with a coin RFID ink spec. device gives pulse or signal, no information Infrared Ink IR-light only detectable under IR-light source soluble/bleeding ink water/solvent bleeding when wetted with water or solvent

22 Securitag biomolecular tracing offered Application of a security tracing device on a primary pharmaceutical packaging Application of an invisible, unique and inviolable coding system Rotogravure and flexo printing security tracing DNA sequence code fingerprinting Highlights protection of commercial interests Cyphermark detection Two level protection: Field level identifying the presence of fluorescent dyes protection against parallel trading and counterfeiting permanent tracing totally secure and anti-counterfeit able various formulations for specific applications needs unequivocal identification of the pharmaceutical packaging harmless secure tracing for the environment and living organisms a strong asset in product certification procedures providing proof of ownership of source Expert level extracting the Cyphermark DNA and secret code information

23 Cold Form Blisters

24 Coldform laminate structures Lidding foil Coldform bottom foil Coldform bottom foil: PVC 60 µm HDPE µm Al 45 µm OPA 25 µm Al 45 µm OPA 25 µm Standard PVC-free

25 Why using coldform blister packs? single unit dose package high convenience (easy opening => push through) tamper evident feature child resistance can be increased by using specific lidding systems (peel & push) ideal barrier properties suitable for all climatic zones image as a high value package opacity increases child resistance contributes to anti-counterfeiting (requires remarkable know-how & equipment)

26 Coldform blister - a High Barrier System 3 2,5 2 1,5 1 0,5 0 Water Vapour Transmission Rates WVTR for flat sheets (not formed) Aluminium offers ideal protection against moisture, oxygen, gas, light and microbiological impact Grams/m²*day/ at 38 C / 90% r.h Barrier properties PVC 250 PVC/PVDC 250/40 PVC/PVDC 250/60 PVC/PE/PVDC250/30/60 PP/COC/PP30/190/30 PVC/Aclar 22A PVC/PE/PVDC250/30/90 Coldform Alu/ Alu = Coldform PVC PP PVC/PVDC PVC/ Aclar PP/COC/PP

27 Protection of the filling good Biological impact mechanical effect gas oxygen moisture light temperature

28 Forming capability of Alu/ plastic laminates In combination with plastic, an elongation of 25-30% can be achieved Al/plastic laminate Forming Force [N] Al-foil opa-film (25µm) Plastic functions as kind of mediator of elongation due to its homogenous structure Forming Depth [mm]

29 Comparison with thermoformed blisters g Coldform technology requires remarkable know-how & equipment (concerning laminate & tooling) Thermoform blister Coldform blister g Coldform blister packages are still bigger than thermoformed blisters due to the lower elongation and therefore less steeper cavity walls Ø16 ø22 ø

30 Processing on packaging machines Form-, fill and seal machines, e.g.: mostly for thermo- & cold forming cycles/minute pinhole detection (> 2µm) servo driven

31 Forming Station (picture: IMA)

32 New tooling concept: High Pressure Cold Forming HPC combines the advantages of drawing material by means of a punch with those of forming shapes in a die using high-pressure gas => the entire reserve of material is used up in an optimum way. HPC - a two forming step process, but in one forming tool 1st forming step: 2nd forming step: forming by using a punch, major strain is applied to the blister wall forming the final shape by using high pressure gas, major strain is applied to the bottom area of the blister High Pressure punch 1st step: forming by a punch of high friction 2nd step: forming by high pressure air Holding device/ clamp Alu/Plastic laminate Quelle: Rohrer ag/ Dr.Raggenbass die HPC- forming tool

33 High Pressure Coldforming Standard Alu-Blister 4.2 ø22 ø Reduction of the blister size of up to 18% 123 HPC-Blister Ø R Index Prices per tablet Without HPC: 3.4 With HPC: PVC/PVDC Coldform Aclar

34 To summarize... manufacturing of coldform laminate requires remarkable know-how the cold forming process is influenced by numerous parameters simulation software for blister & tool design as the basis for an optimal forming process coldform blisters offer ideal barrier properties strong global trend towards the use of coldform blisters

35 Agenda 1 Flexible Packaging for Pharmaceutical Products 2 Home and Personal Care Retail Packaging 3 Digital Solution for Labels

36 Home and Personal Care Global Retail Packaging: 2009 Home Care 124 billion units Beauty and Personal Care 78 billion units Folding cartons 18% Folding cartons 22% Flexible plastic 34% HDPE bottles 24% HDPE bottles 15% 14% Plastic tubes

37 Factors that influence the costs of the packaging Press configuration Substrate Printing inks Coating module Film weight Processing system Features Environment temperature and humidity Further processing/finishing Temporary process of the processing steps

38 Printing inks Oxidative and penetrating (standard) Penetrating (low odour inks) Oxidative (foil inks) Fresh / Overnight inks UV drying Hybrid inks

39 Every day, we are in contact with diverse coatings Automobile coatings Nail varnishes Furniture coatings Overprint varnishes: 100% ACTEGA Terra

40 Home Care Packaging Growth of the Refill Pouch Fast growth of the refill pack Enables consumers to save money Positioned as environmentally friendly Driving uptake of pouches Mainly liquid products Country: UK Product: Fabric Softener Brand: ASDA pl USP: Can be refilled in store 10 times

41 Add-on features and design easy opening dispensing systems reclose options higher level of convenience & functionality product differentiation valves design

42 weldspouts zippers valves

43 Main issues of weldspout insertion? weldspout - same material as the inside layer of the pouch - fast heat transfer => ribbed design - should allow smooth forming around the two sides of the pouch sealing parameters - temperature - pressure - time pouch laminate - blown film inside, normally PE or sometimes PP - for spout insertion: thickness tolerance +- 10% has to be guaranteed filling and closing of the pouch - filling through the open top of the pouch is today s state of the art => Menshen GmbH is the market leader in weldspout technology + high quality - higher price level for value

44 Design

45 Other pouches with stand-up characteristic STIFFLEX/ STIFFFOLD europack BOXI BAG of Atifon Z-flex of xpedx Cheerpack

46 Agenda 1 Flexible Packaging for Pharmaceutical Products 2 Home and Personal Care Retail Packaging 3 Digital Solution for Labels

47 LABELS Market Application Wet-glue-applied 35% Gummed paper 1% Wrap-around 9% Pressure Sensitive Adhesive 45% Shrink sleeves 6% In-mold 3% Security/Smart 1%

48 Label market area % Growth rate ( 04-07) LABEL sales volume worldwide: 33 billion sqm (~ 20 sqm/capita) North America Western Europe China/Asia Pacific Japan Eastern Europe South America India Rest of the world % 5 6% 15-20% / 12-16% 5 7% 17-20% 12 16% 18-23%

49 Embrace the changes of the digital revolution Access your print shop via your smartphone Your job list sorted by job number or customer name Various machine reports Shift reports sorted by shift progress or shift analysis 49

50 Who can benefit from digital printing Companies with added value applications They will benefit from the flexibility of digital printing Companies with conventional equipment They suffer from make ready times Companies looking for extra printing capacity They have short runs problems They can generate free time on conventional Brands wanting to field / market test a new product wanting to localise a product / avoid mass production wanting to reduce stocks and inventory wanting to supply delivery chain just in time, on demand wanting more products of less quantities

51 A workflow using digital technologies Brand owner Design agency Converter Supplier Proofer Job Editing tools Color management Dot gain management Step/Repeat, RIP Imaging Device/ Plate setter PDF JDF archive Efficient, no duplication, same source of data used by all parts, choice for the output only at the end, consistency, colour match,

52 The benefits of a fully digital solution Easier management of the extra volume of jobs Hybrid Workflow Common workflow for all presses Accessible by all players, brand, converter, design agency Reduced digital prepress make ready time Faster make ready time trough automation, increased productivity Repeat jobs without prepress File ready to use, output identical to first run Error reduction Less steps where intervention could bring errors The pre-press and print are clearly separated Web connectivity with the customer Track and trace availability Mobile marketing: QR-code Seamless supply chain

53 Production planning Set-up Production Machine 1 Machine 2 Let s look at it differently Machine 1 Machine 2 Down time Production time It is common to see the down time reaching 50%

54 What digital printing helps on Digital breakeven Machine 1 Digital Digital Digital Machine 2 Digital Digital Digital Let s look at it differently Machine 1 Conventional savings Machine 2 Machine 3

55 Immediate benefits from Digital Printing Reduces production cost up to breakeven Reduces production time up to breakeven Generates savings on waste of substrate Releases conventional capacity Allows more jobs to go through Allows new types of jobs to be done Allows to offer a closer partnership with customer HP Indigo is not only a printing technology, it is a business solution!

56 The real cost and value of a digital print Time x days / weeks Digital cost Conventional cost Distribution - Storage - Handling Waste For the brand Money at risk Inventory 1 day Make ready Printing Real needs

57 Example of a fully digital solution for labels Pre-press Printing Finishing options Laser die cut ABGraphics Klemm Cartes Quark with YTD

58 Security possibilities, added value applications Product Code Track and Trace Digital microtext Hologram Brand protection can be achieved by many components. Some of them are unique with digital printing This is added value possibility for our customers! Copy Detection Pattern Application Security Ink Variable data Conventional QR-code Datamatrix Intaglio Printing Special substrate

59 Thank you