Heat Seal Coatings. Brian Ingraham Product Development Manager, Medical Amcor Flexibles

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1 Heat Seal Coatings Love Them or Leave Them? Brian Ingraham Product Development Manager, Medical Amcor Flexibles

2 Agenda Coated Products Chemistry and Processing Coating-Free Peelable Technology and Evolution Performance Testing: Coated Products vs Coating-Free Peelable Products

3 Medical Packaging Key Performance Requirements: Easy to open (i.e. peel open) at end user Porous region to allow sterilization gas to interact with product Resistance to shipping and handling stress Inert package Proven microbial barrier over life of product

4 Coated Products Chemistry and Processing

5 Substrates Porous Sterilizable Packaging Heat seal coatings are applied to substrates to enhance their properties Typical substrates include: Tyvek Paper Excellent strength properties Excellent breathability Excellent microbial barrier Moderate strength properties Modified options for improved strength properties Good breathability Acceptable microbial barrier

6 Heat Seal Coating Components Heat seal formulations are usually composed of four categories of materials: Backbone Polymer = cohesive strength Tackifying Resin = adhesive strength Rheology / Viscosity Modifier = modifies the softness and/or melt viscosity Additives = preserves or enhances specific properties Adhesion Cohesion Adhesion

7 Heat Seal Coating Formulation Heat Seal Coating formulations are dependant on a number of factors: Specific end use performance requirements Coating substrates Target bond conditions Compatibility of the raw materials Ratios of the raw materials Cost targets Properties can change as the ratios of components change c = c Ethylene o c = c c o c Vinyl Acetate

8 Flexographic Coating Process

9 Flexographic Coating Process Utilizes rubber or photopolymer plates for coating application Coating weight is controlled by anilox roll engraving Usually used for patterned coating / line work type patterns Good for high viscosity coating formulations Typically water based Generally adhesive peel mechanism when opening

10 Rotogravure Coating Process Coating weight controlled by engraved cylinder Good for wide variety of coatings (water and solvent) Cylinder can be heated Good for patterned and overall coating patterns

11 Air Knife Coating Process Coating picked up with a smooth roll Coating applied directly to substrate Excess coating sheared off with high velocity air knife Allows application of breathable coatings Used for all over coating Typically water based Specialized process Most uniform coating application on porous substrates

12 Heat Seal Coating Coating Factors The drying process contributes to breathability: Time, temperature, process used Formula stabilizers also play a role The example is for water-based coatings, but solvent based coatings are similar. Initial Coating Free water loss Ordering, compaction Coagulation, pore formation

13 Heat Seal Coatings - Pros Long track record Broad affinity to most/all forming webs and substrates Wide process window Peel evidence Established raw material base Easy changeovers Ease of opening

14 Heat Seal Coatings - Cons Breathability Particulate formation Aging raw material base Regulatory complexity due to many components Additional processing of porous webs Performance in extreme conditions Cold crack Humid creep Aggressive EtO cycles

15 Coating-Free Peelable Technology and Evolution

16 Conventional Peel Technologies Direct Seal Systems Adhesive failure at seal interface between two substrates Adhesion is a function of sealing parameters Typical direct seal medical device pouch for ETO sterilization: 0.5mil PET/ 2mil LDPE // Tyvek PET PET PET LDPE Seal LDPE Peel LDPE Tyvek Tyvek Tyvek

17 Conventional Peel Technologies Contaminated Systems Usually cohesive failure of seal layer Peel strength is a function of both sealing conditions and concentration of contaminate Typical film contaminate is polybutylene Typical direct seal medical device pouch: 0.5mil PET/ 2mil LDPE // 0.5mil PET/ 2mil Peelable Film Seal Peel

18 Cohesive Peel Technology Core-Peel Technology Peel systems employing multiple functional layers (typically three) Sealing function is achieved as weld seal Peeling function is cohesive failure of buried film layer Easy processing on high speed equipment with consistent peel strength

19 Cohesive Peel Technology Core-Peel Visible Seal Evidence Seal shown is to uncoated Tyvek

20 Cohesive Peel Technologies in Laminates Technology: Possible with the advancement of coextrusion technology (3+ layer) in extrusion coating and lamination Products: PET of OPA / Cohesive Peel Paper / Cohesive Peel PET / Foil / Cohesive Peel Features & Benefits: Clean contact layer offers minimal risk of product interaction Clean, fiber free peel mechanism Applications: Peel pouches Form fill seal applications 4 side seal pouches

21 Cohesive Peel Technology in Coextruded Films Technology: Possible with the advancement of coextrusion technology (7+ layer) in film manufacturing Products: Forming films Bag films Pouch films Features & Benefits: Excellent impact, puncture and tensile strength Excellent peel seal performance to uncoated substrates Improved breathability Applications: Form fill seal, header bags and peel pouches

22 Performance Testing: Coated Products vs Coating-Free Peelable Products

23 Seal Curve Comparison

24 HFFS Process Comparison

25 Lower porosity value = More porous

26 What Happens in the EtO Chamber?

27 EtO Sterilization Seal Failures Heat Seal Coating Seal Creep

28 Humid Creep 350 Humid Creep Test Results 55 C, 100% RH 100 g weight T-Peel, freetail Failure Time (min) No failures for uncoated product, all samples exceeded 300 minutes Coated Uncoated

29 Particulate Generation # particles/cubic fo oot Coated Tyvek // PET/PE Uncoated Tyvek // PET/PE Uncoated Tyvek // Core-Peel System 0.3µm < 0.5µm 0.5µm < 1µm > 1µm

30 Sustainability Story Baseline: 3.0 mil Coex Header Bag with Coated Tyvek Product: 3.0 mil Coex Header Bag with Uncoated Tyvek

31 Header Bag ASSET Results Non-renewable primary energy Greenhouse potential fossil balance Water consumption ReCiPe 2008

32 Header Bag ASSET Results

33 Coated vs. Coating-Free Peelable Products Performance Parameters Coated Conventional Cohesive Peelability + o + Breathability Particulate Formation - o + Seal Window + - o Microbial Barrier Humid Creep Cold Drop Resistance Cost o + + Availability Durability o o +

34 Q & A

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