New Approach to High Barrier Pharma Blister Forming Web. Georgia Mohr, Marketing Director Bemis Healthcare Packaging
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2 New Approach to High Barrier Pharma Blister Forming Web Georgia Mohr, Marketing Director Bemis Healthcare Packaging
3 Today s Review Pharma Blister Packaging Background PVC Barrier Blister Forming Webs Typical Specification Manufacturing Bemis capabilities Alternative Barrier Blister Forming Web Specification Manufacturing Processes Moisture Barrier Approach Barrier comparison Attributes 3
4 Pharma Blister Packaging Background Pharmaceutical Primary Packaging is approaching US $9.0 Billion Blister Packaging accounts for 17% of the total value Blister packaging comprised of blister forming web and a blister lidding The functional purpose of the forming web is to Physically protect the solid unit dose Provide moisture barrier to extend the shelf life of the drug 4
5 Standard Barrier Materials 5
6 Manufacturing Methods Standard Blister Forming Webs manufactured in several steps based on a PVC platform Calendars Converting PVC into film Coating Applying PVDC to PVC to increase barrier Laminators Adhering film substrates PCTFE to PVC (PCTFE = Polychlorotrifluoroethylene) 6
7 Bemis Sheet Extrusion Technologies Forming Materials: PP, HIPS, CPET, APET, PETG, HDPE, Nylon, Other Barrier Materials: PVDC, EVOH, COC, Aclar, Other 7
8 Alternative Manufacturing Method Alternative Barrier Blister Forming webs manufactured Cast Coextrusion Producing a multilayer film having low water vapor permeability Where a modified polyolefin is used to create the barrier PETG (28µ) HBPB* (249µ) PETG (28µ) *HBPB= High Barrier Polyolefin Blend 8
9 Bemis Approach to Barrier Copolyester (PETG) A well established polymer widely used in medical device, Pharma and food packaging Extremely low product/package interaction Good chemical resistance Tie layer Layer used to bond the copolyester cap layers to the core layer High barrier polyolefin blend Proprietary blend that yields high moisture barrier efficiency Copolyester Tie High Barrier Polyolefin Blend Tie Copolyester 9
10 Exterior Moisture Attack All three market systems are adequately designed to prevent moisture ingress from the exterior of the package 10
11 Comparative Barrier Loss through Side Seals PETG (28µ) HBPB* (249µ) PETG (28µ) PETG (28µ) HBPB* (249µ) PETG (28µ) PVC (250µ) Aclar (50µ) PVC (250µ) Aclar (50µ) PVC (250µ) PVDC Coating (90gsm) PVC (250µ) PVDC Coating (90gsm) 11 *HBPB= High Barrier Polyolefin Blend
12 Approach to Moisture Barrier 12
13 PerfecForm SkyBlue Blister Forming Web Formable Web Formed Blister WVTR Flat Sheet WVTR PerfecForm SkyBlue PerfecForm SkyBlue PerfecForm SkyBlue ACLAR Rx160/10 mil PVC PerfecForm SkyBlue * gsm PVdC/ 250μ PVC PerfecForm SkyBlue PerfecForm SkyBlue gsm PVdC/ 250μ PVC PerfecForm SkyBlue PerfecForm SkyBlue * gsm PVdC/ 250μ PVC gsm PVdC/ 250μ PVC * Estimated Test Units 40 RH mg/blister cavity/day 38 RH g/m 2 /day Formed data Whitehouse Lab (ASTM D C, 75% RH), Flat Sheet data Perfecseal 13
14 ASTM Moisture Barrier Data PerfecForm SkyBlue PerfecForm SkyBlue PerfecForm SkyBlue ACLAR Rx160/10 mil PVC PerfecForm SkyBlue gsm PVdC/ 250μ PVC PerfecForm SkyBlue Formed Blister ASTM D C / 75% RH Measurement: mg/blister cavity/day Formed data: Whitehouse Lab PerfecForm SkyBlue gsm PVdC/ 250μ PVC PerfecForm SkyBlue PerfecForm SkyBlue gsm PVdC/ 250μ PVC Blue bars represent SkyBlue data 40 gsm PVdC/ 250μ PVC
15 Where SkyBlue barrier fits into the market Where we Fit? Permeation PVC PP PVC/40g PVDC PVC/60g PVDC Aclar 33C Aclar Rx160 PVC/80g PVDC Aclar 22A Aclar SupRx 900 Aclar 22C Aclar UltRx2000 Aclar 33C 15
16 PerfecForm SkyBlue Blister Forming Web Compared to existing high barrier PVC: Has similar appearance and stiffness Contains no chlorinated components Uses polymers broadly accepted in food, medical and pharmaceutical packaging Does not contribute to corrosion of blister tooling like PVDC/PVC 16
17 PerfecForm SkyBlue Blister Forming Web Compared to existing high barrier PVC: Combines two polymers that are widely collected and recycled Scratch resistance comparable to PVC Provides moisture barrier up to the range of 120 grams PVDC coated PVC Oxygen barrier is poorer than PVC Oxygen barrier can be achieved by adding EVOH 17
18 PerfecForm SkyBlue Blister Forming Web Complies with applicable regulations: 21 CFR parts European Regulation (EC) No 1935/2004 Commission Regulation (EC) No 2023/2006 Commission Regulation (EU) No 10/2011 for use with dry foods at room temperature PerfecForm SkyBlue is listed under U.S. Drug Master File #
19 Any Questions??? 19
20 Georgia C Mohr Marketing Director - Pharmaceuticals Tel: Cell: gcmohr@bemis.com BEMIS HEALTHCARE PACKAGING N. AMERICA L. AMERICA EUROPE ASIA PACIFIC
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Let Us Introduce Gulf Advanced Polymers LLC was established in 2016 with the aim to become one stop source for all kind of polymer requirements. We are engaged in the distribution and trading of Plastic