Thermoformed Sterile Barrier Packaging Material Selection Criteria & Options

Transcription

1 Thermoformed Sterile Barrier Packaging Material Selection Criteria & Options Gary Hawkins Technical Platform Leader Medical Extrusion Applications Development Eastman Chemical Company March 2-4,

2 Outline Medical Packaging Requirements Packaging Decision Making Process Rigid or flexible Material options Total packaging systems cost Conclusion 2

3 Outline Medical Packaging Requirements Packaging Decision Making Process Rigid or flexible Material options Total packaging systems cost Conclusion 3

4 Packaging Requirements Goal of medical device packaging Allow for terminal sterilization Provide physical protection Be compatible with device for shelf life Maintain device safety and functionality Maintain sterility for shelf life Allow for aseptic presentation 4

5 Packaging Design Considerations Health, safety, environmental, regulatory Cleanliness Biocompatibility Product interaction Global acceptance of material Waste Recyclability Sustainability Correct physical characteristics Rigid or flexible Clarity & appearance Toughness Chemical resistance Processability Sterilization stability Device type / needs Content Weight, shape, cost, size Fragility of product Barrier / shelf life Storage considerations Sterilization method Other needs Opening / Presentation Availability / sources Supplier assistance Patents System cost 5

6 Outline Medical Packaging Requirements Packaging Decision Making Process Rigid or flexible Material options Total packaging systems cost Conclusion 6

7 Packaging decision making process - Rigid or flexible? - Device movement isolation - Cost of device - Fragility, size, and weight of device - Sterilize / reuse / dispose - Device volume & automation - Aseptic presentation - Storage High Volume Heavy product: Surgical kits Product volume? Low Volume Low cost Product weight? High volume: Syringes, Catheters Non-Fragile/ Robust Product cost? Light Product Product volume? Rigid or Flexible? Product Fragility? Low volume High/premium: Implants Hybrid products Automation? NO- Preformed Yes-FFS Rigid Tray Rigid Roll stock FFS Fragile Device: MIS Device Heart valves Rigid Package Rigid Rollstock FFS Pre-formed Rigid Trays Yes-FFS Automation? NO Pouch Pouches Pre-formed Rigid Tray- Nails & screws Flexible Rollstock Hospital Storage Space Ease of aseptic presentation, Cleanliness, & Preference Material Selection 7

8 Rigid or Flexible? Packaging decision making process Rigid or Flexible? High Volume Heavy product: Surgical kits Product volume? Low Volume Low cost Product weight? High volume: Syringes, Catheters Non-Fragile/ Robust Product cost? Light Product Product volume? Product Fragility? Low volume High/premium: Implants Hybrid products Automation? NO- Preformed Yes-FFS Rigid Tray Rigid Roll stock FFS Fragile Device: MIS Device Heart valves Rigid Package Rigid Rollstock FFS Pre-formed Rigid Trays Yes-FFS Automation? NO Pouch Pouches Pre-formed Rigid Tray- Nails & screws Flexible Rollstock Hospital Storage Space Ease of aseptic presentation, Cleanliness, & Preference Material Selection 8

9 Rigid or Flexible? Packaging decision making process Rigid or Flexible? Non-Fragile/ Robust Product Fragility? Fragile Device: MIS Device Heart valves High Volume Heavy product: Surgical kits Product volume? Low Volume Low cost Product weight? High volume: Syringes, Catheters Product cost? Light Product Product volume? Low volume High/premium: Implants Hybrid products Automation? NO- Preformed Yes-FFS Rigid Tray Rigid Roll stock FFS Rigid Package Rigid Rollstock FFS Pre-formed Rigid Trays Yes-FFS Automation? NO Pouch Pouches Pre-formed Rigid Tray- Nails & screws Flexible Rollstock Hospital Storage Space Ease of aseptic presentation, Cleanliness, & Preference Material Selection 9

10 Health Care Professional Packaging Preference Rigid is the over-all preferred package type Flexible considered if storage is limited Rigid preferred in operating room Better product protection & sterility Ease of aseptic presentation 92% prefer double entry package 60% prefer double rigid package 76% prefer at least one package to be rigid Clarity is desired for verification & quality inspection AORN Nurse Survey from Healthpack `08 & `09 Validated by EMN Voice-of-the-customer at Select Hospitals 10

11 Outline Medical Packaging Requirements Packaging Decision Making Process Rigid or flexible Material options Total packaging systems cost Conclusion 11

12 Material Selection Very important Mistakes can lead to huge launch delays Mistakes can lead to future field issues Health, safety, regulatory, environmental Chemical composition Correct physical characteristics Opening & presentation Barrier requirements Storage considerations 12

13 Rigid Packaging Materials Thermoforming materials for Rigid Sterile Barrier Packaging Radiation and/or Ethylene Oxide Stable Autoclave and other sterilization methods excluded (<5%) Clear Polyester (C-PET or A-PET) Copolyester (6763 & MP100) Acrylonitrile (AN) Acrylic multipolymer (ACM) Polyvinyl chloride (PVC) Translucent Polypropylene (CPP, IPP, HPP) Clear impact modified polystyrene (CIPS) Opaque High impact polystyrene (HIPS) Pigmented or foamed copolyester 13

14 Eastman Eastar Copolyester 6763 Chemical Resistance DMT Processability 80 C Glass Transition Temperature PETG EG Good Toughness Clarity CHDM Eastar is a BPA FREE material 14

15 Eastman Tritan Copolyester MP100 Chemical Resistance DMT MP100 Processability Improved Aging & Heat Resistance 110 C Tg CHDM TMCD Improved, Outstanding Toughness Improved Clarity & Color Tritan MP100 for packaging was launched 2010 MDMW Tritan is a BPA FREE material 15

16 Global Medical Device Packaging Material Market (Radiation & EO Sterilized) Market share is a strong indication of the ability of a material to meet customer needs & expectations AN 3% AMC 5% Clear Rigid Materials APET 6% Other 2% AN 3% AMC 5% All Rigid Materials APET 6% PVC 13% Other 2% % HIPS 36% PVC 15% % 16

17 Voice-of-the-customer medical device packaging material selection criteria Customer critical Sterilization stability 5 year shelf life (product & sterility protection) Clarity (except for inexpensive or light sensitive products) Medical grade Clean Aseptic presentation Total system cost 17

18 Voice-of-the-customer medical device packaging material selection criteria Sterilization stability HDT Radiation color shift Clarity Sterilization color shift Transmittance / Haze Shelf life Impact Toughness Physical Aging Sealing Total systems cost Physical property measure Medical grade Biocompatible (ISO10993) Food contact No reclaim Clean No angel hair or dust No contamination No or very low visual defects Aseptic presentation Package allows for device transfer to sterile field without human touch 18

19 7 Day B* Yellowness Rigid Packaging Material Property Comparison 50 kgy Gamma Sterilization Sterilization stability Radiation color shift Important Product quality Product Inspection Proxy for package integrity & property retention Unlike other materials, polyesters retain more of their clarity and physical properties after irradiation and recover from the color shift more fully and quickly. 19

20 Rigid Packaging Material Radiation Tolerance Material Maximum Tolerance kgy Comment PET MP ACM 100 PVC 100 AN 1000 SRCPP 40 RCPP 20 CIPS 1000 HIPS 1000 Data supplied by MDS Nordion & Sterigenics Very stable, retains excellent clarity. Very stable, retains excellent clarity. Very stable, retains excellent clarity. Yellows at kgy Substantial yellowing Avoid high doses, reduces toughness Subject to embrittlement & aging Avoid unstabilized PP Begins to yellow at 40 kgy Begins to yellow at 40 kgy 20

21 Rigid Packaging Material Property Comparison 264 psi Heat Deflection Temperature Sterilization stability High HDT indicates that polymer is suitable for EO sterilization (higher temperature duration cycle) Only polycarbonate is heat resistant enough to handle high heat or steam sterilization ( C) 0 54 C minimum HDT for EO sterilization compatibility All materials are suitable for controlled EO sterilization although PP is borderline. 21

22 Instrumented Dart Impact Max Load, J Haze, % Instrumented Dart Impact Max Load, J Haze, % Post Sterilization Property Stability Toughness Optics Affect of EO Sterilization 40 mil Sheet Affect of EO Sterilization 40 mil Sheet MP100 ACM APET 6763 AN MP100 ACM APET 6763 AN # EO sterilizations # EO sterilizations Affect of Gamma Sterilization 40 mil Sheet Affect of Gamma Sterilization 40 mil Sheet Kgy Irradiation MP100 ACM APET 6763 AN Kgy Irradiation MP100 ACM APET 6763 AN

23 Haze, % Rigid Packaging Material Property Comparison Clarity of 30 mil Sheet 100% 23

24 Rigid Packaging Material Property Comparison Shelf life Sealability Typically accomplished with coated Tyvek or a barrier multilayer film or laminate Consistent sealing performance after sterilization & storage Peelable seal strengths Good transfer No channels, leakers Varies with lidding so not compared

25 g/force CoPET Heat Seal Performance Comparison 1300 Theller Heat Seal 1/2 in2 seal area, 40 psig, 3 Sec Dwell mil Eastar mil Mustang MP Temperature, F Sealed to Tyvek 1073B with Perfecseal CR27 heat seal coating 25

26 g/force CoPET Heat Seal Performance Comparison Heat Seal Performance 1/2 in^2 seal area, 40 psig, 3 sec dwell Mustang Mil MP mil Mil 6763 Eastar Temperature, F Sealed to Oliver Ovantex with Oliver-F heat seal coating 26

27 Toughness Rigid Packaging Material Property Comparison Shelf life Impact toughness is a good indicator of long term package integrity Notched Izod is puncture propagation of 10 mil preformed notch Fracture energy more indicative of dropped package /8" Notched Izod (ft-lbf/in) 30 mil Fracture Energy (J) Polyesters are very tough and protect against package failure. 27

28 Mean Failure Height, Inches Gardner Impact Test Results ASTM D mil Sheet 8 lb falling weight MP100 PVC 6763 RCPP AN ACM CIPS 1 HPP 28

29 Rigid Packaging Material Property Comparison Shelf life Physical aging Molecular scale densification or embrittlement All rigid packaging materials age physically to relax free volume since their glass transition temperatures are above room, storage, and sterilization temperature Increased glass transition temperature means decreased physical aging Glass Transition Temp (C ) Slower Aging PETG packaging provides protection & integrity for at least 5 years if good manufacturing practices are followed. 29

30 Yield Stress, Mpa Rigid Packaging Material Property Comparison Shelf life Physical aging Molecular scale densification or embrittlement All rigid packaging materials age physically to relax free volume since their glass transition temperatures are above room, storage, and sterilization temperature Increased glass transition temperature means decreased physical aging Affect of EO Sterilization 40 mil Sheet MP100 ACM APET 6763 AN # EO sterilizations PETG packaging provides protection & integrity for at least 5 years if good manufacturing practices are followed. 30

31 Internal drop test Parameters 6.75 x 10.5 x 2.5 Rectangular tray with sharp corners Filled with 2 lbs ball bearings Sealed with 1073B/Oliver 10 MP 20 packages each variable 1 corner drop test Various heights 70 degree angle Green & Treated 55C, 50% rh, 24 hr Standard Deviation ft 31

32 AFH, Feet Internal drop test results Physical Aging Affects Bruceton Staircase Average Failure Height 40 mil Sheet Untreated Treated 55C / 50%rh / 24 hrs 2 0 APET 6763 MP100 CIPS 1 CIPS 2 ACM AN HPP RCPP IPP Packaging Material 32

33 Acrylic Multipolymer Package Drop Test Failure Escaped Ball Bearings Broken Package Pieces 33

34 Case Study PET (78 C Tg), 6763 (81 C Tg), MP100 (110 C Tg) Medical device packaging validation ISTA 1/3G, ASTM D4728, ASTM D5276, ASTM 4169 Sheet extrusion EtO aeration (130 F, 16 hr) Repeat EtO process 2 more times Validation results Thermoforming EtO sterilized (130 F, 8 hr) Condition 4 Temp / rh cycles 24 hrs each 100% Inspection Product packaging (60 units each) EtO Precondition (130 F, 50% rh, 8 hrs) Vibration 30, 10 side drop test 34

35 % of Packages Passing Validation (No Failure) Case Study Results Medical device packaging validation PET aged 2X more during sterilization & failed 23% of the time Medical Device Manufacturer Packaging Validation Summary 100% 95% 90% 85% 80% 75% 70% 65% 60% APET 6763 MP100 Drop Height Inches / Material 35

36 Rigid Packaging Material Property Comparison MDM preferences Food contact Medical grade Notification of change Continuous improvement Quality system Biocompatible (ISO10993) Virgin resin Single component Environmental perception Design Freedom / Good Thermoforming Clarity Clean No angel hair No dust No contamination No or very low visual defects (includes stress whitening) Based upon voice-of-customer data 36

37 Rigid Packaging Material Property Comparison Material Preferences Cleanliness PET 6763 MP100 ACM PVC AN RCPP CIPS HIPS Poor Forming Copolyester packaging (6763 & MP100) exhibits the best cleanliness & meets device manufacturer material preferences. 37

38 Outline Medical Packaging Requirements Packaging Decision Making Process Rigid or flexible Material options Total packaging systems cost Conclusion 38

39 Rigid Packaging Material Property Comparison Total systems cost Relative cost per pound raw material Yield (cc/g) Case study economic value estimate Better Relative Price/lb Relative Yield (cc/g) 39

40 Total systems cost case study (EVE) PET vs SI tray from 20 mil sheet Material cost 6763 PETG Increased gauge to maintain 23C Forming Higher cost trim tooling & replacement APET Sterilization cost Cost Differential Per Tray Engineering time to research field failures (aging, other) Considering the extra material required for impact resistance, yield, and processing differences, PETG is more cost effective than PET even with a higher relative cost. 40

41 Total systems cost case study (EVE) CIPS vs SI tray from 20 mil sheet PETG 6763 Material cost Increased gauge to maintain 23 C Forming Cost to remove particulate Sterilization cost CIPS Cost to research field failures due to maring, gels, & blend inconsistancies Cost Differential Per Tray Considering the extra material required for impact resistance, yield, and processing differences, PETG is more cost effective than CIPS even with a higher relative cost. 41

42 Outline Medical Packaging Requirements Packaging Decision Making Process Rigid or flexible Material options Total packaging systems cost Conclusion 42

43 Rigid Packaging Material Property Comparison Material Shelf Life Clarity Sterilization Preferences Cleanliness Systems Cost PET 6763 MP100 ACM PVC AN RCPP CIPS HIPS 43

44 Cost vs. performance Conclusion Material with best balance of properties Eastar Copolyester 6763 Sterilization stability (stable physicals, color, good HDT) 5 year shelf life (balance of toughness, aging, sealing) Clarity (low haze, great gloss, virtually no visual defects) Medical grade (ISO10993, food, not blended, no reclaim) Clean (no dusting, no angle hair, no needed cleaning) Enables aseptic presentation (prefer double rigid package) Lowest total system cost (often the best balance of properties for the $)» Used in very demanding packaging applications for over 25 years» Market leading reliable performance 44

45 Conclusion Best product for additional performance Tritan Copolyester MP100 Same great processing & sealing as 6763 Benefits Increased heat resistance» Improved aging» Allows for faster accelerated aging protocols» Greater stability during package life» Increased speed to market» Potential to lower sterilization cost» EO cost/time related to sterilization Temperature» Potential to reduce time & cost of EO sterilization due to 30C increase in Tg 45

46 Conclusion Best product for additional performance Tritan Copolyester MP100 Benefits Best-in-class toughness» Improved long term package integrity» Potential to reduce ancillary packaging» Increase in efficiency & material savings» Potential for down gauging» Ability to reduce package waste Better toughness, heat resistance, and aging» Less technical support required to design packages and solve issues 46

47 Conclusion Additional copolyester benefits Copolyesters are non-halogenated and BPA free Strong physical properties without additives Free of plasticizers Free of impact modifiers Clean burning When incinerated alone, copolyesters (produced without chlorine) do not generate polychlorinated pollutants Sustainable advantages Reduction of material without compromising performance. Because sheet of copolyester is tough, there is a potential to reduce the thickness of packaging, which reduces the weight and amount of material used, and the associated cost to ship Copolyesters are shatter resistant and can withstand the rigor of hospital or patient recovery environments, thereby reducing replacements required with some other materials 47

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