ASTM International Committee F02 Flexible Barrier Packaging

Size: px
Start display at page:

Download "ASTM International Committee F02 Flexible Barrier Packaging"

Transcription

1 ASTM International Committee F02 Flexible Barrier Packaging Michael L. Troedel Cardinal Health, Inc. March 10, 2011

2 Agenda F02 Scope Officers Sub-Committee Organization and Chairs Sub-Committee Activities

3 F02 Scope The development of terminology, test methods, practices, and specifications for flexible barrier packaging, and the promotion of research in this field. Standards under the jurisdiction of other Committees shall be used when applicable. The area of interest of the committee is flexible barrier packaging including the component barrier materials, their properties, and package design, development and production. Flexible barrier packaging for the purpose of this Committee includes any package with at least one flexible component that can be bent or folded back upon itself. Typical flexible barrier materials are paper, nonwovens, plastic films, and metal foils used alone, treated or in various combinations.

4 Officers Chairman: Hal Miller, Pace Solutions LLC Vice-Chairman: John J. Spitzley, Spartan Design Group Recording Secretary: Diona R. Sommario, Boston Scientific Inc. Membership Secretary: Gerald J. Montgomery, Medtronic Inc. Past Chairman: Michael L. Troedel, Cardinal Health, Inc. Member-at-Large: Curtis L. Larsen, Spartan Design Group Member-at-Large: Edward J. Emerson, Mocon Inc. Member-at-Large: Patrick J. Nolan, DDL Inc.

5 Sub-Committee Organization and Chairs F02.10 Permeation - Michael Troedel F02.15 Chemical/ Safety Properties - Marilyn Baker F02.20 Physical Properties - Marie Tkacik F02.40 Package Integrity - Nick Winters F02.50 Package Design and Development - Dhuanne Dodrill F02.90 Executive Committee Officers

6 F02.10 Permeation D (2009) Standard Test Method for Determining Gas Permeability Characteristics of Plastic Film and Sheeting D (2009) Standard Test Method for Water Vapor Transmission of Flexible Heat-Sealed Packages for Dry Products D (2010) Standard Test Method for Oxygen Gas Transmission Rate Through Plastic Film and Sheeting Using a Coulometric Sensor E398-03(2009) Standard Test Method for Water Vapor Transmission Rate of Sheet Materials Using Dynamic Relative Humidity Measurement (WK20329) F119-82(2008) Standard Test Method for Rate of Grease Penetration of Flexible Barrier Materials (Rapid Method)

7 F02.10 Permeation F (2008) Standard Test Method for Determining the Carbon Dioxide Loss of Beverage Containers F Standard Test Method for Water Vapor Transmission Rate Through Plastic Film and Sheeting Using a Modulated Infrared Sensor (WK29258) F (2007) Standard Test Method for Oxygen Transmission Rate Through Dry Packages Using a Coulometric Sensor F Standard Test Method for Determination of Oxygen Gas Transmission Rate, Permeability and Permeance at Controlled Relative Humidity Through Barrier Materials Using a Coulometric Detector

8 F02.10 Permeation F Test Method for the Determination of Carbon Dioxide Gas Transmission Rate (CO2TR) Through Barrier Materials Using An Infrared Detector F Standard Test Method for Oxygen Transmission Rate Through Plastic Film and Sheeting Using Various Sensors WK9915 Guide to Oxygen Permeability Test Methods WK30771 New Test Method for Impermeability of Flexible Barrier Materials to the Passage of Air

9 F02.15 Chemical/Safety Properties F34-02(2007) Standard Practice for Construction of Test Cell for Liquid Extraction of Flexible Barrier Materials F874-98(2008) Standard Test Method for Temperature Measurement and Profiling for Microwave Susceptors F (2008) Standard Test Method for Quantitating Volatile Extractables in Microwave Susceptors Used for Food Products F (2007) Standard Test Method for Calibration of Microwave Ovens F Standard Test Method for Nonvolatile Ultraviolet (UV) Absorbing Extractables from Microwave Susceptors

10 F02.15 Chemical/Safety Properties F (2008) Standard Guide for Selection of Time-Temperature Indicators F (2008) Standard Test Method for Quantitating Non-UV-Absorbing Nonvolatile Extractables from Microwave Susceptors Utilizing Solvents as Food Simulants F (2008) Standard Test Method for Qualitative Analysis of Volatile Extractables in Microwave Susceptors Used to Heat Food Products F (2009) Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method)

11 F02.15 Chemical/Safety Properties F Standard Test Method for Determining Residual Solvents in Packaging Materials F Standard Test Method for Determination of Residual Acetaldehyde in Polyethylene Terephthalate Bottle Polymer Using an Automated Static Head-Space Sampling Device and a Capillary GC with a Flame Ionization Detector (WK 27778) F Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials (WK 28510) F Standard Test Method for Using Aerosol Filtration for Measuring the Performance of Porous Packaging Materials as a Surrogate Microbial Barrier

12 F02.20 Physical Properties F88-09 Standard Test Method for Seal Strength of Flexible Barrier Materials F392-93(2004) Standard Test Method for Flex Durability of Flexible Barrier Material (WK30963) F904-98(2008) Standard Test Method for Comparison of Bond Strength or Ply Adhesion of Similar Laminates Made from Flexible Materials F Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages

13 F02.20 Physical Properties F (2008) Standard Test Method for Slow Rate Penetration Resistance of Flexible Barrier Films and Laminates F (2004) Standard Test Method for Hot Seal Strength (Hot Tack) of Thermoplastic Polymers and Blends Comprising the Sealing Surfaces of Flexible Webs See WK21807 proposed revision F Standard Practices for Making Heatseals for Determination of Heatsealability of Flexible Webs as Measured by Seal Strength F Standard Test Method for Burst Testing of Flexible Package Seals Using Internal Air Pressurization Within Restraining Plates

14 F02.20 Physical Properties F (2007) Standard Test Method for Linear Measurement Using Precision Steel Rule F (2007) Standard Practice for Coating/Adhesive Weight Determination F (2008) Standard Practice for Evaluation of Chemical Resistance of Printed Inks and Coatings on Flexible Packaging Materials F (2008) Standard Test Method for Thickness Measurement of Flexible Packaging Material F (2008) Standard Practice for Evaluating Ink or Coating Adhesion to Flexible Packaging Materials Using Tape

15 F02.20 Physical Properties F Standard Test Method for Mechanical Seal Strength Testing for Round Cups and Bowl Containers with Flexible Peelable Lids WK23455 Abrasion Resistance of Flexible Packaging Films

16 F02.40 Package Integrity D (2008) Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission F (2009) Standard Test Method for Determining Integrity of Seals for Medical Packaging by Visual Inspection F (2004) Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration See also WK23814 proposed revision F Standard Test Methods for Pressure Decay Leak Test for Nonporous Flexible Packages With and Without Restraining Plates

17 F02.40 Package Integrity F Standard Test Method for Detecting Gross Leaks in Medical Packaging by Internal Pressurization (Bubble Test) (WK28919) F (2007) Standard Test Method for Non-Destructive Detection of Leaks in Non-sealed and Empty Medical Packaging Trays by CO2 Tracer Gas Method F (2007) Standard Test Method for Non-Destructive Detection of Leaks in Medical Packaging Which Incorporates Porous Barrier Material by CO2 Tracer Gas Method F Standard Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay Method F Standard Test Method for Measuring Package and Seal Integrity Using Helium as the Tracer Gas

18 F02.40 Package Integrity F Standard Test Method for Oxygen Headspace Analysis of Packages Using Fluorescent Decay WK23964 Oxygen Analysis of Packages Using Headspace Sampling WK25128 Detecting Leaks in Nonporous Packaging or Flexible Barrier Materials by Dye Penetration

19 F02.50 Package Design and Development E171-94(2007) Standard Specification for Standard Atmospheres for Conditioning and Testing Flexible Barrier Materials F17-08 Standard Terminology Relating to Flexible Barrier Materials F99-07 Standard Practice for Writing a Specification for Flexible Barrier Rollstock Materials F (2008) Standard Guide for Use and Handling of Flexible Retort Food Pouches in the Processing Environment

20 F02.50 Package Design and Development F Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices F Standard Guide for Design and Evaluation of Primary Packaging for Medical Products F (2010) Standard Guide for Writing a Specification for Sterilizable Peel Pouches F Standard Practice for Climatic Stressing of Packaging Systems for Single Parcel Delivery (WK 25328)

21

22 F02.50 Package Design and Development

23 Next F-2 Meetings April 13 14, 2011 Anaheim, CA November 2 3, 2011 Tampa, FL

24 Thank you Questions?

ASTM International Committee F02 Flexible Barrier Packaging

ASTM International Committee F02 Flexible Barrier Packaging ASTM International Committee F02 Flexible Barrier Packaging Michael L. Troedel Troedel & Associates, Inc. March 4, 2010 San Antonio, TX Agenda F02 Scope Officers Sub-Committee Organization and Chairs Sub-Committee

More information

ASTM COMMITTEE F02 FLEXIBLE BARRIER PACKAGING. Dhuanne Dodrill March 16, 2016

ASTM COMMITTEE F02 FLEXIBLE BARRIER PACKAGING. Dhuanne Dodrill March 16, 2016 ASTM COMMITTEE F02 FLEXIBLE BARRIER PACKAGING Dhuanne Dodrill March 16, 2016 ASTM INTERNATIONAL ASTM International is a globally recognized leader in the development and delivery of international voluntary

More information

ASTM F02 Flexible Barrier Materials. Dhuanne Dodrill March 12, 2014

ASTM F02 Flexible Barrier Materials. Dhuanne Dodrill March 12, 2014 ASTM F02 Flexible Barrier Materials Dhuanne Dodrill March 12, 2014 F02 Flexible Barrier Packaging flexible package any package with at least one flexible component that can be bent back or folded back

More information

TMElectronics, Inc. Specialists in Leak, Flow and Package Testers

TMElectronics, Inc. Specialists in Leak, Flow and Package Testers Relevant ASTM and ISO Standards - How TME Testers Meet the Need Note from TME: Our package testers, the BT-1000, the BT Integra-Pack, and the TME Solution-C, all conform to certain of the ASTM International

More information

ASTM F e1 Standard Practice for Climatic Stressing of Packaging Systems for Single Parcel Delivery

ASTM F e1 Standard Practice for Climatic Stressing of Packaging Systems for Single Parcel Delivery ASTM F2825-10e1 Standard Practice for Climatic Stressing of Packaging Systems for Single Parcel Delivery Do we really need another conditioning standard? Hal Miller PACE Solutions, LLC hfmiller2@att.net

More information

Packaging for terminally sterilized medical devices. Part 1: Requirements for materials, sterile barrier systems and packaging systems

Packaging for terminally sterilized medical devices. Part 1: Requirements for materials, sterile barrier systems and packaging systems INTERNATIONAL STANDARD ISO 11607-1 First edition 2006-04-15 AMENDMENT 1 2014-07-15 medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems AMENDMENT 1 Emballages

More information

PACKAGE TESTING AND VALIDATION SERVICES

PACKAGE TESTING AND VALIDATION SERVICES PACKAGE TESTING AND VALIDATION SERVICES A sterile medical device, which includes the packaging, must function as labeled for the shelf-life claimed for the device. The primary package must maintain its

More information

PACKAGE TESTING & VALIDATION IN THIS SECTION EXPERT SOLUTIONS FOR PRODUCT DEVELOPMENT

PACKAGE TESTING & VALIDATION IN THIS SECTION EXPERT SOLUTIONS FOR PRODUCT DEVELOPMENT EXPERT SOLUTIONS FOR PRODUCT DEVELOPMENT PACKAGE TESTING & VALIDATION A sterile medical device, which includes the packaging, must function as labeled for the shelf-life claimed for the device. The primary

More information

Medical Device Packaging Benchmarking Project

Medical Device Packaging Benchmarking Project November Medical Device Packaging Initiated by Institute of Packaging Professionals International Safe Transit Association Sponsored by Dupont Administrated by Dennis Young and Associates, Inc. The Survey

More information

Testing Water Vapor Transmission Rates for Flexible Barrier Materials Including Metalized Structures

Testing Water Vapor Transmission Rates for Flexible Barrier Materials Including Metalized Structures Testing Water Vapor Transmission Rates for Flexible Barrier Materials Including Metalized Structures Robert Maixner Michelle Stevens MOCON Inc. ABSTRACT As new materials with increased barrier properties

More information

ASTM E96 VS. F1249 WHICH PROVIDES MORE ACCURATE TEST RESULTS?

ASTM E96 VS. F1249 WHICH PROVIDES MORE ACCURATE TEST RESULTS? ASTM E96 VS. F1249 WHICH PROVIDES MORE ACCURATE TEST RESULTS? Modern barriers require more sensitive and accurate test methods. Does E96 stand up to the test? MOCON, Inc. May 16, 2017 Contents Abstract

More information

General catalog. D. Gas permeability tester For battery membrane, rubber film, laminated flat film and kinds of polymer films Labthink model: BTY-B2P

General catalog. D. Gas permeability tester For battery membrane, rubber film, laminated flat film and kinds of polymer films Labthink model: BTY-B2P General catalog 1. Gas Permeability Tester A, Manometric Gas Permeability Tester For tests of gas transmission rate, solubility coefficient, diffusion coefficient and permeability coefficient through plastic

More information

Bemis Laboratory Services Your Reliable Test Partner

Bemis Laboratory Services Your Reliable Test Partner Bemis Laboratory Services Your Reliable Test Partner Contents 1. Transportation Testing / Distribution Testing to ASTM D4169 and ISTA Page 4 2. Packaging Integrity /Sample Testing 6 3. Age Testing 8 4.

More information

Bemis Laboratory Services

Bemis Laboratory Services Bemis Laboratory Services Kilbeggan Road, Clara, Co. Offaly Testing Laboratory Registration number: 263T is accredited by the Irish National Board (INAB) to undertake testing as detailed in the Schedule

More information

Sterile Barrier System: Common Failure Modes & Design Recommendations

Sterile Barrier System: Common Failure Modes & Design Recommendations Sterile Barrier System: Common Failure Modes & Design Recommendations Kevin Fernandez Presenter Greg Schwinghammer Moderator Eric Lau Presenter March 2013 1 Agenda Packaging System Protective package Sterile

More information

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

Heat Seal Coatings. Brian Ingraham Product Development Manager, Medical Amcor Flexibles Heat Seal Coatings Love Them or Leave Them? Brian Ingraham Product Development Manager, Medical Amcor Flexibles Agenda Coated Products Chemistry and Processing Coating-Free Peelable Technology and Evolution

More information

HEAD. 5. Materials and preformed sterile barrier systems Microbial barrier properties...10

HEAD. 5. Materials and preformed sterile barrier systems Microbial barrier properties...10 DUPONT TYVEK COMPLIANCE TO ISO 11607-1:2006 CONTENTS HEAD Introduction.... 3 ISO 11607-1:2006 Requirements.... 4 4. General requirements.... 4 4.2 Quality systems.... 4 4.3 Sampling.... 4 4.4 Test methods....

More information

CDF Corporation. Worldwide innovator in flexible liquid packaging

CDF Corporation. Worldwide innovator in flexible liquid packaging CDF Corporation Worldwide innovator in flexible liquid packaging CDF Corporation CDF Corporation is an international company that specializes in the manufacture and sale of high quality liners and flexible

More information

PVDC New Developments, New Opportunities

PVDC New Developments, New Opportunities PVDC New Developments, New Opportunities Kirk Paisley SolVin, a division of Solvay Advanced Polymers, L.L.C. Alpharetta, Georgia Introduction The information in this presentation will provide basic background

More information

July 23, 2010 PARTIES INTERESTED IN REFLECTIVE FOIL INSULATION

July 23, 2010 PARTIES INTERESTED IN REFLECTIVE FOIL INSULATION July 23, 2010 TO: SUBJECT: PARTIES INTERESTED IN REFLECTIVE FOIL INSULATION Revisions to the Acceptance Criteria for Reflective Foil Insulation, Subject AC02-0610-R1 (LS/RB) Dear Madam or Sir: In June

More information

Medical and Pharmaceutical Packaging Styles

Medical and Pharmaceutical Packaging Styles Aligned Test Methods and Sampling Plans for DuPont Tyvek Medical and Pharmaceutical Packaging Styles June 2017 Aligned Test Methods The Medical Packaging Transition Project (MPTP) includes manufacturing

More information

FlexAct BT (Bag Tester) Flexboy 2D November, 2015

FlexAct BT (Bag Tester) Flexboy 2D November, 2015 FlexAct BT (Bag Tester) Flexboy 2D November, 2015 Agenda 1 2 3 4 Container Closure Integrity for SUS FlexAct BT Value Proposition FlexAct BT Instruments FlexAct BT SU Flexboy 2D 5 FlexAct BT Validation

More information

GUIDELINES FOR THE PACKAGING AND STORAGE OF PESTICIDES FOOD AND AGRICULTURE ORGANIZATION OF THE UNITED NATIONS

GUIDELINES FOR THE PACKAGING AND STORAGE OF PESTICIDES FOOD AND AGRICULTURE ORGANIZATION OF THE UNITED NATIONS GUIDELINES FOR THE PACKAGING AND STORAGE OF PESTICIDES FOOD AND AGRICULTURE ORGANIZATION OF THE UNITED NATIONS - ii - GUIDELINES FOR THE PACKAGING AND STORAGE OF PESTICIDES FOOD AND AGRICULTURE ORGANIZATION

More information

Aqueous Nanocomposite Barrier Coatings A more sustainable option for high barrier flexible packaging

Aqueous Nanocomposite Barrier Coatings A more sustainable option for high barrier flexible packaging Aqueous Nanocomposite Barrier Coatings A more sustainable option for high barrier flexible packaging Harris A. Goldberg; Carrie A. Feeney, and Michele Farrell InMat Inc. 216 Route 206 Suite 7 Hillsborough,

More information

In-Vacuum Flexo Top-Coating on Metallized Film: An Update on the State of the Art. By: Dante Ferrari, Celplast Metallized Products Limited

In-Vacuum Flexo Top-Coating on Metallized Film: An Update on the State of the Art. By: Dante Ferrari, Celplast Metallized Products Limited In-Vacuum Flexo Top-Coating on Metallized Film: An Update on the State of the Art By: Dante Ferrari, Celplast Metallized Products Limited Introduction Celplast has presented at many previous AIMCAL conferences

More information

Container Closure Integrity Tests (CCIT) for Single-Use Systems

Container Closure Integrity Tests (CCIT) for Single-Use Systems By Lionel Karcher, Head of Microbiology Laboratory, BU Confarma Container Closure Integrity Tests (CCIT) for Single-Use Systems Container Closure Integrity Tests have traditionally been performed using

More information

PDA: A Global. Association. Proposed Revisions to USP <1207> STERILE PRODUCT -

PDA: A Global. Association. Proposed Revisions to USP <1207> STERILE PRODUCT - Proposed Revisions to USP STERILE PRODUCT - PDA: A Global PACKAGE INTEGRITY EVALUATION Now in the Sep/Oct 2014 USP Pharmacopeial Forum For Public Comment Association Prepared by: Dana M. Guazzo

More information

Retort Pouches 2015 to 2019

Retort Pouches 2015 to 2019 Section I: Section II: Introduction A. Retort pouch Retort Pouches 2015 to 2019 B. Study organization C. Geographic regions D. Methodology and organization E. Conventions Executive Summary A. Technology

More information

Originally Issued: 05/03/2013 Revised: 06/06/2016 Valid Through: 05/31/2017

Originally Issued: 05/03/2013 Revised: 06/06/2016 Valid Through: 05/31/2017 EVALUATION SUBJECT: AA-2 VAPOR SHIELD, M-SHIELD, SILVER SHIELD RADIANT BARRIER, FSK SHIELD, RBI SHIELD AND VR PLUS SHIELD REPORT HOLDER: Fi-Foil Company, Inc. P.O. Box 800 612 Bridgers Ave. West Auburndale,

More information

OptiLiner Banded Liner System, Thermal, Metal Building

OptiLiner Banded Liner System, Thermal, Metal Building PROJECT ENGINEER RESPONSIBILITY: This is a general specification guide, intended to be used by experienced construction professionals, in conjunction with good construction practice and professional judgment.

More information

June 1, 2010 PARTIES INTERESTED IN EVALUATION REPORTS ON REFLECTIVE FOIL INSULATION

June 1, 2010 PARTIES INTERESTED IN EVALUATION REPORTS ON REFLECTIVE FOIL INSULATION June 1, 2010 TO: PARTIES INTERESTED IN EVALUATION REPORTS ON REFLECTIVE FOIL INSULATION SUBJECT: Proposed Revisions to the Acceptance Criteria for Reflective Foil Insulation, Subject AC02-0610-R1 (LS/RB)

More information

PACKAGING REQUIREMENTS AND QUALITY ASSURANCE PROVISIONS FOR MIL-DTL-32541, PIZZA SLICE, SHELF STABLE, FOR OPERATIONAL RATIONS

PACKAGING REQUIREMENTS AND QUALITY ASSURANCE PROVISIONS FOR MIL-DTL-32541, PIZZA SLICE, SHELF STABLE, FOR OPERATIONAL RATIONS PACKAGING REQUIREMENTS AND QUALITY ASSURANCE PROVISIONS FOR MIL-DTL-32541, PIZZA SLICE, SHELF STABLE, FOR OPERATIONAL RATIONS SECTION D D-1 PACKAGING A. Packaging. One pizza slice and one oxygen scavenger

More information

WHITE PAPER March 2015

WHITE PAPER March 2015 WHITE PAPER March 215 Medical Packaging Study The Impact of Sterilization and Testing on the Microbial Barrier of Different Materials Author: Nicole Kaller, Packaging Engineer, DuPont Medical and Pharmaceutical

More information

Incorporating Insulating Sheathing into the Design of the Thermal and Moisture Management System of the Building Enclosure

Incorporating Insulating Sheathing into the Design of the Thermal and Moisture Management System of the Building Enclosure Incorporating Insulating Sheathing into the Design of the Thermal and Moisture Management System of the Building Enclosure Peter Baker, Building Science Corporation ABSTRACT With rising utility cost, concerns

More information

Comparison of Atmospheric Plasma and Corona Treatments in Promoting Seal Strength

Comparison of Atmospheric Plasma and Corona Treatments in Promoting Seal Strength Comparison of Atmospheric Plasma and Corona Treatments in Promoting Seal Strength Presented by Rory Wolf Business Unit Manager ITW Pillar Technologies Discussion Agenda o Study Objective o Extrusion Coating

More information

Optimizing the Assembly Process with Cure-On-Demand UV/Visible Light-Curable Adhesives

Optimizing the Assembly Process with Cure-On-Demand UV/Visible Light-Curable Adhesives Optimizing the Assembly Process with Cure-On-Demand UV/Visible Light-Curable Adhesives Virginia P. Read Industrial Market Segment Manager DYMAX Corporation Torrington, CT www.dymax.com Introduction Manufacturers

More information

Meeting the challenges of medical device packaging

Meeting the challenges of medical device packaging Meeting the challenges of medical device packaging Gisela Cristina Mendes Bastos Viegas, S.A. October 14, 2011 Agenda Evaluation and selection Validation Test methods Sterile Barrier Systems EN 868 Parts

More information

GLOBAL QUALITY SOLUTIONS PACKAGE INTEGRITY SEAL INTEGRITY LEAK DETECTION

GLOBAL QUALITY SOLUTIONS PACKAGE INTEGRITY SEAL INTEGRITY LEAK DETECTION GLOBAL QUALITY SOLUTIONS PACKAGE INTEGRITY SEAL INTEGRITY LEAK DETECTION Redefining the standards for accuracy and reliability. About PTI PTI Packaging Technologies & Inspection is headquartered in Tuckahoe,

More information

Pressure sensitive labeling of terminally sterilized medical device packaging: Testing label materials for adhesion and durability over time

Pressure sensitive labeling of terminally sterilized medical device packaging: Testing label materials for adhesion and durability over time Pressure sensitive labeling of terminally sterilized medical device packaging: Testing label materials for adhesion and durability over time Presented by: Dave Olson - Advanced Web Minneapolis, MN March

More information

Sample Size Rationale For Medical Device Package Validation

Sample Size Rationale For Medical Device Package Validation Sample Size Rationale For Medical Device Package Validation Andrew Bevil Engineering Services Manager WESTPAK Steven Walfish President Statistical Outsourcing Services Dec 2017 Agenda Introduction / Definitions

More information

Polymer Linings for Restoration & Corrosion Protection of Steel Surfaces: Crude Oil Storage Tank Repair and Reline in New Zealand

Polymer Linings for Restoration & Corrosion Protection of Steel Surfaces: Crude Oil Storage Tank Repair and Reline in New Zealand Polymer Linings for Restoration & Corrosion Protection of Steel Surfaces: Crude Oil Storage Tank Repair and Reline in New Zealand ~ 2009 SSPC Corrosion Conference ~ By: Greg Severyn, Sauereisen Inc., Greg

More information

Handbook of Seal Integrity in the Food Industry

Handbook of Seal Integrity in the Food Industry Handbook of Seal Integrity in the Food Industry Handbook of Seal Integrity in the Food Industry Michael Dudbridge This edition first published 2016 2016 by John Wiley & Sons, Ltd. Registered Office John

More information

Specifications for Concrete Embedment Liner

Specifications for Concrete Embedment Liner Specifications for Concrete Embedment Liner Part 1: GENERAL 1.01 SECTION INCLUDES A. Specifications and guidelines for MANUFACTURING high-density polyethylene embedment liners. 1.02 REFERENCES A. American

More information

Technical Bulletin No. 110 GAS BARRIER PROPERTIES OF RESINS

Technical Bulletin No. 110 GAS BARRIER PROPERTIES OF RESINS Technical Bulletin No. 110 GAS BARRIER PROPERTIES OF RESINS The most outstanding property of EVAL TM resins is their ability to provide a barrier to gases such as oxygen, nitrogen, carbon dioxide and helium.

More information

Tube Insulation. Fiber Free

Tube Insulation. Fiber Free Fiber Free Tube Insulation Fiber-free, flexible, elastomeric pipe insulation for reliable protection against condensation, mold, energy loss and ultraviolet radiation in residential and commercial applications

More information

FEBRUARY 27, 2018 Single-Use Bag Permeability Testing in Cryopreservation Conditions

FEBRUARY 27, 2018 Single-Use Bag Permeability Testing in Cryopreservation Conditions FEBRUARY 27, 2018 Single-Use Bag Permeability Testing in Cryopreservation Conditions Mike W. Johnson Market Development Engineering Manager Entegris, Inc. AGENDA 01 Single-use technology 01 Permeation

More information

ECOLOGICAL PACKAGING MATERIALS SINCE 1983

ECOLOGICAL PACKAGING MATERIALS SINCE 1983 ECOLOGICAL PACKAGING MATERIALS SINCE 1983 SHELF LIFE EXTENSION BIODEGRADABLE COMPOSTABLE RECYCLABLE ROCK Biodegradable and Compostable Coatings BIOSKA Biodegradable and Compostable Films Biocoextrusion

More information

Radiation of Biopolymers. Jaejoon Han

Radiation of Biopolymers. Jaejoon Han Radiation of Biopolymers Jaejoon Han INTRODUCTION Polymers are macromolecules composed of many small molecules added to each other to form linear, branched, or cross-linked structures. Synthetic origin

More information

Total Window. U-Factor. Total Window U Value. Duralite can improve. Warmer window. comfortable.

Total Window. U-Factor. Total Window U Value. Duralite can improve. Warmer window. comfortable. Total Window U Value 0.34 Total Window U-Factor 0.30 0.31 Duralite can improve the total window U-value. Duralite SuperSpacer Aluminum SB Warmer window U-values makes you feel more comfortable. Simulations

More information

Photo. Materials Testing for Manufacturers and Retailers

Photo. Materials Testing for Manufacturers and Retailers Photo Materials Testing for Manufacturers and Retailers UL helps you bring safe, high performance materials to the market while protecting your brand When end-product manufacturers are searching for materials

More information

10 Things You Should Do Before You Validate Your Next Package

10 Things You Should Do Before You Validate Your Next Package sponsored by 10 Things You Should Do Before You Validate Your Next Package Before you set out to validate a medical device package design or process, you ve got to do your homework. You need to understand

More information

Supplement to the Republic of Zambia Government Gazette dated XX, 2009 GOVERNMENT OF ZAMBIA

Supplement to the Republic of Zambia Government Gazette dated XX, 2009 GOVERNMENT OF ZAMBIA Supplement to the Republic of Zambia Government Gazette dated XX, 2009 GOVERNMENT OF ZAMBIA STATUTORY INSTRUMENT NO. XX OF 2009 The Environmental Protection and Pollution Control Act (Act No. 12 of 1990)

More information

Nanoscale Barrier Coating on BOPP Packaging Film by ALD Presented by: Dr. Johanna Lahti Senior Research Fellow Tampere University of Technology

Nanoscale Barrier Coating on BOPP Packaging Film by ALD Presented by: Dr. Johanna Lahti Senior Research Fellow Tampere University of Technology Nanoscale Barrier Coating on BPP Packaging Film by ALD Presented by: Dr. Johanna Lahti Senior Research Fellow Tampere University of Technology Co-authors: Kimmo Lahtinen (LUT*), Petri Johansson (TUT),

More information

SECTION REFLECTIVE-FACED, MASONRY CAVITY WALL INSULATION

SECTION REFLECTIVE-FACED, MASONRY CAVITY WALL INSULATION MANUFACTURER S GUIDE SPECIFICATIONS SECTION 04 27 23 REFLECTIVE-FACED, MASONRY CAVITY WALL INSULATION 900 Hensley Lane Wylie TX 75098 800-527-7092 www.carlisleccw.com 07.09.13 Carlisle and R2+ are trademarks

More information

Exterior Building Materials & Detailing

Exterior Building Materials & Detailing Exterior Building Materials & Detailing Marquam George Marquam George LLC Juneau, Alaska marquamgeorge@gmail.com Barriers to? V.1950 Air only Vapor only Water only Air & Water 1 V.1990 V.2005 Detailing

More information

Enabling Growth. H.C. Shin Vice Chair and Executive Vice President. December 12, 2017

Enabling Growth. H.C. Shin Vice Chair and Executive Vice President. December 12, 2017 Enabling Growth H.C. Shin Vice Chair and Executive Vice President December 12, 2017 1 Agenda Business Transformation o Enhancing customer experience and 3M productivity Supply Chain roadmap Investing in

More information

Oliver-Tolas Healthcare Packaging

Oliver-Tolas Healthcare Packaging Oliver-Tolas Healthcare Packaging A leading provider of sterile barrier packaging for medical device and pharmaceutical customers around the world Pouching Die-cutting Cleanroom manufacturing Printing

More information

SECTION MODIFIED BITUMINOUS MEMBRANE ROOFING Peel & Roof

SECTION MODIFIED BITUMINOUS MEMBRANE ROOFING Peel & Roof SECTION 07550 MODIFIED BITUMINOUS MEMBRANE ROOFING Peel & Roof This section is based on the products of MFM Building Products Corp., which is located at: 525 Orange St. P. O. Box 340 Coshocton, OH 43812

More information

PERFORMANCE SPECIFICATION PACKAGING OF FOOD IN FLEXIBLE POUCHES

PERFORMANCE SPECIFICATION PACKAGING OF FOOD IN FLEXIBLE POUCHES INCH-POUND MIL-PRF-44073H 24 July 2017 SUPERSEDING MIL-PRF-44073G 11 September 2009 PERFORMANCE SPECIFICATION PACKAGING OF FOOD IN FLEXIBLE POUCHES This specification is approved for use by all Departments

More information

Abcite 585 EF. Technical Data and Application Guide. Product description. Typical applications. Product range. Product certifications.

Abcite 585 EF. Technical Data and Application Guide. Product description. Typical applications. Product range. Product certifications. Product description is a single layer, primer-free, halogen-free, high strength adhesive thermoplastic powder coating which provides shattering protection for glass pieces and preserves the original glass

More information

Julie Glover and Kevin Brown KTA-Tator, Inc. Wind-Driven Rain Assessment

Julie Glover and Kevin Brown KTA-Tator, Inc. Wind-Driven Rain Assessment Julie Glover and Kevin Brown KTA-Tator, Inc. Wind-Driven Rain Assessment Explain the differences between waterproof, weatherproof, and water repellent. Identify a laboratory test method used for determining

More information

Extreme Sealing Tape

Extreme Sealing Tape Extreme Sealing Tape Technical Data September, 2014 Product Description 3M Extreme Sealing Tape is a family of single coated, pressure sensitive adhesive tapes designed for difficult sealing applications.

More information

A Technology Decision Adhesive Lamination or Extrusion Coating/Lamination?

A Technology Decision Adhesive Lamination or Extrusion Coating/Lamination? A Technology Decision Adhesive Lamination or Extrusion Coating/Lamination? Rory Wolf, Enercon Industries Corporation Abstract Extrusion-based coating/laminating and adhesive-based film laminating are different

More information

Paper and Paperboard Converting

Paper and Paperboard Converting Papermaking Science and Technology a book series covering the latest technology and future trends Book 12 Paper and Paperboard Converting Second Edition Totally updated version Book editor Jurkka Kuusipalo,

More information

Polyethylene (HDPE) Thin Wall Containers

Polyethylene (HDPE) Thin Wall Containers Polyethylene (HDPE) Thin Wall Containers For purposes of this design guidance document, thin walled packaging, also known as thin walled containers, are rigid plastic packaging with a wall thickness less

More information

Extruded Technical Film Solutions

Extruded Technical Film Solutions Extruded Technical Film Solutions Ex Tech is a full range of high-perfmance thermoplastic films & sheets, including polyurethane (TPU), polyester, polyamide, polyolefin and aliphatic urethanes. These materials

More information

PET Thermoforms excerpt from The APR Design TM Guide for Plastics Recyclability

PET Thermoforms excerpt from The APR Design TM Guide for Plastics Recyclability PET Thermoformed Packages PET thermoformed packages are produced by extruding a sheet, then heating that sheet to a pliable forming temperature and then usually assisted by a vacuum formed by a mold and

More information

Cougar Packaging Concepts, Inc. & Xenon Corporation. Zap N MAP Shedding new light on shelf life extension

Cougar Packaging Concepts, Inc. & Xenon Corporation. Zap N MAP Shedding new light on shelf life extension Cougar Packaging Concepts, Inc. & Xenon Corporation Zap N MAP Shedding new light on shelf life extension Cougar Packaging Concepts, Inc. Shelf life and food packaging solutions Shelf Life Booster MAP equipment

More information

PERFORMANCE SPECIFICATION PACKAGING OF FOOD IN FLEXIBLE POUCHES

PERFORMANCE SPECIFICATION PACKAGING OF FOOD IN FLEXIBLE POUCHES INCH-POUND MIL-PRF-44073G 11 September 2009 SUPERSEDING MIL-PRF-44073F 4 September 2001 W/ Change 06 28 Mar 16 ES16-024 (DSCP-SS-16-00454) PERFORMANCE SPECIFICATION PACKAGING OF FOOD IN FLEXIBLE POUCHES

More information

TAIEX Workshop on Packaging and package materialsmodern trends in food industry :

TAIEX Workshop on Packaging and package materialsmodern trends in food industry : TAIEX Workshop on Packaging and package materialsmodern trends in food industry : 5. Oktober 2010 1 Index Generality ARCIL Group in a glance ARCIL FFS principle Cups production principles Plastic materials

More information

How Aluminium Foil Improves the Hot Tack of Packaging Laminates

How Aluminium Foil Improves the Hot Tack of Packaging Laminates How Aluminium Foil Improves the Hot Tack of Packaging Laminates Günter Schubert* * Hydro Aluminium Deutschland GmbH, Georg von Boeselager-Strasse 21, R&D, 53117 Bonn, Germany Abstract In descriptions of

More information

Ammonia. Product performance for insulation of ammonia piping

Ammonia. Product performance for insulation of ammonia piping Ammonia Product performance for insulation of ammonia piping ABOUT K-FLEX USA K-FLEX USA IS A LEADING MANUFACTURER of flexible, closed cell elastomeric insulation for mechanical piping, air handling units

More information

Development of next-generation single-use films for optimal performance in biomanufacturing

Development of next-generation single-use films for optimal performance in biomanufacturing Development of next-generation single-use films for optimal performance in biomanufacturing Susan Burke, PhD Bioprocess R&D GE Healthcare, Life Sciences Overview Importance of voice of customer in film

More information

Application Specification:

Application Specification: Application Specification: GacoFireStop2 F5001 (Half-Pound) March 2014 Supersedes 7/11 Division: 07 21 19 GUIDE SPECIFICATION GacoFireStop2 F5001 INSULATION PART 1 GENERAL This guide specification discusses

More information

Guidance for the use of printing inks for paper and board packaging used for contact with food

Guidance for the use of printing inks for paper and board packaging used for contact with food Annex 1 to JIG/002/10E- PIJITF 1 Guidance for the use of printing inks for paper and board packaging used for contact with food 1-Regulations The Framework Regulation (EC) No 1935/2004 states that materials

More information

June 7, 2012 PARTIES INTERESTED IN HVAC DUCT ENCLOSURE ASSEMBLIES

June 7, 2012 PARTIES INTERESTED IN HVAC DUCT ENCLOSURE ASSEMBLIES June 7, 2012 TO: PARTIES INTERESTED IN HVAC DUCT ENCLOSURE ASSEMBLIES SUBJECT: Revisions to the Acceptance Criteria for Metallic HVAC Duct Enclosure Assemblies, Subject AC179-0612-R1 (MB/CA) Dear Colleague:

More information

55 Gallon Bags TYPES OF BAGS. 55 gallon blue bag > high barrier. 55 gallon metalized bag > standard barrier. 55 gallon clear bag > standard barrier

55 Gallon Bags TYPES OF BAGS. 55 gallon blue bag > high barrier. 55 gallon metalized bag > standard barrier. 55 gallon clear bag > standard barrier Company Profile Aran Packaging was established in 1983 in Kibbutz Nachshon, Israel as a manufacturer of Bag in Box packaging. Aran offers a wide variety of bag in box containers for liquids available in

More information

Barrier Coating Options. English

Barrier Coating Options. English Barrier Coating Options English Replacing fossil-based materials with renewable materials There are no longer any excuses to opt for anything but a renewable packaging material. Even in demanding end uses

More information

Standard Test Method for Effects of Heat and Air on Asphaltic Materials (Thin-Film Oven Test) 1

Standard Test Method for Effects of Heat and Air on Asphaltic Materials (Thin-Film Oven Test) 1 Designation: D 1754 97 Standard Test Method for Effects of Heat and Air on Asphaltic Materials (Thin-Film Oven Test) 1 This standard is issued under the fixed designation D 1754; the number immediately

More information

3M VHB Structural Glazing Tape. Technical Guide

3M VHB Structural Glazing Tape. Technical Guide 3M VHB Structural Glazing Tape Technical Guide 2008 Table of Contents 3M VHB Structural Glazing Tape TECHNICAL GUIDE Introduction 3 Technical Support Center.... 3 Product Portfolio.... 3 3M VHB Structural

More information

Guiding Principles for the implementation of fluid management technologies for modern single use aseptic processing

Guiding Principles for the implementation of fluid management technologies for modern single use aseptic processing Guiding Principles for the implementation of fluid management technologies for modern single use aseptic processing Jean-Marc Cappia, Vice President Marketing Fluid Management Technologies Agenda 1. Aseptic

More information

International Fireproof Technology Inc.

International Fireproof Technology Inc. International Fireproof Technology Inc. The Ultimate in Firestop Solutions and Fire Protective Coatings www.painttoprotect.com 949-975-8588 Guide Specifications Alternate Thermal and Ignition Barrier IFRM

More information

Thin Film Internal Epoxy Coating for Pipelines

Thin Film Internal Epoxy Coating for Pipelines Technical and professional requirements TR1114, Version 1.01, Valid from 13.11.2003 Validity area: Classification: Open Contents 1 Introduction...3 1.1 Objective...3 1.2 Warrant...3 1.3 Publication and

More information

Standard for handling, packing, shipping and use of moisture/reflow sensitive surface mount devices

Standard for handling, packing, shipping and use of moisture/reflow sensitive surface mount devices This is a preview - click here to buy the full publication,(&3$6 Edition 1.0 2000-08 Standard for handling, packing, shipping and use of moisture/reflow sensitive surface mount devices 38%/,&/

More information

Table of Contents - i

Table of Contents - i Table of Contents Section I: Introduction... 1 A. Study background... 1 B. Specific materials selected for the study... 2 Table 1 Oxygen Transmission Rates of Flexible Packaging Materials... 3 Table 2

More information

CeRam-Kote Products by Freecom, Inc.

CeRam-Kote Products by Freecom, Inc. CeRam-Kote 99M CeRam-Kote 99M is a thin-film, spray applied and air-dried ceramic coating engineered to provide excellent abrasion and corrosion protection in critical service environments for all metals,

More information

Extreme Sealing Tape 4412N

Extreme Sealing Tape 4412N Extreme Sealing Tape 4412N Exterior Durability Report Technical Bulletin October, 21 Summary of Technical Data: This report provides accelerated aging data, temperature and humidity resistance, and solvent

More information

Air and Vapor Barrier 3015

Air and Vapor Barrier 3015 Air and Vapor Barrier 3015 Technical Data March 2017 Product Description 3M Air and Vapor Barrier 3015 is an air, moisture and water impermeable membrane with an aggressive, high-tack acrylic pressure

More information

Enhanced Water Vapour Permeability Tester for High Barrier Materials. Alyce Hartvigsen, PBI Dansensor A/S, Ringsted, Denmark

Enhanced Water Vapour Permeability Tester for High Barrier Materials. Alyce Hartvigsen, PBI Dansensor A/S, Ringsted, Denmark ON THE QUALITY LINE Enhanced Water Vapour Permeability Tester for High Barrier Materials Alyce Hartvigsen, PBI Dansensor A/S, Ringsted, Denmark 1 Agenda of Presentation Introduction Review of permeation

More information

STEGO WRAP CLASS C VAPOR RETARDER A STEGO INDUSTRIES, LLC INNOVATION VAPOR RETARDERS , VERSION: JAN 5, 2018

STEGO WRAP CLASS C VAPOR RETARDER A STEGO INDUSTRIES, LLC INNOVATION VAPOR RETARDERS , VERSION: JAN 5, 2018 P1 OF 2 STEGO WRAP CLASS C VAPOR RETARDER 1. PRODUCT NAME STEGO WRAP CLASS C VAPOR RETARDER 2. MANUFACTURER Stego Industries, LLC 216 Avenida Fabricante, Suite 101 San Clemente, CA 92672 Sales, Technical

More information

UV & EB Technology for Flexible Packaging. Presented by: Don P. Duncan Director of Research Wikoff Color Corporation

UV & EB Technology for Flexible Packaging. Presented by: Don P. Duncan Director of Research Wikoff Color Corporation UV & EB Technology for Flexible Packaging Presented by: Don P. Duncan Director of Research Wikoff Color Corporation Is That All There Is? Chemistry: UV(100) EB(100) EB(

More information

Tape No. Description Principal Uses

Tape No. Description Principal Uses AVERY DENNISION Specialty Tape Division 250 Chester Street Painesville, OH 44077 Tel: 866.GO.AVERY or 866.462.8379 www.stus.averydennison.com FL 1000 Single coated 2.0 mil foil with 2.2 mils of an acrylic

More information

Dept of Animal Sciences & Industry Kansas State University Manhattan, Kansas-66506

Dept of Animal Sciences & Industry Kansas State University Manhattan, Kansas-66506 Advances in Meat Packaging M. C. Hunt & Anand Mohan Dept of Animal Sciences & Industry Kansas State University Manhattan, Kansas-66506 General Overview Where have we been? Current short comings? Managing

More information

TERPOLYMER ETHYLENE VINYL ACETATE MALEIC ANHYDRIDE

TERPOLYMER ETHYLENE VINYL ACETATE MALEIC ANHYDRIDE TERPOLYMER ETHYLENE VINYL ACETATE MALEIC ANHYDRIDE Hot Melt Formulation To optimise cost/performance, OREVAC Terpolymers are combined with EVATANE. Adhesion tests have been performed in a classical Hot

More information

POLYOLEFINS FOR FLEXIBLE PLASTICS FILM LAMINATES

POLYOLEFINS FOR FLEXIBLE PLASTICS FILM LAMINATES INDIAN PLASTICS INSTITUTE CHENNAI CHAPTER One Day Seminar on FLEXIBLE PLASTICS FILM LAMINATES 20th September 2004 - Hotel Savera POLYOLEFINS FOR FLEXIBLE PLASTICS FILM LAMINATES Presented by : Shri K Hariharan

More information

Bio-Polymers & New Materials: Polymers from Renewable Resources. April 2008

Bio-Polymers & New Materials: Polymers from Renewable Resources. April 2008 Bio-Polymers & New Materials: Polymers from Renewable Resources April 2008 What are Bio-Polymers? Bio-Based or Bio-Sourced means that the product has been made from a biological (living) or renewable source,

More information

SECTION PANEL AND POST AND PYLON SIGNAGE. 1. Non-illuminated Panel and Post signs. 2. Internal illumination Pylon (Cabinet and Post) signs.

SECTION PANEL AND POST AND PYLON SIGNAGE. 1. Non-illuminated Panel and Post signs. 2. Internal illumination Pylon (Cabinet and Post) signs. PART 1 - GENERAL 1.1 SUMMARY A. This Section includes the following: 1. Non-illuminated Panel and Post signs. 2. Internal illumination Pylon (Cabinet and Post) signs. 1.2 PERFORMANCE REQUIREMENTS A. Structural

More information

Vapor Barriers Under Concrete Slabs Guidance for Selection and Location

Vapor Barriers Under Concrete Slabs Guidance for Selection and Location PDHonline Course A125 (1 PDH) Vapor Barriers Under Concrete Slabs Guidance for Selection and Location Instructor: Brian M. McCaffrey, P.E. 2012 PDH Online PDH Center 5272 Meadow Estates Drive Fairfax,

More information