Contact us today to find out how we can ensure the reliability and integrity of your packaging system. Cryopak Package Testing Capabilities

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

PACKAGE TESTING AND VALIDATION SERVICES

Bemis Laboratory Services Your Reliable Test Partner

DDL Overview DDL S MISSION STATEMENT. Accelerated Aging Material Evaluation Shipping/Distribution Simulation Package Integrity Testing

Product and Package Stability Studies The Application of FDA Guidance

10 Things You Should Do Before You Validate Your Next Package

Patient Safety: Medical Device Distribution Evaluation and Sterile Barrier System Integrity

MEDICAL DEVICE PACKAGING VALIDATION GUIDE. A step by step handbook on Package Validation per ISO 11607

Bemis Laboratory Services

WHITE PAPER March 2015

DDL Testing Services. DDL, Inc Valley View Road, Suite 101 Eden Prairie, MN (952) Fax: (952)

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

This document is an OVERVIEW ONLY

ISO Part 1 and Part 2 Compliance Requirements. Cathriona O Neill

Healthpack Conference 2015 Design Validation and Sampling for Thermoformed Packaging. Elizabeth Nugent Vice President of European Sales

Medical Device Packaging Benchmarking Project

ISTA & Package Testing

OVERVIEW OF PROCEDURE 2A

CARE SERVICE USER GUIDE. Sonicision System

OVERVIEW OF PROCEDURE 2B

"Brand protection, is environmental testing the way forward?" Ralph Harris TÜV SÜD Product Service

Eliminating Leaking Containers

A PROCESS VALIDATION GUIDE FOR COLD CHAIN LOGISTICS: ENSURING COMPLIANCE GLOBALLY

Mark R. Chrusciel. Director of Sales. For a copy of the slides

ISO How to translate into action Sterile container systems

L.A.B. Equipment, Inc.

Staff Contact: Erin N. Topper Telephone (703)

The entire document shall be read and understood before proceeding with a test. ISTA 3B Page 1 of 35

The entire document shall be read and understood before proceeding with a test.

AMRI Acquires Whitehouse Laboratories Investment Community Presentation. December 15, 2015

e-commerce Fulfillment for Parcel Delivery Shipment

Because People Rely on Your Products, Everyday, You can Rely on Us

Precision. Proficiency. Proximity.

PACKAGE TESTING LABORATORY. since 1999 Improving packaging sustainability one test at a time ISTA and ISO Accredited

REUSABLE MEDICAL DEVICE VALIDATION

Guidance Document. Qualification of Packaging and Validation of Shipping/Transport Procedures [No. 9, October 23, 2017]

WHITE PAPER September 2018

Developing Temperature Controlled Environmental Test Standards

Session 9: Packaging Quality Assurance & Testing of Packaging For Exports

High Reliability Optoelectronic Devices

UNITED NATIONS / DOT PERFORMANCE CERTIFICATION 4G DESIGN QUALIFICATION

Testing Packaged Products Weighing More Than 150 Lbs.

CRCA Research: Roof Insulation Facers and Water Based Adhesives. January 22,2015. Drury Lanes Conference Center

Product Damage Reduction

Systematic Packaging Development Relation to product design

Shake. Rattle. Roll. Would you do this to your products?

Herb Schueneman (Train Lover ESQ) President & CEO WESTPAK, Inc. June 2015

L.A.B. Equipment, Inc.

Meeting the challenges of medical device packaging

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

It is proposed to amend Item (Rule) 181, Furniture Package Performance Testing, as follows: FURNITURE PACKAGE PERFORMANCE TESTING

UNITED NATIONS / DOT PERFORMANCE CERTIFICATION 4G DESIGN QUALIFICATION

Structural Performance Tests of VHB Structural Glazing Tapes

Adapt to China s Shipping Environment

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

UNITED NATIONS / DOT PERFORMANCE CERTIFICATION 4G DESIGN QUALIFICATION

TEST REPORT. B&W International GmbH Junkendiek Ibbenbühren

The entire document shall be read and understood before proceeding with a test.

ASTM International Committee F02 Flexible Barrier Packaging

Anecto Ltd. Ballybrit Business Park, Galway. Testing Laboratory Registration number: 175T

TEST CODE DEFINITION STERRAD H202. Test Code Test Name Testing Description. Cycle. Efficacy. SE-200 STERRAD 200 Efficacy. Cycle. STD Cycle Efficacy

3M Cold Shrink Silicone Rubber Connector Insulators 8440 Series

Product Catalogue. Physical Testing Permeation & Headspace Package & Seal Integrity ASSURED QUALITY TESTING SOLUTIONS

Sterile Barrier System: Common Failure Modes & Design Recommendations

PACKAGING RULES MIN STANDART SIZE. 150 mm

How Pre-Validated Medical Device Packaging Complies with ISO Standards

LIFE TESTING FOR DEVICE COMBINATION PRODUCTS

SCOPE OF ACCREDITATION TO ISO/IEC 17025:2005

Scientific Standards for Ambient Temperature Profile Development:

February

DANGEROUS GOODS PANEL (DGP) MEETING OF THE WORKING GROUP OF THE WHOLE

ESTABLISHMENT OF A NEW MEDICAL DEVICE PACKAGING LABORATORY

// SAFE AND INNOVATIVE SOLUTIONS FOR THE TRANSPORT, STORAGE AND DISPOSAL OF RADIOACTIVE MATERIALS

Testing Packaged Products Weighing up to 150 Lbs.

UNITED NATIONS / DOT PERFORMANCE CERTIFICATION 4G DESIGN QUALIFICATION. HWS324-4 x 32 Oz. Wide Mouth Glass Jar Packaging TEST REPORT #: 18-MN20004

SECTION A. Product Data: Manufacturer's data sheets on each product to be used, including:

Guidelines for Selecting and Using ISTA Test Procedures and Projects

ASTM D10-F02 Workshop FDA Regulatory Perspective. Patrick Weixel FDA Center for Devices and Radiological Health

ASTM International Committee F02 Flexible Barrier Packaging

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

sterility assurance Prove the power and your processes

Effect of Temperature on Static and Impact Properties of New Softwood Pallets

SterilAmp II Geobacillus stearothermophilus

HP COMPRESSION TEST METHOD A Rev. A

Packing Instructions Class 6 Toxic and Infectious Substances

SECTION A. Product Data: Manufacturer's data sheets on each product to be used, including:

Manitowoc Product Verification Center. Research and development for Grove, Manitowoc, National Crane, and Potain cranes

THE CUBE. New Ideas Come Up From Solving Challenges

Understand the Source of Product Damage with Data Loggers. Author: ShockWatch, Inc. May 2013

Use of Design Guide F 2097 & U.S. FDA Recognition

Pointers on Packaging for Computer Shipments

ISTA 3A PACKAGE PERFORMANCE TEST

New Pressure Sensitive Device to Measure and Predict Package Drops

Packaging Form Comparison:

The Use of Pharmaceutical Stability Tools in Medical Device Stability Programs

Photovoltaic Modules: TÜV Rheinland and DB Schenker Develop New Logistics System for Greater Transparency and Safety in Global Transport

PACKAGING GUIDE FOR SHIPPERS CLAIMS-FREE SERVICE TAKES A TEAM EFFORT.

STYCAST 2850 GT Thermally Conductive Epoxy Encapsulant

Warehousing & Distribution

ROCKSHIELD FOR PIPELINE COATING PROTECTION TUFF-N-NUFF

Transcription:

ISTA Certified Lab

Cryopak offers technical expertise that helps customers ensure a reliable package by providing a wide range of testing capabilities. Cryopak offers quality services for multiple fields including the pharmaceutical, home/personal care, food and consumer goods industries. Cryopak takes great pride in offering exceptional customer service and prompt turnaround time. Contact us today to find out how we can ensure the reliability and integrity of your packaging system. Cryopak Package Testing Capabilities DISTRIBUTION TESTING Distribution Test: ASTM D4169, ASTM D7386, ISTA Series 1, 2 and 3 ASTM D4332 Thermal Conditioning ENVIRONMENTAL CONDITIONING Customer Derived Conditioning ASTM and ISTA Pre-Distribution Test Conditioning Standards ACCELERATED AGING Aging Based on Q10 Theory: ASTMF1980 Dye Leak Testing: ASTMF1929 Vacuum Leak (Flexible Packaging): ASTM D3078 PACKAGE INTEGRITY Vacuum Leak (Rigid Packaging): ASTMD4991 Bubble Leak Testing: ASTM F2096 Visual Inspection: ASTM F1886 PACKAGE STRENGTH Seal Strength Testing: ASTM F88 Burst Strength Testing: ASTMF1140 The above is not a complete list of our testing capabilities. If you require any of these procedures or other additional test methods, please contact us.

Distribution Testing During distribution, packages are shaken, tossed, stacked, dropped and exposed to environmental changes. These distribution hazards can potentially cause damage to the product, resulting in costly replacements and can harm your company s credibility. Cryopak performs tests that simulate these distribution hazards in a controlled and repeatable laboratory setting. Cryopak s lab is certified with the International Safe Transit Association. ISTA is an organization that focuses on matters related to responsible transport packaging. ISTA provides standards to optimize packaging systems and provide protocols to simulate expected distribution hazards. ISTA distribution tests can be used to provide engineers with valuable data used to evaluate effectiveness of protective packaging. In addition, Cryopak follows standard with the American Society for Testing and Materials. ASTM devotes major methodologies for package-product performance in distribution: D4169 and D7386. Cryopak staff are highly knowledgeable on all distribution simulation standards and will work with you to design the right series of tests to ensure your product is fully protected from a variety of distribution hazards. Some examples of tests that can be part of a distribution study are as follows: Manual Handling: Simulates drops from specified heights Mechanical Handling: Simulates a truck or forklift in motion Warehouse Stacking: Simulates compressive loads being applied to the shipping unit Vehicle Vibration: Simulates vertical vibration during transportation in a truck Loose Load Vibration: Simulates repetitive shock on the shipping unit Environmental Hazards: Simulates the changing temperatures and humidity that the shipping unit will be exposed to during transit Concentrated Impact: Simulates low-level impacts that the shipping unit will be subjected to during sorting and transit Low Pressure, High Altitude: Simulates the reduction of pressure when a shipping unit is transported by aircraft

Environmental Conditioning Temperature and humidity extremes can affect packaging and products. Cryopak s programmable thermal chambers will expose your package and product to a custom or ISTA/ASTM industry standard temperature and humidity profile. Environmentally testing your package and product to worst-case scenario temperature and humidity will allow you to make an informed decision on what packaging to use and verify its effectiveness. ISTA provides standard temperature and humidity test profiles accepted by government and nongovernment organizations worldwide. With the help of Cryopak s engineers, many companies have determined the optimal packaging and transit times for temperaturesensitive product. The performance chart above shows testing data from one of Cryopak s thermal studies. The package (Sample 1) was exposed to elevated temperatures from 25 C to 40 C. During the 96 hour test, the internal temperature of the shipper successfully maintained a controlled temperature between 2 C to 8 C.

Accelerated Aging Accelerated aging uses heightened conditioning of heat and humidity to speed up the normal aging process. This test method is accepted by the FDA, the EU and other regulatory bodies to determine shelf life or lifespan when real-time aging data is not yet available. This test will expedite your product to market while real-time aging studies are performed to validate shelf life claims and expiration dates. In addition, accelerated aging will provide an engineer with valuable data on how packaging components and adhesives may breakdown, become brittle or lose bonding capabilities over time. Accelerated aging studies are required for ISO-11607 Packaging for Terminally Sterilized Medical Devices. Cryopak Testing Center has multiple constant temperature chambers maintaining different set points that can be utilized for your accelerated aging needs.

Package Integrity Integrity testing is essential to determining the sterility of a product and how well the microbial barrier packaging performs. After enduring accelerated aging, environmental stress and/or distribution testing, the packaging is evaluated to determine if it was compromised. These tests ensure that the product will not be damaged under typical distribution hazards. Dye Leak Testing ASTM F1929 A high precision test method that is used for locating package seal defects Vacuum Leak (Flexible and Rigid Packaging) ASTM D3078, ASTM D4991 Uses low air pressure to test the overall package integrity Bubble Leak Testing ASTM F2096 Visual Inspection ASTM F1886 Uses water submersion and air pressure to test for bubbles, which indicate a leak Reveals and documents failuresalong the package surface and seal

Package Strength Our fully equipped lab can perform multiple package strength tests which are integral for understanding a package s ability to withstand forces that it may experience. Seal strength testing measures the force it takes to open a package s seal to ensure optimal product safety and customer usability. Burst testing measures a package s ability to withstand internal pressure before failure and exposes weak areas. Seal Strength Testing ASTM F88 Burst Strength Testing ASTM F1140 This test measures the strength of seals in flexible barrier materials. This test determines the ability of packages to withstand internal pressurization. The internal pressure is gradually increased until the package fails, and the peak value is recorded.

Global Headquarters 551 Raritan Center Parkway Edison, NJ 08837 P: 732-346-9200 F: 732-346-0295 sales@