WIXLIB

Committee F02 onFlexible Barrier PackagingDistribution SimulationTestingWhat is the industry doing?ASTM F2 MeetingBarcelona, SpainSeptember 26, 2012

Distribution SimulationTestingWhat is the industry doing?

Outline IntroductionWhat Is Distribution Simulation?Purpose of Distribution SimulationBackground of Standard Writing Organizations(ASTM & ISTA)Identifying Test MethodologiesConsensus StandardsProblems in the utilization of some standardsSo what are people utilizing and why?Protocol DevelopmentFinal Test Report DevelopmentConclusionQuestions

Introduction Many medical device manufactures struggle on a daily basis with whatthey need to do in order to comply with ISO 11607 and whichprocedure to utilize for performance testing (ASTM or ISTA). Throughout this presentation, we are going to look at this situation froma different perspective. Basically, we are going to look at it from theoutside in. DDL works with MDM‟s on a daily basis by helping them executetransportation simulation using various test procedures. The primarilygoal is to have an effective shipping configuration that protects theproduct and package integrity during transit, and ultimately is incompliance with ISO 11607.

What is distribution simulation testing?Distribution simulation testing is a uniform andrepeatable way of evaluating packaging systems byutilizing laboratory equipment to subject thepackaging system to specific hazards that may occurwithin the anticipated distribution environment.

Purpose of Distribution SimulationTransportation simulation testing is simply a conditioning element. There isno specific or variable result derived from these tests. What testing you doafter „conditioning ‟identifies whether the package system passes or fails.The testing for package system validation needs to be established prior totesting.1.Evaluate Product/Package Interaction (Sterility Maintenance)2.Evaluate Product Functionality3.Regulatory Compliance

Distribution Simulation Standards?Where are distribution simulation standards developed? ASTM International (American Society of Testing Materials)D4169 D7386 ISTA2 Series “Partial Simulation Performance Tests” 3 Series “General Simulation Performance Tests” CorporationsOwn protocols Modified published standards.

Standard Writing Organizations ASTM-InternationalPublic Democratic Process Task Group development and approval Subcommittee review and approval Main Committee review and approval All comments and negative ballots must be resolvedbefore approval. Full ASTM membership reviews standardsprior to approval.

Standard Writing Organizations ISTA (International Safe Transit Association)Private industry association (Membership required to participate.) Board of Directors generates new ideas forstandards. Standards are reviewed and approved through “testseries groups” and the ISTA Technical Council. Finalapproval is by Board of Directors. No formal ballot process for ISTA members, outsideorganizations, or industry experts.

Identifying Test Methodologies(ASTM)One of the most prevalent test procedures utilized today is ASTMD4169.“Standard Practice for Performance Testing of Shipping Containers andSystems”First approved in 1982 and is most widely used distribution simulationstandard in the world.Ref. McKinlay, Alfred H. “Measuring Package Performance to AvoidShipping Damage” Standardization News (October 2004)

Identifying Test Methodologies(ASTM)ASTM D4169-05 DC 13“Air & Motor Freight, Local, Single Package Up to 100#‟s”- This single standard is used quite predominately forregulatory compliance.- Currently recognized by FDA as a consensus standard.(A) Manual Handling2. Schedule (C) Compression Testing3. Schedule (F) Loose-Load Vibration4. Schedule (I) Low-Pressure / High Altitude5. Schedule (E) Random Vibration (Truck & Air)6. Schedule (A) Manual TestingSchedue AManual HandlingSchedule CVehicle StackingSchedule FLoose-Load Vibration1. ScheduleSchedule ILow Pressure / High AltSchedule ERandom Vibration (Truck/Air)Schedue AManual Handling

Test Methodologies (ASTM)Schedule AManual HandlingJust Released ASTM D4169-08 (Significant Changes) from 05.Schedule CVehicle Stacking1.2.3.4.5.6.7.Schedule (A) Manual HandlingSchedule (C) Compression TestingSchedule (F) Loose-Load VibrationSchedule (I) Low-Pressure / High AltitudeSchedule (E) Random Vibration (Truck & Air)Schedule (J) Concentrated Impact ( 275# or 40 ECT)Schedule (A) Manual Testing (Bridge Impact)Schedule FLoose-Load VibrationSchedule ILow Pressure / High AltSchedule ERandom Vibration (Truck/Air)Schedule JConentrated Impact32" Drop on Box FacesSchedue AManual HandlingBridge Impact If Needed (12")Box Length 3x Width or Height

Test Methodologies (ASTM)- Newly Released ASTM D7386-08“Standard Practice for Performance Testing of Packages for SingleParcel Delivery Systems”- Generally developed for ALL types of packages moving through thesingle parcel shipping system (UPS, FedEx, etc.)- This standard is dependent upon what type of package you are trying toevaluate. Small Packaged-Product Bagged for Transport (TS-1) Large Flat Packaged Product (TS-2) Long Narrow Packaged Products (TS-3) All Other Packaged Product (TS-4) (Most Typical)

Identifying Test Methodologies(ASTM D7386-08)- Example Situation (Standard shipper, 12”x12”x12” Containing Single BarrierPoly/Tyvek Pouch)- This would follow into the classification of “TS-4”.TS-4 Test Sequence:1. A1. Manual Handling2. D1. Vibration Under Compressive Load3. Kc . High Altitude Testing (Not Needed) – Porous Package4. A2. Manual Handling5. D3. Vibration With Out Compressive Load6. A3. Manual Handling7. L. Concentrated Impacts (36”)This procedure can be strenuous for MDM‟s because of the vibration undercompressive load.

Test Methodologies (ASTM D7386-08)Sequence A1Manual HandlingEdge 3-4Edge 4-6Corner 2-3-5Edge 4-6Sequenc D1Vibration Under Compressive LoadFace 1 or 3 60 MinutesFace 2 or 4 30 MinutesFace 5 or 6 30 MinutesSequence A2Manual HandlingEdge 2-3Corner 2-3-6Edge 2-5Edge 3-5Corner 3-4-5Face 1Sequence KcHigh Altitude Testing(If Applicable)Sequenc D3Vibration WO Compressive LoadFace 1 or 3 30 MinutesSequence IConcentrated Impact36" Drop of all faces

Test Methodologies (ISTA)ISTA Standards (Procedures 1A – 7D) ISTA 1 Series: Non-Simulation Integrity Performance Tests.Challenge the strength and robustness of the product and package combination. Notdesigned to simulate environmental occurrences. Useful as screening tests, particularlywhen used as a consistent benchmark over time. ISTA 2 Series: Partial Simulation Performance Tests.Test with at least one element of a 3 Series type General Simulation Performance Test,Such as atmospheric conditioning or mode-shaped random vibration, in addition to basicelements of a 1 Series type Non-Simulation Integrity test. ISTA 3 Series: General Simulation Performance Tests.Designed to provide a laboratory simulation of the damage-producing motions, forces,conditions, and sequences of transport environments. Applicable across broad sets ofcircumstances, such as a variety of vehicle types and routes, or a varying number ofhandling exposures. Characteristics will include simple shaped random vibration, differentdrop heights applied to the sample package, and/or atmospheric conditioning such asRef: The ISTA 2009 RESOURCE BOOKtropical wet or winter/frozen.

Identifying Test Methodologies(ISTA)ISTA Standards (Procedure 1A) ISTA 1 Series: Non-Simulation Integrity Performance Tests. Challengethe strength and robustness of the product and package combination.Not designed to simulate environmental occurrences. Useful asscreening tests, particularly when used as a consistent benchmarkover time ISTA 1 Series: Non-Simulation Integrity Performance Tests.Many medical device manufactures, still try to utilize ISTA Procedure1A. This procedure was developed for a quick and easy way toevaluate a shipping configuration for drop testing and repetitive shockvibration only. For MDM‟s evaluating a sterile barrier system, this isNOT the procedure that you should be utilizing for dynamic evaluation.This procedure does not take into a account random vibration oratmospheric pre-conditioning and is not truly a „simulation‟. It is alsomeant strictly for domestic shipment.

Test Methodologies (ISTA)ISTA Standards (Procedure 2A) ISTA 2 Series: Partial Simulation Performance Tests. Test with at least oneelement of a 3 Series type General Simulation Performance Test, Such asatmospheric conditioning or mode-shaped random vibration, in addition to basicelements of a 1 Series type Non-Simulation Integrity test. The ISTA Project 2A procedure is a widely utilized test procedure to evaluate sterilebarrier system through dynamics.Pro‟s1. Comparable to ASTM D4169-052. Atmospheric Conditioning3. Fixed Displacement Vibration and or Random Vibration(Both are discussed)Con‟s1. Does not address effects of low pressure high altitude onnon-porous packaging.2. Alternative methods

Test Methodologies(ISTA)Atm os pheric Pre-Conditioning6 Hrs . @ Laboratory ConditionsISTA - Procedure 2ATest Sequence*Could have many other sequencesdepending upon alternative methodschosen.Atm os pheric ConditioningUs er to Specify - Exp.-29C For 72 Hrs . - Extrem e Cold38C @ 85%rH For 72 Hrs . - Hot/Hum id then,60C @ 30%RH for 6 Hrs . - Extrem e Heat, DryCom pres s ion Tes tingVibration Tes ting(Fixed Dis placem ent or Random )Shock/Drop Tes tingVibration Tes ting(Fixed Dis placem ent or Random )

Test Methodologies (ISTA 3A)ISTA Standards (Procedure 3A)Test Procedure 3A is a general simulation test for individual packaged productsshipped through a parcel delivery system. The test is appropriate for 4 differentpackage types commonly distributed as individual packages, either by air orground.Types:- standard packages- small packages- flat packages- elongated packages

Test Methodologies (ISTA)Basic Requirements:- atmospheric pre-conditioning,- random vibration with and without top load- shock testingThis test procedure is used sparingly by Medical Device Manufactures as it issevere with the utilization of top load vibration. MDM’s may encounterDamage that does not happen in the normal distribution environment.This procedure is comparable to ASTM D7386-08.

Test Methodologies(ISTA)ISTA - Procedure 3AStandard PackagedProduct TestAtm ospheric Pre-Conditioning6 Hrs. @ Laboratory ConditionsAtm ospheric ConditioningUser to Specify - Exp.-29C For 72 Hrs. - Extrem e Cold38C @ 85%rH For 72 Hrs. - Hot/Hum id then,60C @ 30%RH for 6 Hrs. - Extrem e Heat, DryDrop TestingVibration TestingWith and Without Top LoadRandom Vibration Under Vacuum(Optional)Drop Testing

Testing Equipment PhotosRepetitive Shock / LooseLoad VibrationRandom VibrationCompression TestingDrop Testing

Identifying Test Methodologies(Environmental Conditioning)In the past, Medical Device Manufactures have only been primarily concerned withpackage/product interaction through dynamic testing. Dynamics play a key role inevaluating the efficacy of the shipping configuration, but most have failed to take intoaccount the physical environmental stresses that packaging materials are subjected to innormal everyday shipment.

Test Methodologies(Environmental Conditioning) Climatic extremes can have an effect on package material strength andresultant performance. By subjecting shipping units to temperature andhumidity extremes prior to physical dynamic conditioning any problematicsituations can be identified and corrected.ISO 11607-1:2006 - Section 6.3:Note: Stability testing and performance testing are separate entities.Performance testing evaluates the interaction between the packagingsystem and the product units in response to the stresses imposed by themanufacturing, sterilization processes and the handling, storage andshipping environment.