Agenda - Institute Of Packaging Professionals

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Sterile Barrier Integrity Task GroupUpdate For Presentation to:The IoPP Medical DevicePackaging Committee November 9, 2004 AgendaMembers and Technical HelpCharter Statement and ObjectivesProgressExperiment 1– Accomplishments– Results– Next Steps Future Experiments11/09/04Sterile Barrier Integrity TaskGroup UpdateSubcommittee Members Brett Baker- Sabin CorporationLaura Bix- MSUSteve Bunnell- MoconSteve Good- AbbottRon Iwaszkiewicz- MSUVarsha Kalynakar- Cardinal HealthHugh Lockhart- MSUBob MaxinerJordan Montgomery- MedtronicTom Misik- Belco Packaging SystemsDave Morris- iTi QualitekMitch Neely- Cardinal HealthJane Severin- MSUGeorge Young- GWY Technologies11/09/04Sterile Barrier Integrity TaskGroup UpdateStudent Workers Kristi Radakovic Becki Schaeff11/09/04Sterile Barrier Integrity TaskGroup Update11/09/04Sterile Barrier Integrity TaskGroup UpdateTechnical Assistance Gary Burgess- Engineering Mechanics, MSU Tom Corner- Microbiologist, Microbiology andMolecular Genetics, MSU Nick Fotis- Director, Packaging Technology Center,Cardinal Health Dennis Gilliland- Statistician, Department of Statisticsand Probability, MSU Earl Hackett Jr. Bruce Harte- Food Science and Human Nutrition, MSU John Linz- Microbiologist, Food Science and HumanNutrition, MSU Mike Rich- Composite Center, MSU Paul Singh- Agricultural Engineering, MSU11/09/04Sterile Barrier Integrity TaskGroup UpdateCharter StatementWe are attempting to answer the question,“What hole size presents a danger inmedical device packages”? So that: Manufacturers can make informeddecisions about the appropriatesensitivity for integrity tests Informed decisions can be made in theevent of a potential recall situation Patient safety is maximized, whilecosts are minimized11/09/04Sterile Barrier Integrity TaskGroup Update1

BackgroundSealed, sterilizedtray11/09/04Sealed, sterilizedtray is bombardedwith microbes(aerosol,immersion or talc)The exterior of thesealed, sterilizedtray is wiped downto thoroughlydisinfect thepackage’s exteriorThe interior of theCulture andpackage isdetermine growthswabbedSterile Barrier Integrity TaskGroup UpdateBackgroundSealed, sterilizedtray11/09/04Sealed, sterilizedtray is “aseptically”filled with sterileagar through aself-sealingseptum using aneedle andsyringeSealed, sterilized,agar-filledpackage isbombarded withmicrobes (aerosol,immersion or talc)The package isincubated at theappropriate conditions(for the agar and themicrobe in question) andexamined to determinegrowthSterile Barrier Integrity TaskGroup UpdateExperiment 1- Working Hypotheses1. “Aseptic” introduction of appropriate agargrowth medium into a sterile package will notresult in unwanted contamination of the package(false positives).2. “Aseptic” introduction of appropriate agargrowth medium into a sterile package will resultin the ability to measure package integrity afterpackages have been subjected to a microbialchallenge11/09/04Sterile Barrier Integrity TaskGroup UpdateProgress11/09/04Sterile Barrier Integrity TaskGroup Update11/09/04Sterile Barrier Integrity TaskGroup UpdateTrays & Lids Tray– Perfecseal Outer Tray(PN350215-001)– PETG Lid– Amcor Flexibles PTH017 Heat Seal Coated1073B Tyvek Heat sealer - SenCorpMD 242011/09/04Sterile Barrier Integrity TaskGroup Update2

Trays & LidsTrays & Lids Septum Options––––Electrical Tape w/ SiliconeDuct Tape w/ SiliconeSilicone OnlySticky Nickel Agar Flow– 16 Gauge needle Faster flow of agar intosyringe– 18 Gauge needle Puncture Location Minimize hole in SNwhen injecting into tray– Syringe used once toinoculate 2 trays 25 ml into each tray11/09/04Sterile Barrier Integrity TaskGroup UpdateMicrobiology MethodsSterile Barrier Integrity TaskGroup Update11/09/04Microbiology Methods Dilution Techniques1 ml Autoclaving and Sterilization TechniquesAgar PreparationGrowth Media PrepGrowth QuantificationTechniques Pipetting11/09/04Sterile Barrier Integrity TaskGroup Update10-21.0 ml11/09/04Microbiology Methods Determination of initial microbial concentration11/09/04Sterile Barrier Integrity TaskGroup Update1 ml1 ml10-41.0 ml10-41 ml10-61.0 ml10-60.1 ml10-710-81.0 ml10-80.1 ml10-9Sterile Barrier Integrity TaskGroup UpdateMicrobiology Methods Plate/Colony Counting11/09/04Sterile Barrier Integrity TaskGroup Update3

Microbiological Methods Plating TechniquesCurrent StudyExperiment 111/09/04Sterile Barrier Integrity TaskGroup UpdateExperiment 1- Working Hypotheses1. “Aseptic” introduction of appropriate agargrowth medium into a sterile package willnot result in unwanted contamination ofthe package (false positives).2. “Aseptic” introduction of appropriate agargrowth medium into a sterile package willresult in the ability to measure packageintegrity after packages have beensubjected to a microbial challenge11/09/04Sterile Barrier Integrity TaskGroup Update11/09/04Study Materials Sealed trays sterilized by CardinalHealthcare Sticky Nickel Septum provided by Mocon Bacteria used: Escherichia coli K-12,ATCC Number 29181 (provided byMedtronic).– 5 Concentrations of E.coli K-12 0, 102, 104, 106, 10811/09/044 Test Groups Test Group 1– Inject ThroughContaminatedArea11/09/04Sterile Barrier Integrity TaskGroup UpdateSterile Barrier Integrity TaskGroup UpdateSterile Barrier Integrity TaskGroup Update4 Test Groups Test Group 2– Inject ThroughContaminatedArea (withAlcoholSwab)11/09/04Sterile Barrier Integrity TaskGroup Update4

4 Test Groups4 Test Groups Test Group 3– Inject ThroughNonContaminatedArea (withAlcohol Swab)11/09/04Sterile Barrier Integrity TaskGroup Update Test Group 4– Positive ControlSterile Barrier Integrity TaskGroup Update11/09/04Results Test Group 1- Inject ThroughContaminated Area (No Alcohol Swab)– 10 per concentration (50 total) 0 concentration- No growth 102- No growth 104- No growth 106- 1 showed growth 108- 2 showed growth11/09/04Sterile Barrier Integrity TaskGroup UpdateResults, Continued Test Group 2- Inject ThroughContaminated Area (Using Alcohol Swab)– PendingSterile Barrier Integrity TaskGroup Update11/09/04Results, Continued Test Group 3- Inject Through NonContaminated AreaResults, Continued Test Group 4- Positive Control– 10 trays per concentration (50 trays total) 0 Concentration– 30 trays total– 9 No growth– 1 outlier fungus 27 No Growth 3 Unknown Particulate11/09/04Sterile Barrier Integrity TaskGroup Update 11/09/04102- No growth104- 1 showed growth106- 2 showed growth108- 6 showed growthSterile Barrier Integrity TaskGroup Update5

Accomplishments Defined Study Methodology Navigated much of the MicrobiologyLearning Curve Successfully Completed two Pilot Studies Successfully found and Connected withCollaborators from a Variety of Disciplines11/09/04Sterile Barrier Integrity TaskGroup Update11/09/04Sterile Barrier Integrity TaskGroup UpdateNext Steps Refine Microbiology Techniques––––Agar handlingUVSticky Nickel handlingEvaluation of Use of Marker MicrobesFuture Studies Complete Experiment 1 If the working hypotheses are true, themethod will be presented to ASTM F-02 forconsideration as a standard. Obtain Funding for future experiments Standard will be used in future studies– Experiments 2 & 311/09/04Sterile Barrier Integrity TaskGroup Update11/09/04Sterile Barrier Integrity TaskGroup UpdateExperiment 2Experiment 2What Hole Size Allows Penetrationwhen Brownian Motion Drives?Identify the minimum hole size(s)through which Bacillus subtilis andE. coli K-12 penetrate a rigid tray whentemperature and RH are standard andgravity serves as the driving forceacross the breached barrier11/09/04Sterile Barrier Integrity TaskGroup Update11/09/04Sterile Barrier Integrity TaskGroup Update6

Experiment 3Experiment 3What Hole Size Allows Penetrationwhen Flight is Simulated?Identify the minimum hole size(s) throughwhich Bacillus subtilis and E. coli K-12penetrate a rigid tray when temperatureand RH are standard and the package issubjected simultaneously to vibrationand pressure differentials that simulatethose recorded during flight11/09/04Sterile Barrier Integrity TaskGroup Update11/09/04Questions?11/09/04Sterile Barrier Integrity TaskGroup UpdateSterile Barrier Integrity TaskGroup UpdateThank You11/09/04Sterile Barrier Integrity TaskGroup Update7

Nov 09, 2004 · Tom Misik- Belco Packaging Systems Dave Morris- iTi Qualitek Mitch Neely- Cardinal Health Jane Severin- MSU George Young- GWY Technologies 11/09/04 Sterile Barrier Integrity Task Group Update Technical Assistance Gary Burgess- Engineering Mechanics, MSU Tom Corner-

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