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An Overview of Package and Seal Integrity Testing

SEAL INTEGRITY MONITORING OF

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An Overview of Package and Seal Integrity Testing

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    Slide 1:An Overview of Package and Seal Integrity Testing

    Darrell R. Morrow, PhD Leak Detection Associates, Inc. Blackwood, New Jersey

    Slide 2:Package/Seal Integrity Testing Via Helium Leak Detection Methods

    HELIUM LEAK DETECTION – A Well-Established, “Old” Technology Many Industries, Such As Automotive, Electronic & Aerospace, Have Employed Helium Leak Detection For Many Years. The Primary Focus For These Applications Has Been The Integrity Of Sealed Mechanical Systems; For Example, Brake Line Seals & O-Ring Seals.

    Slide 3:Package/Seal Integrity Testing Via Helium Leak Detection Methods

    SEAL INTEGRITY MONITORING OF “CONSUMER” PACKAGING – A Validated, “New” Application. Some Pharmaceutical & Medical Device Companies Have Been Employing Integrated Seal Integrity Monitoring Systems For Up To Seven (7) Years. As An “End-Use Performance Test”, These New Applications Have Been Extended To Include: Design & Development Stability Pack-Out Verification Clinical Trial Pack-Out Verification Tooling Validation Process Validation

    Slide 4:Gas/Vapor Barrier Requirements

    Gas and vapor transport can occur via permeation or leakage. The total rate of gas/vapor transport is determined by the total number of holes; regardless of size. Individual gross leaks, due to their size, are readily detectable by most leak test methods. Gross “leaks” due to a multitude of “fine” leaks are not readily detectable by most leak test methods.

    Slide 5:Sterility/Microbial Barrier Issues

    Microbial transport can occur only via leakage. The total rate of microbial transport is determined by the total number of holes with dimensions > the minimum. Leaks corresponding to the minimum size needed to block aqueous-borne microbes are not readily detectable by most leak test methods [single “hole” leak rate < ~1E-6 cc-atm/sec.].

    Slide 6:Leak Detection Test Methods Comparative Sensitivities

    10-1 10-2 10-3 10-4 10-5 10-6 10-7 10-8 10-9 10-10 Leak Rate (cc/s) TEST METHOD/TECHNOLOGY D3078 - VACUUM BUBBLE Vacuum Level = 15" Hg Vacuum Level = 21" Hg Vacuum Level > 21" Hg D3078 - DYE PENETRATION Vacuum Level = 15" Hg Vacuum Level = 21" Hg Vacuum Level > 21" Hg Pressure Decay Carbon Dioxide Sensor Gas Pressure - Bubble @ 10" H2O @ 20" H2O Helium Tracer- Mass Spectrometer Sniffer Mode Hard Vacuum Mode

    Slide 7:Pharmaceutical/Device Industry Needs

    Verify quality of seals and (overall) packaging for stability pack-out samples. Insure integrity of seals and (overall) packages for clinical trials and production run product. Insure medication shelf life.

    Slide 8:Helium Leak Testing: Vacuum Mode

    Packages containing helium can be checked for gross, fine and ultra-fine leaks using a vacuum chamber attached to a helium leak detector [“Hard” Vacuum Method]. The range of Helium leak rates detectable spans from low sensitivity (gross leak) values - E-1 - E-4 cc-atm/sec - to medium sensitivity (fine leak) values - E-5 - E-7 cc-atm/sec - to high sensitivity (ultra-fine leak) values - E-8 - E-10 cc-atm/sec.

    Slide 9:Gas/Vapor/Microbial Sensitive Products

    Active Ingredient Products (Gas/Vapor) A product’s micro-environment must be protected against gas/vapor loss or gain, as needed. The barrier performance (integrity) of the package combined with external environmental conditions determine a product’s shelf life. Sterile Products The package’s integrity controls microbial ingress of the package and resultant loss of product sterility.

    Slide 10:LDA Sims 1282+ Unit

    SIMS Seal Integrity Monitoring System HSAM Head Space (Gas) Analysis Module VTFM Vacuum Test Fixture Module 30+ years - packaging expertise 8+ years - leak testing experience

    Slide 11:Helium Leak Testing Packaging Using a SIMS Unit

    Procedure Helium is flooded at the point of the packaging machine/line process immediately prior to sealing the blister/pouch/card/vial. Helium is, thereby, captured in the head space of the blister/pouch/card/vial.

    Slide 12:Helium Leak Testing Packaging Using a SIMS Unit

    Test Method Filled/sealed blisters/pouches/cards/vials are taken from the production line. Each sample is placed inside a VTFM chamber connected to the integrated helium leak detection system (SIMS 1282+). The VTFM chamber encapsulates the entire package ensuring that any He molecules escaping from the package are captured by the sensor.

    Slide 13:Helium Leak Testing Packaging Using a SIMS Unit

    Results The leak detector is connected to a computer (integrated into the system). The true leak rate is calculated by the software taking into account the helium concentration inside each package; as measured by the HSAM. The test can be non-destructive, or destructive for the packages and the product, depending on materials & form

    Slide 14:Advantages of He Leak Rate Methods and Instrumentation

    Measurement Quality A package-specific vacuum chamber allows the measurement of leak rates of test packages without vacuum-induced failures. The final result takes into account the helium concentration inside the package, thereby providing the actual leak rate (normalized to one atmosphere driving force) for comparison against a pre-set pass/fail (P/F) criterion; dictated by the product.

    Slide 15:Advantages of Helium Leak Rate Methods and Instrumentation

    Measurement quality The helium concentration inside each test package is measured (quantified) via a fixture (HSAM) which measures the helium concentration with a calibrated probe. Gross leaks (>E-4 cc-atm/sec) are detected using pre-determined settings which identify spikes of helium during the test.

    Slide 16:Advantages of He Leak Rate Methods and Instrumentation

    Measurement Quality/Sensitivity Empty (no Helium) packages are identified by the absence of any signal above background due to a lack of helium in the package. Fine (& Ultra-Fine) leaks (<E-5 to E-9 cc-atm/sec) are readily detectable using the Hard Vacuum Mode. When you require high quality seals and a high quality package, you need Helium leak detection technology & leak testing instrumentation.

    Slide 17:The End – OF LOW SENSITIVITY PACKAGE INTEGRITY TESTS The Beginning - OF HIGH SENSITIVITY PACKAGE INTEGRITY TESTS

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