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Introduction to Seal Integrity Testing - FDAS TWO MAIN FUNCTIONS ARE

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Introduction to Seal Integrity Testing - FDAS TWO MAIN FUNCTIONS ARE Powered By Docstoc
					An Overview of Package and
   Seal Integrity Testing


        Darrell R. Morrow, PhD


 Leak Detection Associates, Inc.
      Blackwood, New Jersey
       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.
       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
             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.
      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.].
              Leak Detection Test Methods
                      Comparative Sensitivities
 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

                                   10-1 10-2 10-3 10-4 10-5 10-6 10-7 10-8 10-9 10-10

                                                    Leak Rate (cc/s)
         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.
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.
            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.
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
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.
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.
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
    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.
  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.
    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.
The End   –   OF LOW SENSITIVITY PACKAGE
              INTEGRITY TESTS



                SIMS 180 TD+




The Beginning -                OF HIGH SENSITIVITY
                               PACKAGE INTEGRITY
                               TESTS

				
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posted:6/5/2010
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