ASTM Test Method F3004-13, non-destructive test method for "Evaluation of Seal Quality and Integrity using Airborne Ultrasound Technology." Approval of this test method was developed utilizing PTI's Seal-Scan technology. The equipment is designed to make testing simple to repeat again and again. The edges must be clean-cut and perpendicular to the direction of the pouch seal. 2. Seal Integrity Testing Using the Tracer Gas Method Moisture-sensitive drug products are commonly lyophilized to enhance their shelf life and to prepare them for storage and transport. Locally in Australia, Eurofins BPT Sydney can perform seal integrity or container closure integrity testing via the two methods shown below. one method of closing an open package for seal strength testing as well as a device designed to provide reinforced and a leak-tight air path into a completely sealed package. 10 Leak test selection criteria . Specifically, this ASTM package validation standard covers the determination of channels in the package seal down to a width of 0.003 inches. PTI's VeriPac package integrity testing method is a non-destructive alternative to the conventional water bath leak test or bubble leak test method. Vacuum Bubble Leak Test (if your vacuum is not high) 2. However, they lacked accuracy and reliability in test results. The seal integrity test methods may vary depending on the contents of the package, but the FLEXPAK leak detection system provides all of these testing options with one machine. Traditionally, visual observation is often used as a seal integrity test method by examining the seam and detecting leakage. 3. Precondition test strips at 21-25oC (69.8-77oF) and 45-55% RH, for 40 hours (minimum). 1. ASTM F88 (aka "peel strength testing") is a common seal strength test method. <1207.3> Package seal quality test methods . Internal pressurization Test 3. The Pouch Seal Integrity Test is available for purchase in a quantity of thirty. For non-liquid product packaging, we recommend performing leak testing in immersion to allow the observation bubble formation in holes or leakage in the seal. The most critical component, the Helium Leak Detector Module . Spoilage may result from leakage when improper pressure control is applied during the retorting and cooling operations. This test method tells us the peel force it takes to open the package (Is it too strong, too weak or, just right?). The dye leak test evaluates seal integrity. The USP <1207> Chapter prefers deterministic methods rather than probabilistic methods. The peel test stand uses a gage to measure the amount of force that is required to peel . F2096 is also a destructive test. Our Leak Detectors are available in a variety of sizes, and are built to effectively test a myriad of product and package specifications. This requires a minimum level of headspace, (air or gas) within the package as well as a minimum pressure differential between the package atmosphere and the tank atmosphere during a test. This ASTM Test Method F2338 is also referenced in ISO 11607, USP 1207 guidance and FDA recognized consensus standard. In conclusion, you have the following 4 options testing vacuum sealing packages: 1. All solutions are tool-less, non-destructive and deterministic and can be run in compliance with 21 CFR Part 11. It results in stress on the seam of the can. Package seal quality tests are used to characterize and monitor the quality and consistency of parameters related to the package seal. Cut open sample and remove contents. The sensitivity of this test is 50 microns. Inflation seal strength testing on unrestrained packages, ASTM F1140, provides a fast and effective method of evaluating package seal strength. For liquid product packages such as bottles or jars, we recommend to proceed with leak testing in a dry chamber. Wet the filter with the appropriate fluid, typically water for hydrophilic membranes or an alcohol/water mixture for hydrophobic membranes. ASTM F1886 is the standard test method for determining the integrity of seals for flexible packaging by visual inspection. Earlier, visual inspection or other destructive testing methods were used for seal quality inspection. The device includes a first enclosure member adapted to receive a pre-sealed package formed of two films joined together to form a continuous seal, the two films extending outwardly of the seal to define a marginal edge portion of the package. Helium is used due to its low presence in the atmosphere, its nonexplosive nature, and because it is chemically inert. Seal quality tests and CCI tests work together to ensure package integrity. Data acquired through testing can be used to validate the package design as adequate for maintenance of integrity, to monitor process performance, and to confirm shelf-life performance. Seal Validation Integrity Transit Validation All sterile medical devices require validation of their packaging. Deterministic methods highlighted in the chapter include: HELIUM LEAK TESTING, high voltage leak detection (HVLD), laser Headspace analysis and pressure & vacuum decay methods This method (also known as Electrical Conductivity and Capacitance Test) is used to find leaks in rigid or flexible, non-porous packaging that contains semi-liquid or liquid products. F88 allows you to target a particular seal on the package. NOTE: This test is not intended to be a whole-package integrity test. It enables quantitative analysis of package systems at sensitivity levels as low as 1 x 10 -10 cc/s at room temperature. The ASTM F2391-05 Standard Test Method for Measuring Package and Seal Integrity Using Helium as the Tracer Gas serves to establish the use of helium as an effective Container Closure Integrity test method that is recognized by the global regulatory community. This is also the most complex and expensive method. Package integrity and test method selection . January 21, 2021 Seal integrity test methods are specifically designed to monitor and examine a package's seal quality in order to increase your product's shelf life. Liquid leakage must be blocked Specifications A second enclosure member adapted to cooperate with the first enclosure member upon demand is . Pressurize the system to about 80% of the expected bubble point pressure which is stated in the manufacturer's literature. Any leakage will cause a rise in voltage . Product package maximum allowable leakage Categories . For this test, we take a 1-inch wide cut from the seal, clamp the test specimen into the jaws of our peel test stand, and then use our peel test stand to pull the seal apart. The Sepha BottleScan non-destructive integrity tester tests multiple bottles at the same time and detects a defect down to 15 microns. If the system detects a packaging defect, the product can immediately be removed from the packaging and reworked. Common ASTM test methods requested and performed according to strict GMP standards include ASTM D3078 Determination of Leaks in Flexible Packaging by Bubble Emission A device for testing the integrity and strength of a seal. MediScan FLEXPAK vacuum style leak detector can be used to facilitate testing to standards such as ASTM D3078 (Bubble Emission Test, Tightness Test), ASTM D6653 (Altitude Test . By taking advantage of our signature vacuum chamber enclosure, FlexPak Package Leak Detectors are capable of performing a variety of seal integrity tests in both wet and dry environments. The different techniques exist in order to hold samples at a variety of angles and manage bending forces. Maintaining a constant moisture level in a lyophilized drug product "cake" ensures product quality. Do not disturb seal to be tested. The test allows the user to verify the effective sealing of pouches by checking for leakage or migration of blue (paper/poly) or red (Tyvek) Methylene. 1- Package Leak Test | Seal Integrity Inspection Procedure. Flexible Packaging Six standard methods for testing seals can be modified to meet the needs of a specific package. With Labthink package leak testers, there are mutilple packaging test methods to ensure your package with high quality in seals, closures, and Integrity. It is typically performed during sealer validation or for in-process maintenance. There are three distinct seal integrity test methods that can be used. CS Analytical team can perform a variety of ASTM test methods for detecting leaks and seal integrity regardless of package type or configuration. Hence, inspecting seals after they have been formed is important. Upon doing so the ink will get in contact with the seal and make any weak spots immediately visible. The Pouch Seal Integrity Test is packed in an aluminum package to protect the ink against light influences, and does not use any pipettes or other objects, so it will not damage the seal. Bubble Point Procedure. In Eurofins | ams, seal integrity testing or container closure integrity testing is performed via the two methods shown below. As dictated by ASTM F88, the standard seal strength test techniques are as follows: F88 tests the seal integrity, not a whole package test. The probability of this testing is 60-100%. The test is performed using a specialty dye solution to identify minute defects within a sterile closure seal. Example of probabilistic methods include the bubble leak and blue dye tests. The initial text was prepared by an Expert Panel, Commissioned by the . The Seal Integrity Monitoring System (SIMS) Model 1915+ is a helium-based leak testing system that features an oil-free pump, detector and integrated power system. Package Seal Integrity Test Methods Quality control protocols for measuring seals at production startups and shift changes are determined based on the confidence that seals have integrity, a small degree of variability in labor and sealing equipment, and trust in material consistency. Test Method Features Non-destructive seal integrity and leak detection device that uses force decay technology to detect weak seals and holes down to 10m (pack and material dependent) Can test up to 10 packs simultaneously (standard configurations: 3, 4, 5, 6, 8 & 10 packs) Capable of handling dry, non-porous packages Microbial Ingress method involves immersing media filled package units into a liquid suspension of microorganisms (105-106cfu/mL) for a specified period of time and then removing . This method is to submerge the specimen into water within the vacuum chamber, and then evacuate the vacuum chamber to form differential pressure between the inside and outside of specimen.Observe the bubble emission from the package Labthink product under this ASTM D3078: MFY-01 Leak Tester Bubble Leak Testing Test conditions based on ASTM F2096 Going back over 20 years, the LDA leadership team served on the ASTM Sub-Committee . Common defects that can threaten the integrity of the seal include voids, wrinkles, dust or other random particles. USP 1207 Container Closure Integrity Testing and Crimp Seals: Package Development and Assembly Process Validation Written By BRANDON ZURAWLOW / Chief Scientific Officer Adoption of deterministic, quantitative test methods for comprehensive container closure integrity testing (CCIT) has become the norm over past two decades. During this test, a high frequency, a high-voltage wave of current is passed through the container closure mechanism. 1. Seal-strength testing evaluates the mechanical strength of the seal, ensuring proper material bonding to maintain package integrity throughout package life. Labthink Leak testers can be used to facilitate testing to standards ASTM D3078, ASTM F2096 and other similar standards. ASTM F88 (Peel Strength) measures the strength of the seals in flexible barrier materials. Seal Integrity Test Methods Sepha offers different seal integrity test methods to test flexible packaging including non-porous pouches, sachets bags and stick packs containing powder or solid components. The sterile barrier must be shown to be effective throughout the product's claimed shelf-life, and this is demonstrated through medical packaging seal strength and integrity testing. CO2 or Helium Test We have many more resources on our website that you should check out Package Seal Integrity Testing / Package Leak Testers. Microbial Ingress Method. Another common test used to assess seal integrity is F2096 Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (known as bubble-leak testing), which detects gross leaks and does not have the sensitivity of F3039 dye penetration or AuraSeal. Vacuum Leak is the primary method for the inspection of Preforms and PET containers including seal integrity testing or the testing of the containers integrity.Vacuum Leak Tester can also be used for testing empty containers that require a minimum vacuum level.It is an ideal and highly required testing instrument which is used to test the integrity of the plastic pouches with the high-value . Cut a segment of the seal to produce a test strip (25.4 mm wide and at least 75 mm long). These are Gas leak test: The migration of helium through a sealed package is measured via mass spectrophotometer. Microbial Ingress Method Microbial Ingress method involves immersing media filled package units into a liquid suspension of microorganisms (105-106cfu/mL) for a specified period of time and then removing, rinsing . These provide some assurance of the package's ability to maintain integrity. 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