In the life sciences community, the term package integrity has many meanings. For Medical Device Manufacturers complying with ISO 11607, package integrity is synonymous with sterile barrier packaging (SBS) integrity test methods. For Drug Product Manufacturers, package integrity of parenteral packaging, the “Sterile product–package integrity” is the ability of a sterile product container/ closure system to keep product contents in, while keeping detrimental environmental contaminants out. Such contaminants may include microorganisms, reactive gases, and other substances. The product includes the pharmaceutical formulation as well as the package headspace – which may consist of ambient air or nonreactive gases with a specified water-vapor content, under full or sub atmospheric pressure levels. Sterile, parenteral package integrity is often referred to as Container Closure Integrity Testing, while medical device manufacurers refer to test methods for sterile barrier maintenance simply as Package Integrity Testing.
Whitehouse Laboratories is happy to assist clients to better understand the testing requirements and the available test options. With a consultative approach, we offer a wide variety of testing options when it comes to package integrity testing- Whitehouse Laboratories is your partner in supporting the packaging development process.
A few of our routine package integrity test programs are summarized below.
Container Closure Integrity Testing
Our Container Integrity Testing Laboratory offers numerous state- of-the-art options for leak testing and assessing pharmaceutical package integrity per USP <1207>. Container Closure Integrity test programs established at Whitehouse Laboratories have been successfully used to optimize sealing parameters, evaluate container storage temperature impact, replace sterility tests for product stability batches, screen production lots for faulty packages and support regulatory submission applications for product commercialization around the world.
ISO 11607 Package Integrity Testing
In order to maintain a packaged medical device product’s sterility until it reaches the point of end use, package designs need to incorporate a sterile barrier. Medical Device Manufacturers are required by regulatory agencies to follow ISO 11607 and demonstrate that the integrity of the sterile barrier is not adversely affected by distribution, storage and handling throughout the expected shelf life of the medical device. The efficacy of the sterile barrier packaging materials and design must be evaluated after terminal sterilization and exposure to the environmental and dynamic stresses expected for the final packaging. Following environmental conditioning, accelerated aging and distribution simulation testing, which provide a controlled means to expose a package system to the anticipated environmental and dynamic stresses that the sterile products may encounter in real world distribution, package integrity testing such as whole package bubble emission by vacuum (ASTM D3078) or internal pressurization (ASTM F2096), package seal dye penetration (ASTM F1929 or F3039 for nonporous packaging) can provide the means to evaluate the efficacy of the sterile barrier packaging after exposure.
Leakage and Torque Testing
All containers must be able to contain the primary product. Environmental hazards such as freeze/thaw and low pressure (high altitude) exposure can influence the effectiveness of the container/closure interface. Vacuum leakage testing (ASTM D4991) and altitude simulation (ASTM D6653) can assist in the development process. For pharmacueutical containers, torque degradation studies (ASTM D2063) can help you assess how much closure retention torque may be lost after exposure to temperature cycling, compression and vibration to ensure that child-resistance and senior freindliness are maintained.
Shelf Life Testing
A series of walk-in and reach-in environmental chambers allow our Laboratories to provide product storage programs that help ensure product integrity throughout the product’s shelf life. From Accelerated Aging (AA), Real Time Aging, Freeze/Thaw and High and Low Temperature Exposure, Whitehouse Labs has the chamber capacity to support materials, products and packaging systems shelf life testing.
Packaging Materials Barrier Properties
Our Laboratories offer numerous tests to characterize adsorption, dissolution, diffusion, and desorption of packaging materials, including Oxygen Transmission Rate or OTR via ASTM D3985 or ISO 15105-2 and Water Vapor Transmission Rate or WVTR via USP <671>, ASTM F1249, D7709, ISO 15106-2 and ASTM E96. These barrier properties tests help you plan the optimal packaging material choice for specific applications to maximize preservation and prolong the shelf life of your product.
Regardless whether you manufacture a sterile medical device or a parenteral drug product, package integrity should be reevaluated when changes are required in package design, package materials, or manufacturing /processing conditions. Whitehouse Laboratories is happy to assist customers to better understand the testing requirements, the available test options and how to execute package integrity testing projects on time and on budget. Whitehouse Laboratories is unique in the field of contract testing. No other package testing lab offers cGMP and ISO 17025 accredited services that cover the complete package system – from package development to market.
Whitehouse Laboratories is happy to assist customers to better understand the testing requirements, the available test options and how to execute packaging validation projects on time and on budget.
Have a question about Package Testing?
Contact Us or call 908-823-9336 about your next testing project.