Packaging that effectively protects medical products during transportation and storage and serves as a barrier against contamination and deterioration is crucial for the safe and effective supply chain of drugs, medical devices, and other medical products. The journey of a medical product from manufacturing to the patient is fraught with challenges, including temperature fluctuations, humidity, and physical shocks. Packaging testing, including environmental, durability, and seal integrity tests, ensures the product remains sterile, functional, and free from contamination throughout its lifecycle.

• Environmental tests assess how packaging materials and configurations perform under different temperature and humidity conditions.
• Durability tests subject packaging to various physical stresses, mimicking the rigors of transportation and storage.
• Seal integrity tests ascertain whether the packaging forms an effective barrier against contaminants.

 
Ineffective medical and pharmaceutical packaging not only risks the safety and efficacy of the product, but can also lead to regulatory penalties, product recalls, and lawsuits against businesses. The reputational damage resulting from packaging errors can be long-lasting and difficult for businesses to recover from.

Effective medical and pharmaceutical package testing services simulate various transport and storage conditions to identify and rectify potential failures and safeguard the product’s quality and effectiveness. A lab offering medical and pharmaceutical package testing services can assess a package or container’s readiness for distribution by simulating real-world conditions under the most current ASTM, ISO, and ISTA standards. When looking for high-quality medical and pharmaceutical package testing services, it is important to find a lab that is A2LA-certified, demonstrating its quality system is sufficient to conduct ASTM testing standards.

Each product’s specific distribution method dictates the presence of potentially harmful pressures, which differ in frequency and strength. Package testing typically involves multiple rounds of assessments to gauge the performance of the packaging materials and configurations, and ASTM standards direct most medical device testing.

Infinity Laboratories’ A2LA-certified laboratory provides the highest quality medical and pharmaceutical package testing services and is fully equipped to conduct robust package testing of final drug products or medical devices. Infinity’s package testing laboratory is ISTA and ISO 17025 certified. For medical devices, Infinity’s team conducts all performance testing for packages and containers under ASTM D4169. ISTA standards are typically used for industrial testing, and Military Standards (MIL-STD) are also used when applicable.

• Atmospheric Conditioning: Environmental conditioning product packaging is integral to any distribution or packaging testing. Packages are typically exposed to several different profiles, including but not limited to tropical, tundra, and desert climates, before performing packaging or distribution testing. All environmental conditioning is performed in qualified and calibrated chambers that can accurately control temperature (+/- 2C) and humidity (+/- 5%) – if applicable.

Standard: ASTM D4332

• Atmospheric Conditioning Apparatus: Simulates environmental conditions, like temperature variations, humidity, and pressure changes, the packaged product might encounter during its distribution and storage.

• Compression: Measures the compressive resistance of your package or container to ensure the supply of your best end product. ASTM D642 tests with fixed-head compression to perform corner-to-corner and edge-to-edge orientations on all packages and containers.

Standard: ASTM D642

• Incline Impact: Measures a container’s ability to withstand impacts and whether the interior packaging can protect its contents. It reproduces the shock damage that may result from handling packages, such as rail switching or pallet marshaling impacts. Incline impact tests evaluate containers and compare the performance of different container designs or shipping systems.

Standard: ASTM D880

• Incline Impact Apparatus: Evaluates how well packaging materials and designs can withstand sudden impacts during transportation, handling, or storage.

• Loose Load Vibration: Loose load vibration and fixed displacement vibration testing assess a package’s ability to protect products in three main areas: transit, operational, and warehousing environments. Testing capabilities include bounce testing. All testing methodologies meet ISO requirements standards ISO 8318 and ISO 2247.

Standard: ASTM D999

• Electrodynamic Shaker Apparatus: Assesses how well packaging materials and products can withstand vibrations during transportation, handling, or other environmental conditions.

• Manual Handling: Manual handling and drop testing are conducted to measure the readiness of your package for the sudden shocks of free falls that may happen while in transit. Infinity provides necessary ISTA drop test procedures for any type of packaging to ensure they comply with current ISO and ASTM standards.

Standard: ASTM D5276

• Manual Handling Apparatus: Simulates the manual handling and manipulation of packages in various real-world scenarios, assessing the durability, structural integrity, safety, and overall stability of the package to ensure it navigates distribution intact.

• Random Vibration: Random vibration testing simulates the shakes and bumps that may occur during transit to ensure product integrity. ASTM & ISTA profiles are used to simulate truck or air transit vibrations. Packages will be tested in terms of the number of orientations to be used during shipping.

Standard: ASTM D4728-17

• Electrodynamic Shaker Apparatus: Assesses how well packaging materials and products can withstand vibrations during transportation, handling, or other environmental conditions.

• Tensile Strength Testing: Whether a medical device is designed for single use or intended for re-sterilization and subsequent use, the package must ensure sterility while remaining user-friendly for healthcare professionals. This standard gauges the tensile strength of the adhesives used in product packaging to achieve this balance, ensuring the package maintains its integrity throughout its lifecycle.

Standard: ASTM F88

• Tensile Strength Apparatus: Determines the maximum force a material can withstand before breaking or deforming.

• Gross Leak/Bubble Test: This method detects gross leaks in packaging and is used for tray and pouch packages.

Standard: ASTM F2096

• Gross Leak Testing Apparatus: This apparatus creates a controlled environment in which a package is pressurized or subjected to a vacuum to identify the potential for leaks.

• Burst Testing: These methods evaluate the tendency for package failure when the package is exposed to a pressure differential, such as those that commonly occur during sterilization and transportation.

Standard: ASTM F1140

• Burst Testing Apparatus: Used to determine the burst strength or the amount of internal pressure a package, such as flexible films, bags, pouches, and other containers, can withstand before rupturing or bursting.

• Dye Penetration Testing: Dye penetration integrity tests detect and locate leaks caused by channels formed between a transparent film and a porous material.

Standard: ASTM F1929

• Dye Penetration Apparatus: Uses a colored or fluorescent dye to identify any points of penetration or seepage through the packaging material of a sealed package.

• Abrasion Resistance of Printed Materials: The standard for abrasion resistance of labels on medical device packaging ensures that all information will still be legible after material contact. Tests are performed using the Sutherland Rub Tester, which rubs materials together at a specified rate.

Standard: ASTM D5264

• Sutherland Rub Tester Apparatus: Evaluates the resistance of printed or coated packaging materials to rubbing or abrasion.

• Additional packaging testing apparatuses used by Infinity include:
  • Accelerated Aging Chambers: Accelerates aging conditions by introducing stressors like temperature, humidity, and light in a controlled environment.
    • Standard: ASTM F1980

     

  • Visual Inspection Apparatus: Relies on human visual assessment, aided by appropriate lighting and magnification, to identify issues that could impact the package’s quality, safety, or functionality.

Pharmaceutical and medical device manufacturers are responsible for ensuring that packaging effectively protects medical products during transportation and storage and serves as a barrier against contamination and deterioration. Infinity’s A2LA-certified medical and pharmaceutical package testing services lab simulates real-world transport and storage conditions under the most current ASTM, ISO, and ISTA standards to identify and rectify potential failures and safeguard medical products’ quality and effectiveness.