Package Testing
ServicesTestingPackage TestingPackage testing is essential to ensure the safe and efficient delivery of your pharmaceutical or medical product to its final destination. By simulating real-world conditions under the most current ASTM, ISO, and ISTA standards, Infinity Laboratories assesses your package or container’s readiness for distribution. Our team provides the highest quality testing services and our laboratory is A2LA-certified, demonstrating that our quality system is sufficient to conduct ASTM test standards.
Package testing is essential to ensure the safe and efficient delivery of your pharmaceutical or medical product to its final destination. By simulating real-world conditions under the most current ASTM, ISO, and ISTA standards, Infinity Laboratories assesses your package or container’s readiness for distribution. Our team provides the highest quality testing services and our laboratory is A2LA-certified, demonstrating that our quality system is sufficient to conduct ASTM test standards.
Importance of Package Testing
As your testing partner, Infinity will work to ensure that your package remains intact throughout product distribution. Our comprehensive package testing replicates the conditions of the distribution process in controlled and accelerated settings. Infinity’s package tests encompass a range of distribution-related pressures, such as drops, impacts, environmental stressors, and vibrations.
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 test standards direct most medical device testing.
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 test standards direct most medical device testing.
Infinity Laboratories’ Package Testing Lab
Package Testing Services
Infinity’s package testing laboratory is ISTA and ISO 17025 certified. For medical devices, our 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
Atmospheric Conditioning
Standard: ASTM D4332
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.
Compression
Compression
Standard: ASTM D642
Measures the compressive resistance of your package or container to ensure the supply of your best end-product. ASTM D642 tests with fixed-head and swivel platen compression to perform corner-to-corner and edge-to-edge orientations on all packages and containers.
Incline Impact
Incline Impact
Standard: ASTM D880
Measures a container’s ability to withstand impacts and if the interior packaging can protect its contents. 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.
Loose Load Vibration
Loose Load Vibration
Standard: ASTM D999
Loose load vibration and fixed displacement vibration testing assess a package’s ability to protect products in three main areas: transit environments, operational environments, and warehousing environments. Testing capabilities include bounce testing and ASTM D624. All testing methodologies meet ISO requirements standards ISO 8318 and ISO 2247.
Manual Handling
Manual Handling
Standard: ASTM D5276
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.
Random Vibration
Random Vibration
Standard: ASTM D4728-17
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 the number of orientations to be used during shipping.
Tensile Strength Testing
Tensile Strength Testing
Standard: ASTM F88
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.
Gross Leak/Bubble Test
Gross Leak/Bubble Test
Standard: ASTM F2096
This method covers the detection of gross leaks in packaging and is used for tray and pouch packages.
Burst Testing
Burst Testing
Standard: ASTM F1140
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.
Dye Penetration Testing
Dye Penetration Testing
Standard: ASTM F1929
Dye penetration integrity tests detect and locate leaks caused by channels formed between a transparent film and a porous material.
Abrasion Resistance of Printed Materials
Abrasion Resistance of Printed Materials
Standard: ASTM D5264
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.