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Category: Package Testing
Nelson Laboratories specializes in package integrity testing and has developed test methods for this testing. The basis for packge testing is to help the manufacturer in the development and validation of their packaging operations.
[ more ]Tests available for Package Testing
Header bag packaging validation ISO11607
Packaging Validation
Types: Foil or Poly bag with Tyvek header strip.
Validation includes: Distribution, Accelerated Aging, Dye Migration, Seal Peel on two seals (Tyvek/poly or poly/poly). Aerosol Challenge, and summary report.
Porous packaging validation ISO11607
Packaging Validation
Package types: Tyvek/Mylar, paper/Mylar, Tyvek/poly, etc.
Single or doube pouch systems
Validation includes: Distribution, Accelerated Aging, Dye Migration, Seal Peel, Aerosol Challenge, and summary report.
Non-porous packaging validation ISO11607
Packaging validation
Types: Foil pouches, blister packs, poly/poly, etc.
Validation includes: Distribution, Accelerated Aging, Bubble Emission, Burst, Aerosol Challenge & Summary report.
Accelerated aging AAMI/ANSI/ISO 11607, ASTM F1980
Accelerated aging can be run with a designated time period ranging between one month to five years (or longer). See table of accelerated aging parameters. The time of simulated aging depends on the temperature at which the products are held. Accelerated aging is optional; real-time aging is required when establishing an expiration date.
At 55 °C, 6.5 weeks is equivalent to 1 year on-the-shelf. For example, at 55 °C, two years would be equivalent to 13.0 weeks and five years would be 32.5 weeks.
Performance testing of shipping containers & systems ASTM D4169
Package design is becoming increasingly important within the manufacturing environment. Transportation of these packages can provide exposure to situations that result in product failure before delivery to its final destination. These test methods represent a general simulation test for individual packaged products by demonstrating the ability of the shipping units to withstand the distribution environment.
Some of the simulation tests include: Conditioning, Swing arm drop test. Compression test, Loose load testing, and Vibration testing.
Whole package integrity (microbial aerosol challenge) AAMI/ANSI/ISO 11607
This test is intended to challenge the whole package in order to determine package integrity of a finished product package. Chamber size is 3 cubic feet with a single layer of product, configured for appropriate challenge flow. The test includes the whole package microbial challenge, subsequent sterility testing on the packaged product to determine penetration of the indicator organism used, test controls, and all protocol/report fees.
Microbial ranking (exposure chamber method) ASTM F1608, AAMI/ANSI/ISO 11607
This test procedure is used to evaluate porous materials intended for use in packaging sterile medical devices. This test employs a low flow rate, extended exposure time, and increased challenge level, which allows testing of materials with high differential pressure values. This test method is not intended to predict the performance of a given material in a specific sterile packaging application.
Container closure/integrity, bacterial or dye immersion ISO 7864, ASTM D4991, FDA Docket 980-0021, PDA TR27
The Dye Immersion test is designed to determine the integrity of containers and cap seals used in the medical and pharmaceutical industry.
Burst test for packaging ASTM F1140, AAMI/ANSI/ISO 11607
The burst test determines package strength by pressurizing a package until it bursts. This test method is defined in ASTM F1140 and conforms to ISO 11607 "Packaging for terminally sterilized medical devices."
Creep test for packaging ASTM F1140, AAMI/ANSI/ISO 11607
The creep test determines package strength by pressurizing a package at 80% of the known burst pressure for a set amount of time. This test method is defined in ASTM F1140 and conforms to ISO 11607 "Packaging for terminally sterilized medical devices."
Seal peel test for packaging (heat seals) ASTM F88, AAMI/ANSI/ISO 11607
The seal peel tensile test determines the strength of the seal at a specific place on the package. This can be helpful in setting the sealing parameters. This test method conforms to the standard covered in ISO 11607 "Packaging for terminally sterilized medical devices".
Dye migration ASTM F1929, AAMI/ANSI/ISO 11607
The dye migration test is used to determine the integrity of the package seal. This test involves injecting dye into the package and placing the weight of the solution against each portion of the seal for a specific length of time. The package is examined for evidence of seal failure demonstrated by dye slipping through the seal. This test method covers the dye migration test as defined in ASTM F1929. This test method conforms to the standard covered in ISO 11607 "Packaging for terminally sterilized medical devices".
Bubble emission ASTM 2096-04, AAMI/ANSI/ISO 11607
The bubble emission test is used to determine the package integrity. This test method covers the bubble emission test as defined in ASTM 2096-04. This test method conforms to the standard covered in ISO 11607 "Packaging for terminally sterilized medical devices".