Accelerated aging is an industry-recognized method to achieve a desired performance benchmark, as long as real-time aging is also conducted. With over 3, cubic feet of accelerated aging capacity, we offer a wide range of conditioning temperatures to meet the timelines of your aging and shelf life studies. Every effort in packaging your medical device shares the goal of maintaining sterility to its intended medical use. Integrity testing is part of every sealer qualification, shelf-life and transit validation.
It is the ultimate pass or fail of every validation. We are an independent third-party partner with a proven track record. Our test methods have been validated, so you can count on consistent, quality results.
It is now more important than ever to confirm label durability and legibility. To address these specialized considerations, we offer a number of test methods to set your validation efforts up for success.
With two full-service dynamic and integrity labs equipped with a wide range of environmental chambers and materials testing capabilities, DDL offers the medical device industry a combination of technical expertise, quality and industry knowledge designed to provide device manufacturers with the best service possible.
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Strictly Necessary Cookie should be enabled at all times so that we can save your preferences for cookie settings. If you disable this cookie, we will not be able to save your preferences. A test may be performed either as a single test to investigate the effects deformation, collapse or failure of compression or stacking, or as part of a sequence of tests designed to measure the ability of a package to withstand a distribution system that includes a compression or stacking hazard.
This test may also be used as a stacking test to investigate performance under particular conditions of loading, as, for example, when the bottom package in a stack rests on an open-decked pallet.
This International Standard describes the types of testing equipment available for carrying out compression tests on paper, board, and corrugated fibreboard. It describes two distinct types of instrument:. This tester is preferred because of its better reliability, its ability to test over the range of test levels likely to be found, and because the characteristics of existing instruments have been well defined and universally accepted.
With this type neither rate of stress nor rate of strain is constant. The two instrument types give similar but not necessarily the same test results when used for compression tests; literature shows that the beam deflection machine produces results higher than those of the fixed-platen machine. The extent of the difference depends on the test being conducted and on the characteristics, particularly the elastic characteristics, of the material being tested.
The beam-deflection tester has been inadequately defined in past International Standards for compression tests; among existing instruments there have been different loading rates, different beam stiffnesses, and therefore different rates of strain. Furthermore, in some countries, the stiffness of beams commonly available is such that no one beam is appropriate for all the test levels likely to be found, so that it has been common practice to use two beams of different stiffnesses interchangeably to cover the full range of loads.
This International Standard specifies two methods for carrying out a sinusoidal vibration test on a complete, filled transport package or unit load using a variable frequency. These tests may be used to assess the performance of a package or a unit load in terms of its strength or the protection that it offers to its contents when it is subjected to vertical vibration. Each may be performed either as a single test to investigate the effects of vertical vibration or as part of a sequence of tests designed to measure the ability of a package or unit load to withstand a distribution system that includes a vibration hazard.
This International Standard specifies a method to carry out a vertical random vibration test on a complete, filled transport package s and unit loads using random excitation1. This document also provides methods for assessing the performance of a package in terms of its strength or the protection that it offers to its contents when it is subjected to vertical vibration.
The test discussed in this document can be performed either as a single test to investigate the effects of vertical vibration, or as a part of a sequence of tests designed to measure the ability of a test specimen to withstand a distribution system that includes a vibration hazard. The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application:. This document has been developed with the objective of promoting confidence in the operation of laboratories.
This document contains requirements for laboratories to enable them to demonstrate they operate competently, and are able to generate valid results. Laboratories that conform to this document will also operate generally in accordance with the principles of ISO This document requires the laboratory to plan and implement actions to address risks and opportunities. Addressing both risks and opportunities establishes a basis for increasing the effectiveness of the management system, achieving improved results and preventing negative effects.
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