Qualified or Validated? - Intelsius - A DGP …

1 Qualified or validated ? January 2013. When two words do not mean the same thing As winter closes further on the When even this fails to provide northern hemisphere it is often clarity to the situation you can quoted that the Inuit have 100 understand how confusion arises. words for snow. This may have been disproven, but the fact it In the temperature controlled is believable demonstrates that packaging industry everyone there is often a necessity for offers Qualified solutions. The different words to reflect meaning is very lightweight, if you sometimes subtle differences.

2 Request a system that can offer a duration of 96hrs they will give you The English language can a system Qualified to that. offer dazzling arrays of words However this solution could range which are based upon a similar from a plain envelope up to an meaning, but the use of these actively controlled refrigerated different words can offer a very lorry. big difference. In conversation the words validated and This occurs because to say Qualified can be used pretty something is Qualified to 96 hrs much interchangeably, but you just need to have tested it to when dealing with cold chain maintain temperature for that duration.

3 The envelope can work We do things differently at they have very specific because if you want a 96hr 2-8 C Intelsius . We believe in providing meanings. solution, the supplier can put the transparent results. A look in the dictionary envelope in the fridge for 4 days p r o v i d e s t h e f o l l o wi n g and say that under those The key to selecting a Qualified definitions when the words are conditions it is Qualified . system which meets your used in this context; requirements is in selecting the This is a product qualification and correct conditions with which the Qualified : having complied is often not worth the paper it is shipper complies.

4 At Intelsius we with the specific requirements work with our customers from the written on. These basic off the or precedent conditions shelf qualifications do not even very beginning of the product allow for direct comparison selection and design processes to validated : to support or between systems due to differing make sure that when offering a corroborate on a sound or methodologies and the results solution the product is suitable for aut hor it at ive basis i. e. shown are often not repeatable. the end user. experiments designed to validate the hypothesis.

5 Copyright 2013 Intelsius - A DGP Company All Rights Reserved. Qualified or validated ? Design Qualification, Performance Qualification, Operational Qualification For our Qualified systems we work The ISTA certified laboratory at Intelsius through three processes: can provide rigorous thermal testing of temperature control solutions with full Design Qualification assesses the reporting of the results to give the design of the solution to ensure customer confidence that the solution appropriate properties such as; proposed not only meets their dimensions, mass, temperature requirements but exceeds expectations.

6 Range, preparation time and facilities required meet the customer's A validated solution incorporates a third satisfaction. In this stage Intelsius stage, Operational Qualification. This is makes use of a range of tools to a test of the solutions' real world determine the most suitable product performance. This part of the process or begin work on a new solution. The begins by assessing the performance of most valuable of these is the in the solution in an operational situation with TIME vs. Temperature Graph Showing house, proprietary software either dummy or real product.

7 This Experimental data and simulated data ATMOS T M . (Analytical Thermal involves monitoring of performance, (often lines showing high (+ C) and low Modellng Software) with data loggers) to determine the correct ( C) simulated values. With image operation of component storage and of system packing configuration simu- This software can simulate the preparation, solution dispatch and receipt lated. thermal exposure by analyzing to SOP, performance in the real world and thermal flows into and between the third party adherence to SOP. components of the packaging system, determ ine the performance Intelsius ' technical services capability will characteristics of the proposed guide and assist any customer through solution and whether the protection this process.

8 The support offered can selected is sufficient to meet the range from supplying data loggers up to challenges expected. full guidance with data analysis and report writing. Using ATMOS can save up to 70. percent in packaging development The temperature control experts at time and costs when bringing a new Intelsius are here to help guide you drug to market, moving drugs through through Qualification and Validation just as a new route or preparing for a new an Inuit guide takes one over a clinical trial. Temperature-Controlled Packag- qengaruk and away from a navcaq *.

9 Ing and Cold Chain Solutions Performance Qualification assesses the performance of the solution, often *snow bank and snow cornice respectively When shipping biological and phar- by means of a controlled extremes/ maceutical materials, a minor tem- worst case simulation, in an perature excursion could compro- environmental chamber. These tests mise your payload's integrity. often demand specific scenarios such as payloads (minimum, maximum, typical, empty), durations (minimum hours, within range, until failure) and temperature exposures (off the shelf, Contact me for more information: Neil Sherman, Testing Officer 3rd party, customer specific).

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