Design, Thermal Testing and Qualification
Insulated Packaging Design, Thermal Testing and Qualification
In addition to providing pre-qualified insulated shipping solutions for temperature-sensitive products, Cryopak’s thermal packaging engineers can work with companies on custom thermal package designs and qualifications for shipping in the cold chain environment. Our team works with pharmaceutical, medical device, biotech and food companies to design, manufacture, test and qualify thermal packaging for products that are required to maintain a specific temperature range throughout the cold chain process.
Design of Insulated Packaging
Maintaining product integrity is the key motivation for many of our customers that work with us on a thermal package design.
Whether the customer works in a highly regulated industry, like many of the pharmaceutical manufacturers that we work with, or has a simple thermal packaging need, we can provide the proper level of qualification for the design of their cold chain package.
Thermal Testing of Insulated Packaging
- ISTA Certified Laboratory (one of 4 worldwide certified in Standard 20)
- Tests performed by ISTA Certified Professionals
Home to an ISO9001:2008 certified, 6,000 sq. ft. laboratory and years of industry leading experience, Cryopak’s testing center has both the capacity and the expertise to conduct thermal performance testing projects. In order to simulate real world shipping conditions, our chambers are able to accommodate projects ranging from small parcels to multiple large pallets, subjecting them to temperatures between -35°C to 65°C and relative humidity from 10% to 90%. From the development phase to the execution of tests through the completion of final documentation, staff at Cryopak’s testing center regularly communicate with clients to ensure that the test results meet or exceed all goals. Engineers provide comprehensive, industry compliant test reports that follow FDA guidelines and include testing methods, such as AFNOR, ISTA 7D, ISTA 7E, ISTA Standard 20 and ASTM D3103.
Standard NF EN 99700
Validation method of the thermal performance of insulated packaging and refrigerated packaging for healthcare products.
Procedure 7D Temperature test for transport packaging
Test Procedure 7D is a development test to evaluate the effects of external temperature exposures of individual packaged-products.
Standard 7E is designed to evaluate the effects of external temperature exposures of individual packaged-products shipped through a parcel delivery systems.
This test method is intended for use in evaluating the performance of thermal insulated packaging used for high-value, high-risk materials. This test method may also be used for any product that requires accurate internal package temperature readings while being exposed to a range of external air temperatures.
Qualification of Isothermal Solutions
The climatic chambers at Cryopak Europe comply with the FD X 15-140 standard. We qualify our isothermal solutions following the I.Q (Installation Qualification), O.Q (Operational Qualification), P.Q (performance qualification).
The different steps of this validation process allow to :
- Define and characterize the insulated and cool boxes and their use
- Verify by means of measurement (tests in temperature) the performances of these boxes in the pre-defined conditions and limits of use
- Validate the whole solution (boxes, configuration and preparation) by tests in temperature, proving the reproducibility of the results
The Installation Qualification consists :
- in one hand, in describing and verifying in a documented manner that all the technical characteristics of the solution proposed (insulated boxes and cool boxes) comply with the provider’s specifications and with the user’s particular specifications specified in its request. This operation consists in verifying the adequacy between the request (pre-defined specifications) and the solution proposed after study and design (the product).
- in the other hand, in presenting the validation of the material used to make the OQ and PQ tests of the insulated and cool boxes (measuring system and climatic chambers).
The specifications defined in this phase are :
- Technical Characteristics of the different insulated packages
- Technical Characteristics of the cold sources
- Technical Characteristics of the separating and cushioning materials
- Characteristics of the material used for the OQ and PQ
The Operational Qualification presents the methodology of the temperature measurements and the operating mode of the preparation of the boxes and the cold sources, to verify the functions offered by the insulated boxes during their use. It is achieved by feasibility and/or homogeneity tests allowing, with acceptance criteria, to define, verify and fix for each reference of box the following elements :
- The boxes configuration
- The fields of application and the tolerances
- The operating mode
The Performance Qualification aims to validate the solutions proposed in the operational conditions and in the user limits defined in the protocol. This phase consists in verifying and in demonstrating the performance of each box by the reproducibility results of the tests done on the same reference, with the same configuration, in the same conditions and with the same means of measurement defined and approved in the two last phases IQ and OQ and according to the specifications. The results of this phase are given in the form of reports and curves (sheet tests).