ISOBOX MDP Puzzle and presentation of a new design and validation method of a complete isothermal solution.
A new and innovative product of Mediline Isothermal Solutions.
It is an assembled Isothermal box in an original form of an easy Puzzle (International Patent). The production method provides unique features. No use of adhesive medium is required. The assembly is a very quick and easy procedure. The different parts connect to each other firmly and they form a very rigid result with increased mechanical and isothermal properties.
Additionally, the option to be delivered disassembled, saves storage space up to 200% in contrast to conventional isothermal boxes.
It is the most modern, innovative and ideal solution for perishables protection. An important part of the Pharmaceutical Companies sensitive supply chain.
In conjunction with the professional gel packs produced by our company, ISOBOX isothermal boxes may cover delivery durations from 24 up to 120+ hours, for product safe temperature range between 2o - 8 o C.
In the following lines, you may get a brief view of the 5 step validation in order to find and produce the specific packaging that will serve exclusively your needs and requirements.
For further information, or a thorough presentation, do not hesitate to contact us.
Validation and Design
Isothermal packaging validation and design thorough procedure.
The following five steps, together with their estimated completion time, represent the flow of a validation project that we apply, during our isothermal products design phase.
The following estimated completion time frames are indicative are average values and are directly dependant on each project’s field of application and complexity.
If a rough validation of a product is requested, some of the steps may be omitted.
Step 1: Preparation – Data collection
The fist step of the procedure is actually a preliminary contact with our clients, in order to identify and record each project’s goals.
During this first step, we function mainly as consultants and we present the various available options that our isothermal products are able to offer, together with the common practices for the assessment and design.
With the aid of a typical quiz, we gather all the critical elements that are required to begin the project:
- The projects’ safe temperature range during testing,
- environmental temperature diagrams for winter and summer season, in the area that the transports are to take place,
- the required maximum delivery duration,
- the product’s minimum and maximum load in the isothermal package,
- the cooling element,
- Logistic elements and
- other materials to be used.
The information that is collected by this quiz will determine the specific goals, whether it is a validation for an existing packaging improvement, or completely new design development.
The solutions that our company proposes are based in laboratory tests, where our engineers and analysts utilize a full range of available materials and design an isothermal box that meets the specific requirements of our client.
In this step, all the project’s human resources are determined by both sides. The duties and responsibilities of each person are set as well, in order to achieve effective communication and correct coordination during the whole project. The time frame is also set.
Step 2: Test and pre-validation
The test procedure begins…
At this step, the existing packaging evaluation may also take place, in order for improvements to be decided. In case the results are not satisfactory, or the required standards are not met, a development of a completely new solution begins.
Our personnel are developing an isothermal package design, according to the goals that the client has set.
Upon completion of the initial design, an initial financial evaluation is made, in order for our client to have a rough cost estimation of the new isothermal package.
If this cost is acceptable, we proceed with the production of a prototype that will be forwarded to the laboratory, for the initial validation tests.
The test results will determine whether the prototype is accepted, since it meets the project’s goals, or the necessity for modifications, in order for the prototype to be retested and accepted.
Step 3: Protocol development
This step is actually the official and written work order by our client to our company.
Before the final testing phase, a Test Protocol is developed, that defines the validation parameters and details.
This protocol is a document in which, the validation test instructions are recorded by the laboratory analyst.
The following elements are included:
- Scope: Description of the products and packaging validation.
- Field: Description of the temperature range, test duration, distribution condition simulation elements, the isothermal box itself, the cooling elements, product load and the data acquisition method.
- Assignments: Definition of human resources from both the laboratory and the client that will be responsible for the tests coordination and validation.
- Number of tests: Definition of the number of tests that will take place per any chosen configuration, product load and environmental condition.
- Test procedure: Description of the progressive procedure applied by the laboratory analyst. Definition of all the testing elements, including laboratory equipment requirements and calibration, the packaging materials to be utilized and their features, as well as the environmental conditions to be simulated.
- Acceptance criteria: Definition of the required product temperature range during testing, together with any accepted negative or positive deviations.
Step 4: Validation test
Upon the protocol acceptance by all involved parties, all the additional material that is necessary for the tests are purchased. When all the elements are gathered the test begins.
During testing phase, a continuous contact with the client is maintained until test completion. The final packaging design is made upon the successful test completion and is submitted to the client together with the respective financial offer.
Below you may see, an indicative graphical representation of the transferred product’s temperature fluctuation, as well as the simulated winter and summer environmental conditions.
Step 5: Technical file and project completion.
Upon test completion, a technical file is created, both in hard and soft copies (if required)
The following data are included in the technical file:
- Presentation: Brief procedure presentation until project completion.
- Testing elements: The test reference sheets, graph charts, spreadsheets and raw data, for all the tests.
- Packaging diagrams: Thorough presentation for every successful configuration (isothermal kit)
- Operation manual: Precise description of the correct final product configuration as indicated in every successful test sheet.
- Specifications: Technical specifications for all the packaging materials.
- Logistics elements: Palletizing drawings, and packaging details for the final product and its various parts.
- Calibration details: Full validation for all the testing equipment that was utilized.
- Protocol: The initial test protocol, as well as any modifications is included in he technical file’s appendix.