G.D.P. and H.A.C.C.P. validation and product qualification

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Krautz Temax GDP HACCP validation validatie Validierung

What is a validation
A validation is a confirmation of a certain value. If you for example claim that 2+2=4, a field test can be implemented to test this outcome which we call a validation. A validation is therefore a practical field test that will prove and confirm if a certain claimed result is actually through and valid. If we place this in the cold chain prospective, we can state that the validation of a passive cooling thermal packaging system or an active cooling system is a system that has been tested in the praxis so the claimed temperature preservation is actually confirmed to be through and valid. Yet we need to be careful. A validated thermal packaging on itself is rather called a product qualified system seeing a thermal packaging system can only function correctly if the handling and usage is also performed correctly. If the thermal packaging is good, yet it is used wrongly, the claimed temperature result will not be the same. Therefore we need to apply the total process in the validation meaning that a validated thermal packaging system contains the following subjects:
- Product qualified thermal packaging
- Validated thermal packaging = re-tested results
- Validated usage process (protocols and S.O.P’s - Standard Operation Procedures)

Temax validations (see also page Test results)
The Temax insulation material is validated by several pharmaceutical manufacturers for the transport (Airfreight) of time-temperature sensitive ambient pharmaceuticals (+2°C to +30°C) and is also tested for (+15°C to +25°C) and even perishable (+2°C to +8°C). The Temax insulation material is also use for temperature protection of food products such as fish and meat, milk products, fruits and vegetables, bananas and exotics, etc.. yet also in the chemical industry the Temax insulation material is used for temperature protection of temperature controlled products such as paints and other water based products.

G.D.P. "Good Distribution Practice" for pharmaceutical products

GDP or "Good Distribution Practice" is a directive of guidelines which are used in the transport and distribution of pharmaceutical products - medicines. These GDP directives indicate the points of attention which need to be considered when pharmaceutical products are transported or distributed in order to guaranty the required product quality. When these pharmaceutical products are time-temperature sensitive, what means that temperature fluctuations can influence the quality of the products, extra attention is required in regards to temperature preservation (active or passive cooling) and temperature controlling. This over the total cold chain where through the product is traveling. Next to temperature management, the GDP directives also provide attention points in regards to contamination of the pharmaceutical product during storage and transportation and need to be taken into account. All companies that transport or distribute time-temperature sensitive pharmaceuticals should be acting according these GDP guidelines and can be specially GDP certified.

In our product development and general company strategy we follow the following GDP guidelines
- European Union - European Commission GDP guidelines 05th November 2013. Good Distribution Practice of medical products for human use
- WHO World Health Organisation GDP guidelines 2010 Annex5. Good Distribution Practices for pharmaceutical products

There are also other countries that use their own specific GDP guidelines, yet we maintain our main focus on the current EN and WHO guidelines seeing most or the information and goals in the different  guidelines are equally the same.

General note: The Temax insulation packaging systems are secondary packaging systems and need to be treaded accordingly. Direct contact with non-pre-packed products needs to be avoided due to contamination risks, especially with multiple use applications. In case of multiple use applications, internal guidelines on frequent cleaning and thermal re-calibrations should be in place. In case of single use applications, the Temax insulation composition is 100% recyclable and can be globally organized within the Krautz Temax group.

H.A.C.C.P. "Hazardous Analysis of Critical Control Points" for food products

Also for the transport and distribution of food products, strict directives and guidelines are in place in regards to hygiene and temperature management when time-temperature sensitive products are commercialized. A lot of food products are sensitive to temperature changes, in which the quality of the product can change, and hygienically contaminations which can have an impact on our precious health. It is therefore only logical that certain directives are required by law. Companies which handle food products and are implementing the logistics and distribution of these products need to be able to provide a HACCP plan that shows how the temperatures and hygienically issues are managed through their part of the cold chain and how the critical points are managed. These companies can also get HACCP certified.

General note: The Temax insulation packaging systems are secondary packaging systems and need to be treaded accordingly. Direct contact with non-pre-packed products needs to be avoided due to contamination risks, especially with multiple use applications. In case of multiple use applications, internal guidelines on frequent cleaning and thermal re-calibrations should be in place. In case of single use applications, the Temax insulation composition is 100% recyclable and can be globally organized within the Krautz Temax group.

Protocols and S.O.P's "Standard Operation Procedures"

When structures and guidelines are implemented such as previous GDP and HACCP, protocols are a must. Protocols are specific instructions which are written down to create a fix way of operating or working to make sure that each operation leads to the same result. Without these protocols each employee or co-worker will be using his/her own work-system which may lead to different results and needs to be avoided. It can therefore be stated that it is almost impossible to live-up to the required guidelines without the implementation of the required protocols. It is also possible to qualify or validate each specific protocol showing that the results are actually valid.

Temax validations and product qualifications

Krautz-Temax is developer and manufacturer of thermal packaging systems and active cooling solutions for the transport and distribution of time-temperature sensitive products. Single use and multiple use products can be found in the portfolio. When these products are developed and manufactured, extra attention is given to the material choices, manufacturing procedures and product set-up in order to create an added value to previous GDP and HACCP guidelines. Our products will therefore provide assistance to our customers who are aiming to be in line with the required directives. When our customers transport and distribute time-temperature sensitive products, than we take it upon us to pre-determine the possible realization of the customer's requirement. To do this we are able to thermally pre-engineer the request with our special developed CCRM "Cold Chain Risk Management" engineering or we can perform actual temperature tests in special temperature controlled climate chambers. We have also invested in a special temperature controlled trailer to perform temperature simulations to make sure that we can offer our customers the most ideal and cost effective solution.