PTEXIM sterilization system is Validation confirmed by EUROFINS
With the desire to ensure the best product quality, Phuc Thinh Export Import Investment Corporation (PTEXIM) has invested in a modern sterilization system, imported from Europe with a value of over 1 million EURO, reaching a capacity above 3,000 tons/year.
Going through a strict evaluation process, Eurofins – the world’s leading corporation of testing food qualities, environmental and pharmaceutical products, operating in over 50 countries, has recognized Validation value of PTEXIM steam sterilizer system.
Accordingly, the meanings of Verification and Validation although used often but easy to be misunderstood. Basically, these two concepts are completely different, Verfification is a review activity, a static testing technique, and Validation is an actual test implementation, or dynamic testing technique.
Verification is a process of evaluating intermediate working products (may include documents formed during the development stages such as requirement specification, document design, database design, ER diagrams, test cases, traceability matrix…) of a system life to check if the product meets all standards. While, Validation is the final product evaluation process to check if the system meets all quality requirements. Validation reviews help answer questions about:
1. Will the final products meet all quality requirements?
2. Will the production system suitable for use and quality requirements?
3. Check that “Have you build the right products?”
4. Doing in conjunction with checking the system’s actual operation.
5. Including all dynamic testing techniques, examples all test types like smoke test, regression test, functional test, systems test and UAT…
At PTEXIM Factory, Eurofins has carried out all necessary techniques to check sterilization process and results have recognized the outstanding quality of the sterilization system that PTEXIM is producing with the highest quality products as follows:
|Parameters||Test Methods||Before Steam Sterilized||After Steam Sterilized|
|Foreign Matter||ISO 927:1982||0.2% Max||0%|
|TPC||TCVN 4884:2005 (ISO 4833:2003)||1 x 106 cfu/g||1 x 103 cfu/g – max|
|E. Coli||ISO 16649-2:2001||NO Guarantee||Not Found|
|Salmonella spp.||IRIS Salmonella Method||NO Guarantee||Not Found|
|Yeast and Mold||TCVN 8275-:2010 (ISO 21527 -:2008)||NO Guarantee||Not Found|
|Coliform||TCVN 6848:2007 (ISO 4832:2006)||NO Guarantee||Not Found|
|Staphylococci aureus||TCVN 4830-1:2005 (ISO 6888-1:1999)||NO Guarantee||Not Found|
|Bacillus cereus||TCVN 4992:2005 (ISO 7932:2004)||NO Guarantee||Not Found|
|Clostridium Perfringens||TCVN 4991:2005 (ISO 7937:2004)||NO Guarantee||Not Found|
Once again, Validation certification contributes to affirm PTEXIM’s enthusiasm and efforts on the journey to bring green – clean – quality products to consumers around the world. PTEXIM will continue to persist in the orientation of high-tech production, meeting international standards, towards sustainable development and promoting the growth of Vietnam’s agriculture.