Establishing documented evidence that provides a high degree of assurance that a specific process will consistently produce a product that meets it's predetermined specifications and quality attributes...
VALIDATING PROCESS EQUIPMENT
Validation of disinfection and sterilization processes is our core competence.
Valitech has carried out more than 1500 test runs over the last 12 years during validation of processes at our customers'.
Processes covering autoclaves, washing machines, dishwashers, cabin washers, cold storage rooms and climate chambers.
STEAM TESTING according to DS/EN 285
Test for non-condensable gases, dryness and overheating according to DS / EN 285 (section 13.3)
We have the best equipment from "Keith Shuttelworth & Associates" to test the steam quality in your distribution system or autoclave/sterilizers.
We can test for non-condensable gases, dryness and overheating according to DS / EN 285 (section 13.3). The test isl of course executed on your system after extensive protocol and takes typically 3-4 hours per test point.
Testing of the steam quality is recommended as an annual check or before a validation of your autoclave is required.
The steam test equipment is qualified for steam generators, steam distribution systems and steam supplies for autoclaves in accordance with cGMP (Orange Guide), HTM 01, HTM 2010 (replaced by CFPP01-01): 1994, HTM 2031 (replaced by CFPP01-01): 1997, EN 285: 2006, DIN 58950, ISO 14937: 2000, AAMI ST79, ISPE Baseline Guide for Steam and Water and PDA Technical Reports No. 1 & 48 - TR1 & TR48.
Valitech ApS er et mindre firma der besidder stor kompetence indenfor validering af autoklaver og vaskemaskiner. Vi har mere end 25 års praktisk erfaring fra bla. den pharmaceutiske industri. Valitech ApS er uvildigt, vi er hverken leverandører af udstyret eller direkte ansat hos kunden, herved kan en sammenblanding af interesser undgås og integriteten af den udførte validering opretholdes.