We manage the entire process from start to finish and provide audit-ready temperature studies and report with all supporting evidence customised for your container, routes, and operational variation in your supply chain.
Using our proprietary methods and software, we provide an audit-ready report, with detailed analysis of the data, interpretation and recommendations, pack out, seasonal configurations and environmental chamber testing. All studies are conducted in line with local and global standards. All our recording and measuring devices are calibrated to National Standards, on an annual basis.
Validation of processes according to WHO, MCC, PIC/S, ISTA, and ISPE guidelines and requirements and company defined procedures
15.1 All pharmaceutical products should be stored and distributed in shipment containers which do not have an adverse effect on the quality of the products, and which offer adequate protection from external influences, including contamination.
15.6 Validated Lagged Container.
15.6.1 Thermolabile products are normally transported in lagged containers. During transportation these products must be protected by insulated packaging.
15.6.2 There should be a written procedure available for the validation of the lagged containers.
(h) Temperature data loggers, refrigeration tags, freezer tags, log tags or cold chain monitoring cards that complies with or meets WHO specifications must monitor the temperature of the loaded area of the transportation throughout the trip, and the validated cooler box packaging must have at least a temperature monitoring device that complies or meets with WHO specifications.
(c) In the event of the mode(s) of transport not being specific for the transportation of thermolabile pharmaceutical products, the specialised packaging like validated cooler bag packaging must be used.