Validate as a differentiated capacity
Solistica introduces an end-to-end solution in Colombia to successfully meet the demands of handling controlled-temperature products and the regulations surrounding the Best Manufacturing Practices for heat sensitive products.
The proper handling of controlled temperatures is one of logistics crucial demands in industries such as pharmaceuticals and medical and hospital products. In particular, medications must be kept under adequate temperatures prior to, and during, shipping because the products’ effectiveness, traceability, and integrity during their useful life cycle depends on that.
Solistica faced the specific demands of the pharmaceutical market in Colombia for guaranteeing the warehouse and transportation conditions described in their labels. To do this, we had to master how to control and keep track of the 5 Ms of continuous improvement: Manpower, Materials, Machines, Methods, and Measuring. We based the process on the BPMs set by the World’s Health Organization and endorsed by Colombia’s INVIMA (Institute of Drugs and Food Oversight) and ICA.
With these conditions in mind, Solistica’s validation and quality team worked on a rigorous solution to address the pharmaceutical industry’s logistics requirements. This effort resulted in Solistica introducing its alternative for validating controlled temperatures in the Colombian market.
The solution, called Validate, is the result of experimenting with different temperature configurations (2° C to 8° C , 0° C to 8° C, < de 20° C, between 15° C and 25° C, and < a 30° C) on different materials, such as expanded polystyrene coolers, polyurethane, plastic, and a large number of cooling gels, all following the same method for analysis. In addition to using these materials, we develop suppliers with the necessary capacities, instruments, and monitoring systems to meet the technical specifications for the validation, adjusted to the requirements of the pharmaceutical industry.
To implement the validation solution, Solistica’s team in Colombia carried out usage and monitoring protocols over diverse routes and warehouses, all under the weather conditions of a real operation. The collection of data was essential to support the result of the implementation in a statistical and quantitative manner, as well as the costs involved.
The knowledge generated over four years of experience implementing this solution on real cases has allowed us to offer a unique capacity that is held in the highest regard by pharmaceutical clients and by the authorities who certificate quality processes. We have become a leader in this area: Solistica validates third-party controlled temperature chains for warehouse configuration and transportation of coolers.
Our capacity to develop a value offer such as the validation of controlled temperature, so appreciated by industries with the most strict quality specifications, is a proof of Solistica’s leadership in Colombia and Latin America and a clear example of our willingness to broaden our capacities to give clients the solutions they are looking for.
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