RTT Health Sciences is Africa's leading pharmaceutical supply chain service provider. Based in South Africa, we specialise in multi-channel solutions for delivering essential medicines and consumer health products nationwide as well as to developing markets across the African continent.
At RTT Health Sciences we strive to not only develop high end compliance in our operating procedures, but also to share our knowledge and expertise in the interests of stepping up industry standards of compliance. In the area of cold chain compliance we have made significant progress in eliminating deviance and we believe that our findings can make a substantial contribution to the industry's understanding of best practice in this arena.
MAINTAINING AN UNBROKEN COLD CHAIN
Many practitioners in the pharmaceutical and healthcare sectors in South Africa and on the continent do not understand how critical it is to maintain an unbroken cold chain of between 2 and 8 degrees Celsius in the transport and storage of temperature sensitive pharmaceutical products, such as essential vaccines. While we have a responsibility to meet the manufacturers' requirements for temperature sensitive products, guidelines on how to do this are limited. Consequently the industry experiences inconsistency in cold chain standards of compliance, resulting in deficiencies in the cold chain process which reduce or destroy the potency of the products in our care. Ultimately our mission as an industry should be to ensure that patients are treated with drugs that are fit for purpose. To achieve this, we need to agree as an industry on the benchmarks for best practice management systems.
At RTT Health Sciences we have developed our own standard operating procedures (SOPs) applicable to local conditions that can offer a yardstick for cold chain compliance across the continent. Local conditions bring their own unique variances; we need to be more aware of these and we need to be asking ourselves the right questions if we are to find the right solutions. We have invested some R2.4 million in research and development to improve our cold chain integrity and to maximize our control, verification and review processes.
RESEARCH AND DEVELOPMENT
In January 2012 RTT Health Sciences introduced an improved and patented insulated packaging system, the cost effective, locally made RTT Box and its eutectics, which provides a secure route profiled cold environment. Our box is designed to cope with extreme variances in ambient temperature, such as en route to Springbok in the Northern Cape in mid-summer, where temperatures can soar to above 40 degrees Celsius. This is a commercially available product that is cost effective to produce and eliminates the need to import appropriate packaging.
In consultation with Sarantis Kosmas, Head of Strat Cyro at Strategnos strategy and supply chain consultants, RTT has investigated validation techniques with the aim of improving validation methodology and providing a benchmark for standards of validation that best serve local conditions of variability. Our study* concludes that using 11 probes for testing variability in ambient temperature within a container will produce more reliable results than the WHO recommendation of 9 probes as an acceptable number. While this does not constitute a definitive guideline for validation, our findings do take us closer to establishing an optimum standard for validation techniques suited to our local conditions.
* See the full study published in the SA Pharmaceutical Journal, Oct 2011, 'A critical review of the validation process for insulated containers containing temperature-sensitive pharmaceuticals, and the need for standardisation'.
COLD CHAIN FORUM
RTT is driving the growth of awareness around cold chain compliance via our Cold Chain Forum for stakeholder engagement, with the goal of sharing knowledge with other industry participants, driving continuous improvements, bringing our services on a par with first world practices, promoting the development of appropriate guidelines for South Africa and bringing new knowledge to the international industry.
Mike Harrigan, GM Quality Management, on +27 12 621 4505 or email@example.com