Cold Chain

Cold Chain

Imperial Health Sciences is a leader in cold chain management for pharmaceutical supply chain services. From our fully compliant, world class warehousing facilities, we are practicing internationally benchmarked cold chain procedures and raising the bar for cold chain practice across South Africa and for export into Africa.

Many practitioners in the pharmaceutical and healthcare sectors in South Africa are unaware of the critical importance of maintaining an unbroken cold chain in the shipping and storage of temperature sensitive pharmaceutical products, such as essential vaccines. The mission of the Imperial Health Sciences cold chain management system is to ensure that every man, woman or child who is vaccinated or receives essential medication, is assured of being treated with a drug that is fit for purpose.

Given the limited guidelines for cold chain regulations applicable to local conditions, Imperial Health Sciences implemented standard operating procedures (SOPs) that offer a yardstick for cold chain compliance across South Africa and the continent. Using the baseline of the WHO guidelines for international shipping of vaccines, the PDA Technical Report 39 and 52 guidelines on the control of temperature sensitive medicinal products on good distribution practices, we are striving to contribute to the development of standard South African cold chain guidelines for our local pharmaceutical supply chain industry.

COMPLIANCE

Imperial Health Sciences cold chain warehouse and distribution facilities in Centurion and Cape Town both have GDP compliant cold rooms (2-8°C). Our Quality Management System (QMS) is ISO 9001 certified and licensed by the DOH, MCC and SAPC and we are USP 1079 compliant.

Our cold chain shipping is controlled via environmental monitoring systems, QMS and validation / qualification and mapping. We use qualified packaging systems, receiving and packaging occurs within the cold room environment, and we conduct temperature data logging and analysis as well as quality assessment sampling as required. Our facilities and processes are subject to regular GDP audits to satisfy the stringent regulatory, quality, risk and security standards of our clients.

MINIMIZING RISK

Our actions to minimize risk consist of regular audits of our QMS and reinforcement of training in SOPs, implementing configurations for smooth movement and handling of boxes, maintaining accurate route profiles based on actual data and developing close relationships with our transport operators as well as auditing their processes. Within the transport process we build contingency time into our box life to accommodate any possible delays en route.

RESEARCH AND DEVELOPMENT

Over the past two years Imperial Health Sciences has invested more than R2.4 million in cold chain research and development to improve our QMS, to maximize our control, verification and review processes, and to minimize critical risk.

In January 2012 we introduced a cost effective, improved and patented packaging system, the Imperial Health Sciences Box and its eutectics, which provides a compliant route 2-8°C environment.

We have conducted extensive ambient temperature studies to support the introduction of a more efficient validation methodology to eradicate non-compliance during shipping, with the result that we are now exceeding the WHO guidelines on number of probes required. We aim at continuously improving in the areas of maintaining and auditing route risk profiles, logging and analyzing data, and installing best technology trigger alerts and freeze tags, amongst others.

THOUGHT LEADERSHIP

Imperial Health Sciences is driving the growth of awareness around cold chain compliance within the supply chain industry. We have initiated stakeholder engagement by convening a Cold Facts conference and, together with other industry participants,  establishing the Cold Chain Forum, with the aim of sharing knowledge, driving continuous improvements, bringing our services on a par with first world practices and bringing new knowledge to the international industry. Our ultimate goal is to drive the standardization of guidelines for South African export of pharmaceuticals into Africa.