TEMPERATURE SAFE TRANSIT

Temperature Safe Transit Rationale.

Temperature Safe Transit: Climatic conditions can be extremely challenging for operators charged with delivering temperature sensitive pharmaceutical product.  However just recently it has been highlighted just how deleterious extremes of temperature can be to drug efficacy. It has been demonstrated that with certain drugs a few hours soaking at temperature just 20% outside of the stipulated 2 to 8 degree centigrade; cold chain requirements, can result in a 25% reduction in drug efficacy. Whilst a shorter more extreme transgression can actually render the drug inert. Adding to these problems is the fact that the relationship between efficacy and temperature is probably unique to each individual drug.

Let us now define the temperature range within which we have to work. Recently temperature recorders were installed in the cargo sections of a range of delivery vehicles. These vehicles were engaged in routine delivery tasks across North America. The table below charts out a synopsis of the temperature encompassed, along with soak times at certain extremes of temperature.

North American Regional Temperature Extremes.

Temperature Safe Transit Transport Implications.

Three words that are beginning to have a lot of significance.  Clinics around the world are now reading horror stories regarding vaccines that were silently and irreversibly damaged during storage and or transportation; when none-validated temperature controlled transport and storage facilities were utilized.  Now the regulators are demanding that documented temperature history must be available for all temperature sensitive regulated product; from manufacture to enduser.
  This is the much debated "Cold Chain" and it is with us to stay. The regulations are now in place for all to view, so do not be surprised when you are asked to produce them.  In the UK thousands of people are being re-injected to try and ensure protection.  What will happen when a protected person becomes infected by the very infection they are supposed to be.

Temperature Safe Transit - Approved Transportation Providers

According to a recent study conducted by the U.K. - based Medicines and Healthcare Products Regulatory Agency (MHRA), a staggering 43% of critical and major product deficiencies are related to ineffective temperature safe transit transport problems and or monitoring during storage.

Similarly the World Health Organization (WHO) recently maintained that 25% of all vaccine products arrive at their final destination in a degraded state.  Given the high cost of conducting global clinical trials and the even higher cost of failure, regulatory agencies and pharmaceutical companies alike now demand that every party involved in the pharmaceutical supply chain - transportation and logistics providers included − conform to GxP guidelines.

FDA’s “cGMP / 21 CFR 211”

WHO’s “Good distribution practices for pharmaceutical products” and “Guide to good storage practices for pharmaceuticals”

Canada’s “Guidelines for Temperature safe transit - Control of Drug Products during Storage and Transportation”

Ireland’s “Guide to control and monitoring of storage and transportation temperature conditions for medicinal products and active substances.

”EU’s “Guidelines on Good Distribution Practice of Medicinal Products for Human Use” (94/C 63/03)

The Positioning Of The Data Loggers.

The number of individual data loggers that are required to guarantee temperature safe transit and their exact positioning within the vehicle load area has been rationalized as;
40 foot standard container: Requires 15 individual data loggers. Comprising four strings of three. Each sting running lengthways; two positioned 6 inches from the floor and 6 inches from the - sidewall each side. Similarly two strings positioned 6 inches from the roof and 6 inches from the - side walls each side. The remaining one to be fitted at the centre point of the container volume.

20 foot container: Requires 9 individual data loggers. Comprising of four strings of two. Each string running as the strings for the 40 foot container. The remaining one to be fitted at the center point of the container volume.
10 foot container: Requires 8 individual data loggers. . Comprising of four strings of two. Each string running as the strings for the 40 foot container. No center one is required.

If there are disruptive influences to the general air in /out flows or to the location of the conditioned air inlet and or exhausts then these location would have to be altered and would possibly have to be establish by conducting preliminary container airflow mapping flow study. However when the position and number of sensors has been agreed, the justification for your choice of sensor location for temperature safe transit temperature mapping validation must be documented in the Validation Plan.

TEMPERATURE SAFE TRANSIT.