Pathology or Clinical Trials Samples
One of the largest CRO’s in Sydney, Australia has seen the light and is now using polyurethane containers for shipping research material internationally.
A review took place. This involved reviewing what they currently do and analyzing what they actually needed to tranport clinical trial samples. Part of this review was to look at where they ship to and what courier they use, the time frames needed to ensure plenty of time for delivery building in some just in case of problems en route time. We then completed some preliminary validation work in controlled conditions. We were very careful not to over engineer the packing method but to ensure quality was paramount at all times. We then completed some field trials. We included computer monitors logging their product temperature every five minutes.
When the validation work was completed it was revealed that only 5-7kg of dry ice was needed and not 10-12kg for their international consignments and eliminated dry ice top ups totally, further decreasing freight costs.
Today they use approx 5kgs of dry ice which translates into savings of $150-$250 on freight per container though using a validated method of shipping. Our CRO send a minimum of 15-20 boxes a week which translates into a saving of approximately $117,000 p.a as a minimum. And this does not even include the savings on dry ice and on dry ice top ups.
However peace of mind was one of the major benefits to this customer. They now know through validation the performance of the containers. So if their consignment gets delayed they do not have to worry as they have the assurance through the validation process that their precious clinical research materials are safe. And in today’s climate where security is an issue world wide this is comforting.
This case study highlights that to achieve good cold chain one must analyze all the variables and understand them until they become predictable, and then manage them to their maximum.
CoolPac can help CRO’s achieve optimum Cold Chain logistics by providing the following services:
* Cold Chain Auditing – Assessment of a company’s current Cold Chain procedures and performance.
* Validation of new or existing packaging designs.
* Development, Testing and Implementation of Cold Chain protocols.
* Implementation, including staff training.
Staff training is a vital factor in ensuring correct Cold Chain practices. In a recent validation study where samples were supposed to have been kept at +2 - 8oc the samples were actually being frozen. One cause was the gel packs were not being preconditioned prior to packaging simply because the warehouse staff were not correctly educated. This simply hightlights the need to regularly validate and audit all packaging protocols.
Call us to discuss your specific needs on 1300 266 555