Qualifying shippers for frozen, refrigerated or controlled room temperature products takes time. To shorten the process, many suppliers offer pre-qualified options. “Pre-qualified shippers provide a level of confidence that they will perform properly,” said Tatika Jones, Principal Engineer, Global Packaging Engineering-Cold Chain Packaging at Shire Pharmaceuticals, leader of a roundtable discussion at the BioLogistics Summit (June 26-29, 2016, in San Francisco). In addition, most pre-qualified designs are off-the-shelf and therefore readily available. As a result, pre-qualified shippers can reduce time to market and package testing and may lower costs. However, a pre-qualified shipper may not provide as good a fit for the payload and is not necessarily a drop-in replacement for a custom shipper. Jones recommended biologics makers study the vendor’s qualification documents to ensure its testing and protocols meet their requirements for validating containers. Regulators are asking to see qualification documents so it’s important to know testing details such as sensor placement and payload as well as any results for shock and vibration testing. “You may need to ask the vendor for additional data,” Jones commented. If there are gaps between in-house validation procedures and vendor documents, some in-house testing may be necessary. In fact, the consensus among members of the audience is to accept pre-qualification as a starting point and then perform their own tests to confirm performance in their supply chain. “We’ve had an experience where a 96-hour-rated shipper went out-of-spec in 44 hours when it was tested in-house,” noted one attendee.
