There are a lot of variables in your situation, which raises a number of questions. What is the root cause of the empty bottles? Why are the preventive measures on the line (vision and checkweigher) not working effectively? What are the contents of the bottle (solid dose, liquid, powder) and what is the weight of the content relative to the bottle? Is this line validated? If so, this should not be happening.

I’d be glad to talk to you directly about this if you wish. I can be reached at 763/425-8808.

When qualifying any thermal shipping container, the three basic steps of design qualification, operational qualification, and performance qualification outlined in PDA technical report 39 should be followed.  The design qualification step should provide documented verification that the proposed design is suitable to meet the requirements.  The operational qualification provides documentation that the design yields reproducible results when exposed to expected controlled conditions (typically performed in an environmental chamber). The performance qualification is the last step and provides documentation that the design yields effective and reproducible results during actual shipments.

A prequalified thermal shipping container by definition should provide a high level of assurance that a particular shipper design will pass the operational qualification testing and ultimately the performance qualification testing. Thus, the first step of thermal shipping container qualification (design qualification) yields a prequalified thermal shipping container design.

Many companies that design and manufacture thermal shipping containers now advertise prequalified container solutions.  If performed correctly by the manufacturer, it can save you some time during the design qualification process.  You will still need to define your requirements for the shipper, but instead of performing time consuming thermal and transit testing yourself to provide documented verification that the shipper will meet your requirements, a prequalified container solution already has generic thermal and transit data for you to review and compare against your requirements.  It should be noted that any good testing data provided by a manufacturer should be performed to an industry standard such as ISTA procedure 7D and all equipment used should be ASTM D-3103 compliant (calibrated to a NIST standard).  It is also more credible when the lab performing the work is certified or accredited.  If the test data provides you with a reasonable level of assurance that the design will meet your requirements, you can move on to the operational qualification testing.

While the thought of having to go through the lengthy and time consuming process described above is often dreaded, there are good reasons to be sure your testing and qualification are thorough. First and foremost is safety to the consumer. This is especially true within the pharmaceutical industry where temperature can create conditions that affect both the safety and efficacy of the product. While it may be easy to lose sight of this primary reason to perform shipper testing, the financial exposure can be devastating, and the ethical consequences can be monumental. The other compelling reason to invest in this level of testing is that FDA requires that thermal packaging is qualified under realistic conditions to prove that products arrive unadulterated to patients. FDA audits are often dreaded, but failure to thoroughly qualify your shippers can result in a 483 warning letter detailing the processes that are not done correctly. The investment in testing on the front end will minimize the potential for this situation and ensure product viability and efficacy.

100% bar code verification typically indicates that every code has been graded according to a standard. This is the best way to ensure readability of codes across a supply chain.

Bar code validation can be done utilizing a simple read, and it is useful for ensuring readability of codes within a specified environment. Many in the industry use a hybrid method of bar code validation, which measures readability of codes created based on minimum number of decodes per read cycle.