In this volume, we take a deeper dive into the different packaging components and highlight some of the aspects of ensuring product quality.
Product packaging is important for multiple reasons. It…
In general, most packaging lines at AbbVie package one type of product (bottle, blister, syringe, etc.). However, a single packaging line is often used to package multiple different products!
AbbVie’s main packaging sites are AP16 (Lake County), Waco (Texas), Ludwigshafen (Germany), and Campoverde (Italy).
Primary Packaging is the portion of the packaging that is in physical contact with the drug. For this reason, the primary packaging is extensively studied. We need to ensure no materials from the packaging components leach into the drug and that no portion of the drug is extracted out into the packaging materials. A few examples of primary packaging are shown below.
Fun Fact: Packaging pills into bottles is more common in the United States than it is in European markets! Most European markets prefer blister packaging configurations.
Secondary Packaging consists of all the packaging components that are not physically in contact with the drug. They are the materials that identify the product and all required information. The copy, or text, on these materials frequently changes based on regulatory approvals (ex. new indication, updated safety statement).
Now that you understand a little more about the different types of packaging and the fact that AbbVie packages multiple products one a single packaging line, let’s cover a few processes and controls used during production to ensure quality product is being packaged for our patients!
Fun Fact: Some packaging lines can produce several thousand units an hour!
Line Clearance is the process by which a line is cleaned and verified to be cleared of any material from the prior batch before beginning the next one. This process ensures no cross-contamination or mixed product occurs when moving between products on the same production line. Below is an example of how line clearance is performed at AP16.
In order to package product efficiently, there are many automated steps and inspection. All equipment and vision systems must be “challenged”, or tested, at the start and end of a packaging run in order to ensure they are performing their proper function. Performing these checks at the start and end of a run gives us confidence that they were functioning correctly for the duration of the run.
Fun Fact: Vision systems are cameras used during the packaging process to ensure a certain step was performed properly! Stay tuned on a future issue on these!
A few examples of challenges are:
