Sterile barrier film manufacturers often have little direct input on how their customers will store the f lexible materials they purchase from them. The Sterilization Packaging Manufacturers Council (SPMC®) has released a new white paper titled “Rollstock Storage and Handling” to provide general guidance and insight into how the environment can potentially affect rollstock packaging materials.
Developed by the SPMC®’s Technical Committee, the new document’s guidance explores best practices for the storage and handling of laminated materials. The paper focuses on five key environmental factors—temperature, humidity, environment, physical protection, and time and equilibration—and the role each plays in maintaining the rollstock’s quality and integrity during storage and handling.
Rollstock should ideally be stored at 50 to 80 degrees Fahrenheit (10 to 27 degrees Celsius). Materials will generally expand with increasing temperature and contract with decreasing temperature, according to “Rollstock Storage and Handling.”
The white paper addresses how temperature can induce stress on the rolls depending on their material composition and the way in which they are wound. It also delves into how the coefficient of friction can be impacted by excursions outside the recommended temperature range.
“Rollstock Storage and Handling” recommends maintaining stored rolls at 40%–70% relative humidity in a clean environment without exposure to direct sunlight.
Primary guidance typically calls for wrapping sterile barrier rolls that have a sensitivity to absorbed moisture. The white paper digs deeper, examining how the compositional layers and the way they are bonded can result in material property changes.
It also explains that understanding where the layer is situated within the film’s structure can help determine the roll’s moisture sensitivity and under what conditions that sensitivity can affect sterile barrier system performance.
The actual physical space in which the rollstock is warehoused is addressed by the technical committee. In addition to maintaining the recommended temperature and humidity ranges, the white paper suggests keeping the space free of excessive dust, debris, or other contaminants, as well as avoiding overcrowding within the warehouse.
The report’s authors wrote, “Wrapping a material in a protective coating such as shrink wrap or secured poly bags will help keep materials clean and protect them from dust and particulate.” The document expands on the types of wraps that should be used depending on the sterile barrier system’s composition and light exposure.
Time and Equilibration
Finally, the white paper states that ideally, a 24- to 48-hour conditioning period in the production area is recommended to allow maximum equilibration of the rollstock. It also explains how environmental differences between the warehouse and production areas can impact material performance if not properly handled.
“Rollstock Storage and Handling” is available for download free of charge on SPMC®’s website at sterilizationpackaging.org. An accompanying infographic can also be downloaded for easy reference. In addition to the guidance provided, the authors recommend that medical device manufacturers work closely with their material suppliers to understand the unique storage and handling requirements that some materials may require.
Lourdes Pogue is partner and creative director at Merakke. Reach her at email@example.com.