The Sterilization Packaging Manufacturers Council (SPMC®) released a new white paper titled “Preformed Sterile Barrier Systems Storage and Handling.”
Developed by the SPMC®’s Technical Committee, the paper delivers recommendations and best practices for the storage of preformed sterile barrier systems before their use by a medical device manufacturer or contract packaging manufacturer.
It examines these five environmental factors and explores the role each plays in maintaining the quality and integrity of the stored materials:
- Temperature,
- Humidity,
- Environment,
- Physical protection, and
- Time and equilibration.
“Over the years, we’ve received technical inquiries regarding guidance for the storage of flexible barrier materials used in sterilized packaging,” explains Bill Cassidy, product development manager for Amcor Flexibles and chair of SPMC®’s Technical Committee.
“SPMC®’s Technical Committee created an infographic containing brief guidance on the topic. We also developed an FAQ, which is part of our online FAQ resource. The new white paper is the next step in this guidance as it takes a significantly deeper dive into the issue.”
Temperature
The SPMC® recommends storing preformed sterile barrier systems at 50–80 degrees Fahrenheit (10–27 degrees Celsius). Three possible impacts of temperature excursions beyond the recommended storage conditions are blocking, changes in the coefficient of friction, and curl. The document explains each condition and offers details on how to mitigate each.
The paper also encourages medical device manufacturers to work closely with their pouch suppliers to determine if their preformed sterile materials have special storage requirements beyond these recommendations.
Humidity
Moisture-sensitive materials should be wrapped and stored according to supplier recommendations. Since preformed sterile barrier systems are often composed of various material layers, it is not always clear which materials are moisture-sensitive and what conditions may impact their performance. SPMC®’s white paper offers an understanding of the material science for some of the commonly used materials in preformed sterile barrier systems.
Environment
In addition to the temperature and humidity range recommendations, the paper addresses the presence of nitrogen oxide gases produced by forklifts or other warehouse equipment, which can potentially cause discoloration. Excessive exposure to sunlight can also cause discoloration. Well-maintained heating, ventilation, and air conditioning systems will help achieve the recommended storage conditions.
Physical Protection
The authors outline how to physically protect preformed sterile barrier systems from the elements of the storage environment and during transport and handling. Preformed sterile barrier systems are typically bundled and should be stored in secured protective packaging, preferably double bagged to keep the packages free of dust and particulates.
Time and Equilibration
The last section of the document calls for a 24- to 48-hour conditioning period in the production area to allow the materials to fully equilibrate. When the storage and manufacturing environments are similar, the conditioning time may be shorter. A longer conditioning time is required when conditions between the warehouse and production area are vastly different.
White Paper Available Online
“Preformed Sterile Barrier Systems Storage and Handling” is available for download at no cost on SPMC®’s website at sterilizationpackaging.org/ learning-tools. It joins five other SPMC® white papers that clarify aspects of packaging and help illustrate its value in protecting medical devices and other healthcare products.
Lourdes Pogue is partner and creative director at Merakke. Reach her at lourdes@merakke.com.