5 Safety Threats to Preformed Sterile Barrier Systems Storage & Handling5 Safety Threats to Preformed Sterile Barrier Systems Storage & Handling
Medical device manufacturing can mitigate pre-manufacturing handling and storage risk with these best-practice solutions from the Flexible Packaging Association's Sterilization Packaging Manufacturers Council.

At a Glance
- Best practices for managing temperature, humidity, environmental, physical, and equilibration time.
- A white paper and additional resources are linked for further guidance.
The Flexible Packaging Association’s Sterilization Packaging Manufacturers Council (SPMC) has released recommendations and best practices for storing preformed sterile barrier systems before use by a medical device manufacturer or contract packager. These come by way of a white paper from SPMC’s Technical Committee, Preformed Sterile Barrier Systems Storage and Handling.
The paper examines five environmental factors — temperature, humidity, environment, physical protection, and time and equilibration — and explores how each one affects the quality and integrity of the stored medical packaging materials. SPMC’s goal is to optimize and maintain the quality of the preformed sterile barrier system being introduced to the production environment.
To ask questions, identify gaps in current packaging standards, or suggest ways to improve these methods, visit the SPMC website and post a question in the FAQ area or contact a member company directly.
1. Temperature
Preformed SBSs (pSBs) should be stored at 50 – 80º Fahrenheit. Three possible impacts of temperature excursions beyond the recommended storage conditions are blocking, changes in the coefficient of friction (CoF), and curl. The white paper delves into these conditions and how to avoid them. Temperature can also accelerate the aging and oxidation process associated with packaging materials.
2. Humidity
Moisture-sensitive materials should be wrapped and stored according to supplier recommendations. As pSBSs are exposed to moisture, there may be changes to the overall dimensional stability (i.e., curl) and to the mechanical properties of the materials used in pSBSs. The white paper reviews the expected changes to pSBSs when exposed to humidity. Knowing which pSBSs exhibit sensitivities to moisture is important in preventing process challenges that could arise from changes to dimensional stability, fiber tear, or mechanical properties as well as changes to the usability of pSBSs that may impact the end-user.
3. Environment
Another important consideration regarding the storage conditions for pSBSs is the storage environment. This may include the presence of nitrogen oxide (NOx) gases produced by forklifts or other warehouse equipment that can potentially cause discoloration in pSBS materials. Excessive exposure to sunlight may also cause discoloration. Other protections include maintaining a clean environment to avoid excessive dust, debris, or other contaminants for the storage of the packaging materials. Well-maintained heating, ventilation, and air conditioning systems will help ensure that the required storage conditions can be achieved.
4. Physical Protection
Preformed SBSs should be stored in secured protective packaging, preferably double-bagged. For some materials, prolonged exposure to light may cause discoloration to the pSBSs. Therefore, storage in protective packaging that provides light blockage is recommended. Leaving pSBSs in the original shipping container or transferring the inner protective packaging to a tote for storage is acceptable. Preformed SBSs should be in transport packaging that provides appropriate protection and limits movement. Removal of the protective packaging to prepare products for use or incoming quality assurance checks should be followed by an equivalent or better system of protection.
5. Time and Equilibration
If possible, a 24 – 48 hour conditioning period in the production area is recommended to allow material to fully equilibrate. In cases where the storage and manufacturing environments are similar, the length of conditioning time may be shorter. However, in the case of extreme differences, such as moving materials from a cold winter warehouse into a production area, the equilibration time may be longer. Following these recommended guidelines will optimize the quality of material being introduced to the production environment.
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