Particulate Contamination is a Concern for Critical Product Contact Surfaces
Key Takeaways:
- Cellulose-based sterilization wraps are a known source of particulate contamination, as identified in FDA audit observations, posing a risk to critical product contact surfaces in pharmaceutical manufacturing.
- EU Annex 1 (Section 8.48) emphasizes the need for qualified packaging that minimizes particulate and microbial contamination, especially for sterilized items in sealed containers.
- STERIS Sterility Maintenance Products use spunbonded polyolefin material, which generates significantly fewer particles than cellulose wraps and offers superior microbial barrier properties.
- Our wrapping systems are cleanroom-manufactured and validated, making them ideal for aseptic environments like ISO 5/Grade A cleanrooms where particulate control is critical.
- These products support faster, cleaner wrapping and unwrapping, especially for complex equipment, reducing contamination risk and improving operational efficiency.
EU Annex 1 Revision Section 8.48 - “Where materials, equipment, components and ancillary items are sterilised in sealed packaging or containers, the packaging should be qualified for minimizing the risk of particulate…”
Recent FDA Audit Observations have identified sterilization wrapping as the source of blue cellulose particulate material in pharmaceutical drug product.
Materials of cellulose/paper origin should be evaluated for risk to the process if used in the cleanroom. This is especially critical for sterilization wrapping, as it is in direct contact with product contact parts and equipment. STERIS Barrier Product Solutions (BPS) sterilization wrapping products are constructed of a spunbonded polyolefin material, which is manufactured, processed and packaged in a certified cleanroom environment. Not only do the BPS solutions minimize particulate introduction into critical processes, they also have superior microbial barrier properties when compared to cellulose materials.
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