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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