MATERIAL
Compounding Pharmacy Cleanroom Garb is made using VAI "1700 CleanBlend" material blend. This material is designed for use in either Class 5 cleanroom areas or as a personal protection garment. The 1700 CleanBlend material blend is a heat bonded polypropylene that is laminated with VAIs patented laminate binding material. The material blend is soft and comfortable and is single stitch sewn with bound edges. Particulate and shedding characteristics are very low while filtration efficiency or barrier retention of material measured at 0.45 microns is 100%. The material blend has excellent chemical resistance to a variety of agents.
QUALITY
All VAI Cleanroom Garb products are manufactured with proprietary material blends that are proven to be of the utmost cleanliness when tested for particulate shedding by the Helmke-Yeich® Tumble Drum test method (Details available on request.) All VAI Clean Garb products are lot sterility tested. VAI sterility tests each lot by placing port indicators and material swatches into each irradiation load. The spore indicators and material swatches are subsequently tested for organism viability.
DOCUMENTATION
All Sterile VAI clean garment products are delivered with:
- Certificate of Irradiation
- The Dosimeter readings from irradiation
- Lot specific sterile test report
All other documents are retained in the product batch record