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.
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.
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
It is important to understand the garbing process. Garbing takes place in the anteroom area of the compounding pharmacy. The basic steps for garbing and performing proper hand hygiene are:
- Remove inappropriate items (outer garments, jewelry, cosmetics)
- Put on non-shedding PPE in the following order
- Shoes or shoe covers
- Head cover (bouffant)
- Facial hair cover (if necessary)
- Face mask
- Wash hands and forearms to the elbow for at least 30 seconds using soap and water.
- Put on a non-shedding lab coat or gown that fits snugly at the wrists and is closed at the neck.
- Don protective sleeves over the sleeves of the lab coat.
- Before donning sterile powder-free gloves, perform antiseptic hand cleansing using a waterless, alcohol-based surgical hand scrub with persistent activity
- Don sterile powder-free gloves
After this process, a person is ready to enter the buffer area.