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Ecolab Compounding Pharmacy Cleanroom Garb

Cleanroom Garb

Sterile and non-sterile disposable lab coats, protective sleeves, and surgical masks for the pharmacy compounding cleanroom environment. VAI's Disposable Products Manufacturing Division has designed a range of sterile, disposable garments and textile products which are manufactured under their CMP Clean Manufacturing System incorporates cutting, manufacturing, and packaging (CMP) all products within an ISO Class 6 clean room facility from beginning to end.


PRODUCT DETAILS

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

Product Size Ecolab Part Number Package Size
Sterile Disposable Lab Coat (Medium) 89992040 25 coats per case
Sterile Disposable Lab Coat (Large) 89992041 25 coats per case
Sterile Disposable Lab Coat (XL) 89992042 25 coats per case
Sterile Disposable Lab Coat (XXL) 89992043 25 coats per case
Non-Sterile Disposable Lab Coat (Large) 89992046 25 coats per case
Non-Sterile Disposable Lab Coat (XL) 89992047 25 coats per case
Non-Sterile Disposable Lab Coat (XXL) 89992048 25 coats per case
Protective Sleeves with Elastic at Both Ends 89992045 100 pair per case
Surgical Mask with Elastics 89992038 500 masks per case
Surgical Mask with Ties 89992039 500 masks per case

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:

  1. Remove inappropriate items (outer garments, jewelry, cosmetics)
  2. Put on non-shedding PPE in the following order
    1. Shoes or shoe covers
    2. Head cover (bouffant)
    3. Facial hair cover (if necessary)
    4. Face mask
  3. Wash hands and forearms to the elbow for at least 30 seconds using soap and water.
  4. Put on a non-shedding lab coat or gown that fits snugly at the wrists and is closed at the neck.
  5. Don protective sleeves over the sleeves of the lab coat.
  6. Before donning sterile powder-free gloves, perform antiseptic hand cleansing using a waterless, alcohol-based surgical hand scrub with persistent activity
  7. Don sterile powder-free gloves

After this process, a person is ready to enter the buffer area.