Sterile compounding is performed in pharmacies, hospitals and healthcare institutions, patient treatment clinics, and other related facilities. We offer products that comply with the sterile compounding requirements set forth in both USP Chapter 797 and the upcoming USP Chapter 800, titled Hazardous Drugs – Handling in Healthcare Settings.
Personal Protective Equipment must be worn when receiving intact supplies (remote from the compounding area), receiving suspected/broken supplies, transporting intact supplies or compounded HDs, receiving intact supplies in the compounding area, stocking and inventory control of the compounding area, during nonsterile and sterile compounding, collecting and disposing compounding waste, administering, routine cleaning 460, collecting and disposing patient waste, and managing spills. – USP.org
Sterile Compounding Products Notes:
– Sterile HD compounding shall be performed in a C-PEC that provides an ISO Class 5 critical area
- Only use gloves labeled as ASTM-tested chemotherapy gloves.
- Use powder-free gloves
- Avoid gloves with defects, pin-holes or weak spots.
- Wear two pairs of ASTM-tested gloves when compounding, administering, managing a spill, and disposing of Hazardous Drugs. For sterile preparations, only the outer glove needs to be sterile. Wear the inner glove under the gown cuff and the outer glove over the cuff. Place gloves with long cuffs over the cuff of the gown to protect the wrist and forearm.
- Wear disposable gowns that have been tested to resist permeability by HDs and will protect the individual from contact of any HD’s.
- Wear garments that cover the head, sleeves, and shoes.
- Eye and face protection shall be worn when handling HD’s outside an engineering control.
Metal and Glass devices may achieve sterility and depyrogenation by tightly covering with aluminum foil, and then exposing to dry heat in an oven at a mean temperature of 250° for 30 minutes. (Dry-Heat Sterilization under Sterilization and Sterility Assurance of Compendial Articles 〈USP1211〉 and Bacterial Endotoxins Test 〈USP85〉)
USP 797 states that: floors, walls, ceilings, shelving, hard surfaces, contaminated gloves, and supplies removed from shipping cartons are to be wiped with 70% Sterile Isopropyl Alcohol.