Equipment and Components USP 795
Non-Sterile Compounding
Equipment and Components
Non-Sterile Compounding <795>
Purpose/ Applicability: To provide guidelines for using and maintaining non-sterile compounding equipment and components. Equipment and components shall be utilized specific to the non-sterile compounding task. Equipment must be clean, properly maintained and used appropriately. Equipment and components shall be stored in a manner to prevent contamination and shall be located to facilitate its use, maintenance and cleaning. Dispensary staff will stock and replenish equipment as needed.
Scope: Applies to equipment and components dedicated for non-sterile compounding.
Definition(s): N/A
Equipment:
- Weigh scale
- Disposable weigh boat
- Capsule machine
- Spatulas, mortar & pestles
- Counting trays
- Beakers
- Cleaning agents: soap; 70% alcohol
Procedure:
- Weigh scales will be used for measuring any necessary ingredients. Disposable weigh boats will be available for use. The weigh scale and area around the scale must be properly cleaned with 70% alcohol after use to reduce residue and particles. Weigh scale will have a routine inspection (yearly) and any maintenance updates by the manufacturer company.
- For compounding capsules, the 100 count or 300 count machine will be used. Compounding for different strengths of the same drug recipe (same ingredients) is acceptable. (e.g., compounding two different strengths of gabapentin). The lower strength needs to be compounded first, then the higher strengths. All capsule machine detachable components must be thoroughly cleaned with soap and water and immediately patted dry to avoid buildup of water stains. Any non-detachable parts of the machine must be cleaned with 70% alcohol and wiped dry. Machines must be completely dry prior to compounding use again.
- Spatulas, mortar & pestles, counting trays and beakers will be dedicated for non-sterile compounding and must be clean prior to compounding, and must be effectively cleaned afterwards with soap and water.
- Adequate hand and equipment washing facilities shall be easily accessible to the compounding areas. Areas will be maintained in clean, orderly and sanitary conditions.