Equipment / Components
Sterile Non-Hazardous Compounding <797>

 

Purpose/ Applicability:  To provide a guideline to describe how to properly bring equipment and components into the cleanroom for sterile compounding as well as how to properly store them.

 

Scope: This applies to equipment and components used in sterile compounding within the cleanroom as well as for equipment used prior to processes completed in the cleanroom (e.g. when starting from one or more non-sterile components).

 

Definition(s):

CSP: Compounded sterile product

BUD: Beyond use date

 

Equipment:

Mortar/Pestle

Syringes, Needles, LL connectors

Beakers

0.2 Micron Filter

Syringe Pump

Procedure:

Outside the Cleanroom

 

1. Workstation should be properly sprayed with alcohol and wiped down prior to compounding

 

2. All items being used for non-sterile components of sterile compounding need to be properly cleaned before use
   1. All items should be checked to ensure they are not soiled prior to use.

 

3. If possible, syringe to syringe method should be utilized as opposed to mixing in a mortar and pestle to help maintain a level of sterility

 

4. All vial tops should be wiped with alcohol and no rubber portion of the plungers, needles, or LL connectors should be allowed to touch the surface of the counter while being used

 

5. All components must be sprayed with alcohol when brought into anteroom

 

Inside the Cleanroom

 

1. Equipment and components must be handled under conditions which minimize the risk of contamination by particulate matter and after sterilization, by viable organisms, to the extent possible, handling should be under hoods with laminar air flow

 

2. Components should be properly cleaned (e.g. sprayed down with alcohol) before and after every use as well as during appropriate cleaning schedule

 

3. If component becomes soiled, it should be removed from cleanroom, sterilized, and then brought back to the cleanroom

 

4. Items utilized in the hood should be handled aseptically
   1. All items should be sprayed with alcohol before being brought into the cleanroom and before being brought into the hood
   2. All vial tops should be wiped with alcohol
   3. No rubber portion of the plungers, needles, or filters should be allowed to touch the surface of the hood while in use

 

5. Syringe pump must be properly maintained, cleaned, and calibrated if used for sterile compounding procedures