VersaFlow
TM
Compounding Aseptic Isolator
User Manual
16
Operation
The VersaFlow must be certified before use.
It is recommended to perform several trial runs in the Compounding Aseptic Isolator before initiating
preparation.
1. Ensure the prefilter is fitted properly in its housing at the top of the unit.
2. Ensure the VersaFlow is plugged into a functioning outlet.
3. Turn on the main power switch. The low pressure alarm will sound until adequate pressure is achieved.
4. A minimum of 10 minutes for start-up time is needed to achieve ISO Class 5 cleanliness.
5. Turn on the light switch.
6. Open the viewing panel and inspect under the work tray. Make sure there is nothing below the work
trays. Remove any foreign objects from the work area.
7. Push the end of the electrical outlet into the receptacle located at the top right corner of the work area
and tighten the retaining ring.
8. Install Sleeves and Gloves. Please refer to the section
Procedure for Glove Changes
.
9. Inspect Gloves and Sleeves for any tears. Please refer to the section
Two-Part Glove System
. If
appropriate, change gloves to the preferred type and size.
10. Ensure both interchange chamber doors are closed.
11. If purchased the optional Electrical Height Adjustment, adjust the height of the unit to a comfortable
working height.
12. Be sure the inner interchange chamber door is closed. Always close one interchange chamber door
before opening the other.
13. Place compounding elements into the interchange chamber, wipe down.
14. Remove hands from the interchange chamber and close.
15. Wait at least 10 seconds before bringing compounding elements into work area.
16. Begin preparation.
17. Dispose of waste through the sliding interchange chamber door using the sealed bag method.
18. Remove completed preparation from the work area through the interchange chamber.
For safe and efficient use of the Compounding Aseptic Isolator you should take into account the equipment
and materials necessary for the proposed operation and list the procedural details for each operation. The best
way to accomplish this is through the use of a checklist and/or protocol that includes all equipment, apparatus,
tools, products and supplies necessary for each specific procedure. The list should include the order of events
in enough detail to successfully carry out the proposed operation. This list needs to include such items as initial
cleaning equipment, spill control equipment and even extra gloves in case a change is required in the middle of
the operation.
Always operate with critical sites in first air. This may take practice since the source of the HEPA filtered air is now
above the user instead of in front, as in the commonly used Horizontal Laminar Flow Workstation.
The VersaFlow is not a substitute for good aseptic technique. It will provide a clean environment for
compounding but can be defeated with poor technique and disregard for cleaning and operational procedures.
