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Cleaning & Disinfecting Guide

Cleaning & Disinfecting Guide

For Isolators, Cabinets & Hoods (ISO Class 5 Filling Zones)

 

Contec USP <797> Product Guide

For Isolators, Cabinets & Laminar Air Flow Hoods (ISO Class 5 Filling Zones)

Step-by-Step Cleaning & Disinfecting Guide

For Isolators, Cabinets & Laminar Air Flow Hoods (ISO Class 5 Filling Zones)

1. Assemble packaged cleaning supplies, for example:  a. Low-shedding wipes presaturated with sterile 70% isopropyl alcohol (IPA) b. Cleaning tool for extended reach c. Low-shedding cleaning tool pads presaturated with sterile 70% IPA

2. Wipe gloved hands and cleaning supplies using a low shedding wipe presaturated with sterile 70% IPA. Ensure all surfaces are covered before placing items into the hood or isolator pass through.

3. Wipe gloved hands again with sterile 70% IPA and place into the hood or isolator gloves.

4. For isolators: Open the interior pass through door and transfer all supplies into the work area following the equilibrium time.

5. Using the cleaning tool and low shedding pads presaturated with sterile 70% IPA, begin by cleaning the ceiling of the isolator or cabinet from side to side and then the walls from top to bottom. Each cleaning tool pad should be changed as soon as it appears unclean or no longer wets the contact area. Ensure all surfaces are thoroughly wetted with sterile 70% IPA. Alternate method: Use dry cleaning tool pads with sterile 70% IPA. 

6. Using the wipes presaturated with sterile 70% IPA, wipe the floor of the isolator or cabinet from side to side.

7. Wipe in overlapping parallel strokes. Overlap each stroke by 10-24 percent and present a clean quarter-folded wipe surface with each stroke.

8. Wipe all surfaces including the pass through door, handle and removable transfer tray.

Note: If the interior of the equipment was physically clean before the application of sterile 70% IPA, then the surfaces contacted will have been disinfected. If the surfaces were not physically clean at the beginning, steps 6 to 9 should be repeated since the first wipe-down may have only removed physical contaminants and not effectively reduced the bioburden to within the acceptable limits.

9. Place all soiled wipes, covers and cleaning supplies into a disposal bag and remove from the isolator.

10. Allow surfaces to dry before compounding begins.

Some surfaces, such as acrylic, may be damaged by exposure to 70% IPA over time. In this case, a non-residue generating cleaner and disinfectant, such as Accel TB, applied to non-shedding dry cleaning pads and wipes may be used instead.

This document is for guidance only and should be used with reference to the equipment manufacturer’s instructions for use and existing standard operating procedures for the facility.

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