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USP 797 Cleaning & Disinfecting Guidelines

Recommended USP 797 Cleaning, Disinfecting & Decontaminating for Sterile Compounding

Chapter outlines minimal cleaning and disinfecting requirements for the typical Sterile Compounding Pharmacy environment. Our recommendations are based on a Class 7 Buffer Zone, however, facilities with Class 5 rooms have additional cleaning requirements and may require different products than those listed here. Select cleaning products and tools carefully, considering the area(s) being cleaned and the soil load. Experienced Contec Healthcare representatives can assist you in product selection.

 

 

 

Cleaning & Disinfecting Best Practices for USP 797 Compliance

Cleaning: Removing debris, foreign matter and residue by wiping or mopping. One of the most common cleaning agents is Sterile 70% Isopropyl Alcohol. Sterile water is used to remove residue left behind by cleaning agents.

Always clean from cleanest to dirtiest:
1) ISO 5 Primary Engineering Controls
2) ISO Class 7 Buffer Area
3) ISO Class 7 or 8 Ante Area
4) General Supply Area

Be aware of the impact of cleaning of all tasks on the cleanroom environment. Mops, cleaning tools, and other equipment should be dedicated. Disposable mop heads and covers are cleaner than re-laundered options.

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Always clean top to bottom:

1) Ceilings

2) Walls

3) Floors

Group Purchasing Organizations

Nebo Content Management System Tracking