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Summary of Change

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EXHIBIT C2 – SCOPE OF WORK Cleanrooms and CNC Spaces (Revised SOP 000109483)

Applicable Sites: Applicable Areas:

1.0 Objective This procedure provides requirements for cleaning and disinfecting cleanrooms and controlled not classified (CNC) rooms. Scope This procedure specifies the proper techniques, methods, materials, and frequencies for cleaning and disinfecting Class C/D manufacturing rooms, corridors, and support rooms. Out of scope: Warehouse Cleaning (refer to SOP-000109480 Cleaning cGMP Warehouse) 3.0 Definitions and Abbreviations 1.0

Term / Abbreviation

Definition

Solid overhead surfaces, including lighting fixtures. Excludes camera lenses, HEPA grates, differential pressure sensors and sprinkler head covers. An area where airborne viable and non-viable particle contamination, and viable surface contamination, is controlled within preset limits. A room designed, maintained, and controlled to prevent particulate and microbiological contamination of drug products. Such a room is assigned and meets an appropriate air cleanliness classification. Items used for the cleaning and disinfection of the facility such as mops, wipes, buckets, containers, foggers. CNC space is cleanable, access controlled, and served with filtered air; procedural controls and personnel garment upgrades may be applied at the owner’s discretion. To free from dirt, stains, or impurities.

Ceilings

Classified Areas

Cleaning

Clean Room

Cleaning and Disinfecting Equipment

Controlled Not Classified (CNC)

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