Appendix Files_ALL

A chemical or physical agent that destroys or removes microorganisms when applied to a surface. This includes sporicidal agents.

Disinfectant

Floor The lower surface of a room, or which one may walk. Horizontal Surfaces Tabletops, counters, chairs, benches, racks, door handles, small, trash receptacles and exterior surfaces of all equipment. IPA Isopropyl Alcohol Level 1 Disinfection Daily disinfection (scheduled each working day ± 1 day) Level 2 Disinfection Weekly disinfection (scheduled every 7 days ± 2 days) Level 3 Disinfection Monthly disinfection (scheduled Every 30 days ± 5 days) Level 4 Disinfection Quarterly disinfection (scheduled every 90 days ± 10 days) Level 5 Disinfection Event Response disinfection requiring one application of a low pH solution (Vesta-Syde) followed by two applications using Spor-Klenz. Out of Service (OOS) A condition in which a room/area is temporarily established in which manufacturing or routine disinfection may or may not be occurring, no materials or product are prepared, and routine clean room practices are not followed. This state is intended for maintenance periods. Production Areas Any room or rooms used in the manufacturing, processing, or packaging of a pharmaceutical intermediate or drug product. Sanitizer An agent used to reduce microorganisms in an inanimate environment. An agent that destroys bacterial and fungal spores when used in sufficient concentration for a specified contact time. It is expected to kill all vegetative microorganisms (USP <1072> Disinfectants and Antiseptics) Spor-Klenz (SPK) A fast-acting liquid cold sterilant blend of peracetic acid, hydrogen peroxide and acetic acid. The solution is Ready to Use. Sporicidal Agent Mobile Equipment Equipment that is able to be transported in and about manufacturing areas, including but not limited to: slurry tanks, mobile filter housings, mobile vessels (Mobius tanks, pallet tanks, etc.), carts (cleaning, environmental monitoring, transport, and utility), mobile scales, tube welders, media and buffer pumps, etc.

A procedure where three buckets are used for disinfection, each bucket being used in a specific order. The ‘Method’ is the procedure, the ‘System’ is the equipment. Walls (not including cove), doors (including door frames and door edges), window and window frames, mirrors, wall fixtures (protected outlets, water supplies, gas supplies).

Triple Bucket System (TBS)

Vertical Surfaces

Vesta Syde

Vesta Syde Quaternary Phenolic - disinfectant

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