The FSMA Requirement (21 CFR §117.20 & §117.40): The plant and its equipment must be designed and constructed to be adequately cleanable and maintained in a way that prevents contamination. This includes smooth, non-porous surfaces, proper drainage, and protection from overhead contamination.
Recommended Solution & Expert-Level Pitfall:
- The Solution: When purchasing equipment, insist on sanitary design principles (e.g., NSF-certified, no hollow tubing, no sandwich joints, easily disassembled for cleaning). For the facility, floors must be sloped to drains, and walls/ceilings must be smooth and in good repair.
- The Pitfall to Avoid: “Temporary” fixes and poor maintenance. A piece of duct tape on a torn belt, a zip-tie holding a guide rail, or a persistent ceiling leak are all invitations for microbial harborage. These “temporary” repairs become permanent and create un-cleanable niches. Your preventative maintenance program is a critical sanitation control. Condensate from overhead pipes or refrigeration units must be controlled and routed to a drain, never allowed to drip onto products or surfaces.