Hyper Klean Design Review
Our design review process doesnt just check against known and regular standards. We maintain one of the most thurough and reliable checklists for review that you will find in the industry.
3-A Sanitary
We check against the 3-A Sanitary Standard for General Requirements 00-02 (released in February of 2026 - the foundational "GR" standard for all 3-A equipment standards
FDA / FSMA
We ensure all equipment is designed and planned to be constructed to be cleanable and prevent adulteration per 21 CFR 117.40 standard
USDA / FSIS
We Validate all equipment meets 9 CFR 416.3 and is suitable for its intended use as well as cleanable. We also review to AMS Dairy Equipment Review Guidelines as they are widely applied
AMI / EDTF 10 Principles
We will validate against the Industry Standard checklist used by meat / poultry which has been also adopted broadly. This validates to NSF/ANSI/3-A 14159-1 alignment
SQF Ed10 / BRCGS Issue 9 / FSSC 22000 V6
We also are one of few third party organizations that will ensure that we check against prerequisite programs to ensure machines are designed and constructed to prevent contamination per SQF11.1.7, BRCGS 4.6, and FSSC ISO/TS 22002-1 Clause 5
Compliance
We will review all design documents (CAD, drawings, material certs, weld procedures) to ensure they fully demonstrate adherence; We will validate any cleanability validation plan provided (e.g., EHEDG/ASTM methods accepted under 3-A 00-02); no features create harborage. If all items are met the review will be scored as “Satisfactory” or full points.
Failure / Non-Compliance
Any design feature creates niches, pooling, inaccessible areas, or non-cleanable surfaces will be scored as follows
U = Unsatisfactory: triggers redesign, major non-conformance in GFSI audit, or regulatory violation and must be corrected
M = Marginal: these items require corrective redesign or necessary justification before manufacturing.
Review Process
Use CAD/3D models + marked-up drawings for general design review ahead of full design review.
Review sample material certifications for all items used or planned to be used
Review all weld procedure specs
Review cleanability validation protocol.
Review if pursuit of 3-A Symbol authorization or third-party verification (TPV) for high-risk equipment.
What do we review?
- Materials of Construction
- Product Contact Materials
- Non Product Contact Materials
- Material Compatabilities with Product, Cleaners, and Sanitizers
- Surface Finishes & Fabrication (Weld, Joints)
- Product contact surfaces
- Non-Product Contact surfaces
- Permanent Joints
- Radii, Corners & Geometry (No Niches / Crevices)
- Internal Angles
- No dead legs, recesses, gaps, or niches
- No lap joints or overlapping surfaces
- Drainability & No Liquid / Product Collection (Drip, Drain, and Draw)
- self draining surfaces
- no sagging / drain to ports
- all drip and catch pans drain away from product zones and are removable
- Accessibility for Cleaning, Inspection, and Maintenance
- Product contact services are easily accesible
- Floor, Wall, and Ceiling Clearances met
- Guards, belts, and necessary components are removable for sanitation
- Seals, Gaskets, and Connections
- Gaskets create flush surfaces
- Double seals have visible leak detection paths
- Shaft seals, o-rings, and connections minimize product contact and are inspectable
- Hollow Areas, Framework, and Enclosures
- Hollow frames and tubes are sealed
- Control panels meeet all requirements for their desired location
- Bearing, Lubrication, and operational Features
- Bearings, motors and gearboxes are outside of product contact zone with proper lubricants
- No fan colled motors blowing toward product
- CIP / SIP compatability and validation plan
- Validate all requirements for equipment designed with CIP where pplicable
- Documentation, Certification, and Risk Assessment
- Validate that full design package includes material certs, drawings, weld procedures, and cleanability validation plan
