FDA compliant means that vibratory screening equipment and its components meet the requirements established by the U.S. Food and Drug Administration for use in food, pharmaceutical, dietary supplement, and cosmetic manufacturing. FDA compliance is not a single certification or stamp of approval — it is an ongoing responsibility that encompasses equipment materials, design, construction, documentation, cleaning procedures, and operational practices. Any vibratory screener used in FDA-regulated manufacturing must demonstrate compliance across all these areas.
For vibratory separators, FDA compliance requires that all product-contact surfaces be constructed from materials listed in 21 CFR Parts 174-186 (indirect food additives). In practice, this means 304 SS or 316 SS for metal components and FDA-approved elastomers (silicone, EPDM, Viton) for gaskets and seals. Equipment design must follow cGMP principles: no crevices, smooth finishes, complete cleanability, and documented material traceability. ScreenerKing manufactures FDA-compliant separators for food, pharmaceutical, and supplement applications, with documentation packages that support facility compliance audits.
FDA Compliance Checklist for Vibratory Screeners
| Component | FDA Requirement | Typical Specification |
|---|---|---|
| Metal surfaces (product-contact) | 21 CFR-listed materials; no leaching or contamination | 304 SS or 316 SS, 150+ grit polish |
| Gaskets and seals | 21 CFR 177.2600 (rubber); FDA-approved materials | Silicone, EPDM, Viton; detectable optional |
| Screen cloth | FDA-accepted material; no surface treatments that contact product | 304 SS or 316 SS woven wire; certified alloy |
| Coatings and paints | 21 CFR 175.300 (resinous coatings) if product-contact | Bare stainless steel preferred; no paint in product zone |
| Lubricants | 21 CFR 178.3570 (lubricants with incidental food contact) | H1-rated food-grade lubricants only |
| Documentation | Material certificates, cleaning validation, change control | Full documentation package with each screener |
Why This Matters in Vibratory Screening
- Legal requirement — Manufacturers producing FDA-regulated products must use compliant equipment. Non-compliant equipment can trigger warning letters, seizures, injunctions, and facility shutdowns during FDA inspections.
- Product safety — FDA-compliant design prevents contamination from equipment materials (metal particles, gasket fragments, lubricants) entering the product stream during screening.
- Material selection — Not all stainless steels and elastomers are FDA-acceptable. Specifying the correct alloy (304 SS, 316 SS) and gasket material (silicone, EPDM) is essential at the time of equipment purchase.
- Documentation — FDA auditors require documentation proving equipment materials, surface finishes, and cleaning procedures meet regulatory standards. This documentation must be available before, during, and after equipment installation.
Related Glossary Terms
- GMP — Good Manufacturing Practices mandated by FDA regulations
- Sanitary Design — Equipment design that supports FDA compliance
- 3-A Sanitary Standards — Voluntary standards exceeding basic FDA requirements
- Clean-In-Place — Automated cleaning supporting FDA cleaning validation
- USDA Approved — Additional approval for meat and poultry facilities
FDA Compliant FAQs
What does FDA compliant mean for vibratory screeners?
FDA compliant means all product-contact components meet requirements in 21 CFR regulations, including 304 SS or 316 SS metal surfaces, FDA-approved gasket materials, cGMP-compliant design, and documented material traceability.
What FDA regulations apply to vibratory screening equipment?
Key regulations include 21 CFR Part 117 (food cGMP), 21 CFR Part 111 (supplement cGMP), 21 CFR Part 211 (pharmaceutical cGMP), and 21 CFR Parts 174-186 (indirect food additives covering gaskets and coatings). Equipment must also comply with FSMA preventive controls requirements.
FDA-Compliant Screeners & Replacement Parts
ScreenerKing supplies FDA-compliant vibratory separators and replacement screens with full documentation packages for regulated manufacturing environments.