Core points
- Regulated lines need paper, not just a product: material certificate, compliance declaration, extractables data, surface finish, cleaning validation, FAT/SAT and traceability.
- 316L stainless steel and sintered plastic are the usual sterile/CIP choices; PVDF for hot loops; fiber/ACF for air and gas.
- Request extractables per USP <665>/<1665> for pharma and a 3-A / EU 10-2011 declaration for food contact.
- Keep the cert pack with the batch record - audit readiness is why you pay the premium for a documented cartridge.
The document checklist
| Document | Why you need it | Media where it is critical |
|---|---|---|
| Material certificate (316L EN 1.4404 / PE grade) | Confirms alloy or resin and traceability | 316L SS, sintered plastic |
| FDA 21 CFR 177.1520 / EU 10-2011 declaration | Food-contact compliance | Plastic, PP pleated, PVDF |
| 3-A / USP Class VI | Hygienic / biocompatibility for pharma & food | 316L SS, plastic, PVDF |
| Extractables / leachables report (USP <665>/<1665>) | Proves low leachables into your fluid | All pharma-grade media |
| Surface-finish certificate (Ra≤0.8 µm electropolish) | Cleanability and bacterial control | 316L SS |
| Cleaning / CIP validation protocol | Shows regeneration limits and residue | Sintered 316L, sintered plastic |
| FAT / SAT record | Factory and site acceptance evidence | Custom / large orders |
| Batch traceability (lot-linked certs) | Recall and audit readiness | All regulated media |
Documented, cleanable media for regulated lines - open the product page for certificates available.
Per-media notes
- Sintered 316L stainless steel - the default for sterile, CIP/SIP and high-purity water; ask for electropolish Ra≤0.8 µm and extractables data.
- Sintered plastic (PE/PP) - food and pharma grades with FDA/EU 10-2011; cleanable for many cycles, lower cost than metal.
- PVDF - hot-loop and aggressive-fluid duty; request the extractables and chemical-resistance package.
- Fiber / ACF - air, gas and vent lines; confirm the resin grade and any food/pharma declaration for the application.
What to put in the RFQ
State the regulation (FDA, EU 10-2011, 3-A, USP), the fluid and temperature, and list the certificates you require by name. Suppliers that cannot produce the cert pack are not qualified for the line - no matter the price.
FAQ
What certificates prove food contact?
An EU 10-2011 and/or FDA 21 CFR 177.1520 declaration, often with 3-A for hygienic design. Keep the lot-linked cert with the batch record.
Do I need extractables data for water?
For potable or industrial water, usually not. For pharmaceutical or high-purity electronics water, yes - request the USP <665>/<1665> extractables/leachables report.
What are FAT and SAT?
Factory Acceptance Test (supplier proves the item before shipment) and Site Acceptance Test (you verify on install). Request both for custom or large regulated orders.
Conclusion
The fastest way to a correct specification is to fix the duty first - fluid, temperature, pressure, cleanliness requirement and budget - then shortlist one or two media before you ask for a quote. The articles below go deeper on each media and on the procurement steps.
Applying this to your process?
Send BROLERN your fluid data sheet (chemistry, temperature, flow, target micron and seals) and we will shortlist the media, return a drawing and quote. Start from the product index or the RFQ form. For a staged train or a regulated line, ask for a sample first - see our pilot-order guide.