Flanges for US pharmaceutical and biotech plants
Pharmaceutical plants run two kinds of piping: hygienic product-contact lines and the utilities that serve them. Flanges belong to the second group, and the documents that come with them matter as much as the steel.
In US pharmaceutical and biotech plants, flanges are used on the utility and process-support piping, such as purified water generation, clean and plant steam, chilled water, process cooling, CIP supply and solvent recovery. Hygienic product-contact lines are usually orbital welded or clamped to ASME BPE instead. The usual flange is ASME B16.5 Class 150 or 300 in 316L or 304L, pickled and passivated, with heat-traceable mill test reports and PMI records for the validation package. We supply these from our works in India.
Where flanges are used in pharmaceutical and biotech
| System | Flange | Class and material |
|---|---|---|
| Purified water and WFI generation skids | Weld neck RF at equipment and pump nozzles | 316L, Class 150, pickled and passivated |
| Clean steam and plant steam | Weld neck RF | 316L or A105, Class 150 to 300 |
| Chilled water and process cooling | Weld neck and slip-on RF | A105 or 304L, Class 150 |
| Solvent recovery and tank farms | Weld neck RF; blind flanges at nozzles | 316L or A105 |
| Vessel and reactor nozzles | Weld neck, long weld neck, blind | 316L, Class 150 and 300 |
Where flanges fit, and where they do not
Product-contact piping in biopharmaceutical plants follows ASME BPE, with orbital welded tube and hygienic clamp fittings that drain fully and leave no crevices. Flanged joints have a gasket crevice and are kept off those lines. They are used where equipment has to come apart, on vessel nozzles, pump and heat exchanger connections, and across the plant utilities, where ASME B31.3 applies. We make ASME flanges; we do not make BPE tube or clamp fittings.
Material, finish and verification
| Requirement | Typical value | What we supply |
|---|---|---|
| Grade | 316L (UNS S31603), 304L on utilities | ASTM A182 F316L and F304L |
| Surface condition | Pickled and passivated | To ASTM A380 and A967 on request |
| Material verification | PMI on every piece | 100% PMI, recorded on the certificate |
| Traceability | Heat number on part and certificate | Heat number stamped before machining; EN 10204 3.1 |
| Intergranular corrosion | ASTM A262 Practice E on request | Through an outside laboratory |
Documents for the turnover package
Commissioning and qualification teams need to trace every wetted or utility component to its material. Each flange carries its heat number, and each heat its mill test report with chemistry, mechanical properties and heat treatment, alongside the PMI record. We can also list the flanges by line number on the packing list, which makes receiving inspection and the material traceability log quicker.
Ordering for a US project
Send your line list with the standard, type, size, class, bore or schedule, facing, material and quantity for each line, and we quote every line as specified. Every order ships from our works in Gujarat, India; we have no US office or warehouse. Each line is supplied to your line list, and ordering from India explains the documents, marking, packing and customs.
Frequently asked questions
Do you make sanitary or tri-clamp fittings?
No. We make ASME flanges and forged fittings. Hygienic product-contact lines use ASME BPE tube and clamp fittings from specialist makers.
Can the flanges be supplied passivated?
Yes. Stainless flanges can be pickled and passivated to ASTM A380 and A967, recorded on the certificate.
Is 100% PMI standard?
Yes, on every stainless flange, recorded on the certificate.
Sources
- ASME BPE, Bioprocessing Equipment
- ASME B31.3, Process Piping
- ASME B16.5, Pipe Flanges and Flanged Fittings, NPS 1/2 through NPS 24
- ASTM A182/A182M, Forged or Rolled Alloy and Stainless Steel Pipe Flanges, Forged Fittings, and Valves and Parts for High-Temperature Service
- ASTM A380 and ASTM A967, cleaning, descaling and passivation of stainless steel parts