BioPharm (BPE)

BioPharm (BPE) tube fittings are designed for use in the pharmaceutical industry, manufactured to conventional tube OD specifications, with fine ID electropolish and unique tangents.

In order to understand the difference between Sanitary and BioPharm tube fittings, let’s begin with the certifying organizations.

3-A.org is the standard-setting organization of record in the food and beverage industries. If you see the 3-A symbol on a fitting, you’ll know it’s approved for sanitary use.

BPE is an international standard developed as an aid for the design and construction of equipment intended for use in the manufacturing of biopharmaceuticals.

Both 3-A and BPE fittings are considered to be sanitary, with the ID being polished to an RA of 32 or better. However, while 3-A fittings are polished to 32Ra and often better, BPE comes in several finer finishes, the most common being SF1 (PL) and SF4 (PM). These finishes make them better suited for pharmaceutical use where even the slightest impurity cannot be tolerated in the line.

• SF1 – 20Ra Max ID Electropolish / 32Ra Max OD
• SF4 15Ra Max ID Electropolish / 32Ra Max OD

In addition, BPE fittings have extended tangents, which accommodate orbital weld heads. BPE fittings are available with Butt Weld or Tri-Clamp ends, or with both.

For BPE fittings with one or more clamp ends, Heavy-Duty and High Pressure clamps complete the union between fittings. Gaskets must be properly seated before tightening the clamp, as improper alignment is a leading cause of leaks and contamination. The clamp should be tight and secure, but not overtight. If the gasket bulges, it may push into the process line. This can create spaces for bacteria to develop.

There are several commonly used gasket materials. Below are the types offered by James Duva, Inc.

• Buna – Rubber gaskets for general purpose industrial sealing at moderate temperatures (between -22° and 250°F).
• Viton® – Rubber gaskets providing indefinite seal from 5° to 400°F, and an excellent seal at 600°F up to 48 hours.
• EPDM – A very stable rubber-like gasket that resists heat, oxidation and aging, with flexibility at low temperatures. Working range is -60° to 300°F.
• Teflon® – Also known as PTFE, these chemically resistant plastic gaskets are unaffected by most corrosive liquids and gasses from -400° to 500°F.