Valves and solutions for the BioTechindustry

ASME BPE 2014

The ASME BPE standard provides requirements for systems and components that are subject to cleaning and sanitization and/or sterilization including systems that are cleaned in place (CIP) and/or steamed in place (SIP) and/or other suitable processes used in the manufacturing of biopharmaceuticals.

Regulations

Title 21 CFR

– Code of Federal Regulations in the United States. Chapter 1 Title 21 CFR is the title for pharmaceuticals.

USP

– USP: United States Pharmacopeia, Classes V and VIIn vivo animal biological reactive tests for polymeric materials

FDA

– Food and Drug Administration

Where used?

• Process Support Systems (Indirect Impact)

– Purified water and WFI

– Nitrogen and other Process Gases

– Clean steam

– Compressed air

– Heating and cooling systems

– Steam and hot water systems

– Process vacuum systems

– Potable water

– Mechanical seal fluids

Valve design concept

• Cleaning and maintaining sterility

• Minimize dead legs

• Material conformity

• No entrapment

• Flushing of internal cavities

• Proper drainage

• Valve manifold assemblies

• Proper slope (1-2 %, 0.6°– 1.2°, 10 – 20 mm per meter)

• Minimize distance between valves

48 series TuBore™ valve features

• True bore flow

• Bubble tight Shut-off

• Non-exposed body bolts

• Cast or forged made body and ends

• HermetiX™ stem seal

• TFM seats FDA approved

• 25 Ra max standard surface finish

• ISO 5211 for cast valves

• Locking Device (LD), Fugitive Emission (FE) and spring return handle (SRH) mountable

Materials

• Castings A351 CF3M (316L)

• Forged Stainless steel 316L/1.4435

• Ferrite level < 5% (< 1% optional)

• Controlled Sulfur 0.005 – 0.017%

• FDA approved soft materials PTFE, TFM or virgin PEEK

• Stainless steel bolts, nuts and handle

• Optional - Alloy-C22 castings, AL6XN, Alloy 20, Other exotic alloys

Polishing & electro-polishing

• Standard 25 Ra max

• 15 Ra max for special applications

• Improve Cleanability

• Enhance corrosion resistance

• Removes inclusions

Design features

• Fully drainable valve

• FDA approved materials

• High Cv

• Excellent Shutoff

• Unexposed seats and ball

• Blowout proof Stem

• Simple to Maintain

• Easy to Actuate

End connections

• IMPERIAL– Clamp ends (TC)

– Extended tube OD (ETO)

– ASME BPE

• METRIC– DIN Clamp ends (TCD)

• DIN 32676

– DIN Extended tube (ETD)

• DIN 11850

– Extended tube (ETI)

• ISO 1127

– ISO Clamp ends (TCI)

• ISO 2852

Seats design

• No slots or chamfers

• Low torque

• Bubble tight

• TFM material

• Cavity filler (optional)

Cleaning testing & packaging

• In-House assembly

• Oil free assembly area

• DI Water

• Vacuum oven dry

• 100% testing

• Helium leak test

• Nitrogen bagged

• Marking & MTR’s

Locking Device

• Locked In last position

• In-Line assembly

• Spring loaded

• 6 mm pad lock (not included)

• Sizes ½” to 1½”

• Stainless steel

Flush Tank TuBore™ valve

• Manual or actuated

• Extended mounting kits

• Special balls for draining

• Cavity or Flush ports

CIP ball design

• Flush in open position

• Existence of “Dead Leg” in pipe lines may cause contamination and rejection of valuable process batch

• Habonim introduced to the market a complete line of “Zero pocket” valves which eliminates bacteria colonies development

Valve designs for the BioTech Industry

‘Zero Pocket’ Elbow valves

‘Zero Pocket’ Single Horizontal Cross SHC

Zero Pocket valve

5-way zero pocket valve

Zero Pocket valves

No other manufacturer could offer a solution other than cavity filler

• Close coupled ring main distribution

• Ease of maintenance

• Disassembly of downstream pipework with no affect on valve functionality.

• Fire Safe design