Habonim Valves for the biotech industry

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