This document discusses valves and solutions for the biotech industry. It provides an overview of regulations like ASME BPE and FDA requirements for valves used in biopharmaceutical manufacturing. The 48 series TuBore valve is highlighted, which features true bore flow, bubble tight shut-off, and FDA approved materials like PTFE and TFM. The document also discusses valve design concepts for cleanability, materials of construction, testing and packaging procedures. Finally, it introduces Habonim's line of "zero pocket" valves that eliminate dead legs and bacteria growth.

1. Valves and solutions
for the BioTech
industry

2. 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.

3. 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 VI
In vivo animal biological reactive tests for polymeric
materials
FDA
– Food and Drug Administration

4. 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

5. 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

6. 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

7. 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

8. Polishing & electro-polishing
• Standard 25 Ra max
• 15 Ra max for special applications
• Improve Cleanability
• Enhance corrosion resistance
• Removes inclusions

9. 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

10. 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

11. Seats design
• No slots or chamfers
• Low torque
• Bubble tight
• TFM material
• Cavity filler (optional)

12. 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

13. Locking Device
• Locked In last position
• In-Line assembly
• Spring loaded
• 6 mm pad lock (not included)
• Sizes ½” to 1½”
• Stainless steel

14. Flush Tank TuBore™ valve
• Manual or actuated
• Extended mounting kits
• Special balls for draining
• Cavity or Flush ports

15. CIP ball design
• Flush in open position

16. • 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

17. ‘Zero Pocket’ Elbow valves

18. ‘Zero Pocket’ Single Horizontal Cross SHC

19. Zero Pocket valve

20. 5-way zero pocket valve

21. 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