This document discusses sanitary fittings and hygienic clamps that are designed for use in the pharmaceutical and biotech industries. It provides background on how hygienic clamps were developed to address issues with joint cleanliness, misalignment, and gasket intrusion in those industries. It then describes the features of hygienic clamps produced by Advanced Couplings, including their unique internal design that provides consistent clamping action and controlled gasket compression. Finally, it discusses the benefits that L.J. Star provides as the exclusive distributor of Advanced Couplings clamps in North America, including their technical support, documentation, and involvement in industry organizations.

1. Must Have Information
about Sanitary Fittings
• Manufacturing Process
• Compliance Review
•Features, Advantages and Benefits
•Engineering Truths Checklist

2. Sanitary Fittings – Hygienic Clamps
History
Sanitary Clamp is made specifically for the
Pharmaceutical and Biotech Industries
where joint cleanliness and efficiency are of
paramount importance.

3. Sanitary Fittings – Hygienic Clamps
History
• Pharmaceutical & Biotech had areas of
concern
• Misalignment
• Gasket Intrusion
• Poor clamping action
• No manufacturing standards
• Demanded a better hygienic connection

4. Sanitary Fittings – Hygienic Clamps
A Better Solution was needed
L.J. Star / Advanced Couplings Solution
created stainless steel sanitary fittings and
clamps made from investment castings to
produce a high quality, precision fit assembly.
The clamps are designed to provide quick
access to the joint for cleaning and inspection
without sacrificing safety.

5. Sanitary Fittings – Hygienic Clamps
A Better Solution
• Unique internal clamp design provides
uniform, consistent, repeatable clamping
action.
• Ferrule, clamp, gasket connection provides
controlled gasket intrusion
• More efficient
• More cleanable connection
• Exceeds ASME-BPE requirements.

6. Sanitary Fittings – Hygienic Clamps
Compliance
• Located in United Kingdom & Ireland
• An ISO 9000 Certified Company
• ASME Section VIII, Appendix 24 (ASME
Code)
• British Standard Sizes
• DIN Standard Sizes
• ISO Standards
• CE Compliant
• Pressure Equipment – Directive 97/23/EC
• Machinery – Directive 98/37/EC

7. Sanitary Fittings – Hygienic Clamps
About Advanced Couplings Ltd.
• Advanced Couplings Limited offers the
most
complete line of Hygienic Clamps in the
industry
• Clamps are manufactured in Ireland
• Headquarters and warehouse located in UK
• L.J. Star is the exclusive North American
stocking distributor

8. Sanitary Fittings – Hygienic Clamps
Unique Features
• Offering is not your average offshore produced
clamp
• Unique “Omega” clamp profile is designed to
provide a higher clamping efficiency
• Higher clamping efficiency means a more
efficient clamped connection

9. Sanitary Fittings – Hygienic Clamps
Current Poor Design
Typical clamp design is not predictable –
Resulting in Uneven Gasket Compression.

10. Sanitary Fittings – Hygienic Clamps
Product Offering
• Type “S” Clamp – Single Pin – 304 Stainless
Steel
• Inexpensive alternate to the Type “SH”
clamp
• Type “SH” Clamp – Double Pin – 316
Stainless Steel
• The Flagship Clamp!
• Excellent clamping efficiency and good
pressure rating
• The only complete clamp series being offer
in 316 SS

11. Sanitary Fittings – Hygienic Clamps
Product Offering
• Type “SSH” Clamp – Two Bolt High Pressure
– 304 Stainless Steel
• High Pressure Rating
• Brass or Stainless Steel Nuts
• ASME Code Clamps – Redundant Bolting –
316 Stainless Steel
• Meets the requirements of ASME Section
VIII – Appendix 24
• All 316 Stainless Steel Construction
• Full Material Traceability – All Components!

12. Sanitary Fittings – Hygienic Clamps
Product Offering
• Specialty Clamps
• Safety
• Lockout
• Instrument

13. Sanitary Fittings – Hygienic Clamps
Type “S” Clamp – Single Pin – 304 Stainless Steel

14. Sanitary Fittings – Hygienic Clamps
Type “SH” Clamp – Double Pin – 316 Stainless Steel

15. Sanitary Fittings – Hygienic Clamps
Type “SH” Clamp – Double Bolt – 316 Stainless Steel

16. Sanitary Fittings – Hygienic Clamps
Type “SSH” Clamp – Two Bolt High Pressure – 304 Stainless

17. Sanitary Fittings – Hygienic Clamps
ASME Code Clamps – Redundant Bolting – 316 Stainless

18. Data Sheet
Click to access
PDF of
Stainless Sanitary Fittings

19. Data Sheet

20. Sanitary Fittings – Hygienic Clamps
Fastener Options

21. Sanitary Fittings – Hygienic Clamps
Safety Clamp – Assures Operator Safety

22. Sanitary Fittings – Hygienic Clamps
Safety Clamp – Assures Operator Safety

23. Sanitary Fittings – Hygienic Clamps
Lockout Clamp – Assures No Unauthorized Access

24. Sanitary Fittings – Hygienic Clamps
Lockout Clamp – Assures No Unauthorized Access

25. Sanitary Fittings – Hygienic Clamps
Instrument Clamps – for instrument gaskets
Ports for:
•Sampling Tubes
•Injection Tubes
•Temperature Probes
•Thermo-Coupling Wires

26. Safety Clamp
Data Sheet

27. Lockout Clamp
Data Sheet
Click here for a
PDF of the
Lockout Clamp Data Sheet
.

28. Instrument Clamp
Data Sheet

29. Sanitary Fittings – Hygienic Clamps
Connection Problems
• Biggest problem with the assembled joint is
gasket intrusion into the bore
• Shelves or pockets are areas for bacteria traps
and contamination

30. Sanitary Fittings – Hygienic Clamps
Misalignment
• Inconsistent
dimensions lead to
areas of
contamination
• By controlling the
dimensions of all the
components,
predictable gasket
intrusion can be
achieved

31. Sanitary Fittings – Hygienic Clamps
What is being done to change this?
• New designs available but not readily accepted
by the industry.
• Millions of Hygienic Clamp Fittings (Tri-Clamp)
being used today
• Swagelok® “TS” Fitting (Special Seal Design)
• BBS-Systems Quick Connect (O-Ring Seal)
• DIN 11864 (O-Ring Seal)

32. Sanitary Fittings – Hygienic Clamps
What is being done to change this?
• ASME-BPE
• Developed a standard for gasket intrusion of
+/- 0.025”
• Developing standard dimensions for Hygienic
Clamp Fittings
• NO U.S. STANDARD EXISTS!

33. Sanitary Fittings – Hygienic Clamps
Swagelok
TS DIN 11864
BBS Quick Connect

34. Sanitary Fittings – Hygienic Clamps
What solution do we have to offer?
• By controlling the dimensions of the Ferrules,
Gaskets and Clamps, we can provide an
assembled joint that has +/- 0.005” gasket
intrusion
• Far better than what is allowed by ASME-BPE
• This can be achieved without having to produce
special fittings!
• Standard off the shelf products

35. Sanitary Fittings – Hygienic Clamps
What Makes L.J. Star, Inc. Different?
• Unique internal “Omega” profile design
• Known source of manufacture
• High Quality
• High Performance
• Technical Support
• Leader in the industry
• Continue to develop new designs
• Clamps for Source Gasket
• Safety Clamps
• Plastic Clamps

36. Sanitary Fittings – Hygienic Clamps
• Technical Support
• Complete and Accurate Documentation Packages
• Involvement in Industry Organizations
• ASME-BPE (Active Committee Member)
• ISPE (Active Member)
• EHEDG (Advanced Couplings – John Henry)

37. Sanitary Fittings – Hygienic Clamps
• Training and Education
• Our Representatives
• Customers – Lunch & Learn Presentations
• Trade Shows
• ISPE Local and National Shows
• INTERPHEX
• ASME-BPE
• Our Representatives
• Your commitment and continued support are
what makes the ultimate difference.

38. Engineering Truths Checklist
Specification Fuseview™ Metaglas®
DIN 7079 Standard for Fused-Glass Sight Glasses X Ö
DIN 7080 Standard for Glass Quality X Ö
USP® Type I Standard for Pharmaceutical Use X Ö
No. 1 Used Sight Glass in the World X Ö
Parenteral Use (Drugs for Injection) X Ö
Fusion Ö Ö
Borosilicate Glass X Ö
Third Party Documentation X Ö
Free of cracks, crevices and pits X Ö
Available with Stainless Steel Ring X Ö
Meets Minimal Bubbles to DIN 7079 X Ö

39. Sanitary Fittings – Hygienic Clamps
• For More Information
• Visit L.J. Star Incorporated for more
information on Sanitary Fittings.
• Contact us directly:
• Mailing Address:
L.J. Star Incorporated
P.O. Box 1116
Twinsburg, OH 44087
• Telephone: (330) 405-3040
FAX: (330) 405-3070