Continental Disc Corporation

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2 Continental Disc Corporation Founded in 1965 (almost 50 years experience) Global leader in Rupture Disc Manufacturing We have the Best Rupture Disc in the market!!!

3 Why Rupture Discs?

4 Safeguard against under/overpressure Protect plant and equipment Protect the environment Ultimate can safe lives! Mandatory by law (code, standard, guidelines)

5 Why Overpressure Protection? Chemical reactions External fire Human error Loss of electricity Loss of heating or cooling Control system / valve malfunction Overfilling Insufficient vent capacity

6 What can go wrong?

7 Overpressure protection

8 Vacuum protection

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11 Where are discs used in Pharma? Pressure Vessels (Reactors, Fermenters, Blending, Filtration, Storage, etc.) WFI systems, CIP systems, Utilities Filling and packaging systems Purified water distribution Autoclaves for sterilization Thermal oxidizers Chromatography Heat exchangers Etc.

12 So What is a relief device or a Rupture Disc?

13 Pressure Relief Devices Relief devices Reclosing Non-Reclosing Safety relief valves Pressure/vacuum valves Rupture discs Rupture pin devices

14 So what is a Rupture Disc? A rupture disc, also known as a bursting disc or burst diaphragm, is a non-reclosing pressure relief device that, in most uses, protects a pressure vessel, equipment or system from over pressurization or potentially damaging vacuum conditions.

15 Sometimes described as a Engineered Weak Spot!

16 Important things to remember! Works on P and pressure is always influenced by temperature Always disk + holder assembly Non-reclosing Pressure relief Device Generally subject to the highest category of PED

17 Benefits of a Rupture Disc? Less material Lightweight Leak Tight No Moving Parts Versatility in materials/sizes Less Maintenance Clean Ability

18 Combination Available materials Reclosure for Containment Clean Ability Corrosion Preventions Tight Seal

19 Combination Available materials Reclosure for Containment Clean Ability Corrosion Preventions Tight Seal

20 Where (how) to use a Rupture Disc? Primary Relief Secondary Relief Series Relief

21 Disc Types?

22 Different Basic Disc-types Forward Acting (Tension Type) Pressure on the concave side of the disk Reverse Acting pressure on the convex side of the disk Flat (Bi-Directional) pressure acts on either side of the disk

23 3 important points to consider Tolerances Burst Tolerance Manufacturing range Performance Tolerance Operating-to-burst-pressure-Ratio 50% for flat rupture discs 70% for forward acting discs(80% if with scoring) 90% for reverse acting discs Pulsating or Cycling Pressure Capability Forward acting discs = poor resistance Reverse acting discs = good resistance

24 Temperature Influence Inconel Percent of original burst pressure Nickel Stainless Steel Aluminum Temperature F

25 Evolution of Pharma Rupture Discs GRAFSERT CDC(V) HPX/ULTRX/LOTRX SANITRX / (24 ) 1-4 0,5 20 bar 0,5 20 bar 0,10 68,9 bar 0,3 34,5 bar OR 80% OR 80% OR 90/95% OR 90/95% FRAGMENTS! Non-fragmenting Non-fragmenting Non-fragmenting Between flanges Between disc holder Between disc holder Sanitary ferules

26 Special Pharma Rupture Discs CALVAC (flanged) CALVAC (sanitary) Screw-type rupture discs inch WC OR 80% Bi-directional Non-fragmenting Between flanges inch WC OR 80% Bi-directional Non-fragmenting Between ferule/clamp 1/4-1/2 4, bar OR 80% Non-fragmenting Threaded holders

27 Forward Acting Rupture Discs Pre-bulged - media pressure on concave side of the disk Tensile or stretching burst Subject to fatigue caused by disc flexing (less cycling cap.) Generally requires a vacuum support Random bursting pattern (fragmenting if not scored!) Operating Ratio 70% up to 80%

28 Reverse Acting Rupture Discs Domed shape - media pressure on convex side of the disk Not subject to fatigue because of instant snap (flex back) Non-fragmenting and Full vacuum without support Best performance tolerances (Zero manufacturing range) OR is normally max 95% (100% of minimum burst pressure) Best for cyclic or pulsating conditions (HPX up to 250K cycles)

29 High Purity Rupture Discs?

30 High Purity Discs Surface finish RA20 Optional integral burst disc Indicator Sanitary gaskets Acc. to ASME BPE Best performance tolerances

31 Assembly

32 Clean ability with Safety Valves?

33 Clean ability with Safety Valves? Large L/D (deadleg area)

34 Why is dead leg area an issue? Ferrule TC Connection NA Connector, flush mounted

35 How to Increase Clean Ability?

36 How to Increase Clean Ability?

37 Increase Clean Ability with Disc!

38 Or even better!!! NA-Connect ZERO deadleg

39 Tight Sealing?

40 Tight Sealing Sanitary Gaskets High Purity Rupture Disc designs are BUBBLE TIGHT against internal or external leakage Preserves process environment where high vacuum conditions exist Provides safe working conditions under pressure

41 Tight Sealing Sanitary Gaskets Integral envelope gasket (for use in standard ferrules) For ASME BPE / DIN ferrules and NA-Connectors 3A approved (designed to prevent media build-up) FDA grade and USP Class VI approved Platinum Cured Silicone, Viton (black and white); EPDM (black and white) and PTFE, etc

42 Multi Bold Clamp (MBC) 232 C 121 C 22 C Tri-Clamps only up to 121 C / 34,5barg Longer durability and better performance Under higher pressures/ temperatures Especially for PTFE gaskets 34,5 69,0 103,4

43 Accessories?

44 Integral Burst Disc Indicator

45 Code Compliance?

46 Compliance with Code/Standards ASME Section VIII ISO 4126 PED/CE and ATEX Type design Installation issues Sizing and selection ASME-BPE (2009) USP grade Class VI FDA approval Sanitary issues 3A Sanitary Standard

47 Compliance with Code/Standards ASME Section VIII and ISO 4126 criteria Burst rating maximum for rupture discs Burst rating tolerances Sizing parameters for rupture discs and holders Rupture disc / safety valve combination design Marking or tagging of rupture discs Approved materials of construction for holders Product testing requirements for rupture discs/holders PED is mainly referring to ISO 4126

48 Compliance with Code/Standards ASME BPE-2009 (Bioprocessing Equipment) Defines surface finish options for discs and fittings Defines dimensions and tolerances for ferrules/clamps Traceability of materials of construction Criteria to optimize sterility and cleanability Marking and packaging requirements for fittings Elastomer performance properties (see next slide)

49 Compliance with Code/Standards USP CLASS VI Testing of elastomers for biological reactivity in vivo Testing of elastomers for chemical leaching impact FDA US federal executive departments, responsible for protecting and promoting public health (material compatibility) 3A Sanitary Standard Originated in the Dairy industry but has carried over to food and pharmaceutical applications.

50 Conclusions!

51 Conclusions! Why use Rupture Discs? 100% leak tight (containment, Bio safety, fugitive emissions) Clean Ability with CIP or SIP (reduce/zero dead leg) Accuracy (best tolerances, fixed burst pressures, operating ratio) Code compliance (ASME, ISO, PED, FDA, USP, 3A) Versatility (Materials, pressure ranges, sizes, etc )

52 Richard Neale Mike van den Bos Ronald van der Boon Product Development Regional Sales Manager Managing Director Manager CDC USA CDC NL Romynox B.V. Phone: (816) Phone: Phone: + 31 (0)