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bioPURE 10 and bioPURE 15 SPECIFICATION

for Electropolished, Tubing and Fittings For Use in High Purity Piping Systems December 17, 2001

Quality Assurance

Operations

Engineering

David Baylor Quality Assurance Manager

David Smith Vice President of Operations

Carl Pelech Director of Research and Engineering

bioPURE 10 and bioPURE 15 SPECIFICATION Electropolished, Tubing and Fittings For Use in High Purity Piping Systems December 17, 2001 1.0 1.1 SCOPE This specification will establish criterion for electropolished tubing and fittings for the use and installation in high purity gas and fluid piping systems. This specification is applicable to tubing and fittings with outside diameter of 1/4" through 6" (inclusive)

1.2

2.0

REFERENCE DOCUMENTS ASTM A213 (EAW) Seamless Ferritic and Austenitic Alloy-Steel Boiler, Superheater, and Heat-Exchanger Tubes. ASTM A249 Welded Austenitic Steel Boiler, Superheater, Heat-Exchanger, and Condenser Tubes ASTM A269 Seamless and Welded Austenitic Stainless Steel Tubing for General Service. ASTM A270 Specification for Seamless and Welded Austenitic Steel Sanitary Tubing. ASTM A450 General Requirements for Carbon, Ferritic Alloy, and Austenitic Alloy Steel Tubes ASTM A479 General Requirements for Carbon, Ferritic Alloy and Austenitic Alloy Steel Bar. ANSI/ASME B46.1 Specification for Surface Texture - Surface Roughness, Waviness and Lay. ASME BPE Bio-Processing Equipment

3.0 3.1

MATERIAL REQUIREMENTS All tubing shall be produced from type 316L stainless steel. Seamless tubing shall be manufactured and tested to ASTM A269 and ASTM A213 (EAW). Welded tubing shall be manufactured and tested to ASTM A270 and ASTM A249. The sulfur content of all tubing shall be 0.005 - 0.012% for seamless tubing and 0.005 0.017% for welded tubing. Tubing less than or equal to 4" OD shall be bright annealed in a dry hydrogen atmosphere (dew point <= -40 degrees C), or vacuum annealed (10 micron Hg), at the producing mill. 6" Page 2 of 5

3.2

3.3

bioPURE 10 and bioPURE 15 SPECIFICATION Electropolished, Tubing and Fittings For Use in High Purity Piping Systems December 17, 2001 tubing shall be annealed and pickled. 3.4 Tubing shall be permanently marked with a mechanical etching tool, or other approved method. The mark shall contain: manufacturer's identification, the size and wall thickness, the alloy, and the heat number. Fittings shall be permanently marked with a mechanical etching tool, or other approved method. The mark shall contain: manufacturer's identification, the alloy, and the heat number, ASME BPE and the applicable surface finish designation. Bar stock shall conform to the requirements of ASTM A479.

3.5

3.6

4.0 4.1

FITTING FABRICATION PROCEDURES Fabrication of sub components for tubular tee fittings shall be by pulling, drilling, or notching the joining surfaces prior to welding. To insure uniform production results, all welding during fitting fabrication shall be performed utilizing a pulsed TIG process. The ID and OD of the fitting shall be purged, during the welding procedure, using a cryogenic source of 99.998% pure argon gas. End connections of fittings shall be faced and squared. The fittings will be appropriate for use with automated orbital welding equipment.

4.2

4.3

5.0

SURFACE FINISHING, CLEANING, AND PACKAGING PROCEDURES

5.1 Cardinal BPE does not use mercury or ozone depleting chemicals in the processing of our products. 5.2 TUBING 5.2.1 Tube ID shall be electropolished utilizing automated equipment that uniformly monitors and controls all major variables of the electropolishing process. 5.2.2 Tubes shall be flushed with deionized water, immediately following electrolyte evacuation. 5.2.3 Following initial deionized water rinse, tubes shall be immersed in a 20 - 40% nitric acid, balance deionized water, solution for a minimum of thirty minutes at ambient temperature. 5.2.4 From the nitric acid bath, tubes shall be cleaned with utilizing filtered, deionized water and dried with filtered nitrogen. 5.2.5 All tubing shall be bagged in polyethylene sleeves and capped. Page 3 of 5

bioPURE 10 and bioPURE 15 SPECIFICATION Electropolished, Tubing and Fittings For Use in High Purity Piping Systems December 17, 2001 5.3 FITTINGS 5.3.1 Fittings are loaded onto the appropriate racks and electropolished using equipment that uniformly monitors and controls all the major variables of the electropolishing process. 5.3.2 Fittings are removed from the electrolyte tank and flushed with deionized water. 5.3.3 Following the deionized water rinse, fittings are immersed in a 20% nitric acid, balance deionized water, solution for 2 minutes at ambient temperature. 5.3.4 From the nitric acid bath, fittings are rinsed with deionized water and dried with nitrogen. 5.3.5 Upon conclusion of final inspection, fittings are passivated in a 20 - 40% nitric acid, balance deionized water, solution for a minimum of thirty minutes at ambient temperature, cleaned with deionized water and dried with filtered nitrogen. 5.3.6 All fittings are capped, bagged in 4 - 6 mil. polyethylene bags, and heat sealed.

6.0 6.1

TESTING AND INSPECTION STANDARDS AND PROCEDURES Finished tubing and fittings shall be processed and electropolished in a manner to obtain one of the following ID surface finishes, per ANSI B46.1. bioPURE 15 (Meets or Exceeds ASME BPE SFF4 and SFT4) 10 µin Ra average, 15 µin Ra maximum ID and Bright Annealed OD ­ (B15E) 10 µin Ra average, 15 µin Ra maximum ID and 30 Ra OD ­ (BP15E) bioPURE 10 7 µin Ra average, 10 µin Ra maximum ID and Bright Annealed OD ­ (B10E) 7 µin Ra average, 10 µin Ra maximum ID and 30 Ra OD ­ (BP10E)

6.2

The purity of the deionized water, utilized for the final cleaning process, will meet the following purity levels: Filtration: TOC: Bacteria: 0.1 micron absolute Less than 25ppb Less than 6 colonies/100ml.

6.3

The nitrogen gas, utilized for purging and drying is procured to the following, minimum purity specifications: Moisture: < 1 ppm Oxygen: < 1 ppm Total Hydrocarbons: < 1 ppm Carbon Dioxide: < 1 ppm

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bioPURE 10 and bioPURE 15 SPECIFICATION Electropolished, Tubing and Fittings For Use in High Purity Piping Systems December 17, 2001 7.4 One hundred percent of all CARDINAL BPE tubing, fittings, and related components are visually inspected to insure that the internal surfaces display uniform electropolishing and that they meet or exceed the requirements of the current edition of ASME BPE.

7.5

CARDINAL BPE will measure finished tubing and fittings with calipers, micrometers, or other acceptable methods, to certify that the finished products conform to the dimensional requirements of the current edition of ASME BPE. 7.6 CARDINAL BPE will supply the following reports and certificates of analysis with all orders-- --Mill Test Reports --Certificate of Conformance: --Dimensional Certification --Surface Roughness Certification

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