Asahi-America Validation Guide

ASAHI/AMERICA Life Science Application and Validation Guide

High Purity Piping Systems Specialty Valve & Components Transitioning from Steel to Performance Plastics

Asahi/America Application and Validation Guide

Life Science Application and Validation Guide

Section 1

Section OneIntroduction pg. 1

Section 2

Section TwoApplication and Design: USP Purified Water pg. 5Purad PVDF SDR21, PN16/230psi, Sizes 20-280mm SDR33, PN10/150ps1, Sizes 90-315mm

Section 3 Section 4

Section ThreeAlternative Applications for Thermoplastics pg. 13

Section FourMaterial Comparisons pg. 21PolyPureTM, Natural PP SDR11, PN11/150psi, Sizes 20-110mm

Section 5

Section FiveValidation Plan and Sample Protocols pg. 29

Section 6

Section SixMaterials and Systems Overview pg. 33

Proline Pigmented PP SDR11, PN11/150psi, Sizes 20-500mmAlso Available as SDR17 and SDR32.5

Section 7

Section SevenPiping Design: High Purity Water Systems pg. 47

Section 8

Section EightSpecifications pg. 57

Ultra Proline E-CTFE SDR21, PN10/150psi, Sizes 32, 50, 63, 90 and110mm

Purad, PolyPure, Proline and Ultra Proline are Trademarks of Asahi/America, Inc.

35 Green Street - Malden, MA Phone: (781) 321-5409 Fax: (781) 321-4421 www.asahi-america.com

Introduction

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Section One: Introduction


Section OneIntroductionThis guide contains many possible applications but its main focus is on High Purity Water. High Purity Water Production is perhaps the most visible and important system in a Biopharmaceutical manufacturing facility. As a critical system evaluated for facility licensing, the water systems importance cannot be overstated. The FDA utilizes the water system as a benchmark indicator of a facilitys current Good Manufacturing Practice (cGMP) suitability because it is an universal component, regardless of the intended application. The major goal of this application guide is to provide a high purity water design philosophy to economically improve the quality, reliability, and broaden the utilization of Purified Water (PW) systems in pharmaceutical manufacturing. Too much emphasis has been placed upon the regulatory perceptions of pharmaceutical water systems at the expense of the water quality. PW systems must fulfill their role as the primary water source for most pharmaceutical applications, and expensive Water For Injection (WFI) should be relegated only to applications as defined by the name; water for injection. The conceded microbiological integrity of WFI comes at a price; high cost, low purity and high metals content. Too often, WFI grade water is chosen to meet all facility applications, without regard to quality, to avoid regulatory scrutiny. This is costly both technically and economically. WFI water is not a high grade of water. WFI grade water is in contact with the atmosphere and, when piped in stainless steel, has an alarming metals content (see graph on page 2). Rouging has been treated as an unfortunate byproduct of pharmaceutical water quality and not recognized as the gross contaminant that it is. Hot WFI water, recirculating in 316 L Stainless Steel pipe, will consistently contain Iron, Molybdenum, Tungsten, Chrome, Nickel and Cobalt, as well as Copper, Zinc and traces of other heavy metals. Metal laden WFI water, which has a significant carbon dioxide content, is not suitable for most laboratory, research or chromatographic applications. The water quality varies and is difficult to reproduce from facility to facility. There is a concern that this water impairs some cell culture processes as well.35 Green Street - Malden, MA Phone: (781) 321-5409 Fax: (781) 321-4421 www.asahi-america.com

Hot WFI water can be 10X more expensive than the higher quality DI alternative. Hot WFI requires expensive utilities support and poses safety risks due to its high temperature. High purity DI water should replace low purity WFI water in all applications except the final purification of parenterals. A high purity or DI water system should meet the following objectives: 1) Economically provide high purity water of exceedingly high quality, suitable for all applications. 2) Provide water without disruption 24/7/365 3) Provide water of suitable quality and consistency so as to eliminated water as a variable in research and manufacturing. High quality Purified Water will fulfill virtually all of the technical water requirements of the BioPharm industry. PW quality should not be measured by the minimal regulatory definition of PW, but be defined as the standard of quality routinely delivered by a DI water system. The water should have a TOC less than 50 ppb, preferably less than 10 ppb. The microbial activity should be less than one colony forming unit (cfu/ml), and typically much less. The water should have no detectable endotoxin. The water should exceed 17.5 MegOhm resistivity and there should be no detectable fluctuations in quality, day to day, year to year. The DI water contains no detectable ions to one part per billion. The water should require no heating or cooling to maintain quality. The water quality is reproducible from facility to facility and is easily scaled up. The DI water must be piped in thermoplastic materials and be provided on an instantaneous basis, suitable for all applications, including the feed source of the WFI make up.

Section 1

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PW should comprise the bulk of a facilitys water use with WFI utilized on an as directed basis. This approach provides high quality water on demand with considerable savings on utility infrastructure and support, operating expense and capital equipment savings. This application guide is provided to assist pharmaceutical engineers to apply these concepts based upon a wealth of real world application and experience. The goal is to improve pharmaceutical water quality, reliability and efficiency. This application guide will also investigate other functions in the facility where thermoplastic products can be applied to increase productivity and improve quality. Asahi/America - The Company Asahi/America pioneered the development of corrosion resistant thermoplastic fluid flow products in the United States. As a leader in thermoplastic fluid flow products, Asahi/America offers expertise in product, system design and installation. This approach is the Total Systems Approach. With a focus on high purity and DI water applications, Asahi/Americas knowledge in the application is the foundation for products to meet the

Section 1

challenges of the industry. An Asahi/America system is specified with confidence. With superior product design and ISO 9001 manufacturing, Asahi/America has remarkable product breadth. Valves and pipe are offered in numerous thermoplastic materials, and range from to 24. Offerings include pneumatic and electric actuators, thermoplastic compressed air and ventilation/exhaust systems, and extensive custom fabrication. Products are available through one of the industrys largest distributor networks, nearly 1000 locations nationally and throughout Latin America. Customer support comes from knowledgeable distributors and from a sales and engineering staff dedicated to thermoplastic system design. Please feel free to contact the Asahi/America experts with any questions about its products and how they fit your pharmaceutical and biopharmaceutical applications. Asahi-America - The Wet Process People

HP PVDF vs. 316L SS Pipe100

10

1 316L Stainless Steel Biotech Systems

ppb

0.1

0.01

0.001 High Purity PVDF Semiconductor Systems Ca Cr Co Cu Fe M g Mn Mo Ni

0.0001 A l Ba B

K

Elements

Si

Na Sr

W

Zn

FIGURE 1.A: ION CONTAMINATION COMPARISON BETWEEN FOUR ACTUAL HP INSTALLATIONS. ION CHROMOTOGRAPHY MEASUREMENTS TAKEN ON DYNAMIC WATER SAMPLES DEPICT EXPECTED PURITY LEVELS BETWEEN POLYMER AND STAINLESS SYSTEMS.

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1.1 PURPOSE OF THIS GUIDEThis guide is presented in a unique format, a total stand alone document which answers questions for the design, construction, commissioning and validation of a pharmaceutical PW system or process application. It is a combination handbook and textbook to guide you through the entire process from conception to successful operation. This guide is a source of information for pharmaceutical and biopharmaceutical managers who need to make critical decisions in regard to process systems. It is directed to high purity applications and takes you through conception, validation and successful operation. It is organized in such a way to lead the user through the steps in the design and construction of an engineering project. Asahi/America is prepared to assist you in all phases of a project from start to finish to make your planning and installation as smooth as possible.

5. Create Specifications (Refer to the Section 8 for the specifications of our products). 6. Prepare a Process and Instrumentation Drawing (P&ID). 7. Prepare Equipment and Materials List. 8. Prepare a validation plan. 9. Order the equipment and materials. 10. Prepare construction and piping drawings including isometrics. 11. Prepare construction schedule. 12. Startup and commissioning 13. Validation 14. Operation

Section 1

1.2 HOW TO USE THIS GUIDEThe following is a suggested approach to a typical project: 1. Select your application from the following categories or create a new possible application: - USP Purified Water - Water for Injection (WFI) - Solution and Buffer Preparation - Fermentation or Cell Culture Media Preparation - Clean in Place Systems (CIP) - Pure Air and Gasses - Equipment Hook-up 2. Refer to our generic designs which are shown in Sections 4 and 5. Section 4, (USP Purified Water) includes a basic list of equipment, valves, piping and instrumentation. Also included is information on recommended materials of construction. 3. Define the project including a schedule. 4. Create a preliminary Process Flow Diagram (PFD)


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This Page Intentionally Left Blank

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Section Two: Applications and Design - USP Purified Water


Section TwoApplications and Design USP Purified WaterAs stated in the introduction the major goal of this application guide is to provide a high purity water design philosophy to economically improve the quality, reliability and broaden the utilization of Purified Water systems in pharmaceutical manufacturing. Purified Water systems must fulfill their role as the primary water source for most pharmaceutical applications. Expensive WFI water should be relegated only to applications as defined by the name, Water for Injection. Based on the premise that Purified Water (PW) systems should be the major water source in a manufacturing and lab facility, it then needs to be economical and reliable. Proper utilization of thermoplastic piping systems from Asahi/America is part of the equation. The design options provided in section 4.1 are provided to better understand PW systems and the use of thermoplastics within these systems.

Classification Resistivity (M/cm) Conductivity (S) TOC (ppb) Bacteria* (cfu/100ml) Endotoxin (EU)

Purified 1.5 m > 0.8 m Rt > 6 m > 3 m

C. Pressure Rating All pipes shall meet the requirements of Section 1.4. D. Production Control During pipe production continuous quality controls are performed and monitored. Minimum required production control:Criteria Measurement Surface Color Marking Micropores Inner surface Packaging Labels Test standard ISO/DIS 10931-2 visual visual visual microscope DIN 4768 visual visual Test interval every hour each pipe each pipe each pipe 1x/shift 1x/shift each pipe each pipe

2.4 Fittings A. Production All standard fittings through 4 (110mm) shall be injected molded. All fittings are to be molded with equipment in a clean environment. After secondary machining all fittings shall be cleaned for a minimum of 1 hour in an automated Hot DI rinse. The DI rinse water specification shall be 70 C with resistivity above 18M and TOC less than 10PPB. B. Packaging All fittings are to be packaged in a class 100 cleanroom immediately after the cleaning process. Fittings are to be single bagged in PE/Nylon composite bags. Bags are to be silicone free and antistatic. C. Specialty Fittings Specialty fittings are to include restraint fittings, butt fusion instrumentation fittings, instrumentation donuts, etc. Specialty fittings shall be machined or molded of the same PP resin as the pipe and fittings. D. Pressure Rating All fittings, unless otherwise noted, shall meet the requirements of Section 1.4. E. Production Control During fitting production continuous quality controls are performed and monitored. Minimum required production control:

B. Packaging All pipes shall have ends sealed with PE bags and then capped. Pipe shall be sleeved in full length PE bag (qty dependent). The following chart designates quantities of pipe per PE bag:Size - Inch " " 1" 1 " Size - mm 20 25 32 40 50 63 90 110 Qty Five Four Three One One One One One

Section 8

1 " 2" 3" 4"

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Section Eight: PolyPureTM Specifications


Criteria Measurement Condition Color Markings Inner surface Packaging X-ray test

Test standard ISO/DIS 10931-3 visual visual visual DIN4768 visual visual

Test interval every 2 hours each fitting each fitting each fitting 1x/shift each fitting every 2 hours

Pressure RatingValves Pressure rating of valves shall be per manufacturers recommendations based on materials, valve type and size. Flow Meters: All Vortex Meters shall be made of PolyPure and free of all seal materials. Supplier shall be capable of supplying all sizes - 3 (20mm 90mm) and have a replace electronics module. All Vortex Meters shall be wet bench calibrated and supplied with Calibration Records from the manufacturer. 2.6 Joining Equipment PolyPure installation shall be performed by factory certified and trained installers in accordance with manufacturers ISO procedures, ASTM D 2657 and DVS 2207-15. Date of certification or recertification shall not exceed two years from the beginning of project. Available joining techniques are as follows: A. Butt Fusion Proper equipment selection should be based on pipe size and site conditions. Butt fusion equipment should be designed and tested to provide reliable welds. All equipment should utilize electronically controlled heating elements for accurate welding temperatures. Tools should also incorporate planing units to face ends prior to heating. Butt fusion equipment supplied shall weld joints based on force or pressure and not mechanical stops. B. Socket Fusion Proper equipment selection should be based on pipe size and site conditions. Socket fusion tools shall be available in two styles; one portable style capable of welding 1/2- 2 (20mm 63mm) and a bench style capable of welding 3/4- 4 (25mm 110mm). Heating elements are to be electronically controlled for accurate welding temperatures. Tools should also incorporate male and female heater inserts with Teflon coating. C. Non-Contact Butt Fusion Proper equipment selection should be based on installation requirements and line sizes. Tool shall be either semi automatic (UF2000 style) or fully automatic (SP series).

2.5 Valves All valves shall be produced in the same manner as High Purity Fittings Type 342 Spigot Diaphragm Valves: - 2 (20mm 63mm) shall be the type 342 of the PURAD system. The Valves shall have a PolyPure body and a diaphragm of PTFE with EPDM backing or EPDM. Valves will be spigot single body design. Top Works must include integral lockout device on the handle and position indicator. Type 342 Flanged Diaphragm Valves: 2 shall be type 342 with stub end and backing ring IR welded onto both sides. Top Works must include locking device on the handle and position indicator. Flanged Diaphragm Valves: 3 - 4 shall be type 14 single Proline PP body design with flanges molded as part of the body. Diaphragm shall be PTFE with EPDM backing or EPDM. Top Works must include locking position indicator. Type 343 Reduced Dead Leg Valve: x through 2 x 2 (20mm x 20mm through 110mm x 63mm) reduced dead leg (zero dead leg) valves shall be Type 343 Style from the PolyPure System. Valves shall be made of PolyPure resin. Valve bodies are to be unibody, molded design with a full 150 psi rating at 70F. All metal nuts and bolts must be capped or covered to reduce metal exposure. Top Works must include integral lockout device on the handle and position indicator. (Consult Factory for Availability of Molded T-343) Check Valves: All sizes class 150, ball type Proline PP with FPM or EPDM seat and seals. 150 PSI at 73.4F for sizes through 4.

Section 8


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UF2000 Style: Tool shall be made available in - 2 (20mm 63mm) and 2 10 (75mm 250mm) size ranges. Tools shall possess electronic planer and non-contact heating element. To avoid improper welded joints, tools will utilize and measure the welding pressures to join material and not mechanical stops. All IR fusion equipment shall possess a minimum of the following capabilities: 1. Computer control of the welding process. 2. Ability to store welding data internally on computer memory - up to 1000 welds. 3. Full alignment capabilities (vertical and horizontal) 4. All metal components coated to prevent any particle generation from metals. 5. Ability to download all data to a personal computer. IR equipment shall also have the capability of following options incorporated into the tool for special demands: 1. Protective hood over welding area up to 2 (63mm) 2. Nitrogen purge of the welding area. 3. Automatic nitrogen purge of the pipeline. 4. Security card entry 5. Printer labels for each weld automatically. SP Series: Tool shall be made available in 4 (20mm 110mm) and 2 10 (75mm 250mm) size ranges. Tools shall possess electronic planar and infra heating element. Tools will utilize and measure the welding pressures to join material and not mechanical stops. To avoid improper welded joints, tool shall automatically operate clamps and control joining force. Tools shall possess the following features: 1. Computer control and automatic fusion. 2. Touch screen for tool operation and parameter selection. 3. Restricted access through use of PCMCIA cards. 4. Automatic label printouts after each weld. 5. Ability to display and graph weld status while weld is in process. 6. Memory storage of welds 7. Magnetic clamps to reduce change out time from one size to another. 8. Vertical and horizontal adjustment for pipe alignment.

PART 3 EXECUTION3.1 Installation A. Facilities Subassembly and fabrication work should be conducted in a separate, temporary cleanroom located within the building. Cleanroom should be equipped with the following to provide a clean installation: 1. Provide Laminar flow Hepa filters in room ceiling to reach a level of class 10,000. 2. The quantity of filters should be determined by providing a minimum of 60 room air changes per hour. 3. Ideal set up is to place welding equipment directly under a filter. In addition nitrogen should be available for purging the pipelines with a positive pressure if the assemblies expand beyond the bounds of the room. B. Tools All fusion tools utilized are to be dedicated for clean build only, and should be kept separate. Special attention should be given to the fusion tools to prevent the possibility of contaminating a weld. The contractor shall lease or purchase all necessary welding equipment from the manufacturer. At the end of the installation, any necessary equipment needed on-site should be sold to the owner. Contractor is responsible for proper maintenance and care of the fusion tools during construction. C. Certification Installers shall be pre-qualified as per section 2.6. Manufacturer shall provide on-site training in the assembly and installation of the PolyPure piping system as needed.

3.2 Testing A. Inspection Prior to pressure testing, the system shall be examined for the following items: 1. Pipe shall be completed per drawing layout with all pipe and valve supports in place. 2. Pipe, valves and equipment shall be supported as specified, without any concentrated loads on the system. 3. Pipe shall be in good conditions void of any cracks, gouges or deformation. 4. Pipe flanges shall be properly aligned. All flange35 Green Street - Malden, MA Phone: (781) 321-5409 Fax: (781) 321-4421 www.asahi-america.com

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bolts should be checked for correct torques. 5. All diaphragm valve bonnet bolts shall be checked for correct torques. 6. All joints should be reviewed for appropriate welding technique: Butt: To have two beads, 360 around the joint. Socket: To have two beads on the end of the fitting and on the outside of the pipe in contact. Non-Contact: Identity labels shall identify weld certification by the print welding parameters OK. Joints should have two beads 360 around the joint. Manufacturer to supply inspection procedures beyond the above recommendations. If any deficiencies appear, the quality control manager shall provide directions for repair. B. Pressure Test 1. Test fluid should be deionized water, with quality level set by Quality Control Engineer. In all cases test must be done hydrostatically. Air test is not allowed 2. Filling the systemOpen all valves and vents to purge the system of air. Slowly inject the water into the system, making sure that air does not become trapped in the system. 3. Begin pressurizing the system in increments of 10 PSI. Bring the system up to 100 PSI and hold. Allow system to hold pressure for a minimum of two hours and up to a recommended 12 hours. Check pressure gauge after one hour. Due to natural creep effects on plastic piping the pressure will have decreased. If drop is less than 10% pump the pressure back up. At this time the system may be fully pressurized to desired test pressure. 4. If after one hour the pressure has decreased more than 10%, test is consider a failure. Note the 10% value may need to be greater for larger systems, or systems experiencing significant thermal changes. 5. Test is to be witnessed by Quality Control Engineer and certified by the contractor.

Section 8

3.3 Cleaning of PolyPure Piping System System shall be cleaned at completion of project according to requirements set by owner.35 Green Street - Malden, MA Phone: (781) 321-5409 Fax: (781) 321-4421 www.asahi-america.com

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Section 8

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Section Eight: Proline Specifications


Section EightProduct SpecificationsProline, High Purity PPPART 1 GENERAL1.1 Summary Furnish a complete high purity pigmented PP piping system to include pipe, fittings, anchors, specialty fittings and valves. 1.2 References The following standards apply to products used within this section. ASTM D 1598 ASTM D 2122 ASTM D 2837-85 DVS 2207-11 ASTM D 1599 ASTM D 2657 ASTM D 4101

1.6 Submittals Submit the Following: A. Product data for the system specified; relative to materials, dimensions of individual components, profiles and finishes. B. Product certificates signed by manufacturer of Proline PP piping product, stating compliance to stated requirements. C. Welder certificates, certifying that welders comply with the installation procedures as outlined by ASTM D-2657 & DVS 2207-11. All required training should be scheduled and completed at job start-up. D. Qualification of firms supplying Proline: Firms must have a minimum of five years experience in HP design, installation and operation of thermoplastic high purity piping systems.

The system design shall meet the requirements of ASME/ANSI B31.3 for design criteria where temperature and pressure fall within the limits of the code. 1.3 Definitions Proline Pigmented Polypropylene 1.4 System Description and Pressure Rating System shall be a Proline system made of uniform pipe and fitting resin. System pressure ratings shall be based on continuous use of 50 years. Proline Pipe and Fittings shall be based on a Standard Dimensional Ratio (SDR) of 11, through 12 (20315mm). Pressure rating for pipe and fittings, unless otherwise noted, shall be 150 psi (10 bar) for all SDR11 material. 1.5 System Performance Requirements System performance requirements shall handle the following:Operating Pressure: Operating Temp: Test Pressure: Media: (TBD by Engineer/Project Owner) (TBD by Engineer/Project Owner) (TBD by Engineer/Project Owner) Deionized Water

1.7 Quality Assurance Obtain components from a single source having responsibility and accountability to answer and resolve problems regarding proper installation, compatibility, performance, and acceptance. 1.8 Delivery, Storage and Handling A. Deliver all Proline pipe to arrive on-site inside protected for shipment. B. Deliver all Proline fittings to arrive on-site single bagged in boxes layered with bubble packing to prevent damage. C. Store products on elevated platforms in a dry location with protection from the environment. D. Lift, support and transport Proline piping per manufacturers recommendations. 1.9 Warranty Warranty period is one year after date of substantial completion. 1.10 Extra Material Turn over to owner at end of construction necessary welding equipment as suggested by manufacturer for repair, additions and maintenance of Proline piping system.

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PART 2 PRODUCTS2.1 Manufacturers Subject to compliance with requirements products which may be incorporated in the work include: The Proline System as supplied by Asahi/America, Inc. of Malden, Massachusetts, (781) 321-5409. Produced by Alois Gruber GmbH AGRU of Bad Hall, Austria. 2.2 Material Pipe, valves and fittings shall be made from resin produced by one supplier. The resin shall meet or exceed the requirements outlined for a random copolymer resin according to ASTM D 4101-96a and DIN 16774. MFI shall be 0.30 g/10min per 230/2.16 according to ASTM D 792. In addition, manufacturer shall test all lots to ensure the melt flow index is within allowable range. 2.3 Pipe A. Production All pipe shall be produced on a dedicated extruder completely within a dedicated clean area. Surface finish smoothness is as follows: C. Pressure Rating All pipe shall meet the requirements of Section 1.4.

D. Production Control During pipe production continuous quality controls are performed and monitored. Minimum required production control:Criteria Measurement Surface Color Marking Micropores Inner surface Packaging Labels Test standard ISO/DIS 10931-2 visual visual visual microscope DIN 4768 visual visual Test interval every hour each pipe each pipe each pipe 1x/shift 1x/shift each pipe each pipe

Size mm 20-40 50-110 (inch) ( - 1") (1" -4")

Surface Finish Ra > 1.5 m > 0.8 m Rt > 6 m > 3 m

2.4 Fittings A. Production All standard fittings through 12 (315mm) shall be injected molded. All fittings are to be molded with equipment in a clean environment. After secondary machining all fittings shall be cleaned for a minimum of 1 hour in an automated Hot DI rinse. The DI rinse water specification shall be 70 C with resistivity above 18M and TOC less than 10PPB. B. Packaging All fittings are to be packaged in a class 100 cleanroom immediately after the cleaning process. Fittings are to be double bagged, purged with clean dry class 100 air in PE/Nylon composite bags. Bags are to be silicone free and antistatic. C. Specialty Fittings Specialty fittings are to include restraint fittings, butt fusion instrumentation fittings, instrumentation donuts, etc. Specialty fittings shall be machined or molded of the same PP resin as the pipe and fittings. D. Pressure Rating All fittings, unless otherwise noted, shall meet the requirements of Section 1.4. E. Production Control During fitting production continuous quality controls are performed and monitored. Minimum required production control:

B. Packaging All pipes shall have ends sealed with PE bags and then capped. Pipe shall be sleeved in a PE encasement and heat-sealed. Pipe is then packed into a hard PE tube for shipping protection. Cardboard tubes are not acceptable. The following chart designates quantities of pipe per PE shipping tube:

Size - Inch "

Size - mm 20 25 32 40 - 315

Qty Five Four Three One

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" 1" 1 " - 12"

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Criteria Measurement Condition Color Markings Inner surface Packaging X-ray test

Test standard ISO/DIS 10931-3 visual visual visual DIN4768 visual visual

Test interval every 2 hours each fitting each fitting each fitting 1x/shift each fitting every 2 hours

Pressure RatingValves Pressure rating of valves shall be per manufacturers recommendations based on materials, valve type and size. Flow Meters: All Vortex Meters shall be made of PolyPure and free of all seal materials. Supplier shall be capable of supplying all sizes - 3 (20mm 90mm) and have a replace electronics module. All Vortex Meters shall be wet bench calibrated and supplied with Calibration Records from the manufacturer. 2.6 Joining Equipment Proline installation shall be performed by factory certified and trained installers in accordance with manufacturers ISO procedures, ASTM D 2657 and DVS 2207-15. Date of certification or recertifications shall not exceed two years from the beginning of project. Available joining techniques are as follows: A. Butt Fusion Proper equipment selection should be based on pipe size and site conditions. Butt fusion equipment should be designed and tested to provide reliable welds. All equipment should utilize electronically controlled heating elements for accurate welding temperatures. Tools should also incorporate planing units to face ends prior to heating. Butt fusion equipment supplied shall weld joints based on force or pressure and not mechanical stops. B. Socket Fusion Proper equipment selection should be based on pipe size and site conditions. Socket fusion tools shall be available in two styles; one portable style capable of welding 1/2- 2 (20mm 63mm) and a bench style capable of welding 3/4- 4 (25mm 110mm). Heating elements are to be electronically controlled for accurate welding temperatures. Tools should also incorporate male and female heater inserts with Teflon coating. C. Non-Contact Butt Fusion Proper equipment selection should be based on installation requirements and line sizes. Tool shall be either semi automatic (UF2000 style) or fully automatic (SP series).

2.5 Valves All valves shall be produced in the same manner as High Purity Fittings Type 342 Spigot Diaphragm Valves: - 2 (20mm 63mm) shall be the type 342 of the PURAD system. The Valves shall have a PolyPure body and a diaphragm of PTFE with EPDM backing or EPDM. Valves will be spigot single body design. Top Works must include integral lockout device on the handle and position indicator. Type 342 Flanged Diaphragm Valves: 2 shall be type 342 with stub end and backing ring IR welded onto both sides. Top Works must include locking device on the handle and position indicator. Flanged Diaphragm Valves: 3 - 4 shall be type 14 single Proline PP body design with flanges molded as part of the body. Diaphragm shall be PTFE with EPDM backing or EPDM. Top Works must include locking position indicator. Type 343 Reduced Dead Leg Valve: x through 2 x 2 (20mm x 20mm through 110mm x 63mm) reduced dead leg (zero dead leg) valves shall be Type 343 Style from the PolyPure System. Valves shall be made of PolyPure resin. Valve bodies are to be unibody, molded design with a full 150 psi rating at 70F. All metal nuts and bolts must be capped or covered to reduce metal exposure. Top Works must include integral lockout device on the handle and position indicator. (Consult Factory for Availability of Molded T-343) Check Valves: All sizes class 150, ball type Proline PP with FPM or EPDM seat and seals. 150PSI at 73.4F for sizes through 2 nominal 100 PSI at 73.4F for sizes 3 and 4.

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UF2000 Style: Tool shall be made available in - 2 (20mm 63mm) and 2 10 (75mm 250mm) size ranges. Tools shall possess electronic planer and non-contact heating element. To avoid improper welded joints, tools will utilize and measure the welding pressures to join material and not mechanical stops. All IR fusion equipment shall possess a minimum of the following capabilities: 1. Computer Control of the welding process. 2. Ability to store welding data internally on computer memory - up to 1000 welds. 3. Full alignment capabilities (vertical and horizontal) 4. All metal components coated to prevent any particle generation from metals. 5. Ability to download all data to a personal computer. IR equipment shall also have the capability of following options incorporated into the tool for special demands: 1. Protective hood over welding area up to 2 (63mm) 2. Nitrogen purge of the welding area. 3. Automatic nitrogen purge of the pipeline. 4. Security card entry 5. Printer labels for each weld automatically. SP Series: Tool shall be made available in 4 (20mm 110mm) and 2 10 (75mm 250mm) size ranges. Tools shall possess electronic planar and infra heating element. Tools will utilize and measure the welding pressures to join material and not mechanical stops. To avoid improper welded joints, tool shall automatically operate clamps and control joining force. Tools shall possess the following features: 1. Computer control and automatic fusion. 2. Touch screen for tool operation and parameter selection. 3. Restricted access through use of PCMCIA cards. 4. Automatic label printouts after each weld. 5. Ability to display and graph weld status while weld is in process. 6. Memory storage of welds 7. Magnetic clamps to reduce change out time from one size to another. 8. Vertical and horizontal adjustment for pipe alignment.

PART 3 EXECUTION3.1 Installation A. Facilities Subassembly and fabrication work should be conducted in a separate, temporary cleanroom located within the building. Cleanroom should be equipped with the following to provide a clean installation: 1. Provide Laminar flow Hepa filters in room ceiling to reach a level of class 10,000. 2. The quantity of filters should be determined by providing a minimum of 60 room air changes per hour. 3. Ideal set up is to place welding equipment directly under a filter. In addition nitrogen should be available for purging the pipelines with a positive pressure if the assemblies expand beyond the bounds of the room. B. Tools All fusion tools utilized are to be dedicated for clean build only, and should be kept separate. Special attention should be given to the fusion tools to prevent the possibility of contaminating a weld. The contractor shall lease or purchase all necessary welding equipment from the manufacturer. At the end of the installation, any necessary equipment needed on-site should be sold to the owner. Contractor is responsible for proper maintenance and care of the fusion tools during construction. C. Certification Installers shall be pre-qualified as per section 2.6. Manufacturer shall provide on-site training in the assembly and installation of the Proline piping system as needed.

3.2 Testing A. Inspection Prior to pressure testing, the system shall be examined for the following items: 1. Pipe shall be completed per drawing layout with all pipe and valve supports in place. 2. Pipe, valves and equipment shall be supported as specified, without any concentrated loads on the system. 3. Pipe shall be in good conditions void of any cracks, gouges or deformation. 4. Pipe flanges shall be properly aligned. All flange35 Green Street - Malden, MA Phone: (781) 321-5409 Fax: (781) 321-4421 www.asahi-america.com

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bolts should be checked for correct torques. 5. All diaphragm valve bonnet bolts shall be checked for correct torques. 6. All joints should be reviewed for appropriate welding technique: Butt: To have two beads, 360 around the joint. Socket: To have two beads on the end of the fitting and on the outside of the pipe in contact. Non-Contact: Identity labels shall identify weld certification by the print welding parameters OK. Joints should have two beads 360 around the joint. Manufacturer to supply inspection procedures beyond the above recommendations. If any deficiencies appear, the quality control manager shall provide directions for repair. B. Pressure Test 1. Test fluid should be deionized water, with quality level set by Quality Control Engineer. In all cases test must be done hydrostatically. Air test is not allowed 2. Filling the systemOpen all valves and vents to purge the system of air. Slowly inject the water into the system, making sure that air does not become trapped in the system. 3. Begin pressurizing the system in increments of 10 PSI. Bring the system up to 100 PSI and hold. Allow system to hold pressure for a minimum of two hours and up to a recommended 12 hours. Check pressure gauge after one hour. Due to natural creep effects on plastic piping the pressure will have decreased. If drop is less than 10% pump the pressure back up. At this time the system may be fully pressurized to desired test pressure. 4. If after one hour the pressure has decreased more than 10%, test is consider a failure. Note the 10% value may need to be greater for larger systems, or systems experiencing significant thermal changes. 5. Test is to be witnessed by Quality Control Engineer and certified by the contractor.

3.3 Cleaning of Proline Piping System System shall be cleaned at completion of project according to requirements set by owner

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Section Eight: Ultra Proline Specifications


Section EightProduct SpecificationsUltra Proline, High Purity E-CTFEPART 1 GENERAL1.1 Summary Furnish a complete high purity E-CTFE piping system to include pipe, fittings, anchors, specialty fittings and valves. 1.2 References The following standards apply to products used within this section. ASTM D 1598 ASTM D 2122 ASTM D 2837-85 ASTM D 1599 ASTM D 2657

1.6 Submittals Submit the Following: A. Product data for the system specified; relative to materials, dimensions of individual components, profiles and finishes. B. Product certificates signed by manufacturer of Ultra Proline piping product, stating compliance to stated requirements. C. Welder certificates, certifying that welders comply with the installation procedures as outlined by ASTM D-2657. All required training should be scheduled and completed at job start-up. D. Qualification of firms supplying Ultra Proline: Firms must have a minimum of five years experience in HP design, installation and operation of thermoplastic high purity piping systems.

The system design shall meet the requirements of ASME/ANSI B31.3 for design criteria where temperature and pressure fall within the limits of the code. 1.3 Definitions Ultra Proline Halar Ethylene Tetrafluoroethylene (E-CTFE) 1.4 System Description and Pressure Rating System shall be an Ultra Proline System made of uniform pipe and fitting resin. System pressure ratings shall be based on continuous use of 50 years. Ultra Proline Pipe and Fittings shall be based on a Standard Dimensional Ratio (SDR) of 21, 1 through 4 (20-225mm). Pressure rating for pipe and fittings, unless otherwise noted, shall be 150 psi (10 bar) for sizes up to 1 and 120 psi (8.3 bar) for sizes 2 (63mm) and above. 1.5 System Performance Requirements System performance requirements shall handle the following:Operating Pressure: Operating Temp: Test Pressure: Media: (TBD by Engineer/Project Owner) (TBD by Engineer/Project Owner) (TBD by Engineer/Project Owner) Deionized Water

1.7 Quality Assurance Obtain components from a single source having responsibility and accountability to answer and resolve problems regarding proper installation, compatibility, performance, and acceptance. 1.8 Delivery, Storage and Handling A. Deliver all Ultra Proline pipe to arrive on-site inside protected hard black PE tubes. Cardboard tubes are not allowed. B. Deliver all Ultra Proline fittings to arrive on-site double bagged in boxes layered with bubble packing to prevent damage. C. Store products on elevated platforms in a dry location with protection from the environment. D. Lift, support and transport Ultra Proline piping per manufacturers recommendations. 1.9 Warranty Warranty period is one year after date of substantial completion. 1.10 Extra Material Turn over to owner at end of construction necessary welding equipment as suggested by manufacturer for repair, additions and maintenance of Purad PVDF piping system.Section 8


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PART 2 PRODUCTS2.1 Manufacturers Subject to compliance with requirements products which may be incorporated in the work include: The Ultra Proline System as supplied by Asahi/America, Inc. of Malden, Massachusetts, (781) 321-5409. Produced by Alois Gruber GmbH AGRU of Bad Hall, Austria. 2.2 Material Pipe, valves and fittings shall be made from Halar resin produced by Solvay Polymers. MFI shall be 3.0 6.0 g/10min per 275/2.16 according to ASTM D 792. All resins shall not introduce contaminations into the ultra high purity water. Specifically, all raw materials in product manufacturing shall be free of chemical additives, fillers, property enhancers and reinforcements, such as antioxidants, anti static agents, colorants, flame retardants, heat stabilizers lubricants, mold release agents, pigments, plasticizers, processing aids, ultraviolet stabilizers and viscosity depressants. In addition, manufacturer shall test all lots to ensure the melt flow index is within allowable range. 2.3 Pipe A. Production All pipe shall be produced on a dedicated extruder completely within a class 100 cleanroom and shall be packaged within a class 100 section of the cleanroom. Pipe shall be stress relieved on line as itSize mm 32 - 90 110 (inch) (1 - 3) (4) Surface Finish m 0.2 0.35 ( inch) (7.8) (13.8)

B. Packaging All pipes shall have ends sealed with PE bags and then capped. Pipe shall be sleeved in a PE encasement and heat-sealed. Pipe is then packed into a hard PE tube for shipping protection. Cardboard tubes are not acceptable. The following chart designates quantities of pipe per PE shipping tube:

Size - Inch 1" 1" - 4"

Size - mm 32 32 - 110

Qty Three One

C. Pressure Rating All pipe shall meet the requirements of Section 1.4. D. Production Control During pipe production continuous quality controls are performed and monitored. Minimum required production control:Criteria Measurement Surface Color Marking Micropores Inner surface Packaging Labels Test standard ISO/DIS 10931-2 visual visual visual microscope DIN 4768 visual visual Test interval every hour each pipe each pipe each pipe 1x/shift 1x/shift each pipe each pipe

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is extruded. Post extrusion annealing is not allowed. Surface finish smoothness is as follows: In addition manufacturer shall conduct continuous checking for micropores. The micropores shall not exceed a size of 1 micron.

2.4 Fittings A. Production All standard fittings through 4 (110mm) shall be injection molded. All fittings are to be molded with equipment in a class 100 cleanroom environment. After secondary machining, all molded fittings shall be cleaned for a minimum of 1 hour in an automated 6-basin Hot DI rinse stations. The DI Rinse water specification shall be 70 C with resistivity above 18M and TOC less than 10PPB. B. Packaging All fittings are to be packaged in a class 100 cleanroom immediately after the cleaning process. Fittings are to be double bagged, purged with clean dry class 100 air in PE/Nylon composite bags. Bags are to be silicone free and antistatic.

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C. Specialty Fittings Specialty fittings are to include restraint fittings, butt fusion instrumentation fittings, instrumentation donuts, etc. Specialty fittings shall be machined or molded of the same PVDF resin as the pipe and fittings. D. Pressure Rating All fittings, unless otherwise noted, shall meet the requirements of Section 1.4. E. Production Control During fitting production continuous quality controls are performed and monitored. Minimum required production control: 2.5 ValvesCriteria Measurement Condition Color Markings Inner surface Packaging X-ray test Test standard ISO/DIS 10931-3 visual visual visual DIN4768 visual visual Test interval every 2 hours each fitting each fitting each fitting 1x/shift each fitting every 2 hours

certified and trained installers in accordance with manufacturers ISO procedures and ASTM D 2657. Date of certification or recertifications shall not exceed two years from the beginning of project. Available joining techniques are as follows: A. Butt Fusion Proper equipment selection should be based on pipe size and site conditions. Butt fusion equipment should be designed and tested to provide reliable welds. All equipment should utilize electronically controlled heating elements for accurate welding temperatures. Tools should also incorporate planing units to face ends prior to heating. Butt fusion equipment supplied shall weld joints based on force or pressure and not mechanical stops. C. Non-Contact Butt Fusion Proper equipment selection should be based on installation requirements and line sizes. Tool shall be either semi automatic (UF2000 style) or fully automatic (SP series). UF2000 Style: Tool shall be made available in - 2 (20mm 63mm) and 2 10 (75mm 250mm) size ranges. Tools shall possess electronic planer and non-contact heating element. To avoid improper welded joints, tools will utilize and measure the welding pressures to join material and not mechanical stops. All IR fusion equipment shall possess a minimum of the following capabilities: 1. Computer control of the welding process. 2. Ability to store welding data internally on computer memory - up to 1000 welds. 3. Full alignment capabilities (vertical and horizontal) 4. All metal components coated to prevent any particle generation from metals. 5. Ability to download all data to a personal computer. IR equipment shall also have the capability of following options incorporated into the tool for special demands: 1. Protective hood over welding area up to 2 (63mm) 2. Nitrogen purge of the welding area. 3. Automatic nitrogen purge of the pipeline. 4. Security card entry

All valves shall be produced in the same manner as High Purity Fittings Type 342 Spigot Diaphragm Valves: 1 - 4 (32mm 110mm) shall be the type 342 of the PURAD system. The Valves shall have a ECTFEbody (Halar Resin) and a PTFE diaphragm with EPDM backing. Valves will be spigot single body design. Top Works must include integral lockout device on the handle and position indicator. Type 342 Flanged Diaphragm Valves: 1 2 (32mm 63mm) shall be type 342 with stub end and backing ring IR welded onto both sides. Top Works must include locking device on the handle and position indicator. Pressure RatingValves Pressure rating of valves shall be per manufacturers recommendations based on materials, valve type and size. 2.6 Joining Equipment Ultra Proline installation shall be performed by factory

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5. Printer Labels for each weld automatically. SP Series: Tool shall be made available in 4 (20mm 110mm) and 2 10 (75mm 250mm) size ranges. Tools shall possess electronic planar and infra heating element. Tools will utilize and measure the welding pressures to join material and not mechanical stops. To avoid improper welded joints, tool shall automatically operate clamps and control joining force. Tools shall possess the following features: 1. Computer control and automatic fusion. 2. Touch screen for tool operation and parameter selection. 3. Restricted access through use of PCMCIA cards. 4. Automatic label printouts after each weld. 5. Ability to display and graph weld status while weld is in process. 6. Memory storage of welds 7. Magnetic clamps to reduce change out time from one size to another. 8. Vertical and horizontal adjustment for pipe alignment.

installation, any necessary equipment needed on-site should be sold to the owner. Contractor is responsible for proper maintenance and care of the fusion tools during construction. C. Certification Installers shall be pre-qualified as per section 2.6. Manufacturer shall provide on-site training in the assembly and installation of the Ultra Proline piping system as needed.

3.2 Testing A. Inspection Prior to pressure testing, the system shall be examined for the following items: 1. Pipe shall be completed per drawing layout with all pipe and valve supports in place. 2. Pipe, valves and equipment shall be supported as specified, without any concentrated loads on the system. 3. Pipe shall be in good conditions void of any cracks, gouges or deformation. 4. Pipe flanges shall be properly aligned. All flange bolts should be checked for correct torques. 5. All diaphragm valve bonnet bolts shall be checked for correct torques. 6. All joints should be reviewed for appropriate welding technique: Butt: To have two beads, 360 around the joint. Non-Contact: Identity labels shall identify weld certification by the print welding parameters OK. Joints should have two beads 360 around the joint. Manufacturer to supply inspection procedures beyond the above recommendations. If any deficiencies appear, the quality control manager shall provide directions for repair. B. Pressure Test 1. Test fluid should be deionized water, with quality level set by Quality Control Engineer. In all cases test must be done hydrostatically. Air test is not allowed 2. Filling the systemOpen all valves and vents to purge the system of air. Slowly inject the water into the system, making sure that air does not become trapped in the system.

PART 3 EXECUTION3.1 Installation A. Facilities Subassembly and fabrication work should be conducted in a separate, temporary cleanroom located within the building. Cleanroom should be equipped with the following to provide a clean installation: 1. Provide Laminar flow Hepa filters in room ceiling to reach a level of class 10,000. 2. The quantity of filters should be determined by providing a minimum of 60 room air changes per hour. 3. Ideal set up is to place welding equipment directly under a filter. In addition nitrogen should be available for purging the pipelines with a positive pressure if the assemblies expand beyond the bounds of the room. B. Tools All fusion tools utilized are to be dedicated for clean build only, and should be kept separate. Special attention should be given to the fusion tools to prevent the possibility of contaminating a weld. The contractor shall lease or purchase all necessary welding equipment from the manufacturer. At the end of the

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3. Begin pressurizing the system in increments of 10 PSI. Bring the system up to 100 PSI and hold. Allow system to hold pressure for a minimum of two hours and up to a recommended 12 hours. Check pressure gauge after one hour. Due to natural creep effects on plastic piping the pressure will have decreased. If drop is less than 10% pump the pressure back up. At this time the system may be fully pressurized to desired test pressure. 4. If after one hour the pressure has decreased more than 10%, test is consider a failure. Note the 10% value may need to be greater for larger systems, or systems experiencing significant thermal changes. 5. Test is to be witnessed by Quality Control Engineer and certified by the contractor.

3.3 Cleaning of Ultra Proline Piping System System shall be cleaned at completion of project according to requirements set by owner.

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ASAHI/AMERICA, INC.35 Green Street P.O. Box 653 Malden, MA 02148 Tel: 800-343-3618; 781-321-5409 Fax: 800-426-7058 Email: [email protected] Website: www.asahi-america.com

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Asahi-America Validation Guide

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