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Gayer, Holloway America J. Giffen, PBM M. Harrison, Harrison Electropolishing B. Henon, Contributing Member, Magnatech G. Kroehnert, Neumo C. Navabi, Genzyme L.

Petrillo, Millennium Facilities Resources R. Raney, UltraClean Electropolish J. Rau, Dockweiler AG P. Solamon, Feldmeier Equipment C.

Kelleher, Janssen Biologics P. Marshall, Perrigo R. Obertanec, Clark-Reliance C. Pacheco, Amgen G. Page, Jr.

Parker, Jr. Pitolaj, Garlock Sealing Technologies J. Pouliot, Amgen A. Powell, Consultant R. Rieger, John Crane W. Sams, Steriflow R. Schroder, Newman Sanitary Gasket Co.

Smith, Flowserve S. Tanner, Garlock Sealing Technologies J. Zumbrum, Sartorius Stedim M. McFeeters, Chair, Steridose J. Westin, Secretary, Roplan Steridose D. Baram, Clifton Enterprises J. Blumenthal, Perceptual Focus J. Day, Fisher Controls S. DeFusco, Integra Companies D.

Dubiel, Parker Hannifin P. Giffen, PBM B. Haman, Fristam L. Harvey, Gemu Valves D. Helmke, Flow Products M. Inoue, Fujikin D. Irish, Carten Controls C. Jain, W. Kollar, Dow Corning Co. Larkin, Amgen J. Mahar, 3M Purification M. Pitchford, Parker Hannifin P. Priebe, Sartorius Stedim R. Seiler, Arkema R. Snow, Sanofi Global J. Stover, NewAge Industries, Inc.

Johnson, Chair, Entegris P. Knox, Vice Chair, W. Allard, NewAge Industries, Inc. Anant, MilliporeSigma J. Andrews, CPC G.

Cobb, W. Davis, Nordson Medical S. Evans, Ace Sanitary T. Fridman, Vanasyl L. Harrison, Harrison Electropolishing W. McCune, Allegheny Bradford T. Roll, Astro Pak W. Anderson, Northland Stainless R. Avery, Nickel Institute R. Campbell, Bechtel J. Kettermann, Chair, RathGibson T. Huitt, Secretary, W.

Campbell, Bechtel T. Dvorscek, Abbott Laboratories R. Elbich, Exigo Manufacturing E. Hutton, Plasticwelding. LLC K. Kimbrel, UltraClean Electropolish K. Solamon, Feldmeier Equipment T. Kresge, CRB A. Muth, Wika Instruments J. Nerstad, Magnetrol International V. Pai, Advent Engineering P. Petrillo, Millennium Facilities Resources G. Placide, CrossPoint Engineering R.

Tischler, Vega Americas P. Wagner, Anderson Instrument Co. Woods, CrossPoint Engineering J. Wynn, Paul Mueller Co. Klees, Chair, Magnetrol International T. Anton, Contributing Member, Qualtech J. Blumenthal, Perceptual Focus R. Bond, Anderson Instrument Co. Bragg, Burns Engineering R. Defeo, Hoffer Flow Controls J. Featherston, Weed Instrument Co.

Gleeson, Hamilton Co. Customary column revised Table DT Engineering judgments must be consistent with the fundamental principles of this Standard. Such judgments shall not be used to override mandatory regulations or specific prohibitions of this Standard. The ASME Bioprocessing Equipment Standard was developed to aid in the design and construction of new fluid processing equipment used in the manufacture of biopharmaceuticals, where a defined level of purity and bioburden control is required.

The Standard typically applies to a components that are in contact with the product, raw materials, or product intermediates during manufacturing, development, or scale-up b systems that are a critical part of product manufacture [e. This Standard shall govern the design and construction of piping systems for hygienic service. When an application is covered by laws or regulations issued by an enforcement authority e.

This Standard also provides requirements for single-use systems and components used in the above listed systems and components. This Standard may be used, in whole or in part, for other systems and components where bioburden risk is a concern. This Standard applies to a new system and component design and fabrication b definition of system boundaries c specific metallic, polymeric, and elastomeric e. Examination personnel qualifications are not covered in this section but shall be in accordance with ASME B An individual who is not yet certified to any level shall be considered a trainee.

Trainees shall work under the direction of a certified Quality Inspector Delegate and shall not independently conduct any tests or write a report of test results. This individual shall be qualified to properly perform specific calibrations, specific inspections, and specific evaluations for acceptance or rejection according to written instructions.

This individual shall be qualified to set up and calibrate equipment and to interpret and evaluate results with respect to applicable codes, standards, and specifications.

The QID-2 shall be thoroughly familiar with the scope and limitations of the inspection they are performing and shall exercise assigned responsibility for on-the-job training and guidance of trainees and QID-1 personnel. This individual shall be capable of establishing techniques and procedures; interpreting codes, standards, specifications, and procedures; and designating the particular inspection methods, techniques, and procedures to be used.

The QID-3 shall have sufficient practical background in applicable materials, fabrication, and product technology to establish techniques and to assist in establishing acceptance criteria when none are otherwise available. The QID-3 shall be capable of training personnel. For a system or component to be BPE-compliant, adherence to all applicable parts of this Standard is required.

Examiner, defined as a person who performs quality control examinations for a manufacturer as an employee of the manufacturer as defined in ASME B To be considered as a QID-1, personnel shall meet the following: 1 be a trainee for a minimum of 6 mo of documented relevant industry experience. Alternate methods for meeting the work experience requirement are at least one of the following: -a prior or current certification as a QID-1 GR The capabilities requirements are listed in Table GR It is required that a capability listed for a lower level of qualification is also required for subsequent higher levels of qualification.

X Chapter VI X Project Planning a Review contract requirements b Prepare weld inspection criteria c Review specifications d Prepare purchase specifications e Develop inspection plan Audit a Perform vendor audits b Perform fabricator audits c Prepare audit and surveillance plan To be considered as a QID-2, personnel shall meet the following: 1 be a QID-1 for a minimum of 6 mo of documented relevant industry experience. To be considered as a QID-3, personnel shall meet the following: 1 be a QID-2 for a minimum of 24 mo of documented relevant industry experience.

The employer is responsible for training, testing, and certification of employees. The individual shall have natural or corrected near distance acuity in at least one eye such that the individual is capable of reading a minimum of a Jaeger Number 2 or equivalent type and size letter at a distance designated on the chart but no less than 12 in. This test shall be administered initially and at least annually thereafter. The individual shall demonstrate the capability of distinguishing and differentiating contrast among colors.

This test shall be administered initially and, thereafter, at intervals not exceeding 3 yr. These examinations shall be administered by an ophthalmologist, optometrist, medical doctor, registered nurse or nurse practitioner, certified physician assistant, or other ophthalmic medical personnel and shall include the state or province or applicable jurisdictional license number.

A QID-1, QID-2, or QID-3 whose employment has been terminated may be recertified to their former level of qualification by a new or former employer based on examination, provided all of the following requirements are met: a The employee has proof of prior certification. The notification of an impending inspection should be mutually agreed to by the manufacturer and the inspector. Inspectors shall have the right to audit any examination, to inspect components using any examination method specified in the Design Specification including Purchase Order , and to review all certifications and records necessary to satisfy the requirements of GR The manufacturer shall provide the Inspector with work progress updates.

Certificates of Compliance C of Cs for all polymeric and other nonmetallic process components shall be provided. Documentation required for cGMP-validated distribution systems, including the vessels, tubing systems on modules, super skids, skids, the shop or field fabrication of tubing, etc.

The combination of documents, including C of Cs and MTRs, for all valves and fittings having process contact surfaces shall include the following information, as a minimum: a ASME BPE Standard, including year date b material type c heat number or code traceable to the original heat d chemical composition e AWS classification of filler metal, if used f alloy designation and material specification of insert, if used g postweld heat treatment documentation, if applicable h mechanical properties are not required, but if included, must be accurate to the raw material specification MTRs for other components made to a material specification shall contain the minimum information specified by the material specification incorporated by reference.

The manufacturer of polymeric and other nonmetallic components shall issue a Certificate of Compliance that the components meet requirements as shown in Table PM This form includes the required data plus some other information that is not required.

Additional agreements may be required. Manufacturing documentation shall be maintained throughout the design and manufacture for each component, assembly, part, or unit. Material specifications for metallic materials are listed by product form in Part MM.

Records and retention of records associated with piping and tubing shall be in accordance with ASME B GR-6 U. Nonmandatory Appendix T has been provided as a guide for U.

Customary and SI unit conversion. Martin Luther King, Jr. Box , Columbus, OH www. See also seal weld. See also gas tungsten-arc welding. The equipment may or may not perform the loading and unloading of the work. See also machine welding. Current design and operating practices developed by the pharmaceutical industry to meet FDA requirements as published in the Code of Federal Regulations, Chapter 1, Title 21, Parts and Usually used for incidental heating in pharmaceutical applications.

Concavity is measured as a maximum distance from the outside or inside diameter surface of a welded joint along a line perpendicular to a line joining the weld toes. A consumable insert can also be used for the root pass in a multiple pass weld with the addition of filler wire also called insert ring.

Usually associated with oxidation occurring on the weld and heat-affected zone on the outside diameter and inside diameter of the weld joint as a result of heating the metal during welding.

Colors may range from pale bluish-gray to deep blue, and from pale straw color to a black crusty coating. Convexity is measured as a maximum distance from the outside or inside diameter surface of a welded joint along a line perpendicular to a line joining the weld toes. A discontinuity is not necessarily a defect. The downslope portion of a welded joint is seen as a tapering of the end of the weld bead with a reduction of penetration from the beginning to the end of the downslope so that the final weld bead is small with minimal penetration.

A crack may not be detected with a stylus. A linear crack will produce a liquid penetrant indication during liquid penetration inspection, X-ray, or ultrasound. This term designates rejectability. See also discontinuity. See also elastomeric material. GTAW may be performed by adding filler material to the weld, or by a fusion process in which no filler is added. See also convexity. This can be accomplished by filtration, precipitation, or centrifugation. See also discoloration.

For a tubeto-tube weld, no unfused portions of the weld joint shall be visible on the inside diameter of a fully penetrated weld. Shielding is obtained from a gas or gas mixture. This process is sometimes called TIG icicles: localized regions of excessive penetration, which usually appear as long, narrow portions of weld metal on the weld underbead. See also convexity and excessive penetration.

Material Test Report mill test report or MTR : a document in which the results of tests, examinations, repairs, or treatments required by the material specification to be reported are recorded.

This document includes those of any supplementary requirements or other requirements stated in the order for the material. This document may be combined with a Certificate of Compliance as a single document. When preparing a Material Test Report, a material manufacturer may transcribe data produced by other organizations, provided he accepts responsibility for the accuracy and authenticity of the data. Also, in welding of tubing, when the weld fully penetrates the wall thickness but misses the joint, leaving some portion of the inner inside diameter weld joint with unfused edges.

The maximum working temperature should relate to the maximum working pressure and the fluids involved. A mechanical seal is a prefabricated or packaged assembly that forms a running seal between flat surfaces. Actually, the blowhole is stretched out in the direction of rolling. Linear porosity generally occurs in the root pass from inadequate joint penetration. T, for testing an anomaly or an indication. See also variance in luster. The equipment may or may not perform the loading and unloading of the works.

See also automatic welding. PE: polyethylene, polymer material composed of carbon and hydrogen. PFA: perfluoroalkoxy, copolymer of tetrafluoroethylene and perfluorovinyl ether. Orbital welding can be done with the addition of filler material or as a fusion process without the addition of filler. For bioprocessing equipment, pipe does not include tube. O-ring: ring seal of circular cross section. Degree of slope or elevation. Also, in an orbital weld, that amount by which the end of the weld bead overlaps the beginning of the weld bead not including the downslope on a single-pass weld.

They can be synthesized either through chain reactions or by templating. Some examples of polymers are plastics, proteins, DNA, and dendrimers.

Process components include, but are not limited to, piping, fittings, gaskets, vessels, valves, pumps, filter housings, and instruments.

Examples of product contact surfaces may include the interior surfaces of bioreactors, transfer tubing, chromatography columns, vessels, and recirculating segments of CIP systems. The loss or minimizing of chemical reactivity exhibited by certain metals and alloys under special environmental conditions. PTFE: polytetrafluoroethylene, homopolymer material of tetrafluoroethylene.

SDR: standard dimension ratio, a sizing system for polymer piping systems that relates wall thickness to pressure rating as defined by ISO.

See also autogenous fillet weld. Ra: log of the arithmetic mean of the surface profile. Ra max. Three types of rouge have been categorized. Class I rouge: a rouge that is predominantly particulate in nature that tends to migrate downstream from its origination point and can deposit on process contact surfaces. It is generally orange to red-orange in color. These particles can be wiped off a surface and are evident on a wipe.

Surface composition under the rouge remains unchanged. Class II rouge: a localized form of active corrosion. It occurs in a spectrum of colors orange, red, blue, purple, gray, black. It can be the result of chloride or other halide attack on the surface of the stainless steel. Class III rouge: a surface oxidation condition occurring in high-temperature environments such as pure steam systems.

This surface oxidation initiates as a stable layer and is rarely particulate in nature. It is an extremely stable form of magnetite iron sesquioxide, Fe3O4. SEM: scanning electron microscope. The advance of the welding is manually controlled. A sanitary weld must be completely penetrated on the weld I. A tube or pipe installed in the horizontal plane is said to slope if one end is positioned higher than the other. See also static spray device and dynamic spray device.

Once formed, these materials can be reshaped. Once formed, these materials cannot be reshaped. For bioprocessing equipment, tube does not include pipe. These inclusions are often considered defects that must be removed and the weld repaired prior to final acceptance. Tungsten inclusions may be invisible to the unaided eye, but are readily identified in a radiograph. Seal chamber for shaft seals. See also packing. See also concavity.

The particles are usually compounds such as oxides, sulfides, or silicates, but may be a substance foreign to and essentially insoluble in the matrix. WFI: water-for-injection, a classification of water according to compendial standards. The purpose of Part SD is to establish design guidelines applicable to bioprocessing equipment.

The purpose of this Part is to provide requirements for the specification, design, fabrication, and verification of process equipment and systems that are fit for intended use, and to minimize risk to the product. Figures in this Part are intended to illustrate accepted applications of general design principles and are not intended to limit alternate designs. The scope of Part SD encompasses requirements for equipment, process systems, and utilities that could potentially impact product quality.

All process contact surfaces subjected to SIP shall reach the required temperatures, under the required saturated steam pressure conditions, during the SIP cycle. This does not apply to single-use or precleaned components. Fabrication shall be performed in facilities where the process contact surfaces are protected from contamination.

During field welding and assembly, surface contamination shall be prevented. Systems, equipment, and components shall be cleaned with a suitable cleaning agent and covered for protection before shipment.

The use of preservative fluids is not recommended. All surface coatings shall remain intact and be tolerant to the process, SIP and CIP fluids, and temperatures, without peeling or cracking. Surface imperfections e. Bolted attachments should be eliminated whenever possible. When markings are required on process contact surfaces, other methods of identification shall be used. The equipment shall be free of areas of low flow and velocity or impact where soil or contaminants could collect.

Generally, materials such as stainless steels, duplex stainless steels e. Metallic materials of construction are listed in Part MM. When nonmetallic materials are used e.

The conformance of material shall be explicitly stated e. Polymeric materials and other nonmetallic materials of construction are listed in Part PM. The number of drain points should be minimized.

The equipment manufacturer shall indicate the proper orientation to optimize drainability. Minimum Slope, deg 0. These lubricants shall be identified by name, manufacturer, and grade and shall conform to FDA or other applicable regulatory codes. For the purpose of bioburden control and cleaning, gravity is an effective way to facilitate drainage.

To achieve gravity drainage, lines should be pitched to designated points at a specific slope. Refer to Nonmandatory Appendix C for suggested method of slope measurement.

Line sections up to 10 in. Equipment located in clean areas is periodically cleaned by wash-down or manually cleaned by wipe-down with harsh cleaning solutions. Such equipment shall conform to the following: a Materials of construction should be corrosion resistant, easily maintained, cleaned, and sanitized without flaking or shedding.

Supporting skid frame structures and modules should be constructed from fully sealed tubes or pipes, which are easily cleaned. Frames should have rounded rather than sharp edges.

The physical characteristics of the system e. System leveling should be considered for mobile equipment that is gravity-drained. The recommended minimum slope designation for gravitydrained process contact lines is GSD2. The nameplates should be attached and sealed or attached with a corrosion-resistant wire loop. Elevated equipment under open frames should have a minimum clearance of 6 in. In other cases a minimum of 4 in. All paint systems shall be FDA compliant. The requirements of hygienic tubing e.

To ensure the highest degree of hygienic design, the piping systems should use welded connections except where make-break connections are necessary. For valves, L shall be measured to the seal point of the valve.

Tables SD With sufficient flow through a primary pipeline, a branch may not constitute a dead leg. The orientation of a branch is critical to the cleanability of the system. The branch shall be oriented to avoid a dead leg e. However, it may not be achievable with certain equipment and process configurations as they are currently manufactured. Butt-welded connections should be used wherever practical. Fittings shall be so designed that there will not be any crevices or hard-to-clean areas around the gasketed joint.

ASME raised-face or flat-face flanged joints should be avoided where possible see Fig. The use of short welding ferrules should be incorporated into the design.

Nominal Branch Size, in. The centerline radius of field-bent tubes should be not less than 2. See SD Passivation of electropolished surfaces is not required unless the surface has SD Methods of separation used in industry are 1 removable spool piece 2 U-bend transfer panel 3 double block-and-bleed valve system see Fig.

Proper installation sequencing of the piping system can reduce the number of blind welds. See MJ The metallic pipe or tube to be installed shall meet the straightness criteria of ASTM A to optimize drainability. The support spacing shall not exceed a distance that will permit the piping to deflect under operating conditions.

When properly installed, stress concentration points will be minimized. Considerations shall be made to ensure drainability and overcome any deflection, such that pooling is minimized. These are commonly available in stainless steel or fiberglass reinforced plastic FRP materials.

Hygienic support design should incorporate drainable geometry to facilitate cleanability, have no exposed threads, and have minimal potential for collecting and trapping debris or liquids on the hanger. Materials of construction shall be corrosion resistant and compatible with the chemical, thermal, and physical performance requirements of the installed location.

Hygienic support systems shall assist in maintaining the required slope and alignment under all operating conditions, taking into account thermal cycling, distortion, settling, moment loads, fluid specific gravity, etc. The support system should be designed to distribute loads and stresses from any potential movement. The supports shall be installed without adding stress to the tube or pipe in an attempt to achieve a desired slope.

The designer should take into account system and equipment movement when planning the design. Anchoring systems should be designed to avoid piping motion in any of the three Cartesian axes. Guiding systems should be designed to allow piping axial motion due to thermal or mechanical loads. An anchor serves to secure the piping in place, and a guide will allow axial motion of the piping and is used to allow for thermal expansion.

The manufacturers of agitators and mixers shall verify the cleanability of their equipment as specified and agreed to with the end-user.

The designer shall ensure that 1 the use of O-rings or hygienic gaskets to seal between mating surfaces shall be consistent with the current guidance provided in Part SG see Fig. All voids should be closed by either fabrication welding or approved sealing techniques O-ring seals, etc. Portable tanks shall be designed in accordance with SD The connections for static grounding should be designed to be cleanable. See examples in Fig.

Accepted fastener types include 1 hex-head cap screws 2 acorn-head cap screws 3 threaded studs with acorn nuts h Fastener heads shall be free of raised or engraved markings that might inhibit cleanability.

Figure SD Examples of accepted fastener seals are shown in Fig. It is the responsibility of the end-user to establish compliance with applicable standards e. Hollow pedestal SD The technique should minimize surface imperfections e.

If requested by the end-user, the manufacturer shall supply a sectioned sample of the bend area. Minimum Bend Radius in. The process contact surfaces shall be free of crevices, pockets, and other surface irregularities. Tagging nozzles on the back side of panels will help reduce the number of incorrect piping connections during field installation. If this holdup is unacceptable, then the manufacturer shall design some type of assist to aid draining, such as an air blowdown.

Acceptance criteria for these welds shall meet the requirements of Table MJ Heat exchanger manufacturer to slope inlet on bonnet to match inlet tubing slope. Caps may include bleed valves or pressure indicators for safety or operating purposes. Recommended tolerances are per Table DT and Fig.

The intended function is to collect spilled fluids that can occur during jumper or cap removal. The depth of the drain pan is determined by calculating the largest spill volume and accommodating it with a sufficient pan holding volume. Consideration should be given to increasing the drain port connection size in lieu of increasing pan depth. The preferred drain port location is central bottom draining or central back draining. All-encompassing lines including long runs with the exception of subheaders, manifolds, and nozzles may be sloped as defined in SD Zero-static diaphragm valves are recommended for low-point drains if available from the manufacturer [see Fig.

Low-point drain designs that incorporate a spool piece allow for full rotation of the drain valve [see Fig. This design ensures that the drain valve is always at the true low point of the assembled jumper connection in any specified orientation.

Any reduction in line size should be made behind the primary nozzle connection behind panel structure , thus allowing all connections to be the same size on the front of the panel. The use of a ferrous magnetic material is required; however, it must be fully encapsulated to ensure that the ferrous material does not contaminate the classified manufacturing area. The acceptance criteria for welds joining the sensor stem to the jumper shall meet the requirements of Table MJ In addition, the temperature rating of the magnet should withstand the specified temperature ranges for process and SIP without compromising the magnet performance.

This design consists of the following features: a a socket bore that is machined into a base or cartridge plate into which the filter cartridge O-ring adapter is inserted. The cartridge tabs shall travel through the narrowing tab retainers until a tight fit is achieved. The taper shall be on the upper portion of the tab retainer.

Full capture of cartridge tabs by the locking tab retainers is not required to secure cartridges for operation. The cartridge manufacturer shall validate that its cartridge design fits, seals, and remains in place with one of the housing designs shown in Tables DT Static spray devices have no moving parts. Examples of static spray devices include static spray balls, stationary nozzles, and spray wands.

Both produce a defined impact pattern by moving multidirectional spray s. Dynamic spray devices have moving parts, which may include bearings, gears, and turbines. Rotation can also be turbine or motor driven.

When motor driven, the body and nozzles are turned mechanically by the motor. Spray devices are generally not interchangeable without considering the specific flow, pressure, equipment design, spray pattern, and drainability of the spray device s. Recommendations in this section are valid for waterbased cleaning solutions. The flow rate recommendations in this section are for metallic vessels. Spray devices are also used in other applications [e. Differential pressure and its resulting flow are key parameters of spray devices.

Reference Fig. The majority of the flow is directed toward the upper one-third of the vessel to ensure coverage of appurtenances and provide the sheeting action. The majority of the flow is directed toward the upper head to ensure coverage of appurtenances and provide the sheeting action. Spray holes for nozzle annulus Drain hole at lowest point Fig. Polymeric material requirements for leachables and extractables are listed in Part PM.

Steam trap bodies shall have an internal surface finish excluding the bellows assembly as agreed to by all parties. Surface finish specification shall match the clean steam condensate tube finish specification unless the condensate downstream of the trap is used in the process or sampled for quality assurance.

Operating conditions include heat-up, hold, and cool down. Sampling may be either aseptic or nonaseptic. They shall be designed for CIP. Crevices and holdup volumes should be minimized. Nonself-draining valves may be used for liquid streams that flow continuously e. The sampling device shall be installed to maintain the aseptic barrier between the process fluid being sampled and the environment.

Consideration should be given to ease of assembly and subsequent handling of the sample. The end-user should determine whether check valves that use a spring are acceptable for other process contact applications. Applications where spring check valves are typically acceptable include condensate removal lines and dry process gases. Regulator designs, where a portion of the valve stem penetrates the sensing diaphragm, shall be avoided unless provisions are made to avoid entrapment of foreign matter and any leakage through the interface between stem and diaphragm, especially after SIP.

All gasketed fittings should be constructed in such a manner as to avoid dead legs and crevices. The distance H of the physical break should be at least twice the inner diameter of the hoses, drain valves, or any other component leading to drains or sinks to avoid back-siphoning into the POU assembly.

The break shall be at least 1 in. Where used, the additions of these components will require a blowdown to ensure drainability.

Ra or 0. All L-type internal surfaces shall be passivated. Process equipment connection Clean gas or clean steam Min. Process Equipment Min. Drain Min. The use of air vents installed at locations where air is likely to be trapped, such as at the ends of steam headers, can assist in this requirement. Where necessary, increases in height should be achieved by vertical risers see Fig.

These shall be trapped at the bottom. The line size reduction can be made after the branch to the trap leg see Fig. The use of overhead, direct-coupled, pressurized condensate return systems should be avoided see Fig. Threepiece-body ball valves should be used instead of singlebody designs for both cleanability and maintainability.

The bore of the ball valve assembly shall match the inside diameter of the tube see Fig. Thermal expansion loop Min. All components shall be supplied or rendered both hydrocarbon free e. When copper is used, it should be hard drawn and installed in accordance with the current edition of NFPA 99, Chapter 5. When stainless steel tubing is specified, the materials of choice are L-type or L-type alloys.

Orbital welding is the recommended joining method. Inside clean rooms, the materials of choice are L-type or L-type stainless steel tubing and fittings. Features such as slope, high-point vents, and low-point drains need not be incorporated into these systems. The system design shall ensure that gas will remain pure throughout its delivery. The final point-of-use gas purity shall comply with the process requirements.

By designing systems that can be cleaned and rendered safe for access and preventive maintenance, reliable operation may be achieved. The manufacturing of biologics generates liquid waste in various quantities that may or may not contain viable microorganisms. The liquid waste comes directly from the process fluids and may include cleaning solutions mixed with product components, buffers, or media. The performance of process waste treatment systems may benefit from the sanitary design requirements of Part SD.

The design of the process waste transfer line s 64 16 ASME BPE shall prevent process waste backflow to the process system s , reducing the risk of contamination. The effectiveness and safety of process waste treatment systems have been shown to benefit from incorporating the design principles of Part SD. This is true of bio-inactivation systems where heat or chemical dosing is used, or where biosafety containment is required. Process-contacting subassemblies require special design consideration for cleaning and bioburden control.

A bioreactor shall be designed in accordance with a biosafety level requirement as defined by the National Institutes of Health or equivalent organization e. To meet a specific biosafety level requirement, special operational considerations e. If the bioreactor has been used to grow an organism that requires biohazard containment, provision shall be made to decontaminate all surfaces that may have come in contact with the product prior to CIP, or to contain and decontaminate the fluids used for CIP.

The vessel shall be constructed, tested, inspected, and stamped in accordance with local ordinances, regulations, and codes. Autoclaved components or assemblies shall be capable of being steam sterilized without degradation to any of the elastomers or polymers that make up the components or assemblies.

Depending on the type of waste, the treatment method is chosen based on effectiveness, efficiency, and jurisdictional requirements. Bio-inactivation may be designed to be continuous or batch type and is achieved using one or more of the following methods: a thermal b chemical c radiation The system design should minimize fouling and buildup of solids and films. Bio-inactivation systems should be cleanable to allow safe disassembly and maintenance.

Where biosafety containment is a requirement, the system shall be sanitizable. In bio-inactivation systems, piping design features specified in SD-2 and SD-3 may help in achieving proper and repeatable operation of these process waste systems.

A bioreactor or fermentor shall be defined as a vessel-based system used in the growth of microorganisms or plant, mammalian, or insect cells. As a minimum, the bioreactor sterile envelope or boundary shall include the following see Figs. If redundant sterilizing-grade filters are used in series, the inlet filter element farthest from the reactor vessel shall define the sterile boundary. If redundant sterilizing-grade filters are used in series, the exhaust filter farthest from the reactor vessel shall define the sterile boundary.

The inlet gas assembly shall be defined as a piping assembly that has the ability to deliver controlled amounts of filtered gases into a bioreactor vessel. However, provisions shall be included within the design to prevent instrumentation damage due to SIP procedures and backflow. The inlet filter assembly shall be defined as the filter s local to the bioreactor.

The exhaust gas assembly is defined as a piping assembly that maintains the integrity of the sterile boundary with respect to sterility and pressure. The assembly shall include but is not limited to the items in SD The housings shall be installed in such a way as to prevent the collection of condensate in the elements due to SIP. In addition, provisions shall be included for draining condensate from the piping between the filters. This section applies to sparge lances, wands, rings, and other devices see Figs.

Sparge device assemblies shall meet the requirements of SD They allow you to match acceptable discoloration levels perfectly, so as to help assure optimum safety and code-compliance.

Intended for regulatory agencies, multinational corporations, plant owners, pressure-equipment fabricators, designers, constructors, materials suppliers, inspection organizations, and others.

The ASME BPE Standard standardizes specifications for the design and construction of new fluid processing equipment used in industries that require a defined level of purity and bioburden control. Table of Contents. Sorry, we only have available spots for this course.

Would you like to add those to your cart? ASME Membership 1 year has been added to your cart. The price of yearly membership depends on a number of factors, so final price will be calculated during checkout. A - Bioprocessing Equipment has been added to your cart. View Cart. Publisher: ASME. Publish Date: Language: English - US. ISBN: Print or Share. Standard Options Format.

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