This article discusses ASME’s BPE-1997 Standard that relates directly to orbital welding of tubing which irectly or indirectly come ito contact with the product. This includes weld criteria, weld documentation, inspection and qualification of welding procedures to the Standard. The article also addresses other parts of the standard such as material selection, surface finish of tubing, and dimensional tolerances of fittings to be stalled by orbital welding. Figure I. Weldng opzcar oo ste ot Fc Instto de Technolog Baz using on ital ube welder in the fabicaion of fly forte production of exces. A weer ‘ealng nit. placed undemecth the power suis used cao! the weld heads ding wel Pre eae Uaey ela y Orbital Welding in Compliance with the New ASME Bioprocessing Equipment (BPE) 1997 Standard by Barbara K. Henon, Ph.D. Introduction tandards are important determinants of ‘quality in fabrication, Adecade ago, weld- ing for pharmaceutical applications would have simply been qualified to ASME Section IX of the Boiler and Pressure Vessel Code with reference to ASME B31.3. This as- sured the structural integrity ofthe weldments, bbut was not specific as to the quality ofthe weld surface on the inside of tubing which is essen- tial for bioprocess applications. The 3A Sani- tary Standards, first implemented by the Dairy industry in the US in the 1950s, offered guide- lines for materials and fabrication techniques that mandated fully penetrated welds in sani- tary pipingsystems, and attempted to set guide- lines for workmanship and quality control in recognition that weld quality was a determin: ing factor in the ability to maintain a piping systom in a sanitary or hygienic condition. How- ever, with the emerging biotechnology indus. ty, it was folt that now standards wore needed to meet the higher quality demands for the ‘mare complex, often delicate, and very costly bioengineered products. In particular, it was felt that there was a need for design eriteria for equipment to enable it to be effectively cleaned and sterilized, and an emphasis on assuring weld surface quality once the requirement for strongth was met. A need for standardized deft nitions also was recognized as well as the need to integrate existing standards for vessels, pip- ing, appurtenances, and other equipment for the bioprocess industry without infringing on those other standards. In response to the spe- cial needs of the biopharmaceutical industry, the American Society of Mechanical Engineers (ASME) has developed a new standard to proFigure 2. An obital weld of two eecwoposhed 316L stinks steel tubes. The tubing ws 2.00 inches (508 mm) OD with 0.085 inch (1.85 mm wa The wad od ify penetrated to the ID ofthe wel join. The weld bead i inform in ie without ar wander and the wed profil fly flat onthe OD and D. There arena wb cracks or ores Ligh ulation cn be seen in the Heat fected Zone HAZ} ofthe wel. The oxen Ive! of he ono 1D purge wor 8 ppm. vvide guidelines for the design and fabrication of facilities in ‘which pharmaceutical products are manufactured by means of bioprocess technology. ‘The purpose of this discussion is to familiarize the reader with the concepts and intent of the BPE Standard, and the rationale for the use of orbital welding in the fabrication of bioprocess equipment and piping systems. It also is intended to guide those wishing to qualify orbital welding procedures to this Standard, ILis not intended to be complete, nor toeover all parts of the Standard which pertain to welding, nor topics covered by the Standard but unrelated to welding, nor to be a substitute for the Standard whieh can be obtained from the ASME, ‘Thonow ASME Bioprocessing Equipment Standard, ASME BPE-1997, was released in October of 1997, but the process of ‘writing this standard began much earlier when individuals at the 1989 ASME Wintor Annual Meeting determined that there ‘was interest in the industry for such a standard, and ap- proached the ASME Council on Codes and Standards to de- velop a standard for the design of equipment and components for use in the growing biopharmaceutical industry. The project was approved by the Council and a directive issued to the Board on Pressure Technology to initiate the project. The scope of the proposed standard included the design, materials of construction, inspection, testing of vessels, piping, and related accessories such as pumps, valves, and fittings for use in the biopharmaceutical industry. The ASME standard was not intended to replace existing standards, but wherever possible, the new ASME standard was expected to reference existing standards that are applicable to biopharmaceutical equip- ment design and fabrication. Throughout the writing of the standard, close relationships were established with other standards groupsincluding the European CEN, ASTM, and 3A Dairy Standards. The writing of the standard was accomplished by a Main Committee and several subcommittees which met several times each year until the standard was completed. These subcommittees were: General Requirements; Design Relating to Sterility and Cleanability of Equipment; Dimensions and ‘Tolerances; Material Joining; Surface Finishes and Seals. Applicability ‘The BPE Standard applies to all parts of equipment and piping that contact either the product, raw materials, or product intermediates during process development, scale-up, or manu- facturing and all equipment systems that are a critical part of product manufacture. This includes systems such as water for-injection (WFD, clean steam, purified water, ultrafiltra- tion, and intermediate product storage. Piping systems or parts of the system that donot contact the finished product are not covered by the BPE Standard, Pressure vessels, and steam-sterized systems or any other systems which require pressure operation must conform to all applicable require- ‘ments of ASME Section VIII and ASME B31.3, Process Piping. Qualification to the BPE Standard does not exempt users in any ease where municipal, provincial or federal codes regulat- ing pressure vessels and piping are in effect. The requirements ofthese codes must be met. Weldingis used asa joining method ‘throughout biopharmaceutical plants. It is used in the con- struction of pressure vessels and bioreactors as well as in the Joining of piping systems. Orbital welding, which uses the Gas ‘Tungsten Are Welding (GTAW) process, is not used for pres- sure vessels or tanks as other welding processes are more suitable for this purpose. However, the GTAW process is frequently used for the product contact side ofa vessel because ofits high quality while faster methods are typically used for subsequent passes, Inthis standard, tube and pipe are differentiated with tube referred toby its nominal OD, and pipe referred to by diameter and schedule, Orbital welding may be used to weld either tube or pipe. The dimensional tolerances of tubing makes it more suitable for autogenous orbital welding, but autogenous or- bital welds of schedule pipe are practical for wall thicknesses of up to 0.154 inches (2 inch schedule 40). Orbital welding of pipe on applications requiring the addition of filler to the weld can be done using equipment with wire feed capabilities in sizes from 1/2 inch NPS and up. Orbital welding is commonly used to join tubing in piping systems for WFI, clean steam, and product lines. Italso is used to connect tanks and vessels tothe piping systems in the construction of equipment such as multi- offect stills as well as to connect biopracess equipment mounted Fre 3. Concepts ofthe BPE Standord place an empha n design for drsinabilty and steno of boproces ytara to preven growth of unwanted Imroorgnisms. An iuswoon ofthis concep shown nthe vessel wich features 2 sloped rather than fat bt fr ease of dranng Ping i oo sloped alow drang by gray aneFigure 4. Fermentor used for the producin of eigen instled ino Class 100,000 fermertaon rou no fay for the production of veces. Oriel welding was Speed fo the WAI ppirg,ciled water ar and clean team, Phot ‘courtesy of Focuz Institute de Tecnologie em Inunbilois in Br. ‘on skids. Typical tubing diameters for biopharmacoutical applications are 1 to inches, but 1/2 inch OD instrumentation tubing (or smaller) may be orbitally welded and autogenous orbital welds with enelosed weld heads ean be done an tube diameters up to 7 inches OD, Autogenous orbital welds of tube sizes up to 8 inches have been done for pharmaceutical instal: lations using the more complex orbital welding equipment ‘with filler wire capabilities which is generally used for larger diameter pipe. This type of equipment can be used for autog- enous welds on pipe sizes up to 14 inch schedule 10. The decision on whether to use tube or pipe for a particular application would be based upon the pressure requirements of the system, surface finish requirements, availability of fittings with the proper end-preparation for orbital welding, ete. Design Concepts for Cleanability and Sterilizability A key feature of the BPE Standard is the concent of hygienic design where hygienic is defined as “of or pertaining to equip- ‘ment and piping systems that by design, materials of construc- tion, and operation provide for the maintenance of cleanliness s0 that products produced by these systems will not adversely affect human or animal health.” In keeping with this concept, the Design Partof the Standard had as its objective to deseribe and outline aecepted practices which have been shown to result in the fabrication of bioprocessing equipment that is both cleanable and sterilizable. It makes the distinetion be- tween preferred, recommended, and not recommended desig- nations for particular designs and fabrication practices, Bioprocess equipment is generally designed to be cleaned- in-place (CIP) rather than being disassembled for cleaning (cleaned-out-of-place or COP). The BPE Standard addresses only automated or manual CIP processes and automated ssteam-in-place (SIP) processes, but nothot water, 176°F (80°C) sanitizing, or other methods of sterilization. In order for CIP and SIP to be effective, the inner surfaces of piping and equipment must be smooth and free of crevices so that it is cleanable and resists to the extent possible the colonization by microorganisms. Equipment also must be designed and fabri- cated so that deadlegs are held to an absolute minimum where a deadleg in a piping system is defined as a pocket, tee, or extension from a primary piping run that exceeds a defined number of pipe diameters (L) from the ID of the primary pipe (). For bioprocessing piping systems an L/D ratio of 2:1 is considered to be achievable for most valve and piping configu- rations. A deadleg is undesirable because it provides an area of entrapment which may not be reached by cleaning or sterilizing procedures and thus leads to contamination of the product, It has been shown that it takes more heat over a longer period of time to achiove sterilization in an air pocket than in spaces that are reached by steam since moist heat is much more effective in achieving sterilization than dry heat.” Cleaning solutions used for CIP must be able to reach all parts of the system at sufficient velocity to ensure the removal of soil or deposits by chemical and/or mechanical cleaning, and all Joints must be eapable of being CTP cleaned and SIP sterilized. Drainability is important for maintaining bioprocess sys- tems in a clean and sterile condition, Fluid remaining after draining becomes a colonization site for bacteria or other ‘microorganisms creating an unacceptable bioburden to the gystem. Sites where fluid accummulates also may become a corrosion-initiation site adding additional contaminants to thesystem. The design Part ofthe BPE Standard calls for hold- up volume, or that amount of liquid which remains in the system after draining is complete, to be minimized by design, Fora piping aystem to be drainable, lines must be sloped to no less than 3 inches per 50 ft (75 mm per 15 m) or 0.5% as a minimum with a recommendation for 1/4 inch per foot (20.8 mm per m) or approximately 2% for short runs and 1/5 to W/6 ineh per foot for field runs, skids, and transfer panels Connections to equipment shall use acceptable hygienic design connections as agreed to by the owner/user and the ‘manufacturer contractor) which means that threaded connee- tions must not be used where they would come in contact with ‘the process sinco the machined threads are likely to entrap soiled material and provide areas that cannot be reached by cleaning. Similarly, the number of bolts must he held to a ‘The optimum design for cleanability and sterilizability of bioprocess systems will have a minimal number of connec- tions. For those connections that are required, buttwelded connections are to be used wherever possible sineo welded connections present the lowest risk of contamination. For welding of biopharmaceutical tubing in the US, the ends of the tubing are mechanically squared, butted together, and typi- cally joined in an autogenous weld using automatic orbital tube welding equipment. An autogenous or fusion weld is one which is fused without the addition of filler metal. Welding is not limited to tube-to-tube welds, but is used to join tubes to fittings and is recommended for joining all hygienic valves into the process line ‘When ferrules and ferrule connections are used, itis recom- mended that they be as short as possible to ensure thatFigure S.A smal erica weld head being used to wal 12 inch dometer tubing on « borer si. The tubing supples goes such as ongen fo the reactor. Photo ‘ortesy of Braun Botech Geadlegs are minimized. Any fittings used must be designed so ‘that the interior is of a flush design or with a bulge concavity not exceeding 5% of the wall thickness so that a readily cleanableand drainable surface is exposed to the bioprocessing. Aluid ‘Although welds are the most secure type of joining method, the surfaces of the weld bead on the inside of the tubing must bbe smooth and crevice-free in keeping with the concept of hygienic design. Any lack of fusion, porosity, or excessive buildup of material on the ID may provide a site which is inaccessible to cleaning or sterilization procedures. While hygienic systems ean be achieved with manual wolds, orbital welds are generally smoother and much more likely to provide a crevice-free surface on a repeatable basis, Materials For bioprocessing systems, the materials of construction for product contact surfaces must be fairly inert so as not to contaminate or otherwise affect the integrity of the product. ‘The materials must be compatible with the bioprocessing environmentincluding the temperatures reached during team sterilization which are saturated steam at a minimum tem- perature of 266°F (130°C) fora duration of at least 100 hours under continuous steady state conditions. The materials also must be able to withstand high operating pressures and endure harsh chemical and mechanical cleaning procedures. ‘The material recommended for use in bioprocessing systems is type 316 stainless steel (UNS 31603), or where itis to be welded, type 316L. Other higher alloy materials such as AL- GXN or 2205 duplex may be used where highér corrosion sistance is needed, or other materials may be used as agreed upon by the purchaser and manufacturer. However, materials, shall be identified by an industry recognized standard. Type 316 and316L belong to the 300 series of stainless steels which fare included in P number 8 according to the elassifieation in ASME Section IX BPVC in which base metals with similar properties are grouped. The 300 series was selected by 3A for use in the dairy industry hecause it was eleanable and reason- ably corrosion resistant, nd that standard has een applied by the pharmaceutical industry. Although type 804 was the most commonly used alloy in the past, it has gradually leon re- placed by types 316 and 3161 for hygienic applications because these alloys, although very similar to 804 in chemical compo- sition, contain 2-3. molybdenum which significantly increases the corrosion resistance. Fluids used in bioprocess systems are frequently high in chloride concentration presenting 2 chal- lenge to the corrosion resistance of stainless steel systems. The choice of 300 series was fortuitous for welding since it, is easily weldable and machinable, Compared to higher alloys, the loss of corrosion resistance by autogenous welding for 3161, is minimal. Autogenous welding is less costly than welding with filler not only because the expense of filler is avoided, but also because orhital welding equipment for autogenous weld- ingis less expensive than orbital welding equipment which has the capability of adding filler wire to the weld. Thusa material that can be autogenously welded is an economical choice. Furthermore, welding procedures are fairly simple since no preweld nor postweld heat treatments are required. These properties make 916 stainless steel a practical and cost- effective choice for bioprocess systoms. The chemical composition of type 316 stainless steel is specified by ASTM 269, Seamless and Welded Austenitic Stainless Steel Tubing for General Service; ASTM A270, Specification for Seamless and Welded Austenitic Stainless Steel Sanitary Tubingand ASTM A31¥/A312M, Seamless and Welded Austenitic Stainless Steel Pipes. The L version of 316 has a lower earbon content which is 0.035 rather than 0.08% in standard 316, The low carbon version is preferred for welding ‘because it reduces sensitization or earbide precipitation which may occur in the heat-affected-zone (HAZ) of welds during welding. In the temperature range of 800 to 1500°F, which occurs at some distance at either side ofthe weld, carbon comes ‘out ofsolution inthe austenite grains and migrates tothe grain boundaries, Chromium migrates from the grain boundaries to ‘combine with the carbon as chromium carbide leaving the grain margins depleted of chromium. Since the corrosion resistance of austenite stainless steel depends upon a uniform distribution of chromium throughout the metal, depletion of chromium at the grain boundaries makes it susceptible to corrosion. The reduced carbon version of 316 does not com- pletely suppress the formation of chromium carbide, but re- sults in less loss of chromium during welding, and therefore, less loss of corrosion resistance. ‘The element sulfur, which is present as a contaminant in stainless steel, has a significant effect on weldability as well as ‘n the quality of surface finish that itis possible to achieve on any particular heat of base material, Although the sulfur content of AISI 316 and S161 stainloss stec! has a maximum of 0.090% sulfur, the BPE Standard has limited the sulfur content for weld fittings and tubing to between 0.005 and 0.017%. The reasons for this restriction are complex. Sulfur at higher concentrations promotes a tendency towards eracking and gives a rough appearance to the weld bead. Sulfur com- bines with manganese in the base metal to form manganese sulfide inclusions. During processing, these inclusions are rolled out and appear in scanning electron micrographs as “stringers.” Corrosion tends to occur preferentially at the inelusion sites and when the inclusions are removed during cleetropolishing or passivation they leave a pitted surface." For this reason, tubing manufacturers which have to moct strin- gent surface finish requirements for the semiconductor and bioprocoss industries profer materials which are very low in sulfur. However, when the sulfur concentration gets into the very low levels, ie., less than 0.005%, the material often becomes difficult to weld. The fluid dynamies of the weld poolFigure 6, An oritol wel of short sont fre ta pulled tee an 3161 less sel ubing The use of short welded fers i recommended 1 keep eadegs to 2 minimum and ths i easly ecarplied wih eral welding techno changes when the temperature coefficient of surface tension goes from positive to negative at low sulfur concentrations.* ‘This has the effect of transferring heat in the weld pool outwards from the center of the weld so that when heat is, applied the weld pool becomes wider before becoming deeper ‘and the weld is shallow with a tendency to form a concave weld bead. With higher sulfur concentrations, heat is transferred in an inward direction resulting in deeper penetration with a narrower weld bead which is desirable. The higher sulfur coneontration makes it easier to get a satisfactory weld. In compliance with the BPE Standard ASTM has added A270-95a Supplementary Requirements, S2 Pharmaceutical Quality Tubing 816, a supplement to ASTM A270 which limits the sulfur content to between 0.005 and 0.017%. This is a compromise which avoids the very lowest sulfur material which is difficult to weld, but restriets higher sulfur contents which are known to result in higher non-metallic inclusions ‘and lower corrosion resistance. Users should be aware that ‘welding of very low sulfur heats of material to heats in the intermediate to high levels of sulfur may result in deflection of the welding arc towards the low sulfur heat." This may result ina weld bead that fully penetrates the low sulfur side, but ‘misses the weld joint. This problem is minimized by the sulfur requirements of the BPE Standard, but users should be aware of sulfur contents when welding unmatched heats together such as would be the case for the welding of tubes to fittings or to valves, Surface Finish "The Surface Finish Part of the BPE Standard defines the criteria for the specification of interior surface finishes for vessels, distribution systems, and other components having contaet with the product. Surface anomalies which would be detrimental to the process are defined and classified as a basis for acceptance or rejection of the material. Type 1 anomalios ‘are those caused by an inherent property ofthe material such as non-metallic inclusions, while anomalios of Type 2 are caused by inadequate control of processing which would in- clude scratches, grind marks, localized corrosion from inad- ‘equate removal of residuals, ete. Tables with acceptance crite- ria for the various anomalies are presented. Welds are classi- fied according to whether the interiar is to be ground smooth and flush on the ID with removal of visual pits and defects, ‘ground smooth but not flush with the pits and dofects in place, or as-welded with no grinding. ‘The smoothness of the surface finish is quantified by Ra measurements using a profilometer. For tubing Ra Average is used which is derived from readings taken at four cross sections approximately 90 degrees apart. The Ra, or roughness average is the og of the arithmetic mean of the surface profile. Itis usually expressed in j-inehes (or -meters) where the Ra of As-Drawn and/or Mechanically polished tubing may be from. 20 rinches (0.5 je-meters) to 30 z-inches depending upon the Classification group with an Re max of 30 - 45 j-inches again depending on the classification. Tubing that has been me- chanically polished followed by electropolishing will have an Ra of from 10 j-inches up to 20 juinches depending on the classification with an Ra max of 15-30 z-inches, Similar tables ‘of readings for fittings and valves are presented. Itshould be noted that welds on mechanically polished and ‘lectropotished tubing invariably havea rougher surface than that of the unwelded base metal. Although the smoothness of the ID weld surface is somewhat material dependent, orbital ‘welds willin most eases be considerably smoother than manual ‘welds on the same material. Dimensional Tolerances (DT) for ‘Automatic Weld Fittings ‘The DI Part of the Standard includes tables showing accopt- abledimensions for stainless steel hygienic clamp type fittings, and 316L tube fittings to be joined by automatic welding. Fittings for automatie welding of pipe sizes are not included. ‘The specifications for the dimensional tolerances for weld fittings to be used for orbital welding are important because ‘he production of consistent high quality orbital welds depends ‘upon consistent fit-up between tube and fitting in the orbital ‘weld head, Good fit-up in turn demands consistently good end preparations of tubing and fitting as well as consisteney of wall, thickness and diameter. Fitting tangent lengths for orbital welding were based upon dimensions of the weld heads of the various orbital welding equipment manufacturers. Ideally, the straight length of the fitting should be long enough to reach from the outside edge of the tube clamp inserts whieh hold the tube orfitting inthe weld head to the center of the weld head where the tungsten clectrode is typically positioned. With some orbital weld heads, it is posible to relocate the tungsten closer to the edge of the head to accommodate fittings with shorter stick-out. ‘The fitting ends mustbe square ut without burrsor breaks. Squareness is measured as a distance from a line drawn perpendicular to the tangent plane to the edge of the fitting ‘which is 0.005 in (0.127 mm) for a 14 inch tube and 008 inches fora2inch tube, etc. Itube or fitting ends are not square, there vill be a gap between the ends when they are positioned in the weld head, and the resulting weld may appear concave or, in severe cases, the are may completely fil to fill the gap. Itis expected that the nominal wall thickness of the fitting be the same as that of the tuhe it is to be welded to. Welding current for orbital welding is based upon the wall thickness of the weld joint with approximately 75 amps of primary welding current and 25 amps of background current in the first level for ‘a wall thickness of 0.065 inches. Inconsistent wall thicknesses will result in inconsistent welds. The wal thickness of fittings outside the control portion, such as the outside radius of an elbow, shall have at least 65% of the nomimal wall thickness. ‘The OD dimension is important since ifthe OD of the fitting isWELD PUDDLE PROFILES ARC DEFLECTION ee SS LOW SULFUR 0.001 - 0.008 % ; » MEDIUM TO HIGH ‘SULFUR 0.008- 0.030 % 0.002% S 0.012% $ igure 7. Lf The element sur hos a refund effet on the fd dynamics of te weld poo. When sur isin the medium to high range of AS! 316 $5, heat from the oes wonsfrred downward i the weld pel resting goed penetaton When the sulfur content i below 0.08 heat warsferred toward the edges of he wel pool reeling ln shallow penetration wth a tendency towards OD concn, ght When ane heat win sir ad the thet the medlum t high range, the ae may deflect towards the low suf hea In exteme cates, the weld bead may iss he ain on the 1D different from that of the tube, there will be a ridge on the ID of the weld that may interfere with drainability ofthe system. ‘When welding is used in the manufacture of fittings for this, standard, the welds must meet the weld criteria of the Stan- dard. Fittings, whether welded or not, must meet specified pressure ratings. Buttweld fittings made to this Standard ‘would be 3161 stainless steel unless otherwise agreed toby the ‘owner/user and contractor. Weld fittings must be labelled with the heat number of materials used to make each part of the fitting. This is important to know in case of incompatability botwoon heats when welding tubo to fitting. If the fitting is small, code numbers may be used for heat identification. The surface finish specifications for weld fittings must be in com- pliance with the surface finish part of the Standard, and fittings are to be protected by either sealed plastic bags or end shrink wrap for shipping and handling. Material Joining (MJ) ‘The MJ Part of the Standard applies to the joining of bioprocessing equipment which includes pressure vessels, tanks, and any vessels designed and built to the ASME Boiler and Pressure Vessel Code, Section VIII, Division 1; piping built to ASME BSI; tubing and fittings, ands intended tobe used in conjunction with these standards as they apply. The [MJ Part, as with the other parte of the Standard, covers only ‘those process systems which contact bioprocessing products or product-process streams, For the purpose of this discussion, only those aystems which can be orbitally welded will be considered, Although joining methods other than welding are mentioned, at this point the MJ Part is concerned almost, exclusively with the welding of 316L stainless steel. Where ‘weld surfaces that contact the process are to be finished ater welding, welding processes aze limited to the are or high «energy beam (eleetron beam and laser beam) processes defined in ANSIAWS A300, Where weld surfaces that contact the process are tobe used aa is, that is in the as-welded condition, welding processes are limited to the inert-gas are processes (uch as gas tungsten are welding and plasma are welding) or the high energy beam (electron beam and laser beam) pro- cesses. The Standard recommends that every effort be made to ‘use an automatic or machine welding process such as an orbital tube welder. However, where size or space does not permit access with the weld head, manual welding may be used, but only by agreement between the owner/user and contractor. All welding processes are to be qualified to section ‘MJ-8 of the BPE Standard, ‘Weld and finish samples are recommended before a job is, begun to demonstrate that the desired quality ean be obtained. "The use of test coupons was recommended by the 3A standards in the 1950s and such test results demonstrated that the ‘manual welder had the skill to make an acceptable weld. The use of test coupons is important for orbital welding because with orbital welding, it is possible to establish wold param- eters to obtain an optimal quality weld on a particular heat of ‘material that once established can be repeated with a high degree of aceuraey from weld to wold indefinitely. Because of heat-to-heat variations in stainless steel, itis recommended that weld samplos be done on the actual heat of material to be used on the job. For example, the degree of smoothness of the weld bead, the amount of weld bead penetration at a particular current setting, and even a tendency towards discoloration during welding is influenced by the quantities of trace ele- ‘ments in the base material Although the degree of repeatability is assured by the accuracy of the power supply, other factors which affect the weld also must be controlled in order to obtain weld consis- toney. These include consistency of tube and fitting end- preparation, dimensional tolerances of tubing and fittings ineluding valve stubs, cleanliness of materials, geometry and condition of tungsten clectrodes, and workmanship standards. ‘The standard provides for sample welds to be made on a regular basis as decided upon by the owner/user and contractor to demonstrate that the orbital welding equipment has been set up and is functioning properly, and that the purging procedures are effective. It is recommended that sample welds bbe made at the beginning of cach work shift, whenover the purge source bottle is changed, and when the automatic or ‘machine welding equiment is changed in some way such as by‘a change of weld head. . ‘Acceptance criteria for welds on piping must be in accord with ASME B31.3 paragraphs 41.32 through 341.94 and ‘Table 341.324. For hygienic tubing and fittings, visual weld acceptance criteria including acceptance eriteria for borescopie examination are detailed in the MJ Part of the Standard. Again the emphasis is on weld qualities which are consistent with the concept of hygienic design. Discontinuities such as cracks, voids, porosity, or joint misalignment that would pro- ‘mote contamination of the product are disallowed. Radio graphic inspectionis nota requirement ofthis Standard unless ‘agreed upon by the owner/user and contractor or unless it is specified by another applicable code. Radiography is recom- ‘mended for all joints which have been welded using consum- able inserts to assure complete fusion. All butt welds must have full penetration ofthe weld bead to the ID. Lack of penetration where the weld bead is incom- pletely fused on the ID would create acrevice condition. The ID weld bead should be straight and uniform in width without indication of are wander or erratic bead placement. The Stan- dard specifies thatfor welds that cannotbe inspectedon the ID, that a minimum width of the OD weld bead must not be less than 50% of the widest part of the weld bead. However, ifthere is much variation in weld bead width on either the OD or the ID when using an orbital welding machine, this would indicate that the weld schedule needs further adjustment to assure uniform penetration of the complete weld joint from weld to weld. If pretacking is done, the tacks must be fully consumed by the weld. Ifthe weld ID is not purged with inert gas during the tacking procedure, the welding are may detour around the tacks resulting in a lack-of-penetration. Alignment of tubing or other parts must be accurate so as, to prevent a ridge that would lead to an unacceptable hold-up volume which would contribute to product contamination, ‘This means that fittings and tubing must conform to dimen- sional tolerance standards and be installed by personnel ‘trained in good workmanship practices. A maximum misalign- ment of 15% of the nominal wall is allowed. ‘The weld bead profile of an autogenous weld should be flush on the ID and OD surfaces. Welds done with filler wire should he slightly convex, never caneave, on the OD. Autog- ‘enous welds of pharmaceutical type tubing are usually flat on the OD unless excessive heat is applied in which ease they will be concave on the OD with excessive penetration onthe ID. The BPE Standard has a generous allowance for OD concavity allowing as much as 10% of the wall (0.0065" for an 0.065 wall ‘tube) around the entire weld circumference or as much as 15% of the wall for up to 25% of the circumference, While orbital ‘tube-to-tube welds are usually flush, it may be more difficut to do certain types of tube-to-fitting welds without some OD concavity. Excessive purge pressure on the ID will cause the ‘weld bead to be convex on the OD and concave on the ID. Concavity on the ID of the weld bead is limited to 10% of the ‘nominal wall. OD convexity is limited to 0.015 inches. OD and ID concavity combined must not reduce the wall thickness of the weld joint to less than the minimum specified design thickness for the tube or fitting Discoloration of the weld and HAZ may oceur during welding as @ result of oxidation, Oxidation, or heat tint as itis sometimes called, is known to cause a reduction in the corro- sion resistance of stainless steel in proportion to theamount of oxygen contamination of the ID purge gas. The BPE Standard calls for the amount of discoloration of the ID surface to be minimized such that the weld bead is free of color, but with ‘gure An ample ofan ore weld of tube o-anabow fr use no ‘oprecess application. Pato fom B. Braun Biotech ‘some light discoloration of the HAZ, accepted provided that it, is tight to the surface, The amount of discoloration to be allowed is subject to agreement between the owner/user and ‘the contractor. It should be noted that color-free orbital welds fare the norm for the semiconductor industry that routinely’ purifies purge gas to the low parts per billion levels of contami: nants. The standard argon purge gas supplied for welding generally contains trace amounts ofoxygenin thelow parts per ‘million range which should be no greater than 7 ppm, and also contains minimal amounts of moisture. In Burope, the stan- dard for hygienic tubing discoloration is “light straw color” ‘which occurs at about 20 ppm oxygen in the ID purge gas. It is possible to obtain color free welds on many lotsof material with ‘g00d purging techniques with standard argon purge gas with 1-2 ppm of oxygen and moisture. However, on some heats of ‘material, particularly in the larger sizes, there is often a light blue “halo” or yellowish tint in the HAZ. It is more difficult to purge larger diameter tubing, and also more difficult to purge ‘mechanically polished tubing than tubing that has been electropolished."” ‘The inert gas shield provided by an enclosed weld head offers more protection of the weld OD from oxidation during welding than an open frame type of head. It also protects the ID of the weld since the tubing ends may separate somewhat during the welding process allowing the exchange of gases botwoen the ID and OD of the tube. Ifthe tubing OD is open to atmosphere rather than to an inert gas environment provided by an enclosed head, there is a greater potential for contami- nation of the weld, In the semiconductor industry and increasingly in biopharmacentical installations, the use of gas purifiers and an oxygen analyzer to verify that the ID purge gas has not picked up contaminants before reaching the weld joint has become an accepted practice. Many mechanical contractors hhave experience in both the semiconductor and bioprocess industries, and are very familiar with high-purity purging techniques. This is an area that will need further attention in the future. The semiconductor industry is concerned enough with loss of corrosion resistance and contamination to experi- ment with heats of stainless steel with low manganese in ordor toprevent the precipitation of manganese on the HAZ which is associated with some of the discoloration. There is no clear standard in any industry for detecting color on welds since it may be visible in some lights but not other. One semiconduetormanufacturer inspects their orbital welds with specified inten- sities of visible light and also with blacklight to detect discol- oration. The biopharmaceutical industry has not yet reached this level of concern, and perhaps for many applications, itis unnecessary. However, itis important to understand that the technology is already in place for achieving a very high level of ‘weld quality which will result in the optimal eorrosion resis- tance for the material, Weld Inspectors and owner/users are to be allowed free access to work areas while work assigned to them isin progress as well as relevant certifications and documentation. An in- spection plan, including the types of examinations to be made, shall be agroed upon in advance of the job by the owner/user and contractor. Inspectors who perform borescopic examina- tions are required at the owner/users’ discretion to meet the requirements of ASME B31.3 paragraphs 340.4, 342.1 and 342.2, and may be certified as an AWS-QC1 Certified Welding. Inspector. All welds are tobe visually inspected on the OD and ‘at least 20% of the welds selected on a random basis for each section are to be inspected on the ID either directly or with a borescope. Random inspections are important since welds of ‘tube-to-fitting in which differentheats are welded together are more likely to present a problem than tube-to-tube welds Welding defects which may be repaired by rewelding include Jack-of-penetration for which one additional pass is permitted and lack-offusion. However, it should be noted that each successive passona weld addsto the heat input and may result in a significant loss of corrosion resistance. Other defects must be ent out or otherwise repaired at the owners’ discretion, Experienced contractors have been able to reduce orbital weld reject rates to very low levels. One me- chanical eontractor was able toreduce the rejectrate for orbital ‘welds in bioprocess applications over a period of several years from 1.8 to 0.2%. Weld Qualification to the ASME BPE-1997 Standard requires that the welds be certified to ASME Sect. IX of the BPVC, and meet the requirements of 831.8 Process Piping. For this, there must be a QA manual and a QA program ineffect as well as a set of general weld standards which reference the BPE Standard. Qualified weld procedures must be developed, preferrably on the actual heats of materials to be used. The orbital weld schedule which lists weld parameters such as welding currents, pulse times, rotational speed, and times is, frequently used as part of the Procedure Qualifieation Record (QR). Test coupons must be generated and subjected to destruc- tive testing. Although existing standards have been used to qualify systems which have been installed by orbital welding, those standards were written with manual welding in mind, and this has lead to some confusion when qualifying autog- ‘enous orbital welds. Autogenous orbital welds are expected to be flush on the OD and ID, and do not require grinding in preparation for destructive testing. The tests include bend tests over a certain-sized radius in which two each of root and face bends are required to determine the ductility of the weldiment. The test coupons must be carefully inspected after bending for cracks in the weld or HAZ, Tensile testing must be done to demonstrate that the base material still meets the minimum tensile strength (PSD specified after welding. Ifthe test specimen breaksin the weld, but still meets the PSI rating for the material, the weld is considered good. The limits of the weld range are deterimined by taking the minimum wall thickness qualified and then allowing up to two times the thickness with an unlimited diameter range. Radiography is Lia | os = | 1D rs% runaccepable-” (b) Misalignment (Mismatch) 10% t unacceptable BS (c) 0D Coneavity >10% 1 unacceptable (d) 1D Concavity (Suckback) © Unacceptable {0} Lack of Penetration: None Allowed c 0.018 in. max ( Convexity Figure 9. Acceptable and unacceptable wld profes, not required by the BPE Standard unless it is required for another applicable standard. When satisfactory test results have been obtained, the results must be recorded on the Weld Procedure Specification (WPS) Form QW-482, and the PQR Form QW-483, or equiva-Figue 10, Weld quafcaon and qualy con! for real weldng inves the use of sample welts known a5 est coupons made before the start af job and at Specified ierval during the ob. Once acceptable procedures have been developed for obit welding, consistent high quaity wel con be produced wih «high degree of repectbiey. Photo courtesy of Bly and Snider Mechanical Contactors lent forms. For welder certification, each welder must submit either 6 inches of linear weld (a 1,000 inch OD weld is 3.14 linear inches) for testing or multiple coupons, but nomore than 4, Welder test results must be recorded on the Welder Perfor- mance Qualification form QW-484. Signatures of test person- nel and a supervisor are required in confirmation of test results, Forms are available from the ASME. Each time a new welder is certified, he or she must repeat the above procedures for each and every weld which may be evaluated by either a bond test or Xray. Passivation Very little attention is directed towards passivation by this standard. Tt merely states that passivation of all welded systems shall be dane after cleaning and prior to use if agreed to by the owner/user and the manufacturer. Passivation is typically dane to improve corrosion resistance whichis accom plished by the removal of any free ion or other contaminants that remain on the product-oontact surface after fabrication and welding. Passivation s doneaccarding to ASTM 380 which specifies the procedures used to treat the completed system wwith a nitric acid aclution or a proprietary mixed chalant formulation. Passivation of welded surfaces is important be- cause welding disturbs the passive flm on stainless stel ‘which is responsible for maintaining the corrosion fesistance During welding, the chromium in the weld area is greetly reduced, while the iron content increased which disturbs the favorable chrome/iton ratio, Passivation restores the natural chromefiron ratio, and much ofthe corrosion resistance that i= lost by welding.® However, passivation only affects the outer 50 A of the weld surface. Deep heat tint, which has been correlated with a considerable loss of corrosion resistance ‘which occurs when the ID purge gas containgcaygun above the Jow parts pr million range, cannot be removed by passivation. For optimal corrosion resistance of welded tubing systems, the best possible purge should be used on the weld ID followed by a proven passivation procedure. Documentation of weld qualification results including ‘the WPS, PQR, and welder WPQ are to be presented to the ‘owner/user at the completion of the job and retained for a period ofatleast3 yoars. In addition, weld mapsofbioprocessing ‘components and weld inspection logs which must include the type of inspection and the date must be maintained, and the welder identification must be recorded either on the weld inspection log or on the weld map. This type of information as ‘well as the serial numbers of the weld head and power supply ‘may be entered into some orbital welding power supplies and printed out on the weld schedule sheet and used as part ofthe documentation. Similar information is frequently recorded on the OD of the tubing or pipe next to the weld and used in conjuction with the weld log incase ofa question at alater date. Other records, such as Material Test Reports (MTRs) listing ‘the chemical composition and test data of the heats of mater als used, surface finish test reports, and results of pressure testing, passivation, and other documentation required by the ‘Section on Design, also shall be presented to and retained by the owner/user for the required period. ‘Although it has been released, work on the BPE Standard far from over. A Main Committee meeting as well as subcommittee meetings were held in March in Philadelphia to coincide with INTERPHEXUSA’98. Addendums for the Stan dard are planned for October of 1998 and 1999 with a new addition expected by the year 2000. The meetings were well attended attracting new recruits to expand and modify the Standard in response to industry needs. Whereas earlier codes and standards were written with manual welding in mind, other standard writing groups are now in the process of updating their standards to inelude references to orbital weld- ing. The Baseline® Pharmaceutical Engineering Guide, Vol: ume 4: Water and Steam Systems Draft of October 80, 1997 includes recommendations for orbital welding, and the AWS standards writing group also will reference orbital welding, Orbital welding has become the accepted joining technology for the high purity industries, but its suitability for other indus- tries, such as the food, dairy and beverage industries which have in common the need to eliminate hacterial growth and minimize corrosion, should be apparent. Fare 11, Orbital wed for bophormaceutclapplcaons oe inspected vualy tthe 0, while Boescape i used to spect ospecfed percentage of weds on the ID. On the above instalation a videoandscope wos used to store de images of the welds for FDA documentation, Photo courtesy offer Animal HeathReferences ASME Section 1X of the Boiler and Pressure Vessel Code. ASME Bioprocessing Equipment Standard (BPE-1997) available from the American Society of Mechanical Engi- neers, 22 Law Drive, Box 2900, Fairfield, New Jersey (07007-2900. Tel: 800-843-2763; Fax: 201-882-1717; E-Mail: Infocentral@asme.org. ASME Section VILL ‘ASME B13, Process Piping. ‘ASTM A270, Specification for Seamless and Welded Aus- tenitic Stainless Stcel Sanitary Tubing. 6. Burgard, P. and C.R. Heiple. Interaction Between Impu- rities and Welding Variables in Determining GTA Weld Shape. The Welding Journal, June, 1986. 7. Burton, C. Effect of Stainless Steel Melt Methods on the Corrosion Resistance of Welds in UHP Gas Lines. Pro- sented at Semicon West, San Francisco, California, 1997, 8 Cohen, R. M, Identifying Trace Elements Affecting the Weldability of 3161 Stainloss Stocl Tubing. FUTURE FAB International Volume 2., 1997. 9. Fihey, J.L., and R. Simoneau. Weld Penetration Variation in GTA Welding of some 8041 Stainless Steels. Presented atthe Ameriean Welding Society Conference, Kansas City, ‘MO., 1982, 10. Grant, A., Henon, BLK, and F, Mansfeld. Effects of Purge Gas Purity and Chelant Passivation on the Corrosion Resistance of Orbitally Welded 3161 Stainless Steel Tub- ing. Pharmaceutical Engineering, Jan/Feb, Mar/Apr, 1997. 11, Pollard, B. The Effects of Minor Elements on the Welding Characteristics of Stainless Steel. The Welding Journal, September, 1988. 12, Young, J. The Engineering of Sterilization and Decontami- nation. Presented at the ASME Bioprocess Technology Program, Bioprocess Equipment Technology, Bioprocess Equipment Design. University of Virginia, 1992. ‘About the Author Barbara Henon is Manager of Technical Publication at Are Machines, Ine, Dr, Henon reosived her PRD in biological sciences from the University of Southern California, and did postdoctoral research in neurophysiology at the Beckman Research Insitute ofthe City of Hope in Duarte, California. An AWS member since 1988, anda member of SPE, she also is active in the ASME and is the former Chairman ofthe ASME Bioprocess Engineering Subdivision. Dr. Henon has been a member ofthe ASME Bioprocess Equipment Main Committee tnd Material Joining Suibommittee since 1989 whieh in collaboration with other subcommittees, recently published {the new ASME BPE-1997 Standard forthe design and fubrin- tion of bioprocessing equipment and piping systems. Her primary esponsibility at Are Machines, Ine ie writing articles on customers applications of orbital welding in a ‘arity of industries which have in common a need fr high quality and high purity piping systems. Dr. Henon is experi- heed in welding education with 12 years of fld experience training obial welding operators. ‘Are Machines, ne. 10800 Orbital Way, Pacoima, CA 91381 Please visit our Web ileal wort aremachinescom for other published articles. @ This article was adapted from a presentation ‘conducted at the PRIMER SIMPOSIUM INTERNACIONAL, DE SOLDADURA ‘98 Monterrey, Nuevo Leén, Mexico March 14, 1998