ASME BPE-2002 pdf free download.BIOPROCESSI EQUIPMENT
This Standard provides the requirernents applicableto the design of bioprocessing equipment,includingaspects related to sterility and cleanability, dimensionsand tolerances,surface finish,materialjoining,andseals.These apply to:
(a) conponents that are in contact with the product,raw materials, or product intermediates during manufac-turing, development, or scale-up;
(bj systems that are a critical part of product manu-facture [e.g.,water-for-injection (WFI),clean steam,filtration,and intermediate product storagel.
This Standard does not apply to those cornponentsof the system that are not in contact with the finishedproduct or are a part of the intermediate manufacturingstages (e.g., computer systems,clectrical conduits, andexternal system support structures).
Steam sterilized systems normally meet pressure ves-sel design codes.Other equipment or systems as agreedto by the manufacturer and owner/user may not requireadherence to these codes.
when operating under pressure conditions，the systems shall be constructed in accordance with the AMEBoiler and Pressure Vessel Code (BPVC), SectionVm,
Division 1, and the ASME B31.3, Process Piping Code,respectively. The ownerluser can stipulate additional specifications and requirenents. When an application iscovered by laws or regulations issued by an EnforcementAuthority (e.g., municipal, provincial, state,or federal),the final construction requirements shall comply withthese laws. However,all the previously mentionedconstruction codes shal1 be satisfied including thoseinstances where these codes are not referred to in thecurrent BPEStandard (e.g-,weld acceptance criteria,inspection requirements，pressure testing, etc.).
02)GR-2 scOPE
This Standard deals with the requirements of the bioprocessing industry,covering dirrctly or indirectly the subjects of materials,design,fabrications,pressuresystems (vessels and piping),examinations, inspections,testing,and certifications. Items or requirements thatare not specifically addressed in this Standard cannotbe considered prohibited. Engineering judgments mustbe consistent with the fundamental principles of thisStandard.Such judgments shall not be used to overridemandatory regulations or specific prohibitions of thisStandard.
GR-3 INSPECTION
The inspection requirements are specified ineachPart of this Standar.If an inspection or examinationplan is required,it shatl be developed and agreed toby thc owner/user，contractor，inspection contractor,andor engineer ensuring that the systems and compo-nents mect this Standard.
GR-4 INSPECTOR/EXAMINER
Inspector and examiner in this Standard shall bedefined for:
(a) Pressure Vessels. An Authorized Inspector、asdefined in ASME BPVC，Section VIHI，Division 1,para.UG-91;
(b)Piping,Tubing, and Non-Code Vessels. Anownerhuser’s inspector，as defined in ASMEB31.3,para.340.4(a;and
(c)Piping and Tubing. An exaniner，defined as aperson who performs quality controf exarninations fora manufacturer as an employee of the manufacturer asdefined in ASME B31.3，para.341.1.
When local regulations require that pressure equip-ment be designed and constructed in accordance withstandards other than ASML codesistandards, the inspec-tor in this Standard is defined as one who is acceptableto the reievant reguiatory authority.
GR-5 RESPONSIBILIT1ES
The responsibilities of inspection personnel are de-fined as follows.
(02)GR-5.1 Pressure Vessels
The responsibilities of the owner’s Inspector shallbe thc same as the inspector in ASME BPVC, SectionVMI,Division 1，UG-91.
{02) GR-5.2 Piping,Tubing, and Noncode Vessels
The responsibilities of the owneruser’s inspectorshall be in accordance with ASME B31.3, para.340.2.
(02) GR-6 ACCESS FOR INSPECTORS
Manufacturers of bioprocessing equipment and com-ponents shall allow free access of owner/user andauthorized inspection personnel at all times while workonthe equipment or components is being perforrmed.The notification of an impending inspection should bemutually agreed to by the manufacturer and the inspec-tor. Access may be limited to the area of the manufactur-er’s facility where assernbly,fabxication，welding, andtesting of the specific equipment or components isbeing performed. Inspectors shall have the right toandit any examination,to inspect conponents usingany examination method specified in the Design Speci-fication (including Purchase Order),and review allcertifications and records necessary to satisfy the re-quirements of GR-5.The manufacturer shali providethe inspector with work progress updates.
(02) GR-7 MANUFACTURER’S QUALITY ASSURANCE PROGRAM
The manufacturer shall implement a quality assuranceprogram describing the systems，methods,and proce-dures used to control materials, drawings, specifications,fabrication,assembly techniques，and examination/in-spection used in the nanufacturing of bioprocessingequipment.
GR-8 METRIC
Metric units in this Standard are conversions fromU.S.Customary units,and are for reference purposesonly unless specified otherwise.ASME BPE pdf download.ASME BPE-2002 pdf free download
