ASME BPE:2002 pdf download BIOPROCESSING EOUIPMENT
GR-1 INTRODUCTION
This Standard provides the requirements applicableto the design of bioprocessing equipment inciudingaspects related to sterilily and cleanability,dimensionsand tolcranccs, surfacc finish, material joining, andscals. Thcsc apply to:
(a) componcnts that arc in contact with the productraw materials, or product intermediates during manufacturing, development, or scale-up;
(b) systems that are a critical part of product manu-facture [eg, water-for-injection (WFI)，clean steam,filtration, and intermediate product storage].
This Standard does not apply to those componentsof the system that are not in contact with the finishedproduct or are a part of the intermediate manufacturingstages (e.g., computer systems, clectrical conduits, andcxternal system support structurcs).
Steam sterilized systems normally meet pressure vessel 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 ASIMEBoiler and Pressure Vessei Cude (BPVC),Section VIilDivision 1, and the ASME B31.3, Process Piping Codercspectivcly.The owncr/user can stipulate additionalspecifications and requirements. 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 shaii be satisfied inciuding thoseinstances where these cudes are not referred to in thecurrent BPE Standard (c.g, weld acceptance criteria,inspcction requirements, prcssurc testing, ctc.).
GR-2 SCOPE
This Standard deais with the requirements of thebioprocessing industry, covering directly 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 tis Siandard cannotbe considered prohibited. Engineering judgments mustbe consistent with the fundamental principles of thisStandard. Such judgments shall not be used to overrridemandatory regulations or specific prohibitions of thisStandard
GR-3 INSPECTION
The inspection requirements are specified in eachPart of this Standard, if an inspection or examinationplan is required, it shall be developed and agreed toby the owneruser, contractor,inspection contractor.and/or ongincor ensuring that thc systems and components meet this Standard.
GR-4 INSPECTOR/EXAMINER
Inspector and examiner in this Standard shall bedefined for:
(a) Pressure Vessels An Anthorized Inspector, asdefined in ASME BPVC，Section VIDivision 1.para.UG-91:
(b) Piping,Tubing, and Non-Code Vessels.Anowner/user’s inspector, as defined in ASME B31.3.para.340.4(a); and
(c) Piping and Tubing. An examiner. defined as aperson who performs qualfty cuntrol exarminations fora manufacturcr as an employee of the manufacturer asdefined i ASMB B31.3,para.341.1.
When local regulations require that pressure equipment be designed and constructed in accordance withstandards other than ASME codes/standards, the inspector in this Standard is defined as one who is acceptableto the relevant regulatory authority.