ASME BPE 2009 pdf download

ASME BPE 2009 pdf download.Bioprocessing Equipment.
GR-1 INTRODUCTION This Standard provides the requirements applicable to the design of equipment used in the bioprocessing, pharmaceutical, and personal care product industries, including aspects related to sterility and cleanability, materials, dimensions and tolerances, surface finish, material joining, and seals. These apply to (a) components that are in contact with the product, raw materials, or product intermediates during manu- facturing, development, or scale-up (b) systems thatare a critical partofproductmanufac- ture [e.g., water-for-injection (WFI), clean steam, filtra- tion, and intermediate product storage] This Standard applies to new construction only. It is not intended to apply to the operation, examination, inspection, testing, maintenance, or repair of piping/ tubing, or equipment that has been placed in service. The provisions of this Standard may be optionally applied for those purposes, although other considera- tions may be necessary. For installations between new construction that ties into an existing system that has been placed in service, the boundaries and requirements must be agreed to between the owner/user and contrac- tor and inspection contractor. This Standard does not apply to those components of the system that are not in contact with the finished product or are a part of the intermediate manufacturing stages (e.g., computer systems, electrical conduits, and external system support structures). Steam sterilized systems normally meet pressure ves- sel design codes. Other equipment or systems as agreed to by the manufacturer and owner/user may not require adherence to these codes.
GR-2 SCOPE This Standard deals with the requirements of the bio- processing, pharmaceutical, and personal care product industries as well as other applications with relatively highlevels ofhygienic requirements, coveringdirectlyor indirectly the subjects of materials, design, fabrication, pressure systems (vessels and piping), examinations, inspections, testing, and certifications. Items or require- ments thatare notspecificallyaddressed in this Standard cannot be considered prohibited. Engineering judg- ments must be consistent with the fundamental princi- ples of this Standard. Such judgments shall not be used to overrride mandatory regulations or specific prohibi- tions of this Standard. GR-3 INSPECTION The inspection requirements are specified in each Part of this Standard. If an inspection or examination plan is required, it shall be developed and agreed to by the owner/user, contractor, inspection contractor, and/or engineer ensuring that the systems and components meet this Standard. GR-4 INSPECTOR/EXAMINER Inspector and examiner in this Standard shall be defined for the following: (a) Pressure Vessels. Authorized Inspector, as defined in ASME BPVC, Section VIII, Division 1, para. UG-91. (b) Piping, Tubing, and Non-Code Vessels. Owner’s inspector, as defined in ASME B31.3, paras. 340.4(a) and (b). Inspector’s Delegate, as defined in GR-10, meets the additional requirements listed in GR-4.1.
GR-4.1 Inspector’s Delegate Inspector’s Delegate qualifications shall be in accor- dance with the requirements listed herein. The employer ofthe Inspector’s Delegate shall have documented train- ing and qualification programs to ensure the qualifica- tions and capabilities of personnel are met. The capabilities requirements are listed in Table GR-1. It is required that a capability listed for a lower level of qualification is also required for subsequent higher lev- els of qualification. GR-4.1.1 Levels ofQualification. There are four lev- els ofqualificationfor Inspector’s Delegate. Examination personnel qualifications are not covered in this section but shall be in accordance with ASME B31.3, para. 342. (a) Trainee. 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. (b) Quality Inspector Delegate 1 (QID-1). This individ- ual shall be qualified to properly perform specific cali- brations, specific inspections, and specific evaluations for acceptance or rejection according to written instruc- tions. A QID-1 may perform tests and inspections according to the capabilities’ requirements under the supervision of, at a minimum, a QID-2. (c) Quality Inspector Delegate 2 (QID-2). This individ- ual 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. A QID-2 may perform tests and inspections according to the capabilities requirements.