ASME BPE-2005 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 that are a critical partofproduct manufac- ture [e.g., water-for-injection (WFI), clean steam, filtra- tion, and intermediate product storage]. 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. When operating under pressure conditions, the sys- tems shall be constructed in accordance with the ASME Boiler and Pressure Vessel Code (BPVC), Section VIII, Division 1, and the ASME B31.3, Process Piping Code, respectively. The owner/user can stipulate additional specifications and requirements. When an application is covered by laws or regulations issued by an Enforcement Authority (e.g., municipal, provincial, state, or federal), the final construction requirements shall comply with these laws. However, all the previously mentioned con- struction codes shall be satisfied including those instances where these codes are not referred to in the current BPE Standard (e.g., weld acceptance criteria, inspection requirements, pressure testing, etc.).
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: (a) Pressure Vessels. An Authorized Inspector, as defined in ASME BPVC, Section VIII, Division 1, para. UG-91; (b) Piping, Tubing, and Non-Code Vessels. An owner/ user’s inspector, as defined in ASME B31.3, para. 340.4(a); and (c) Piping and Tubing. An examiner, defined as a per- son who performs quality control examinations for a manufacturer as an employee of the manufacturer as defined in ASME B31.3, para. 341.1. When local regulations require that pressure equip- ment be designed and constructed in accordance with standards other than ASME codes/standards, the inspector in this Standard is defined as one who is acceptable to the relevant regulatory authority. GR-5 RESPONSIBILITIES The responsibilities of inspection personnel are defined as follows.
GR-5.1 Pressure Vessels The responsibilities of the owner’s Inspector shall be the same as the inspector in ASME BPVC, Section VIII, Division 1, UG-91. GR-5.2 Piping, Tubing, and Noncode Vessels The responsibilities of the owner/user’s inspector shall be in accordance with ASME B31.3, para. 340.2. GR-6 ACCESS FOR INSPECTORS Manufacturers of bioprocessing equipment and com- ponents shall allow free access of owner/user and authorized inspection personnel at all times while work on the equipment or components is being performed. The notification of an impending inspection should be mutually agreed to by the manufacturer and the inspec- tor. Access may be limited to the area of the manufactur- er’s facility where assembly, fabrication, welding, and testing of the specific equipment or components is being performed. Inspectors shall have the right to audit any examination, to inspect components using any examina- tion method specified in the Design Specification (including Purchase Order), and review all certifications and records necessary to satisfy the requirements of GR-5. The manufacturer shall provide the inspector with work progress updates. GR-7 MANUFACTURER’S QUALITY ASSURANCE PROGRAM The manufacturer shall implementa quality assurance program describing the systems, methods, and proce- dures used to controlmaterials, drawings, specifications, fabrication, assembly techniques, and examination/ inspection used in the manufacturing of bioprocessing equipment. GR-8 METRIC Metric units in this Standard are conversions from U.S. Customary units, and are for reference purposes only unless specified otherwise.