ASME BPE-2005 pdf free download.Bioprocessing Equipment.
ASME BPE 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 manufacturing, development, or scale-up;
(b) systems that are a critical part of product manufacture [e.g., water-for-injection (WFI), clean steam, filtration, and intermediate product storagel.
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 vessel 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 systems shall be constructed in accordance with the ASM E Boiler and Pressure Vessel Code (BPVC), Section VIII, Division 1, and the ASME 1331.3, 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 construction codes shall be satisfied including those instances where these codes are not referred to in the current BPF Standard (e.g.. weld acceptance criteria, inspection requirements, pressure testing, etc.).
GR-2 SCOPE
This Standard deals with the requirements of the bioprocessing, pharmaceutical, and personal care product industries as well as other applications with relatively high levels of hygienic requirements, covering directly or indirectly the subjects of materials, design, fabrication, pressure systems (vessels and piping), examinations, inspections, testing, and certifications. Items or requirements that are not specifically addressed in this Standard cannot be considered prohibited. Engineering judgments must be consistent with the Fundamental principles of this Standard. Such judgments shall not be used to overrride mandatory regulations or specific prohibitions of this Standard.
GR-3 INSPECTiON
The inspection requirements are specified in each T’art 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;
(ii) Piping, Tufring, 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 person 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.