ASME BPE-2012 pdf download

ASME BPE-2012 pdf download.Bioprocessing Equipment.
GR-1 INTRODUCTION The ASME Bioprocessing Equipment Standard was developed to aid in the design and construction of new fluid processing equipment used in industries that require a defined level of purity and bioburden control. The Standard typically applies 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] The General Requirements Part states the scope of the ASME BPE Standard and provides references and definitions that apply throughout the document. When operating under pressure conditions, systems shall be constructed in accordance with the ASME Boiler and Pressure Vessel Code (BPVC), Section VIII, and/or ASME B31.3 Process Piping Code or applicable local, national, or international codes or standards. The owner/user may stipulate additional or alternative specifications and requirements. This Standard shall govern the design and construc- tion of piping systems for hygienic service. For process piping systems designed and constructed in accordance with ASME B31.3, it is the owner’s responsibility to select a fluid service category for each fluid service. Should any fluid service meet the definition of high purity fluid service (ASME B31.3, Chapter X) it is recom- mended that such fluid service be selected and the requirements of this Standard and ASME B31.3, Chapter X be met. When an application is covered by laws or regulations issued by anenforcementauthority(e.g., municipal, pro- vincial, state, or federal), the final construction require- ments shall comply with these laws. Items or requirements that are not specifically addressed in this Standard are not prohibited. Engi- neering judgments must be consistent with the funda- mental principles ofthis Standard. Such judgments shall not be used to override mandatory regulations or spe- cific prohibitions of this Standard. 1 GR-2 SCOPE OF THE ASME BPE STANDARD The ASME BPE Standard provides requirements for systems and components that are subject to cleaning and sanitization and/or sterilization including systems that are cleaned in place (CIP’d) and/or steamed in place (SIP’d) and/or other suitable processes. This Standard also provides requirements for single use sys- tems and components. This Standard applies to (a) new system (and component) design and fabrication (b) definition of system boundaries (c) specific metallic, polymeric, and elastomeric (e.g., seals and gaskets) materials of construction (d) component dimensions and tolerances (e) surface finishes (f) material joining (g) examinations, inspections, and testing (h) certification This Standard is intended to apply to new fabrication and construction. It is not intended to apply to existing, in-service equipment. If the provisions of this Standard are optionally applied by an owner/user to existing, in- service equipment, other considerations may be neces- sary. For installations between new construction and an existing, in-service system, the boundaries and require- ments must be agreed to among the owner/user, engi- neer, installation contractor, and inspection contractor. For a system or component to be BPE-compliant, adherence to all applicable parts of this Standard is required. GR-3 MANUFACTURER’S QUALITY ASSURANCE PROGRAM The manufacturershallimplementa qualityassurance program describing the systems, methods, and proce- dures usedto controlmaterials, drawings,specifications, fabrication, assembly techniques, and examination/ inspection used in the manufacturing of bioprocessing equipment.
GR-4 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-4.1 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-8, meets the additional requirements listed in GR-4.2. (c) Piping and Tubing. Examiner, defined as a person who performs quality control examinations for a manu- facturer 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-4.2 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-4.2-1. It is required that a capability listed for a lower level of qualification is also required for subsequent higher levels of qualification.