ASME BPE-2016 CHAPTER 1

 The ASME Bioprocessing Equipment Standard was developed to aid in the design and construction of new

fluid processing equipment used in the manufacture of biopharmaceuticals, where a defined level of purityand bioburden control is required.

 The Standard typically applies 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 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 applicablelocal,national, or international codes or standards. The owner/user may stipulate additional or alternative specifications and requirements.

 This Standard shall govern the design and construction 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 highpurity fluid service (ASME B31.3, Chapter X) it is recommended 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 an enforcement authority (e.g.,

municipal, provincial,state, or federal), the final construction requirements shall comply with these laws.