BioProcessing Equipment SubCommittees

The following subcommittees report to the BPE Main Committee.  Task Groups are formed to address specific assignments. 

• Subcommittee on Material Joining
  This Subcommittee establishes requirements for material joining (welding) associated with BPE equipment where high purity and process control is essential.  They develop requirements for orbital and manual welding, weld acceptance/rejection criteria, fitup, concavity, and weld geometry, and procedures and performance qualifications.
  
  
• Subcommittee on Surface Finish
  This Subcommittee’s primary emphasis is on the selection of appropriate material and its related surface finish that will enhance efficient cleaning and sterilizing procedures.  The requirements they develop address potential cleanliness, sterility and purity problems.
  
  
• Subcommittee on Seals
  This Subcommittee establishes requirements for various mechanical seals and gaskets used with BPE equipment such as pumps, valves, rotating and reciprocating equipment, pressure vessels and piping.
  
  
• Subcommittee on Dimensions and Tolerances
  This Subcommittee is responsible for establishing requirements for overall dimensions, pressure ratings, tolerances, marking, and packaging of sanitary tubes and fittings.  It reviews existing national standards and incorporates them as required.
  

Additionally, the Subcommittee works to standardize hygienic fitting dimensions, develop marking procedures for identity, and develop workable standard tolerances for exacting fit up.

• Subcommittee on Design Relating to Sterility and Cleanability of Equipment
  This Subcommittee develops criteria for BPE equipment and systems to establish industry requirements for cleanability, cleanliness, sterility and aseptic processing.
  
  
• Subcommittee on General Requirements and Editorial Review
  This Subcommittee coordinates the drafts produced by the other Subcommittees.  It is responsible for developing a Lexicon of terms encompassing all the different parts of the standard.
  
  
• Subcommittee on Polymers and Elastomers
  This Subcommittee establishes requirements that are applicable to and unique to the use of polymer based materials used in bioprocessing equipment, components, assemblies and bioprocessing systems.  Polymer based materials include thermoplastics and thermosetting materials both virgin and composite forms.
  
  
• Subcommittee on Metallic Materials of Construction
  This Subcommittee's primary emphasis is on the selection of acceptable metallic materials of construction and definition of mechanical and physical properties, testing procedures, and other attributes for these materials.  Additionally, they will define a method by which other metallic materials of construction may be submitted for consideration.
  
  
• Subcommittee on Process Instrumentation
  This Subcommittee establishes requirements applicable to the proper design, installation, and use of process instrumentation. It addresses any process instrumentation and associated integrally mounted components in direct contact with the product, raw materials, or product intermediates.
  
  
• Subcommittee on Certification
  This subcommittee provides requirements for the certification of organizations providing components in accordance with the standard.  It also provides requirements for the authorization of organizations to mark with the ASME BPE Symbol Stamp.