ASME BPE

ASME BPE

BIOPROCESSING EQUIPMENT
Bioprocessing Equipment
Bioprocessing Equipment
BIOPROCESSING EQUIPMENT
Supplement to ASME BPE Bioprocessing Equipment
Bioprocessing Equipment
Bioprocessing Equipment
Bioprocessing Equipment
Bioprocessing Equipment
BIOPROCESSING EQUIPMENT
Bioprocessing Equipment
Bioprocessing Equipment
BIOPROCESSING EQUIPMENT
Bioprocessing Equipment

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$275.00

Standard Details

Full Description

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 used in the manufacturing of biopharmaceuticals. This Standard also provides requirements for single use systems and components used in the above listed systems and components. This Standard may be used, in whole or in part, for other systems and components where bioburden risk is a concern.

Product Details

Published: 10/14/2016ISBN(s):9780791871171 ANSI ApprovedNumber of Pages:354File Size: 1 file , 11 MB

Publication Date: 01/01/2016 - Complete Document

Document Type : Complete Document

Page Count : 352

Publication Date : 01/01/2016

Revision : 16

Status : F

Title : BIOPROCESSING EQUIPMENT

Publication Date: 10/10/2014 - Complete Document

Description :

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 used in the manufacturing of biopharmaceuticals. This Standard also provides requirements for single use systems and components used in the above listed systems and components. This Standard may be used, in whole or in part, for other systems and components where bioburden risk is a concern.

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) materials 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, inservice equipment, other considerations may be necessary.

For installations between new construction and an existing, in-service system, the boundaries and requirements must be agreed to among the owner/user, engineer, installation contractor, and inspection contractor. For a system or component to be BPE-compliant, adherence to all applicable parts of this Standard is required

Document Type : Complete Document

Language : English

Page Count : 328

Publication Date : 10/10/2014

Revision : 14

Status : Current

Title : Bioprocessing Equipment

Publication Date: 09/28/2012 - Complete Document

Description :

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 systems 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, inservice equipment, other considerations may be necessary. For installations between new construction and an existing, in-service system, the boundaries and requirements must be agreed to among the owner/user, engineer, installation contractor, and inspection contractor.

For a system or component to be BPE-compliant, adherence to all applicable parts of this Standard is required.

Document Type : Complete Document

Language : English

Page Count : 292

Publication Date : 09/28/2012

Revision : 12

Status : Historical

Title : Bioprocessing Equipment

Publication Date: 06/01/2011 - Complete Document Supplement 1

Document Type : Complete Document

Page Count : 240

Publication Date : 06/01/2011

Revision : 09

Status : Historical

Supplement : 1

Title : BIOPROCESSING EQUIPMENT

Publication Date: 06/01/2011 - Amendment Supplement 1

Description :

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.

Document Type : Amendment

Language : English

Page Count : 4

Publication Date : 06/01/2011

Revision : 09

Status : Historical

Supplement : 1

Title : Supplement to ASME BPE Bioprocessing Equipment

Publication Date: 10/20/2009 - Base Document

Description :

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.

Document Type : Base Document

Language : English

Page Count : 234

Publication Date : 10/20/2009

Revision : 09

Status : Historical

Title : Bioprocessing Equipment

Publication Date: 01/01/2007 - Complete Document

Description :

FOREWORD

At the 1988 ASME Winter Annual Meeting (WAM), many individuals expressed interest in developing standards for the design of equipment and components for use in the biopharmaceutical industry. As a result of this interest, the ASME Council on Codes and Standards (CCS) was petitioned to approve this as a project. The initial scope was approved by the CCS on June 20, 1989, with a directive to the Board on Pressure Technology to initiate this project with the following initial scope:

This standard is intended for design, materials, construction, inspection, and testing of vessels, piping, and related accessories such as pumps, valves, and fittings for use in the biopharmaceutical industry. The rules provide for the adoption of other ASME and related national standards, and when so referenced become part of the standard.

(a) At the 1989 WAM, an ad hoc committee was formed to assess the need to develop further the scope and action plan. The committee met in 1990 and there was consensus concerning the need to develop standards that would meet the requirements of operational bioprocessing, including:

(1) the need for equipment designs that are both cleanable and sterilizable;

(2) the need for special emphasis on the quality of weld surfaces once the required strength is present;

(3) the need for standardized definitions that can be used by material suppliers, designers/ fabricators, and users; and

(4) the need to integrate existing standards covering vessels, piping, appurtenances, and other equipment necessary for the biopharmaceutical industry without infringing on the scopes of those standards.

(b) The BPE Main Committee was structured with six functioning subcommittees and an executive committee comprising the main committee chair and the subcommittee chairs. The subcommittees are:

(1) General Requirements;

(2) Design Relating to Sterility and Cleanability of Equipment;

(3) Dimensions and Tolerances;

(4) Material Joining;

(5) Surface Finishes; and

(6) Seals.

(c) Throughout the development of the Standard, close liaison was made with the European CEN, ASTM, and the AAA Dairy Standards. The purpose was to develop an ASME standard that would be distinctive, germane, and not in conflict with other industry standards. Wherever possible, the Committee strived to reference existing standards that are applicable to biopharmaceutical equipment design and fabrication.

This Standard represents the work of the BPE Standards Committee and includes the following Parts:

(1) General Requirements;

(2) Design for Sterility and Cleanability;

(3) Dimensions and Tolerances for Stainless Steel Automatic Welding and Hygienic Clamp Tube Fittings;

(4) Material Joining;

(5) Stainless Steel and Higher Alloy Interior Surface Finishes;

(6) Equipment Seals; and

(7) Polymer-Based Materials.

Document Type : Complete Document

Language : English

Page Count : 136

Publication Date : 01/01/2007

Revision : 07

Status : Historical

Title : Bioprocessing Equipment

Publication Date: 01/01/2005 - Complete Document

Description :

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.

Document Type : Complete Document

Language : English

Page Count : 130

Publication Date : 01/01/2005

Revision : 05

Status : Historical

Title : Bioprocessing Equipment

Publication Date: 07/26/2002 - Complete Document *

Description :

This Standard deals with the requirements of the bioprocessing industry, covering directly or indirectly the subjects of materials, design, fabrications, pressure systems (vessels and piping), examinations, inspections, testing, and certifications. Item 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 override mandatory regulations or specific prohibitions of this Standard.

Document Type : Complete Document

Edition : Addenda A: 2004

Language : English

Page Count : 214

Publication Date : 07/26/2002

Revision : 02

Status : Historical

Title : Bioprocessing Equipment

Publication Date: 01/01/2004 - Amendment

Document Type : Amendment

Page Count : 106

Publication Date : 01/01/2004

Revision : 02

Status : Historical

Title : BIOPROCESSING EQUIPMENT

Publication Date: 01/01/2002 - Base Document

Description :

This Standard deals with the requirements of the bioprocessing industry, covering directly or indirectly the subjects of materials, design, fabrications, 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.

Document Type : Base Document

Language : English

Page Count : 108

Publication Date : 01/01/2002

Revision : 02

Status : Historical

Title : Bioprocessing Equipment

Publication Date: 10/17/1997 - Complete Document *

Description :

This Standard covers, either directly or by reference, requirements for materials, design, fabrication, examina- tion, inspection, testing, certification (for pressure sys- tems), and pressure relief (for pressure systems) of vessels and piping for bioprocessing systems, including sterility and cleanability, dimensions and tolerances, surface finish requirements, and seals for the bioprocess- ing systems in which the pressure vessels and associated piping are involved. This Bioprocessing Equipment (BPE) Standard does not address all aspects of these activities, and those aspects that are not specifically addressed should not be considered prohibited. Engi- neering judgment must be consistent with the philosophy of this Standard, and such judgments must never be used to ovemde mandatory requirements or specific prohibitions of this Standard.

Document Type : Complete Document

Edition : Addenda A 9/11/2000

Language : English

Page Count : 150

Publication Date : 10/17/1997

Revision : 97

Status : Historical

Title : Bioprocessing Equipment

Publication Date: 09/11/2000 - Amendment

Document Type : Amendment

Page Count : 51

Publication Date : 09/11/2000

Revision : 97

Status : Historical

Title : BIOPROCESSING EQUIPMENT

Publication Date: 10/17/1997 - Base Document

Description :

At the 1988 ASME Winter Annual Meeting (WAM), many individuals expressed interest in developing standards for the design of equipment and components for use in the biopharmaceutical industry. As a result of this interest, the ASME Council on Codes and Standards (CCS) was petitioned to approve this as a project. The initial scope was approved by the CCS on June 20, 1989, with a directive to the Board on Pressure Technology to initiate this project with the following initial scope:

This standard is intended for design, materials, construction, inspection, and testing of vessels, piping, and related accessories such as pumps, valves, and fittings for use in the biopharmaceutical industry. The rules provide for the adoption of other ASME and related national standards, and when so referenced become part of the standard.

At the 1989 WAM, an ad hoc committee was formed to assess the need to develop further the scope and action plan. The committee met in 1990 and there was consensus concerning the need to develop standards that would meet the requirements of operational bioprocessing, including:

(a) the need for equipment designs that are both cleanable and sterilizable;

(b) the need for special emphasis on the quality of weld surfaces once the required strength is present;

(c) the need for standardized definitions that can be used by material suppliers, designers/fabricators, and users; and

(d) the need to integrate existing standards covering vessels, piping, appurtenances, and other equipment necessary for the biopharmaceutical industry without infringing on the scopes of those standards.

The BPE Main Committee was structured with six functioning subcommittees and an executive committee comprised of the main committee chair and the subcommittee chairs.

The subcommittees are:

(a) General Requirements;

(b) Design Relating to Sterility and Cleanability of Equipment;

(c) Dimensions and Tolerances;

(d) Material Joining;

(e) Surface Finishes; and

(f) Seals.

Through out the development of the Standard, close liaison was made with the European CEN, ASTM, and the AAA Dairy Standards. The purpose was to develop an ASME standard that would be distinctive, germane, and not in conflict with other industry standards. Wherever possible, the Committee strived to reference existing standards that are applicable to biopharmaceutical equipment design and fabrication.

This Standard represents the work of the BPE Standards Committee and includes the following Parts:

(a) General Requirements;

(b) Design for Sterility and Cleanability;

(c) Dimensions and Tolerances for Stainless Steel Automatic Welding and Hygienic

(d) Material Joining;

(5) Stainless Steel and Higher Alloy Interior Surface Finishes; and

(6) Equipment Seals.

This edition was approvedas an American National Standard on May 20, 1997.

Requests for interpretations or suggestions for revision should be sent to Paul Stumpf, Secretary, BPE Committee, The American Society of Mechanical Engineers, United Engineering Center, 345 East 47th Street, New York, NY 10017.

Document Type : Base Document

Language : English

Page Count : 99

Publication Date : 10/17/1997

Revision : 97

Status : Historical

Title : Bioprocessing Equipment

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