ASME BPE : 2016
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
BIOPROCESSING EQUIPMENT
Hardcopy , PDF
06-05-2019
English
10-14-2016
Important note : All end users must be registered with an Account prior to user licenses being assigned.Specifies requirements for systems and components that are subject to cleaning and sanitization and/or sterilization including systems that are cleaned in place (CIPd) and/or steamed in place (SIPd) and/or other suitable processes used in the manufacturing of biopharmaceuticals.
| DocumentType |
Standard
|
| ISBN |
9780791871171
|
| Pages |
354
|
| PublisherName |
American Society of Mechanical Engineers
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
The purpose of this Part is to identify metallic materials considered acceptable for use in hygienic service. It identifies material specifications, grades and alloys, matching filler metals, fabrication guidelines, and other attributes necessary for this service. It also specifies the data that must be submitted to the MM Subcommittee for any new or unlisted alloy that is proposed for inclusion in Part MM..
| ASTM E 2898 : 2014 : REDLINE | Standard Guide for Risk-Based Validation of Analytical Methods for PAT Applications |
| ASME B31.3:2016 | PROCESS PIPING |
| ASME PTB 2 : 2009 | GUIDE TO LIFE CYCLE MANAGEMENT OF PRESSURE EQUIPMENT INTEGRITY |
| ASTM E 3060 : 2016 | Standard Guide for Subvisible Particle Measurement in Biopharmaceutical Manufacturing Using Dynamic (Flow) Imaging Microscopy |
| AAMI TIR 43 : 2011 | ULTRAPURE DIALYSATE FOR HEMODIALYSIS AND RELATED THERAPIES |
| PIP PHSMV026 : 2017 | HYGIENIC STAINLESS STEEL BALL VALVE DESCRIPTIONS |
| PIP PHSMV025 : 2015 | HYGIENIC STAINLESS STEEL CHECK VALVE DESCRIPTIONS |
| PIP PHSMV029 : 2017 | HYGIENIC STAINLESS STEEL OTHER VALVE DESCRIPTIONS |
| PIP PHSMV027 : 2017 | HYGIENIC STAINLESS STEEL BUTTERFLY VALVE DESCRIPTIONS |
| PIP PHSMV047 : 2017 | HYGIENIC PLASTIC AND PLASTIC LINED BUTTERFLY VALVE DESCRIPTIONS |
| PIP PHSMV042:2017(R2024) | PIP PHSMV042 Hygienic for Food/Beverage/Consumer & CGMP Products Plastic Diaphragm Valve Descriptions |
| PIP PHSMV042 : 2017 | HYGIENIC PLASTIC DIAPHRAGM VALVE DESCRIPTIONS |
| ASME B31.3 SPANISH : 2010 | PROCESS PIPING |
| PIP PHSMV022 : 2018 | HYGIENIC STAINLESS STEEL DIAPHRAGM VALVE DESCRIPTIONS |
| ISO 815-2:2014 | Rubber, vulcanized or thermoplastic Determination of compression set Part 2: At low temperatures |
| CFR 21(PTS200-299) : 0 | FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 200-299 |
| ASME PV CODE 9 : 2017 | BOILER AND PRESSURE VESSEL CODE - WELDING, BRAZING, AND FUSING QUALIFICATIONS - QUALIFICATION STANDARD FOR WELDING, BRAZING, AND FUSING PROCEDURES; WELDERS; BRAZERS; AND WELDING, BRAZING, AND FUSING OPERATORS |
| ISO 815-1:2014 | Rubber, vulcanized or thermoplastic Determination of compression set Part 1: At ambient or elevated temperatures |
| ASME B31.3:2016 | PROCESS PIPING |
| DVS 2202-1:2006-07 | Imperfections in thermoplastic welding joints - Features, descriptions, evaluation |
| ASTM E 644 : 2011 : REDLINE | Standard Test Methods for Testing Industrial Resistance Thermometers |
| ASME B46.1 : 2009 | SURFACE TEXTURE (SURFACE ROUGHNESS, WAVINESS, AND LAY) |
| ISO 34-1:2015 | Rubber, vulcanized or thermoplastic Determination of tear strength Part 1: Trouser, angle and crescent test pieces |
| ASTM A 380 : 2006 | Standard Practice for Cleaning, Descaling, and Passivation of Stainless Steel Parts, Equipment, and Systems |
| ASME PTC19.3 : 1974(R2004) | PERFORMANCE TEST CODE - PART 3: TEMPERATURE MEASUREMENT |
| ASME PVHO 1 : 2016 | SAFETY STANDARD FOR PRESSURE VESSELS FOR HUMAN OCCUPANCY |
| AWS B2.4 : 2012 | SPECIFICATION FOR WELDING PROCEDURE AND PERFORMANCE QUALIFICATION FOR THERMOPLASTICS |
| AWS A3.0 : 0 | STANDARD WELDING TERMS AND DEFINITIONS - INCLUDING TERMS FOR ADHESIVE BONDING, BRAZING, SOLDERING, THERMAL CUTTING, AND THERMAL SPRAYING |
| ASTM E 2500 : 2013 : REDLINE | Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment |
| AWS QC1 : 2007 | STANDARD FOR AWS CERTIFICATION OF WELDING INSPECTORS |
| ASTM E 220 : 2013 : REDLINE | Standard Test Method for Calibration of Thermocouples By Comparison Techniques |
| IEC 60751:2008 | Industrial platinum resistance thermometers and platinum temperature sensors |
| ASME PV CODE 5 : 2017 | BOILER AND PRESSURE VESSEL CODE - NONDESTRUCTIVE EXAMINATION |
| ASME PV CODE 8 SET : 2013 | ASME BOILER AND PRESSURE VESSEL CODE (BPVC) - RULES FOR CONSTRUCTION OF PRESSURE VESSELS (SET) |
| ISO 37:2017 | Rubber, vulcanized or thermoplastic — Determination of tensile stress-strain properties |
| ISO 48:2010 | Rubber, vulcanized or thermoplastic Determination of hardness (hardness between 10 IRHD and 100 IRHD) |
| ISO 11137:1995 | Sterilization of health care products Requirements for validation and routine control Radiation sterilization |
| AWS G1.10M:2016 | GUIDE FOR THE EVALUATION OF THERMOPLASTIC WELDS |
| ISO 34-2:2015 | Rubber, vulcanized or thermoplastic Determination of tear strength Part 2: Small (Delft) test pieces |
| ISO 816:1983 | Rubber, vulcanized — Determination of tear strength of small test pieces (Delft test pieces) |
| ASTM D 471 : 2016-02 | TEST METHOD FOR RUBBER PROPERTY - EFFECT OF LIQUIDS |
| ASTM B 912 : 2002 | Standard Specification for Passivation of Stainless Steels Using Electropolishing |
| ISO 1817:2015 | Rubber, vulcanized or thermoplastic Determination of the effect of liquids |
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.