The ASME BioProcessing Equipment (ASME BPE) is an international standard recognized in over 30 countries. This standard provides the requirements applicable to the design of equipment used in the bioprocessing, pharmaceutical, and personal care product industries, including aspects related to sterility and cleanability, dimensions and tolerances, surface finish, material joining, and seals. These apply 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].
Topics include:
- General Requirements
- Design for Sterility and Cleanability
- Worldwide Accepted Dimensions and Tolerances for Stainless Steel Automatic Welding and Hygienic Clamp Tube Fittings and Process Components
- Material Joining
- Stainless Steel and Higher Alloy Interior Surface Finishes
- Equipment Seals
- Polymer-Based Materials
- Certification
- Metallic Materials of Construction for Hygienic Processes
- Rouge and Stainless Steel
- Passivation
- Electropolishing
- Bioreactor/Fermentor Design
- Sterilizer/Autoclave Design
- CIP and Process Gas Distribution Systems
