Have you ever enjoyed a wine and cheese night? You could thank the ASME BPE-2022: Standard for Bioprocessing Equipment for the last time you indulged in your cheese board with a glass of wine because this standard provides the requirements for bioprocessing equipment, which is essential in transforming foods like grapes into wine and renin and milk into cheese.
The ASME BPE-2022 Standard for Bioprocessing Equipment
ASME BPE-2022 specifies the requirements for the design of pure and safe equipment used in various industries, including bioprocessing, pharmaceutical, and personal care products, with high levels of hygienic requirements. Bioprocessing refers to the technique or operation used in the manufacture and/or purification of biopharmaceuticals: pharmaceuticals manufactured by biotechnology sources with the products having biological sources.
The ASME BPE Standard was developed to aid in the specifications for the design and construction of new fluid processing equipment used in biopharmaceutical industries that require a defined level of purity and bioburden control. This standard provides requirements for materials, design, fabrication, inspections, testing, and certification. The standard typically applies to:
- Components that are in contact with the product, raw materials, or product intermediates during manufacturing, development, or scale-up.
- Systems that are a crucial part of product manufacture [e.g., water-for-injection (WFI), clean steam, filtration, and intermediate product storage].
ASME-BPE is the leading standard for designing and building equipment and systems used in the production of biopharmaceuticals. Companies that apply ASME-BPE often achieve production efficiencies, lower development and manufacturing costs, and increase quality and safety, while complying with regulations.
What is Bioprocessing?
Bioprocessing is the creation of a useful product through the use of a living organism, which is usually cells or cell components, viruses, or a whole animal. Bioprocessing can be divided into two categories:
1. Upstream: manages the initial steps of a fermentation process development of a host life form to deliver a product and involves screening and identification of microorganisms (e.g., bacteria and fungi), media preparation, multiplication of microbes inside a bioreactor, and incubation.
2. Downstream: involves the final steps of a bioprocess that manage product harvest. These steps include extraction, purification, and packaging of the product that resulted from the fermentation.
Upstream and downstream bioprocessing thereby are the two main steps of a bioprocess to create an end product. End products range from biofuels produced from algae, antibiotics created from mold (e.g., penicillin), cheese created from mixing milk with an enzyme called renin, and beer produced from yeast. Bioprocessing byproducts thereby can be made by modern chemical techniques like for bioethanol and biodiesel, or they may require natural techniques like for wine, cheese, and biological washing powder.
Which Bioprocessing Equipment Is Covered in ASME BPE-2022?
ASME BPE-2022 provides the requirements for the design of bioprocessing equipment. Equipment includes mirrors/magnifiers; measuring devices (steel rule, dial and digital calipers, fillet gauge, radius gauge, temperature-sensitive crayon, slope level, undercut gauge); borescope/fiberscope, profilometer, positive material identification, and calibration records (inspection equipment).
Changes to the ASME BPE-2022 Standard
ASME BPE-2022 revises the previous edition of the bioprocessing equipment standard, which was published in 2019. New topics added during the 2022 revision of ASME BPE include:
- Aseptic and Containment Isolators
- Immersion (COP)
- Seals Applications Guide for Compendial Water Systems
- Mechanical Seal Face Material Selection for Compendial Water Pumps
- Pure Steam Distribution Systems; Conductivity Sensors Selection
- Pressure and Turbine Flow
- Thermal Welding of Thermoplastic Elastomer Tubing
- Mechanical Hose Barb Connections
ASME BPE-2022 Standard for Bioprocessing Equipment is available on the ANSI Webstore.