Andrew Lamore

*The ASME BPE Standard provides requirements for components, equipment, and systems when there is
contact with the product, raw materials, or product intermediates during clinical or commercial manufacturing of molecules intended for human or animal medicinal applications. It also applies to supporting systems that could directly or indirectly affect the clinical or commercial process [e.g., water-for-injection (WFI), clean steam, filtration, and intermediate product storage].

This… Show more

*The ASME BPE Standard provides requirements for components, equipment, and systems when there is
contact with the product, raw materials, or product intermediates during clinical or commercial manufacturing of molecules intended for human or animal medicinal applications. It also applies to supporting systems that could directly or indirectly affect the clinical or commercial process [e.g., water-for-injection (WFI), clean steam, filtration, and intermediate product storage].

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. If the provisions of this Standard are optionally applied by an owner/user to existing, inservice equipment, other considerations may be necessary.

*YES -THIS IS NEW!* Show less

This ASME Standard provides the requirements applicable to the design of equipment used in the bioprocessing, pharmaceutical and personal-care products industries, as well as other applications with relatively high levels of hygienic requirements. It covers materials, design, fabrication, inspections, testing and certification.

ASME-BPE is unique in the world, having resulted from widespread industry requests for standardization. It is the leading Standard on how to design and build… Show more

This ASME Standard provides the requirements applicable to the design of equipment used in the bioprocessing, pharmaceutical and personal-care products industries, as well as other applications with relatively high levels of hygienic requirements. It covers materials, design, fabrication, inspections, testing and certification.

ASME-BPE is unique in the world, having resulted from widespread industry requests for standardization. It is the leading Standard on how to design and build equipment and systems used in the production of biopharmaceuticals. It incorporates current best-practices for enhancing product purity and safety. Companies that rigorously apply ASME-BPE often can achieve production efficiencies, lower development and manufacturing costs, and increase quality and safety, while complying with regulations.

New topics from the last revision include:

• Aseptic and Containment Isolators
• Immersion (COP) Washers
• 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
• Nomenclature

ASME-BPE is referenced in ASME’s B31.3 Code on Process Piping.

Moreover, two weld discoloration acceptance criteria color charts, ASME BPE MP-2012 and EP-2012, are available separately. They allow you to match acceptable discoloration levels perfectly, so as to help assure optimum safety and code-compliance.

Intended for regulatory agencies, multinational corporations, plant owners, pressure-equipment fabricators, designers, constructors, materials suppliers, inspection organizations, and others.

The ASME BPE Standard standardizes specifications for the design and construction of new fluid processing equipment used in industries that require a defined level of purity and bioburden control. Show less

An article that postulates that sensors have a lot of data, and that we should be more clever about how we use it in today’s modern world!

The best (and only) consensus standard in the world that describes how to construct a modern Biopharmaceutical facility.

The ASME Bioprocessing Equipment Standard was
developed to aid in the design and construction of new
fluid processing equipment used in the manufacture of
biopharmaceuticals, where a defined level of purity and
bioburden control is required.

A "virtual coffee table book" for activities at Burkert Canada!

ASME BPE serves the needs of those involved in the BioProcessing, Pharmaceutical, and Personal Care Product industries.
The ASME BioProcessing Equipment (ASME BPE) Standard provides designers and process engineers with a reliable and measurable way of specifying Hygienic Tubes, Valves and Fittings for use in High Purity applications such as Water-for-Injection (WFI), clean steam, ultrafiltration, etc. As a result, the process of design installation, validation and maintenance will be easier… Show more

ASME BPE serves the needs of those involved in the BioProcessing, Pharmaceutical, and Personal Care Product industries.
The ASME BioProcessing Equipment (ASME BPE) Standard provides designers and process engineers with a reliable and measurable way of specifying Hygienic Tubes, Valves and Fittings for use in High Purity applications such as Water-for-Injection (WFI), clean steam, ultrafiltration, etc. As a result, the process of design installation, validation and maintenance will be easier to manage and should assist in minimizing overall project and maintenance costs.

My group ensured that the Process Instrumentation subsection of the standard had a "shared voice" - as if written by a single author. Show less

A regular, detailed, yet succinct international update of the Pharmaceutical processing industry - for regulatory matters, technical concerns and overall trends.

Some simple, straightforward, "shoot from the hip" videos of Burkert products in action!