Do You Know What’s New for 2018?
While creating an industry standard is a big challenge, it takes an equal amount of effort to maintain and grow a Standard. In the Bioprocessing Industry, I think we’ve been lucky to have a very dedicated group of people continuously refining and improving the American Society of Mechanical Engineers Bioprocessing Equipment (ASME BPE) Standard, the only international standard for bioprocessing equipment.
Most of you probably know that a new edition of the BPE is released every two years, with the next edition coming out later this year. As usual, there are a number of changes for the next edition. The range of changes is broad — from entirely new content to minor text changes. Below, we give you a quick breakdown of what you can expect. I think you will find some of this really useful.
New for 2018
Pressure Sensors: defines the requirements for proper selection, installation and mounting, as well as, key performance requirements.
Nonmandatory Appendix on Conductivity Sensor Selection: gives guidance on the selection of conductivity sensors. It includes a table on the pros and cons of the different types of conductivity sensor technologies available.
Nonmandatory Appendix on Static Seal Application Guide for Compendial Water Systems: provides general information on static seals to help users make the best choices for the static seals in their systems. This includes descriptions of the materials as well as the following table rating chemical resistance, maintenance, and physical/mechanical properties.
Nonmandatory Appendix on Mechanical Seal Face Material Selection for Compendial Pumps: will have guidance on selecting the appropriate seal face materials for compendial pumps by grading how well the different material types work with each other.
Nonmandatory Appendix on Quality Management Systems (QMS) for ASME BPE Certificate Holders and Applicants: highly useful section for manufacturers who intend to eventually become BPE certified. It lays out the requirements for the Quality Management System (QMS). One of the most important factors to note here, is that the QMS requirements for BPE certification are not the same as those for ISO 9001 (“…With the understanding that an ISO 9001 QMS is not the same as that of a BPE QMS, simply changing the title of an ISO 9001 QMS will typically not be approved.” — From Bioprocessing Piping and Equipment Design: A Companion Guide for the ASME BPE Standard by Bill Huitt)
New terms: There are several new terms defined in this edition including direct visual examination, interrupted electropolish and remote visual examination.
Of course, in addition to all of the new material being added there are refinements of varying degrees throughout the standard, including:
Changes to the marking requirements for fittings and valves
Dimensional changes to some Tee and Cross fittings
New material added to the Metallic Materials Table 5.2.6-1
Throughout the Standard, other changes have been made to clarify and fine-tune the text
These proposed changes and additions are currently working their way through the process to be included in the next edition. After the material is approved, the BPE will be updated and proofed before being finalized later this year.
You can read more about the ASME BPE on our web site. Or, contact our outstanding customer service department at 800-882-3886 for more information.
Best wishes,
Mark