From today, your pharmaceutical clients have an additional tool for selecting suppliers: ASME BPE certification, which was historically reserved for the sanitary aspects of plant systems, now extends to pressure vessels. Those who are prepared for this change will have a competitive advantage. Those who are unprepared will not.
What’s changing, in brief
Until recently, there was a paradox: pressure vessels, such as for example bioreactors, fell outside the scope of the BPE regulations, even though they were already designed and manufactured with these requirements in mind in practice. The only thing missing was official certification. With the 2026 Edition, that gap has been closed.
Initially, I was a little confused, because the new Designation is not explained in full: U-BPE is mentioned only in a brief paragraph, without clarifying in detail what it refers to. I therefore wrote to the Committee and received a clarification which I am sharing with you:
- U-BPE applies to pressure vessels compliant with both ASME Section VIII Div. 1 and ASME BPE.
- BPE, for pressure vessels constructed in accordance with a national or international code (e.g. EN 13445) and, in addition, ASME BPE.
In fact, Chapter GR-1 states: “When operating under pressure conditions, systems shall be constructed in accordance with the ASME BPVC, Section VIII or ASME B31.3 or applicable local, national, or international codes or standards”.
What is the rationale behind this decision?
ASME BPE covers the hygiene and sanitisation aspects of bioprocessing systems. However, it is not a recognised standard for pressure resistance, even though there are sections that address these issues.
Therefore, in both cases (U-BPE or BPE), one point remains clear: for pressure vessels
ASME BPE does not replace the code governing pressure resistance; it complements it. Your pressure vessel must still be designed and constructed in accordance with a recognised code (BPVC Section VIII Div. 1, EN 13445, or another applicable standard), whilst BPE adds the hygiene compliance required by the pharmaceutical and biotech sectors.
Let us clarify this point with regard to ASME Section VIII Div. 1. Paragraph U-3 lists the standards recognised by the Code. ASME BPE is not among these standards; therefore, any component manufactured in accordance with BPE is not automatically recognised by BPVC.
What is the benefit of this new edition of ASME BPE for pressure vessel manufacturers?
For those working in the bioprocessing market, the benefit of this choice is the ability to certify their products to ASME BPE, regardless of the code used to address safety concerns relating to hazards arising from pressure and the fluids contained within.
As I have already written in another article, the risk will not come with a formal warning but will arise quietly: some companies will not lose contracts; they will simply cease to be invited to tender. The specifications of major pharmaceutical groups and international engineering companies have included ASME BPE requirements for years. Those who do not meet them are excluded during the supplier qualification phase, even before price comes into play.
For a manufacturer of pressure vessels for the bioprocessing market, this means one concrete thing: failing to comply today will not be a neutral choice. It is a choice that will restrict the market accessible to them tomorrow.
What needs to be done, in practice
Before going into the technical details, the real question to ask at management level is this: which of your target markets will require U-BPE, and which will be satisfied with the BPE designator alone? Everything else depends on the answer to this question: timelines, investment and the certification process.
Once this has been clarified, the decision-making process is as follows:
1. Assess the current gap
Does your company already have expertise in the pressure resistance code you use (BPVC, EN 13445, or another)? And in BPE? The product will need to comply with both simultaneously: this is the first requirement to address.
2. Understand which certification is actually required
- If the market requires only the BPE designator, the path is more straightforward: a 3-day ASME survey, conducted by two ASME Team Leaders, to obtain the Certificate of Authorisation.
- If the market requires U-BPE, the company must already be an ASME-certified manufacturer for BPVC, or apply for Dual Certification (BPVC + BPE together). In this case, the Joint Review lasts 4 days, again with 2 ASME Team Leaders.
3. Drawing up (or updating) the Quality Manual
The core of certification is not a document that merely reiterates the codes, but an operational manual that describes how the requirements of the standards are met. In other words, it sets out who does what, when, where and how, to ensure compliance with GMP (and, where applicable, GVP) requirements. It covers areas such as: responsibilities and delegations, supply requirements, design, materials, surface finishes, gasket management, cleanability and drainability, welds, non-destructive testing, heat treatments, document management, product compliance test and conformity marking. It is a task that requires preparation well in advance of the survey date.
4. Plan well in advance
The survey or joint review is not the starting point; it is the culmination of a preparation process. The sooner you begin the internal gap assessment, the sooner you can be ready to participate in tenders that now require this standard.
The question to raise in meetings is not whether to comply, but how much time you have before your competitors do so first.
