ASTM International has published E3470-25, a first-edition guide on using FMECA and HACCP/HARPC to identify, analyse and control risk in pharmaceutical and medical device cleaning processes. It is the method layer that E3106 required but did not fully specify.
What happened
ASTM International has published E3470-25, Standard Guide for Using FMECA and HACCP for Performing Risk Identification, Risk Analysis & Risk Control on Cleaning Processes for Pharmaceuticals and Medical Devices. It is a first-edition standard — the "25" denotes the year of original adoption — developed under Committee E55, Subcommittee E55.13 on Process Evaluation and Control. The ASTM store lists it as Active, 21 pages, Book of Standards Volume 14.01, ICS 11.120.10, DOI 10.1520/E3470-25, with a "last updated" stamp of 19 June 2025. Third-party resellers carry a publication date of 1 May 2025 — a metadata artefact rather than two editions, but worth knowing when dating an internal reference.
It did not appear without warning: it is the published form of ASTM Work Item WK85802, discussed in ASTM's own cleaning-standards articles and in E55 team articles on criticality levels in cleaning FMECAs.
Why it matters
ASTM E3106 — Standard Guide for Science-Based and Risk-Based Cleaning Process Development and Validation — established the lifecycle framing: cleaning processes should be developed, qualified and verified under a science-, risk- and statistics-based approach consistent with ICH Q8 to Q12 and ISO 14971. It also asserted, following ICH Q9, that "the level of effort, formality, and documentation for cleaning should also be commensurate with the level of risk."
What E3106 stated as a requirement it did not fully methodise. Section 4.1 of E3470 is explicit: this standard "provides guidance on using failure modes, effects and criticality analysis (FMECA), and hazard analysis and critical control points (HACCP) to perform the risk identification and risk analysis on cleaning procedures as required in Guide E3106." E3470 is the tool-level companion to E3106's programme-level expectation. Teams writing cleaning risk assessments with an improvised scoring scheme now have a published reference describing which tools to use.
What is particularly interesting
FMECA rather than plain FMEA. FMECA adds criticality: a failure mode is classified against specifications, and those specifications can be derived from health-based exposure limits. That ties the severity axis to toxicology rather than opinion.
HACCP/HARPC enters cleaning. Both the scope and the significance sections pair HACCP with its preventive-controls variant HARPC, borrowed from food-safety practice: hazard identification, determination of critical control points, defined monitoring — a structure closer to process control than to a one-off study.
Three cleaning modes, one framework. Section 4.2 states the approach supports data-driven risk reduction and control for manual, semi-automated (clean-out-of-place) and automated (clean-in-place) procedures, and can be adapted to specific cases. Manual cleaning — the mode where human variability dominates and where most sites struggle to defend a risk assessment — is expressly in scope.
Explicit boundaries. Section 4.1.1 notes that medical devices may use an HBEL approach analogous to pharmaceuticals, in which case E3470 applies; where that is not appropriate, the ISO 10993 series governs. Section 4.1.2 is candid that microbiological hazards are not directly addressed through the HBEL route, while pointing to PDA Technical Report No. 54 for the hazard identification and HACCP steps. Section 4.3 links the approach to evaluating PAT tools per Guide E2476.
Other tools are not excluded. Section 4.1 states plainly that while E3470 describes FMEA/FMECA and HACCP/HARPC, "other risk assessment tools may be used as well," citing ICH Q9(R1) and ISO 13053. The standard is a reference method, not a mandate.
What could we learn
The value of E3470 lies less in introducing FMECA or HACCP — both long established — than in legitimising them for cleaning and in tying criticality to HBEL-derived specifications. Third-party technical articles by ASTM cleaning-team members report that criticality is resolved on a Shirokizawa matrix, plotting the compound's toxicity score (from its HBEL, per ASTM E3219) against the cleaning process's capability score, placing a product into one of eight categories with associated risk-reduction and risk-control expectations. Those descriptions are consistent, but the matrix sits behind the paywall: treat it as a characterisation, not a verified reproduction of the standard's text.
The practical consequence, if that characterisation holds, is that monitoring intensity and analytical method specificity become traceable outputs of a documented risk assessment rather than policy defaults — from specific methods with statistical process control at the high-criticality end to qualified visual inspection alone at the low end.
Questions worth asking in our own programme
- Is our cleaning risk assessment built on a named, documented method, or on a scoring table inherited from an older template?
- Do our severity ratings trace back to something defensible — an HBEL, a specification — or to consensus opinion in a workshop?
- Have we applied the analysis equally to manual cleaning, COP and CIP, or does it quietly cover only automated equipment?
- Are our critical control points monitored continuously, or do we assess risk once at validation and never revisit it?
- Where cleaning is manual, how is operator variability represented in the occurrence axis of the analysis?
- Have we excluded microbiological hazards from the HBEL-based analysis and then failed to address them by any other route?
Wider context
E3470 is one publication in a deliberate ASTM programme expanding E3106 into implementable method standards — alongside E3219 on deriving HBELs, limits standards, and work items on clean-by-design, cleaning-validation-programme risk assessment and process capability. ASTM standards come from a voluntary consensus process, which matters for how regulators may treat them. ICH Q9(R1), adopted 18 January 2023 and effective in the EU from 26 July 2023, supplies the risk-management vocabulary E3470 uses throughout.
Sources
- ASTM E3470-25, product page (title, scope, significance, committee, page count, DOI): https://store.astm.org/e3470-25.html
- ASTM E3106-22, scope and significance: https://store.astm.org/e3106-22.html
- ASTM E55.13 subcommittee listing: https://www.astm.org/membership-participation/technical-committees/committee-e55/subcommittee-e55/jurisdiction-e5513
- ICH Q9(R1) guideline, adopted 18 January 2023: https://database.ich.org/sites/default/files/ICH_Q9%28R1%29_Guideline_Step4_2023_0126_0.pdf
- ASTM E55 cleaning team article on criticality levels and the Shirokizawa matrix (third-party characterisation of E3470): https://www.bioprocessonline.com/doc/a-data-derived-approach-for-selecting-criticality-levels-in-fmecas-for-cleaning-process-risk-analysis-0001
- Risk-based analytical method selection using ASTM standards (third-party characterisation): https://www.meddeviceonline.com/doc/risk-based-analytical-method-selection-in-cleaning-validation-using-astm-international-standards-0001
- ASTM International Pharmaceutical Cleaning Standards: Current Status And Future Direction: https://www.pharmaceuticalonline.com/doc/astm-international-pharmaceutical-cleaning-standards-current-status-and-future-direction-0001
Validation takeaway
E3470-25 supplies the method layer that ASTM E3106 required but left open: FMECA and HACCP/HARPC applied to cleaning risk identification, analysis and control, for manual, COP and CIP processes. It does not replace E3106 or ICH Q9(R1) and does not mandate a single tool - but it gives a published reference against which an existing cleaning risk assessment can be benchmarked, and it links criticality to HBEL-derived specifications rather than to opinion.
Questions worth asking in our own programme
- Is our cleaning risk assessment built on a named, documented method, or on a scoring table inherited from an older template?
- Do our severity ratings trace back to a defensible specification such as an HBEL, or to consensus opinion in a workshop?
- Have we applied the analysis equally to manual cleaning, clean-out-of-place and clean-in-place, or does it quietly cover only automated equipment?
- Are our identified critical control points monitored on an ongoing basis, or was risk assessed once at validation and never revisited?
- Where cleaning is manual, how is operator variability represented in the occurrence axis of the analysis?
- Have microbiological hazards been excluded from an HBEL-based analysis and then left unaddressed by any other route?
