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For MS&T and E&L teams

Cumulative extractables risk, from drawing to dossier.

EluteCAD turns multi-vendor single-use assembly drawings into audit-ready USP <665> cumulative extractables risk assessments in minutes — computed by a deterministic, fully traceable engine instead of a twelve-week consulting cycle.

Start an assessmentSee the method

Cumulative patient exposure vs. limit

4 unit operations · 5 components · 3 vendors · engine v0.2.0

Pass · 14 flags to disposition
  • Synthetic phosphate degradant B98.5%
  • Synthetic cyclic siloxane E1.54%
  • Synthetic antioxidant degradant A1.27%
  • Synthetic phosphite antioxidant C0.400%
  • Synthetic cyclic siloxane D0.0306%
  • Synthetic lactam monomer F0.00250%
Binding compound Synthetic phosphate degradant B reaches 1.97 µg/day of a 2.00 µg/day limit; 98% comes from one component in Formulated bulk hold. Every number is traceable to its vendor data point.Illustrative output of the EluteCAD engine on synthetic data. Not vendor data.

How it works

  1. 01

    Ingest vendor extractables data

    USP <665> and BioPhorum validation guides from every supplier — GC-MS, LC-MS and ICP-MS results for pH 3, pH 10 and 50% ethanol at each time point — mapped to exact part numbers and sterilization dose, with page-level provenance for every value.

  2. 02

    Build the fluid path

    Import a BOM or drawing, or assemble the train by hand: media bag → silicone tubing → Y-connector → PES filter → bioreactor → TFF. Wetted area comes from geometry; each step carries volume, time, temperature, fluid and clearance.

  3. 03

    Scale deterministically

    Surface-area scaling, bracketed time, Arrhenius temperature extrapolation, downstream clearance and patient dose — calculated by a versioned engine, never a language model. Every number expands into its derivation.

  4. 04

    Swap, review, sign, export

    Substitute a back-ordered part and see in seconds which compound, if any, crosses its limit. Disposition flags, sign with record-bound e-signatures, and export a report for Module 3.

Deterministic by design

Language models help read vendor PDFs; they never do the math. The scaling engine is a small, pure, versioned library with exact decimal arithmetic, so the preview in your browser and the signed report on the server are bit-for-bit identical.

  • Conservative defaults. No credit for shorter contact, lower temperature or clearance unless you justify it — and every credit is flagged for review.
  • Independently verified. A second implementation in a different language must agree to 30 significant digits on every golden case.
  • Explainable. Each compound's dose decomposes into per-component contributions, solvent choice, time point, temperature factor and carry-through.

Model, per compound j

Areal mass from vendor extract
mA,j = Ctest,j · Vtest / SAtest
Component contribution
Mi,j = mA,j(ti) · fT · SAi · ni
Temperature (Arrhenius)
fT = exp[ −(Ea/R) · (1/Ti − 1/Ttest) ]
Cumulative patient dose
Dj = Σi Mi,j · Πk>i(1 − CFk,j) · Vdose / Vbatch
Margin of safety
MoSj = PDEj / Dj ≥ 1

Built for inspection

Append-only audit trail

Every change to a regulated record is written to a hash-chained log that the database itself enforces, so tampering is detectable.

Record-bound e-signatures

Each signature carries name, time and meaning, requires re-authentication, and is bound to the SHA-256 of the exact result signed.

Four-eyes data curation

Extractables data stays unverified until a second person checks it against the source document; only approved data can be signed off.

Designed to support 21 CFR Part 11 and EU GMP Annex 11 controls. EluteCAD supports — and does not replace — the judgment of a qualified toxicologist and your quality unit.