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AI agent for process development scientists

Cleaning Validation Review Agent

Show that every cleaning result meets its acceptance limit or has a documented corrective action.

ComplianceQuality controlScience and research
See how it worksGet access
Cleaning Validation Review Agent: what goes in, what the agent does and what you get

What it does

After equipment is cleaned, swab and rinse samples are tested for residue, and the results need to be checked against limits that depend on the product, the batch size and the shared surface area. This agent reads the swab and rinse results, recalculates the acceptance limits from the current product data, and compares each result. It flags failures and near misses, and checks that sampling locations and the number of samples meet the protocol. For failures, it proposes a retest, a change to the cleaning method or a longer rinse, and checks the new results the same way. It builds the validation summary with each result and decision. It never closes a validation. The scientist approves the summary. Edge case: a result below the detection limit is recorded as such and checked against the method's limit.

How it works

Follow the arrows from top to bottom. The orange dashed arrow is the loop: when a check fails, the agent goes back and tries again.

Start and resultWhat it doesA check on its own workWaits for your OKGoes back and retries
Yes, continueApprovedYes, continueApprovedNoNo 1 STARTS WHEN Cleaning results received 2 DOES Load results and the sampling plan, then recalculateacceptance limits from product and batch data 3 DOES Compare each result and mark pass, warning or fail 4 CHECKS THE RESULT Were all planned sampling locations tested? If not: list the missing locations and request samples.Back to step 2. 5 DOES Propose retests or cleaning changes for failures 6 YOU APPROVE Scientist approves the proposed actions 7 USES A TOOL Read the new results after the actions 8 CHECKS THE RESULT Do the new results pass at every location? If not: reconsider the cleaning method and repeat thecomparison. Back to step 3. 9 DOES Write the validation summary 10 YOU APPROVE Scientist approves the summary 11 RESULT Cleaning validation summary
Read the steps as a list
  1. Cleaning results received
  2. Load results and the sampling plan, then recalculate acceptance limits from product and batch data
  3. Compare each result and mark pass, warning or fail
  4. Were all planned sampling locations tested?If not: list the missing locations and request samples. Back to step 2.
  5. Propose retests or cleaning changes for failures
  6. Scientist approves the proposed actionsThe agent waits here for your OK.
  7. Read the new results after the actions
  8. Do the new results pass at every location?If not: reconsider the cleaning method and repeat the comparison. Back to step 3.
  9. Write the validation summary
  10. Scientist approves the summaryThe agent waits here for your OK.
  11. Cleaning validation summary

How it decides

It compares each result with the recalculated limit and treats any result above the limit as a failure. It treats results above 80% of the limit as a warning.

  • Fail any result above the calculated limit
  • Warn when a result exceeds 80% of the limit
  • Recalculate limits when the next product or batch size changes
  • Treat missing locations as not validated

Make it yours

Every agent is a starting point. You choose these settings for your own situation.

  • Limit rules and safety factor
  • Warning level (default 80%)
  • Sampling locations
  • Summary format
  • Retest policy

What keeps you in control

It always asks you first

  • Actions after a failure
  • The validation summary

Hard limits

  • Never close a validation
  • Never adjust a result

It stops when

  • Done: all locations pass and the summary is approved
  • Stop: cleaning cannot meet limits with available methods

Set it up

We guide you through the set-up, step by step

Members get the full set-up guide for this agent. No technical skills needed: you copy, paste and upload.

10 minto set it up in your AI
5 AIsChatGPT, Claude, Copilot, Gemini, Grok
  • One set of instructions to paste into your AI, with the clicks for ChatGPT, Claude, Microsoft 365 Copilot, Gemini and Grok
  • The agent then walks you through connecting your own data, one source at a time
  • A downloadable copy with the flow chart, the rules and the full guide
Get access to this agent

An example run

What happensAfter cleaning a reactor, 12 swabs were tested for the previous product. The recalculated limit was 4.2 ug per swab. Nine passed, 2 were at 3.6 and 3.8 (warnings), and the valve swab read 5.9. The agent proposed a longer rinse. The retest read 2.1 at the valve. The scientist approved the summary with a note on the warnings.

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