Cleaning validation software with PDE-based MACO and worst-case matrix built in.
V5 replaces the cleaning-validation spreadsheet stack: PDE/HBEL-based MACO calculation, worst-case product and equipment matrices maintained continuously, sample-plan generation, swab and rinse result capture with LIMS link, and the validation summary report exported to submission format.
What breaks without this.
MACO calculated once, never updated
A new product enters the shared train and nobody recalculates the limit. The old MACO is now non-conservative and the auditor spots it.
Worst-case matrix on paper
Solubility, toxicity, dosage strength ranked in a locked spreadsheet from 2019. Three product launches later, the ranking is wrong.
Swab results live in QC, MACO in engineering
The result never gets compared to the current limit at the moment of release — it happens once a year at revalidation.
Records-by-execution. Compliance, by design.
PDE / HBEL-based MACO calculation
Per EMA 2014 guideline: MACO from PDE, batch size, shared surface area, sampling recovery — recalculated automatically whenever any input changes.
Living worst-case matrix
Products ranked by hazard × solubility × dosage × cleaning difficulty; the matrix refreshes on every new SKU introduction and flags if the worst case has shifted.
Sampling plan generator
Swab locations mapped to equipment CAD; rinse volumes, recovery studies, blank controls calculated per protocol.
Real-time result → MACO comparison
Every swab and rinse result compared to the live MACO; a failure holds the equipment before the next campaign starts.
Continuous cleaning verification (Annex 15)
Post-validation verification cycle scheduled, executed, and trended — evidence that the validated state is maintained.
What to look for when you're buying.
Cleaning validation moved to HBEL/PDE with EMA guidance and ICH Q3D toxicology. Spreadsheets that still use 1/1000-dose don't survive the audit.
HBEL/PDE calculation
What it tests: Are limits driven by PDE/HBEL toxicology with sourced data?
Why it matters: Legacy 1/1000-dose is no longer accepted alone.
V5: PDE/HBEL native; sourced toxicology captured with the calculation.
MACO with worst-case matrix
What it tests: Are MACO calcs product-by-product with a worst-case matrix?
Why it matters: The matrix drives validation scope.
V5: MACO computed per product-equipment pair; worst-case matrix visible.
Sampling plan
What it tests: Are swab and rinse locations, recoveries and analytical methods captured?
Why it matters: Sampling plan defensibility is where audits linger.
V5: Sampling plan under change control; recoveries versioned.
Dedicated vs shared equipment
What it tests: Does the model distinguish dedicated and shared paths?
Why it matters: Cross-contamination risk depends on this.
V5: Equipment tagged; dedicated paths excluded from shared MACO.
Continuous cleaning verification
What it tests: Is CCV data captured and trended?
Why it matters: EMA expects ongoing verification.
V5: CCV native with trend per equipment.
Spreadsheet vs legacy QMS vs V5.
Cleaning validation approaches.
| Capability | Spreadsheet | Legacy QMS | V5 Ultimate |
|---|---|---|---|
| HBEL/PDE | Rare | Add-on | Native with toxicology source |
| MACO matrix | Manual | Static | Live matrix |
| Sampling plan control | Word | Version limited | Under change control |
| CCV trending | Ad-hoc | Optional | Native |
The clauses, verbatim — and how V5 answers each.
Cleaning validation clauses.
Cleaning validation should be performed to confirm the effectiveness of a cleaning procedure...
V5: Effectiveness demonstrated with validated methods and CCV trending.
Setting health based exposure limits...
V5: PDE/HBEL calculation native with sourced toxicology.
Equipment and utensils shall be cleaned, maintained, and, as appropriate for the nature of the drug, sanitized...
V5: Cleaning execution and verification captured in-system.
Elemental impurities...
V5: Elemental-impurity data feeds MACO where relevant.
Step by step on the floor.
Cleaning validation in V5.
- 1Toxicology
PDE/HBEL captured
Sourced values captured with expert signoff.
- 2MACO
Matrix built
Product-equipment worst-case identified.
- 3Plan
Sampling & method
Locations, recoveries, methods under control.
- 4Execute
Validation runs
Results captured with signed effectiveness.
- 5Verify
Ongoing CCV
Live trend; excursion opens investigation.
The math, with the assumptions visible.
Cleaning ROI is scope and cycle time.
Validation cycle time
Live matrix and controlled plan.
Cleaning-related audit findings
HBEL/PDE and CCV close the classic gaps.
Product-changeover cost
Data-driven MACO.
The changeover savings alone typically pay for the module.
What changed on the floor.
Setting
A multi-product oral solids plant.
Before
MACO in Excel; audit cited legacy 1/1000 approach; changeovers oversized.
After
PDE-based MACO adopted; audit finding closed; changeovers rationalised — throughput up 6%.
Proof points
- MACO recalculated automatically on any input change
- Worst-case matrix living, not frozen
- Swab result → MACO comparison in real time, not annually
- EMA PDE / HBEL and FDA health-based limits both supported
Built to satisfy
- EMA/CHMP/CVMP/SWP/169430/2012 (health-based exposure limits)
- EU GMP Annex 15 (qualification and validation)
- FDA Guide to Inspections Validation of Cleaning Processes (1993)
- ICH Q7 §12 (validation of cleaning procedures)
- PIC/S PI 006 (validation master plan)
Related on V5
Frequently asked questions
Does V5 support HBEL / PDE per the EMA 2014 guideline?+
Yes. PDE is entered per active with the toxicological rationale attached; MACO is derived from PDE, shared surface area, batch size and recovery factor per the current EMA methodology.
How does V5 handle dedicated vs. shared equipment?+
Equipment is tagged as dedicated, shared or campaign; the worst-case matrix and MACO calculation apply only to shared trains and campaign changeovers.
Can V5 integrate with our TOC analyser and HPLC?+
Yes — direct instrument integration or via LIMS. Swab and rinse results flow in with instrument ID, analyst, method version and calibration status.
See V5 on your own line.
Free trial, no card. Live in 7 days with guided onboarding.