GMP quality reports · Training guide

Sterilisation Validation Report

Write the validation report for moist heat sterilisation, sterilising filtration or dry-heat depyrogenation, with every run or batch checked against the acceptance criteria.

Writes: 3.2.P.3.5 3.2.P.2.5 Report
Product type: Small molecule and biologics
Guidance it follows: EU GMP Annex 1 (2022) 8.33–8.100; FDA Sterile Drug Products Produced by Aseptic Processing (2004); FDA Submission Documentation for Sterilization Process Validation (1994); EMA Guideline on the sterilisation of the medicinal product (EMA/CHMP/CVMP/QWP/850374/2015); USP <1229> series, <1228.1>; Ph. Eur. 5.1.1; ASTM F838; PDA TR 1, 3 and 26; EN 285
Time to learn: About 20 minutes with the example

Open the tool at https://app.cmcfy.com/app/sterilisation-validation.html. This guide is also online at https://cmcfy.com/guides/sterilisation-validation.html

1. What this module does

Moist heat: the tool calculates the spore log reduction from F0 and the D121 of the biological indicator, and the SAL for the bioburden approach, and checks the temperature band and the BIs.

Filtration: it checks the bacterial retention challenge and every pre- and post-use integrity test. Dry heat: it checks the endotoxin reduction, temperature and time.

What you get

A Word or PDF report: Sterilisation validation report.

2. Before you start

Have these ready. You can still start with the example data and replace it piece by piece.

Run data: F0 at the cold spot, temperatures during the hold and BI results (steam).
Retention test and integrity test results (filters).
Endotoxin challenge results (dry heat).

Your data stays on your computer. The bar under the title counts every network request the page makes; it stays at 0 because your data never leaves your computer. Download offline copy saves a single file that opens from your own computer with all network access blocked, for air-gapped PCs.

3. Step by step with the example

Open the tool at app.cmcfy.com/app/sterilisation-validation.html. The example is loaded when the page opens, so every panel already has realistic data. Follow the steps to see how it works, then replace the example with your own data.

Choose the method
Choose moist heat, filtration or dry heat, and initial validation or requalification.
Enter the runs
Moist heat: one row per run with the load, minimum F0, temperatures and BIs. Filtration: one row per batch with the bubble points.
Read the result
The headline gives the outcome: "Moist heat validated · 6 runs pass".
Runs and lethality.
Resolve alerts and download
Insufficient lethality, a temperature outside the band, a positive BI or a failed integrity test is critical. Fewer than three passing runs per load is flagged. Then preview and download.

4. Field reference

Every input in the tool, panel by panel. Tables accept rows pasted straight from Excel, comma-separated text, or a loaded file; check the columns after loading a file. Fields marked “when it applies” appear only for the choices that need them.

1 · Process

Field	What to enter
Product or item sterilised	Type it in.
Regulations	Choose one: US: FDA; EU: EU GMP Annex 1, EMA; Both US and EU.
Method	Choose one: Moist heat (steam) sterilisation; Sterilising filtration; Dry-heat depyrogenation.
Equipment	Type it in.
Report number	Type it in.
Study type	Choose one: Initial validation (three consecutive runs); Requalification.

2 · Moist heat

One row per run and load. F0 at the coldest point; temperatures during the hold.

Field	What to enter
Setpoint (°C) when it applies	Type a number.
Hold time (min) when it applies	Type a number.
Approach when it applies	Choose one: Overkill (SLR ≥ 12); Bioburden-based (SAL ≤ 10⁻⁶).
D121 of the biological indicator (min) when it applies	Type a number.
BI population (log10 per carrier) when it applies	Type a number.
Maximum bioburden (cfu per unit) when it applies	Type a number.
Runs when it applies	Use the same load name for runs of the same load pattern. A table. Columns: Run \| Load \| Min F0 (min) \| Min temp in hold (°C) \| Max temp in hold (°C) \| BIs positive \| BIs exposed. Paste rows from Excel, type comma-separated rows, or press Load file (Excel, CSV, Word, PDF or a scan).
Empty chamber heat distribution and cold spot when it applies	Type or paste text.

3 · Sterilising filtration

Field	What to enter
Filter when it applies	Type it in.
Bacterial retention challenge (cfu/cm², B. diminuta) when it applies	Type a number.
Filtrate sterile in every retention test (3 membrane lots) when it applies	Tick the box if it applies.
Viability of B. diminuta in the product shown (or surrogate fluid justified) when it applies	Tick the box if it applies.
Chemical compatibility and extractables assessed when it applies	Tick the box if it applies.
Product-specific bubble point specification (psi, minimum) when it applies	Type a number.
Integrity tests when it applies	A table. Columns: Batch \| Pre-use bubble point (psi) \| Post-use bubble point (psi). Paste rows from Excel, type comma-separated rows, or press Load file (Excel, CSV, Word, PDF or a scan).
Pre-use post-sterilisation integrity test (PUPSIT) performed when it applies	Tick the box if it applies.
PUPSIT risk assessment (if not performed) when it applies	Type or paste text.

4 · Dry-heat depyrogenation

Field	What to enter
Setpoint (°C) when it applies	Type a number.
Runs when it applies	A table. Columns: Run \| Load \| Min temp (°C) \| Time at or above setpoint (min) \| Endotoxin log reduction. Paste rows from Excel, type comma-separated rows, or press Load file (Excel, CSV, Word, PDF or a scan).
Minimum exposure time at setpoint (min) when it applies	Type a number.

5 · Deviations

Field	What to enter
Deviations and their impact	Type or paste text.

5. Checks and alerts

Calculations and pass/fail outcomes always come from fixed rules, never from AI. The tool checks:

SLR ≥ 12 (overkill) or SAL ≤ 10⁻⁶ (bioburden).
Temperature band and BIs.
Retention challenge, integrity tests and PUPSIT; endotoxin reduction.

How to resolve alerts

Critical alerts block the download and must be fixed in the data. A failing result can instead be linked to an investigation: type the investigation reference and outcome and press Record.
Major alerts block the download until you fix them or type a justification and press Accept justification.
Minor alerts do not block anything. They are listed in the documents so the reviewer sees them.
Some alerts have an Apply fix button that makes the change for you. Reopen undoes a justification.

Narratives

This module writes: Discussion and conclusion. Each narrative is written by fixed rules from your data. You can edit it in the box. Rewrite with AI (where your plan includes AI) rewrites it in regulatory style; every number in the text is checked against your data, and a number that does not match is flagged under the box and blocks the download until you correct it. Reset to rule-based text brings back the original.

6. Preview, gap review and download

Press Preview next to a section, or Preview and download all. The document opens in a preview window, exactly as the Word file will read.
The left side lists the review, run on your device: gaps in the data (missing values, open alerts), gaps in the report (missing content the guidance expects, placeholders such as [site] or TBD left in the text) and, if you load the approved protocol under Compare with the protocol, differences from the protocol (requirements, criteria, batches or time points it plans that the report does not show).
Click a finding to jump to the place in the preview. Fix it in the tool, then preview again.
Optional AI review: a second read for contradictions, claims without data and vague wording. The report text is sent to Claude only when you press it, and only where your plan includes AI. Check every AI finding; AI can be wrong.
Press Download Word (.docx) or Download PDF. With several documents open, All as Word (.zip) and All as PDF (.zip) download the set. The download buttons stay disabled while a blocking alert is open; the preview still works.

Documents this module produces

Section	Document
Report	Sterilisation validation report

Use Save project to keep your work as a file on your computer, and Open project to continue later. Start blank clears every field; Load example brings the example back. Nothing is stored on CMCfy servers.

7. US and EU submissions

EU follows EU GMP Annex 1 (2022) and the EMA sterilisation guideline. US follows the FDA aseptic processing guidance (2004) and USP <1229>.

8. Working with other modules

Aseptic filling is validated in the Media Fill (APS) Report report; equipment in Equipment Qualification Report.

9. Common pitfalls

BIs not at the coldest point.
No post-use integrity test.

10. Practice exercises

Each exercise starts from the example (press Load example to reset). We run these on every update of this guide, so the result you see should match.

Lower the lethality
Change the minimum F0 of run PQ-2 from 16.4 to 9.0 minutes.
Expected resultThe headline shows one run failed.