1. What is ISO 11607-3 in one minute?
- It is a new, first-edition part of the ISO 11607 series, published in September 2026.
- It covers how to develop the forming, sealing and assembly processes that make a sterile barrier system (SBS), such as a pouch, a tray with a lid, or a header bag.
- It is about the stage before validation: understanding your process well enough that validation is likely to pass the first time.
The easy way to remember it
Part 3 helps you build a good process. Part 2 asks you to prove that the process works. Part 1 makes sure the packaging design and materials are right.
2. Where Part 3 fits in the ISO 11607 family
| Part | Main focus | Typical question it answers | Who uses it most |
|---|---|---|---|
| ISO 11607-1 | Materials, SBS and packaging system design | Is this package design right for the device and the sterilization method? | Packaging design and R&D engineers |
| ISO 11607-2 | Validating forming, sealing and assembly (IQ, OQ, PQ) | Can we prove the process gives good packages every time? | Validation and quality engineers |
| ISO 11607-3 (new) | Developing those processes before validation | Do we understand which settings matter, and why? | Process, manufacturing and packaging engineers |
3. Key terms in plain language
| Term | What it means in practice |
|---|---|
| Sterile barrier system (SBS) | The minimum packaging that keeps the device sterile until it is opened, such as a sealed pouch. |
| Forming | Shaping material into a cavity, for example thermoforming a blister or tray. |
| Sealing | Joining two layers (usually with heat, pressure and time) to close the package. |
| Assembly | Putting all the parts together: the materials, the device and any inserts. |
| Process variable | A machine setting you can change that affects the result, such as temperature. |
| Control | Keeping a variable within set limits. |
| Monitoring | Watching and recording a variable or result to show it stays in range. |
| Process equivalence | Showing that a second machine or line gives the same result as the first one. |
4. General requirements at a glance
- Quality system: carry out process development inside your QMS (for example ISO 13485), with controlled records.
- Risk management: link process risks to product and patient risk, using the ISO 14971 approach.
- Sampling: have a reason for each sample size. Do not just pick a convenient number.
- Test methods: use suitable, validated methods for seal strength, seal integrity and visual inspection.
- Documentation: record each decision, data set and rationale so that validation and audits can follow it.
5. The process development journey, step by step
- 1Start from the SBS specification: know what a good package must achieve, such as seal width, strength range, integrity and appearance.
- 2Write a draft process specification: list the outputs you need and the acceptance criteria for each one.
- 3Do an initial process risk analysis: ask what could go wrong in forming, sealing or assembly, and how bad it would be.
- 4Identify the process variables: find the settings that really change the output, and how much they change it.
- 5Plan initial control and monitoring: decide how each important variable is held in range and checked.
- 6Finalise the process specification: write down the confirmed settings, limits and outputs.
- 7Set up a process risk management plan: keep the risk file up to date as you learn more, through validation and routine production.
Loop back when controls are weak
If your risk review shows that a control is not strong enough, go back, adjust the variables or controls, and review again. Do not move to validation just to stay on schedule.
6. The three sealing variables that matter most
| Variable | What it affects | If it is too low | If it is too high |
|---|---|---|---|
| Temperature | How well the seal layer softens and bonds | Weak or incomplete seal, channels | Burnt or brittle seal, material damage, tearing on opening |
| Contact pressure | How closely the layers touch | Gaps, wrinkles, uneven seal | Thinned material, squeeze-out, weak seal edges |
| Dwell time or line speed | How long heat is applied | Under-sealed areas | Over-sealed, distorted seal, slower output |
7. Finding the sealing window
The aim is to find a range of settings where the seal is both strong enough and looks good. You can then run production in the middle of that range, not at its edges.
- Run trials across a range of temperatures, keeping pressure and time fixed at first.
- Measure the seal strength at each setting and plot it, to make a seal curve.
- Score each seal visually (for example channels, wrinkles, burns, how it peels) on a simple scale.
- Choose the range where both strength and appearance meet your specification. Set your process limits inside that range.
- Repeat for pressure and dwell time, or use a designed experiment (DOE) to study them together.
| Check | Too cold | Right window | Too hot |
|---|---|---|---|
| Look | Seal patchy, not fully transparent | Even, uniform seal across the width | Discoloured, shiny or distorted |
| Peel | Opens too easily, may open on its own | Smooth, consistent, clean peel | Tears material, fibres or film pull off |
| Integrity | Risk of channels and leaks | Passes integrity testing | Risk of pinholes or cracks at the seal edge |
8. Heat sealing basics: how seals open
| Peel type | What happens when opened | What to watch for |
|---|---|---|
| Adhesive peel | The seal layer separates cleanly from one surface | Clean, consistent opening. A good sign for most peel pouches. |
| Cohesive peel | The seal layer splits inside itself, leaving coating on both sides | Must be designed for. Check that no particles are left behind. |
| Material tear or delamination | The packaging material itself tears or splits | Often means over-sealing, or a material problem. Investigate. |
- Know your materials: uncoated, coated and film-to-film combinations each behave differently.
- Ask your supplier for the recommended sealing ranges, then confirm them on your own equipment.
- Look at the opened seals as well as the strength numbers. The way a seal peels tells you a lot.
9. Sealer features that make validation easier
Equipment checklist (pouch sealers, tray sealers, form-fill-seal)
- Shows actual temperature, pressure and time, not just the set points
- Independent sensors that can be calibrated
- Alarms or a stop when any variable goes outside its limits
- Rejects or flags packages sealed outside the limits
- Recipe or parameter lock, so settings cannot be changed without control
- Records data or logs each cycle, if needed for traceability
- Clear maintenance points, such as seal bar condition and parallelism
- Supplier documents ready for IQ
10. A simple FMEA example for heat sealing
| Failure | Effect | Possible cause | Control |
|---|---|---|---|
| Channel in seal | Loss of sterility | Wrinkle in material, low pressure | Material handling SOP, pressure alarm, visual inspection |
| Weak seal | Pouch opens in transport | Temperature drift | Calibrated sensor, temperature alarm, periodic peel test |
| Over-sealed seal | Tear or particles at opening | Temperature or dwell time too high | Upper process limit, recipe lock |
| Wrong material loaded | Seal does not bond as expected | Mix-up at line set-up | Line clearance, label check, barcode check |
| Contaminated seal bar | Uneven seal | Residue build-up | Cleaning schedule, start-up check |
11. Process equivalence: can a second sealer be used?
Companies often add a second sealer or move a process to another site. Part 3 gives a structured way to decide whether the new set-up can be treated as equivalent to the first, instead of starting development from zero.
| Ask yourself | If yes | If no |
|---|---|---|
| Are the SBS specifications and requirements the same? | Continue | Treat it as a new process |
| Are the materials the same? | Continue | Develop the process again for the new materials |
| Does the equipment work on the same sealing principle, with similar control? | Continue | Development work is needed |
| Do the outputs (strength, integrity, appearance) match, based on data? | Equivalence can be justified | Investigate and adjust |
- Evidence to keep: side-by-side seal data, a statistical comparison, equipment specifications and a written rationale.
- Possible data sources: development trials, existing validation data, routine production data and supplier data.
- Equivalence supports validation. It does not remove the need for it. Follow ISO 11607-2 for the validation itself.
12. Weak practice vs good practice
| Weak practice | Good practice |
|---|---|
| Copy the supplier's settings straight into OQ | Confirm the settings with your own trials and seal curve |
| Study temperature only | Study temperature, pressure and time, and how they interact |
| Choose sample sizes without a reason | Record a statistical or risk-based reason for each sample size |
| Check seal strength only | Check strength, integrity and visual quality together |
| Run production at the edge of the window | Set the normal running point near the centre of the window |
| Fill in the risk file after validation | Use the risk analysis to guide which variables you study |
What auditors usually ask
How did you choose these sealing parameters? Expect to show your development data, seal curves, your reasons for the chosen limits, and how risk shaped the decision. "The supplier told us" is not enough on its own.
13. Implementation checklist
Before you start validation
- SBS specification approved, with measurable acceptance criteria
- Draft process specification written
- Initial process risk analysis done and linked to product risk
- Key variables identified and their effects studied
- Sealing window found using strength and visual data
- Process limits set inside the window, with a rationale
- Sample sizes justified
- Test methods suitable and validated
- Equipment able to control, monitor and alarm on key variables
- Control and monitoring plan drafted
- Final process specification approved
- Process risk management plan in place for validation and routine production
14. Where to go next
Once your process is developed, the next step is to validate it. Our free Packaging Validation course takes you through ISO 11607-1 and -2: seal integrity, ageing and transport testing, and building an audit-ready packaging file. It ends with an exam and a certificate.
Note: this article is a plain-language summary written for training purposes. Always refer to the official ISO 11607-3:2026 standard for the exact requirements.
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Medical Device Packaging Validation — A Complete Guide
A free course on ISO 11607-1/-2, seal integrity, ageing and transport testing, and audit-ready packaging files, with an exam and a certificate.
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