The full packaging validation program, managed end to end.

In short

What a packaging validation program delivers

Packaging validation program management means one firm owns the whole evidence chain: the plan, the test matrix and its rationale, the sample size justification, the laboratory statement of work, the chain of custody, the data review and the final report. The program delivers eleven documents and costs $25,000 to $40,000 all in, laboratory charges included at cost. Three to six months assumes an accelerated arm of one to three months; a longer claim or a cooler chamber runs past it.

What you are actually buying.

A laboratory sells machine time. It runs the protocol you specify, to the letter, and the reasoning that produced that protocol stays yours to defend. A packaging section can carry every test anyone would expect and still come back as an Additional Information request, because what fails is the connection: a sample size with no stated basis, a set of tests with no recorded reason, and no line drawn from the packaging decisions to the risk file. That line is what ISO 11607-1 AMD1:2023 asks for, and it is what we build.

Packaging validation is document work and laboratory work. The plans, protocols, justifications and reports are built by us and reviewed by you. Your samples go to the accredited laboratory whose scope covers the method and whose schedule fits your submission date, wherever in the country that is. We are tied to none of them, so that choice is made on merit and on your dates.

Eleven documents, and each one is yours to file and defend.

Each one is a document that lands in your quality system under your document number, written so a reviewer can follow the reasoning without calling you. We run the program end to end, from the intake record to the final report.

01Discovery and intake record

The device, the sterile barrier system and its maker, the sterilization method and maximum cycles, the shelf-life claim, the distribution profile and the submission date, agreed in writing before any work starts. Everything downstream traces back to it.

02Packaging Validation Plan

The controlling document: scope, the packaging system under validation, the standards and editions applied, acceptance criteria set in advance, and the linkage to your ISO 14971 risk file. You approve it before anything is booked.

03Test matrix and rationale

Every test set against the requirement that calls for it, with the reason it is there and the reason the alternatives were not taken. The rationale column is the part a reviewer reads.

04Sample size justification

The statistical basis for the numbers, tied to the risk of the failure mode being tested, written to be defended in an Additional Information response rather than assembled after one arrives. A laboratory saying a number is common practice is not a rationale.

05Sample build and chain of custody records

Which units, built when, from which materials, sterilized on which cycle, handled by whom, shipped where, received by whom. Untraceable sample provenance is one of the quiet ways a validation package fails an audit long after the testing passed.

06Individual test protocols

One protocol per method: seal strength (ASTM F88/F88M), dye penetration for seal integrity (ASTM F1929), whole-package integrity (ASTM F2096), accelerated aging (ASTM F1980), and distribution simulation (ASTM D4169, or ISTA 3A where the path is single parcel rather than palletized). Written for your packaging system, not a template with the device name changed.

07Laboratory statement of work

What the laboratory is instructed to do, in the form its scheduler and technicians work from, with its scope of accreditation checked for each method before samples ship. A laboratory can hold ISO/IEC 17025 and still not be accredited for the method your device needs. Accreditation is scope-specific, and checking it against your method set is part of what you are paying for.

08Deviation and nonconformance handling

The route for an unexpected result, decided in advance and recorded when it is used. A failing result is a valid outcome of a correctly specified test. How it was investigated and dispositioned is part of the evidence, not an embarrassment to be tidied away.

09Test data review

The raw data checked against the protocol before it becomes a conclusion, including confirmation that acceptance criteria were fixed before the results existed. Criteria written after the results are not evidence, and a reviewer who spots it is likely to doubt the rest of the file.

10Validation Summary Report with clause traceability

The connected story. Every conclusion traced to a clause of ISO 11607-1 or ISO 11607-2, every number traced to a data set, every decision traced to the rationale that produced it. This is the document your submission cites, and it is the reason to hire us rather than call the laboratory directly.

11Change control and revalidation guidance

What triggers a re-run and what does not: a material substitution, a sealer change, a new sterilization cycle, a shelf-life extension. Written so your change control process can act on it without calling us first.

Two branches, not a sequence.

Performance and stability are separate branches, not stages of one sequence. ASTM F1980 section 1.5 puts distribution, handling and shipping events outside the scope of the aging guide, so the two arms answer different questions about the same package. No order between them is mandated, and no order is wrong. If anyone tells you there is a required order, the question to ask is which clause says so, and we hold ourselves to the same question.

What matters is which arms your product's risk profile justifies, whether any of them are combined, and whether the reason is written down. Combining a distribution challenge with an aged sample removes your ability to tell an event-related defect from a time-related one, and it moves the severity of the challenge away from the real distribution path in a direction you then have to justify in the protocol rather than assume. It is taken where the risk assessment calls for it, with the reasoning recorded. That decision is the part a laboratory cannot make for you, because the laboratory is running the method you specified.

What happens if a regulator asks a question.

A question about packaging usually arrives months after delivery, and it arrives on your desk. For 24 months after delivery we remain available to help you answer questions from a regulator, notified body or certification body about our work. Four hours are included per validation program, and one hour per Gap Assessment. Beyond that, support is charged at the rate in your statement of work.

Both the hours and the rate are in your statement of work before you sign, so what a regulator's question costs is a number you can read at signature rather than one you meet at invoice time.

You own the file, and it works without us.

Deliverables and protocols are your property from the day they are written. The plan, the protocols, the justifications and the report are built for your quality system in your document numbering, and they are yours whether the program continues or not. The protocols are written so your own engineer or your laboratory could execute them from the document alone. You are buying an asset, not a dependency. The quality manual and the supplier qualification pack are both sent on request.

Where our work ends, and yours begins.

Those eleven documents are the whole of what we build for you. Everything below is who owns what, so the split is never a surprise once the program is running.

• The testing runs at an accredited laboratory, under its own ISO/IEC 17025 accreditation, selected for the method and verified against its scope before samples ship. We specify it, instruct it, and review what comes back.
• You are the manufacturer. You approve and own the validation, and yours is the only name in the approval block.
• Packaging evidence is the whole of what we sell, so the recommendation is only ever about your evidence.
• Sterilization process validation stays with your contract sterilizer. We work from its outputs and build the packaging evidence around them.
• ISO 11607-2 sealing process validation is quoted separately when it is in scope. Confusing Part 1 with Part 2 is the tell, and we would rather price them apart.

The 2026 deadline changes your paperwork, not your testing.

FDA recognition 14-530, the un-amended ISO 11607-1:2019, is not accepted for declarations of conformity in premarket submissions after 20 December 2026. A program that finishes after that date, or that supports a submission made after it, is written against the amended edition from the start, which is a documentation matter rather than extra testing. It applies to premarket submissions only. Devices already on the market are not affected and nothing here requires you to revalidate them.

Questions worth asking before signature.

How much does a full packaging validation cost?

A full program is scoped at $25,000 to $40,000 all in, including laboratory charges at cost. The professional fee is fixed at scoping, laboratory fees are passed through at the laboratory's price with that charge shown against the line, and our charge for managing them is a stated percentage of those fees, written into your statement of work before anything is booked and shown on every invoice.

What puts a program above the range?

Laboratory charges do. A method set or a pull-point schedule can carry laboratory charges near $30,000, and a program of that size is quoted above the range with the proposal showing the laboratory's own numbers and the reason each method is there. The professional fee is still fixed at scoping, so the part you are paying us is settled before the laboratory quotes.

How long does it take?

Three to six months where the accelerated arm is one to three months. The document work is weeks. The chamber time is set by the claim and the chamber temperature, and it can run longer than the range: a three-year claim held at 50 C is 169 days in the chamber on its own. Your dates are calculated at scoping rather than quoted from a bracket. Real-time aging continues past your submission by design.

Can you do it faster?

The paperwork, yes. The aging, no. Q10 arithmetic sets the chamber time, and a shorter run supports a shorter claim. What can be compressed is everything before the samples reach the laboratory: the plan, the protocols and the sample build.

Can you guarantee our submission clears?

No, and nobody can. A promised regulatory outcome is worth a second look wherever you hear it. What we commit to is the scope, the schedule, the sampling rationale in writing, and the included support hours if a regulator asks a question about our work.

Do you make the submission?

You do, and that is deliberate. You are the manufacturer, yours is the only name in the approval block, and the evidence package is written to be filed under your document numbers by your regulatory team or your consultant. What we hand over is a report your submission can cite without rework.

What happens if a test fails?

A failing result is a valid outcome of a correctly specified test. The deviation is investigated and dispositioned against a route the plan set out in advance, and the record becomes part of the evidence. A failure found in validation costs money. The same failure found after submission arrives as an Additional Information request, and the response has to be built while your submission waits.

Can we use our own laboratory?

Yes, subject to two checks. We confirm that its scope of accreditation covers each method we intend to run, and that its test method validation position is documented. Those are the same checks we apply to any laboratory. If a method is not covered, we say so in writing and you decide what to do about it.

We already have a protocol. Can you review it instead?

Yes. That is the Gap Assessment: $2,500, ten business days, no laboratory testing, and a clause-by-clause read of what you already have against ISO 11607-1, ISO 11607-2 and Amendment 1:2023.

Who does the work?

A senior packaging specialist, from the intake record to the final report. There is no account manager between you and the specialist writing your protocols, and the specialist who writes your file is the one who supports it afterwards, on the terms set out under support below.

Three questions that tell you whether you need us.

Run it in house if you can answer three questions today. Do you have a written sampling rationale you would defend in an Additional Information response? Do you have a recorded decision on which test arms run, in what combination, and why? Do you have a test method validation position for every method you intend to use? Three yeses and your file already holds. A no to any one of them is the gap, and a gap of this kind is not found when the decision is made. It is found when somebody reads the file.

If you are not sure which of the three is missing, start with the Gap Assessment. It is $2,500, ten business days, no laboratory testing, and a possible finding is that you have no gap and need nothing.

Thirty minutes, and you leave with something.

No slides. We talk through the device, the sterilization method and the submission date, and you leave with an outline of what a program for your device would involve, what it would cost and how long it would take. A reply the same business day, from the specialist who would run your program, not a queue.