Methodology
How we work, and how we correct errors
You should be able to check anything we tell you against a primary source. So here is how: where every statement comes from, how a standard edition is verified before it reaches our copy, how a published error is corrected, and what we say when a question is still open.
In short
The rules this site's copy is written to
A statement about what a standard requires carries the clause number. If we cannot give you the clause, we do not make the statement. Where we have only seen a clause quoted elsewhere and have not read that edition ourselves, we say so or leave it out. Our readings are labeled as ours, and we do not cite ourselves. Corrections are dated and left on the page that carried the error. Where we do not know, we say so.
Sources
Where a statement on this site comes from
Packaging validation is a field where a confident sentence with no clause behind it travels a long way before anyone checks it. So we rank sources, we say which rank a statement came from, and we do not promote a lower rank by writing it more firmly.
- 1The text of the standard
Cited by designation, edition year and clause: ASTM F1980-21 section 1.5. Where we quote, the words are the standard's own. We do not paraphrase a clause and leave the paraphrase looking like a quotation. Where a standard is one we have not bought, we say that instead of citing it anyway.
- 2The regulator's own record
The FDA Recognized Consensus Standards database, FDA guidance documents, and the Code of Federal Regulations. A recognition number, a recognized edition and a transition date come from the database entry itself, never from somebody's summary of it.
- 3Our reading, labeled as ours
Standards leave choices open on purpose. Where the text is silent or offers a range, we say the position is ours and give the reasoning under it. One worked instance rather than an abstraction: at a chamber temperature of 60 C against an ambient of 23 C, with Q10 taken as 2.0, the acceleration factor is 12.996, so a three year claim is 84.26 days. We schedule 85. Rounding down would age the samples for less time than the claim they support, so we round up and record that we did. That is our position, and we label it as one. A judgment is never written as a requirement.
- 4Everything else, treated as opinion
Laboratory and consultancy articles, white papers, webinars and conference slides. Often useful, sometimes correct, never authority. We do not cite a vendor article as the basis for a requirement, and we do not repeat a claim that arrives without a clause reference, however many places it appears in.
- 5Practitioner forums
Read constantly, cited for one thing only: evidence of what people in this job are actually asking and where the standards are hardest to apply. A forum answer is not a source for what a standard requires, even when it is right.
The rules that follow from that
- A statement about what a standard requires carries the clause number. If we cannot give you the clause, we do not make the statement.
- Where we have only seen a clause quoted elsewhere and have not read that edition ourselves, we say so or we leave it out.
- We do not cite ourselves. A page on this site is not evidence for another page on this site.
- Every editorial and reference page carries a named byline, the date it was last reviewed and the date it was last changed. The sitemap reports the date the content actually changed, not the date of the last rebuild.
Editions
Why a standard designation on its own is not a citation
The edition FDA recognizes is not always the latest edition the standards body has published, recognition can be superseded, and a superseded recognition can stay usable for declarations of conformity until a date the database states. The designation alone therefore tells you very little. What matters is the recognized edition and the date attached to it, and both are checkable in a public database in under a minute.
- We name a test method by its designation wherever that is the plain way to refer to it, for example ASTM F1980 for accelerated aging.
- A recognition number, a recognized edition year or a transition date appears in our copy only after that entry has been read in the FDA Recognized Consensus Standards database. We record the date it was read and keep a copy of the entry.
- Where the check has not been done, the number does not go on the page. That is why some pages here name a method with no edition year against it.
- The same rule governs deliverables, not just the website. The standards and editions table in a report is built from one internal standards register, and that register is checked against the database before a report is issued, not on an annual cycle.
The FDA Recognized Consensus Standards database
Free, public, and the place to check anything we tell you about a recognition. If our copy and that database disagree, the database is right and we want to hear about it.
The FDA Recognized Consensus Standards databaseThe recognitions we publish, and what they do and do not mean
- 14-530
ISO 11607-1:2019, without Amendment 1
Entry read in the FDA Recognized Consensus Standards database on 4 August 2026, and a copy of it kept.
Declarations of conformity to this recognition are accepted for premarket submissions until 20 December 2026.
- 14-594
The recognition that supersedes 14-530, for the edition including Amendment 1:2023
Entry read in the FDA Recognized Consensus Standards database on 4 August 2026, and a copy of it kept.
This entry records which recognition supersedes which, and nothing more. What Amendment 1:2023 requires is a statement about the text of a standard, so under the first source rule above it travels with the clause that carries it. That citation is not in our standards register yet. It goes here when it is, with the date it was read.
- 14-531
ISO 11607-2:2019, without Amendment 1
Entry read in the FDA Recognized Consensus Standards database on 4 August 2026, and a copy of it kept.
Declarations of conformity to this recognition are accepted for premarket submissions until 20 December 2026, the same date the entry for Part 1 states. The two parts carry separate entries, so we read both rather than carrying one date across to the other.
- 14-595
The recognition that supersedes 14-531, for the Part 2 edition including Amendment 1:2023
Entry read in the FDA Recognized Consensus Standards database on 4 August 2026, and a copy of it kept.
As with 14-594, this settles which edition is recognized and nothing about what the text of ISO 11607-2 requires. We have not bought that standard, so no clause of it appears anywhere on this site.
- 14-596
ASTM F88/F88M-23, seal strength of flexible barrier materials
Entry read in the FDA Recognized Consensus Standards database on 4 August 2026, and a copy of it kept.
Recognized as a complete standard, with no transition period stated.
- 14-600
ASTM F1929-23, detecting seal leaks in porous medical packaging by dye penetration
Entry read in the FDA Recognized Consensus Standards database on 4 August 2026, and a copy of it kept.
This is the current recognition. It supersedes 14-484, which covers the 2015 edition, and declarations of conformity to 14-484 are accepted for premarket submissions until 4 July 2027. That is a second transition date on this site, it is not 20 December 2026, and it is worth checking which one a protocol of yours is written against.
- 14-359
ASTM F2096-11 (Reapproved 2019), detecting gross leaks by internal pressurization
Entry read in the FDA Recognized Consensus Standards database on 4 August 2026, and a copy of it kept.
Recognized as a complete standard, with no transition period stated. Gross leaks, to a stated detection limit. It is not a fine leak method and we do not describe it as one.
- 14-575
ASTM F1980-21, accelerated aging of sterile barrier systems
Entry read in the FDA Recognized Consensus Standards database on 4 August 2026, and a copy of it kept.
Recognized as a complete standard, with no transition period stated. It is a guide rather than a pass or fail criterion, and the recognition says nothing about what any section of it contains.
- 14-576
ASTM D4169-22, performance testing of shipping containers and systems
Entry read in the FDA Recognized Consensus Standards database on 4 August 2026, and a copy of it kept.
Recognized as a complete standard, with no transition period stated.
The two ISO 11607-1 statements and the two ISO 11607-2 statements are about what a premarket submission declares conformity to. None of them is a statement about devices already on the market, none is a recall, and none means anyone has to revalidate. If you have cleared products and no submission pending, these dates do not apply to you, and anyone telling you otherwise is worth a second look. None of these entries tells you what any standard requires. A recognition entry records the edition, its extent and its dates, and that is all it records.
Limits
What we say when a question is still open
The most dangerous sentence in this business is "you are fine". The next most dangerous is a confident answer to a question nobody actually checked. Both are cheap to say and expensive to have believed.
- We say the words. "We do not know" and "that is not in the standard" are complete answers, and both are cheaper for you than a guess that has to be defended later in an Additional Information response.
- We say what would settle it: which clause, which database entry, which document of yours, and roughly how long it takes to find out.
- An unverified number does not ship. Common practice is not a requirement, and we do not let one stand in for the other because it sounds more certain.
- We never promise a regulatory outcome. Asked whether we can guarantee clearance, the answer is no. What we commit to is scope, schedule, the rationale in writing, and, for 24 months after delivery, being available to help you answer questions a regulator asks about our work: four hours included in a validation program, one hour in a gap assessment, and chargeable at the rate in your statement of work beyond that.
- A gap assessment can conclude that you have no gap and need nothing. That is a real finding, written up with the evidence it rests on and the limits of what was reviewed. Nothing about our fee changes with the finding, which is the point of asking someone whose fee does not move with the answer.
Open questions we have not closed
This list is maintained, not decorative. Each entry is a question a buyer of this work could reasonably expect us to answer and that we cannot yet answer from a primary source. Entries leave the list by being answered, not by aging out of it.
- What happens to a premarket submission already under FDA review on 20 December 2026?
Open. We have not read FDA's own account of this at source, so we do not answer it here, and we do not answer it on a call either.
Any FDA statement accompanying the transition, read at source and recorded with the date read. The 14-530 and 14-594 entries themselves have been read. What is missing is FDA's handling of a submission already in the queue.
- How many production lots should a packaging validation draw samples from?
Open. A particular lot count is repeated widely as though it were a requirement. We traced our own use of it to a source that gave no basis for it, so we withdrew it, and we do not restate the number here. See the corrections log below.
A requirement in the text of a standard, a statement from a regulator, or an explicit risk-based rationale written for a specific device and process. The third is the one that can be defended if it is questioned, and that rationale, not the number, is the deliverable.
Corrections
How a correction is made
We sell document control. A site that quietly edits its own claims while selling document control has already answered the question of whether it practices what it sells.
- A correction is made on the page that carried the error. The URL does not change, and the page is not deleted to make the problem go away.
- The correction is dated and states three things: what the page said, what it says now, and the source that settled it.
- The notice stays. It is not removed once the page has been quiet for a while. It is part of the page.
- Anything that changes what a page asserts is logged below as well as marked on the page, so every correction is visible in one place. Typographical fixes are not logged.
- If you told us, we say that you told us, unless you would rather we did not.
- If an error reaches a deliverable rather than a web page, this policy is not the remedy. The document is re-issued at a new revision, the change is recorded inside it, and you are told directly rather than left to spot it. Superseded versions are retained for seven years.
Corrections log
Two entries, both dated before this site went live, and both claims we had made in our own internal material and would otherwise have published. The log starts there rather than at launch, because a corrections policy that opens with a clean sheet on day one is not evidence of anything.
- A mandated test order that does not exist
2026-08-03
Our internal positioning material stated that performance testing comes before stability testing, that samples are transit tested and then aged, and that a reviewer notices when aged samples were never transit tested.
There is no mandated order, and therefore no wrong order to point at. ASTM F1980 section 1.5 places distribution, handling and shipping events outside the scope of the aging guide, so aging evidence and distribution evidence answer different questions about the same package. They are separate branches off the sterilized product, and whether to combine them is a documented risk-based decision. Our reading, labeled as ours under the source rules above: combining them can make the plan more severe than the real distribution path, and it makes an event-related defect harder to distinguish from a time-related one.
The claim traced to a single vendor article carrying no clause reference. Our own internal worked example had handled it correctly, setting out both orders, choosing one and recording why. The summary written on top of that worked example hardened the choice into a rule, and the summary was the version that got reused.
Corrected before launch. No page here has ever carried the claim. The entry exists anyway, because the standard we are asking you to hold us to is that you get to see the error, not just the corrected text.
- A lot count we could not source, withdrawn
2026-08-03
Internal material listed a specific number of production lots as one of the details that signals competence to a reviewer. We do not repeat the number here, because repeating it is how it spread.
It came from the same sentence and the same unverified source as the sequencing claim above. Once one of the pair was disproved, we withdrew the other rather than keep it on the balance of probability. It is blocked from anything we publish or deliver, including diagrams, sample size material and report templates, until it is either verified at a primary source or replaced with a risk-based rationale written for the device it applies to.
Two claims traveled together in one sentence for so long that they were being checked as one claim. They were not one claim.
Open. Listed under open questions above.
Independence
How we are paid, and by whom
Much of the packaging advice a small manufacturer receives comes from someone who also sells the tests being recommended. That is not dishonesty, it is the structure of the market. Our position on it is a set of facts you can check on an invoice rather than a claim about our character.
- We own no laboratory and hold no interest in one. We sell no packaging and no materials.
- We take no commission, referral fee or rebate from any laboratory or supplier. If we are ever paid by anyone other than you in connection with your work, you are told before it happens.
- Laboratory charges are passed through at cost, with the laboratory's own charge shown against them and our handling charge on its own line. You can see what we are paid.
- The gap assessment fee is not credited against later work, so what we find does not change what we earn.
- We hold no ISO/IEC 17025 accreditation and no ISO 13485 or ISO 9001 certification, and we claim none. No physical testing happens here. It is subcontracted to a laboratory selected for the method. Accreditation is scope specific, so what we check before selecting one is whether its accredited scope covers the method your device needs, not that a certificate exists.
Document control
This page is a controlled document
It carries a named author, a review date and a change date, and it changes the same way everything else here does. The quality manual that governs our records, retention and document control is available on request.
- Supplier qualification pack
The documents you need on file to bring us in as a consultant under your own supplier controls. The page is free to read; the documents themselves are sent on request.
- How a program runs
The same discipline applied to the work itself: what gets decided, what gets written down, and what you receive.
Corrections welcome
If we have something wrong, tell us
Every editorial and reference page here carries a named byline, and the address goes to the person named on it rather than to a queue. Send the clause or the database entry and you get a personal reply the same business day. If you are right, the page changes and says that it changed, with your name on it if you want it there.