Version and scope
These terms are not the agreement for paid work. If you engage us, a separate signed agreement governs that work.
In these terms, a "signed agreement" means any agreement you and we have both signed, including a master services agreement, a short form engagement for a gap assessment, and a confidentiality agreement. Where a signed agreement and these terms touch the same subject, the signed agreement controls. Section 4 explains the boundary.
1Who runs this site
probitysciences.com (the "site") is operated by Probity Sciences, a packaging validation consultancy based in the Greater Seattle Area, Washington, United States. Probity Sciences is an independent packaging validation consultancy. In these terms, "we", "us" and "our" mean Probity Sciences.
Probity Sciences is not a registered company. There is no incorporated entity behind the trading name today. Until there is, these terms are an agreement between you and the proprietor operating as Probity Sciences. When an entity is formed, this page will name it and will be re-dated.
You can reach us at info@probitysciences.com. Notices, requests and complaints under these terms go to that address. We publish no phone number and no street address.
1.1What we are, and what we are not
This matters enough to put in the terms rather than leave to the marketing pages, because it is the thing a reader is most likely to assume wrongly.
- We are a consultancy. We are not a laboratory. We own no test equipment, and we do not perform testing or generate test data. Where a validation program we manage requires testing, it is performed by an independent laboratory holding its own accreditation.
- We hold no accreditation. We do not hold ISO/IEC 17025 accreditation and we do not claim it.
- We hold no financial interest in any laboratory or packaging supplier, and we take no commission on testing. Where we recommend a laboratory, we are recommending it and nothing else.
- We are not a certification body, a registrar, a notified body or a regulator, and we are not affiliated with, endorsed by or acting for any of them, or for ISO, ASTM, AAMI or the FDA.
Nothing on this site, and nothing in these terms, should be read as suggesting otherwise.
2Accepting these terms
These terms apply to your use of the site. They set out the basis on which everything here is published.
If you submit the contact form, you accept these terms and confirm you have read our privacy policy.
If you only read the site, these terms still set out the basis on which the content is published. Sections 4, 5, 6, 7, 8, 12 and 13 describe what the content is, what it is not, and how it may be relied on. They apply to anything you read here.
Agreeing to these terms is not agreeing to receive marketing. Nothing in this document is a consent to be emailed, texted or called. Section 11 sets out how any such consent would be given, separately, by an act you have to take yourself.
The site is written for professionals at medical device manufacturers and their suppliers. It is intended for business use by adults. It is not directed to children.
3What you may use the site for
Use the site for your own professional reference, and for evaluating whether to work with us. Please do not:
- scrape, crawl or bulk-download the site or its content with automated tools, except as any robots.txt or llms.txt we publish allows, and except for ordinary indexing by a search or answer engine that respects them;
- republish substantial portions of our text, tables, worked examples or calculator logic as your own, or present our work as yours;
- try to break, overload, probe or gain unauthorized access to the site or the systems behind it;
- obtain or attempt to obtain material or information through any means we have not intentionally made available through the site;
- use the site for anything unlawful, or to harass, defraud or harm anyone;
- use the contact form, or any address published here, to send us unsolicited commercial messages.
We may take steps to stop abuse of the site, including asking our hosting provider to restrict access.
Linking to our pages, quoting a sentence or two with attribution, or citing a figure with a link back is fine and welcome. Section 7 sets out what you can do with the content in more detail.
4This site is not the engagement
We publish technical content so that a quality or regulatory engineer can judge whether we know the work. Reading it does not start an engagement, and neither does contacting us.
- Nothing on this site is an offer to perform work, and nothing on it is a quote, a proposal or a commitment to accept an engagement.
- No professional, consulting, advisory or client relationship is created by reading a page, using a calculator, receiving a document from us, sending us an email, booking or taking an introductory call with us, receiving a scope and fee outline after that call, or submitting the form on our contact page. A relationship begins only when you and we have signed an agreement covering the specific work.
- An introductory call, and any scope or fee outline that follows it, are not an engagement and are not a validation deliverable for your device. They exist so that both sides can decide whether to work together. Any figure or opinion given in that conversation is preliminary, is given without sight of your file, and is superseded by a signed agreement.
- The scope, deliverables, responsibilities and terms of any paid work are set by the signed agreement, not by this page and not by anything on the site. Where these terms and a signed agreement conflict, the signed agreement controls.
- We are not liable for decisions you make in reliance on the site, in the absence of a signed agreement covering the specific work. That is not a hedge about the quality of what we publish. It is the plain consequence of the fact that we have not seen your device, your process, your data or your file. Section 13 sets out the limits and applies to this.
4.1Sending us information
The contact form asks what your device is and gives you space to describe the problem. What you send there is held in confidence. It is used to respond to you, to assess whether we can help, and to keep a record of the inquiry in the systems this practice runs on. We do not publish it, we do not sell it and we do not share it for anyone else's marketing. Our privacy policy sets out where it is held and who processes it.
The form is not the right place for controlled documents. There is no way to attach a file to it, and please do not paste drawings, specifications, protocols or test data into it. If your organization needs a signed confidentiality agreement in place before that material moves, say so in your message and we will put one in place first.
If you send us information on behalf of an employer or a client, you confirm you are permitted to send us that information.
We aim to reply to every message the same business day, and that is the commitment stated on the contact page. It is a commitment we work to, not a contractual guarantee, and an unanswered message is not a rejection or an acceptance of anything. If a reply matters to a deadline you are working to, say so in the message and agree it with us rather than assuming it.
5The technical content, and any calculators
This is the section to read if you are going to use anything from this site in your own work.
5.1What the published content is
We publish technical material about ISO 11607, ASTM F1980, accelerated aging arithmetic, sample size justification and related subjects. It is written for engineers, and it is written to be checked. Our practice is to set out, on the same page, the arithmetic behind a number and the source it comes from. If you find a number here without them, tell us and we will fix the page.
That content is general technical information. It is written without any knowledge of your device, your packaging system, your sterilization method, your materials, your process, your data, your quality system or your regulatory strategy. So, specifically:
- it is not regulatory advice and not legal advice;
- it is not a validation deliverable: it is not a protocol, a report, a rationale or a justification for your product;
- it is not a review of your file and not an assessment of anything you hold;
- it is not a statement of what any regulator, notified body, certification body or reviewer will accept, require or do. We do not speak for any of them and we do not predict them.
5.2If this site provides a calculator
Where a page on this site provides a calculator, it does one thing: it applies arithmetic that is published in full on the page beside it. You enter inputs, the tool applies the stated method, and it returns the result together with the working. There is no hidden model and no proprietary adjustment. You can do the same calculation with a pencil and get the same answer, and we would rather you checked than took it on trust.
What a calculator cannot do is choose your inputs. The inputs are engineering and regulatory judgments about your product: the shelf life you are claiming, the Q10 you are assuming, the ambient conditions you are designing to, the reliability and confidence you are targeting, what counts as a failure. Change an assumption and the answer changes, legitimately. The tool does not know which assumption is right for your device, and neither do we until we have looked at it.
So the output of a calculator is an input to your justification, not the justification. It is a number produced by a stated method from inputs you chose. Whether that method and those inputs are appropriate for your device, your process and your submission is an engineering judgment that belongs to you.
Using a calculator, reading its output or printing it creates no engagement and no professional relationship between you and us. See section 4.
5.3Your validation, and your submission, remain yours
If you are a manufacturer, you are responsible for the validation of your packaging system and for everything you put in front of a regulator. Nothing on this site changes that, and nothing on this site is capable of changing it.
- You choose the inputs, you apply the result and you own the conclusion.
- You approve your own documents. We do not approve anything through this site, and our name does not belong in your approval block.
- You remain responsible for your regulatory submissions, your technical documentation and your quality system records, including the decision to use any figure taken from this site.
- If you use a number, a method or a form of words from this site in a submission, you are adopting it as your own, having satisfied yourself that it is right for your device. That is how any reference source is used, and it is how this one should be used.
5.4Accuracy, and what happens when we get something wrong
We publish the arithmetic beside the answer so that it can be audited, and we correct what is shown to be wrong. That is a description of how we work, not a warranty. The disclaimer in section 12 and the limits in section 13 both apply to it. Two honest qualifications:
- 1Standards and regulations change
ISO 11607 and the standards around it are revised, and regulatory expectations move. A page that was correct when it was written can be overtaken. Where a page carries a review date, that is the date we last checked it against the sources, not a guarantee that nothing has moved since.
- 2We can make mistakes
Anyone publishing technical material can. What we commit to is the remedy rather than the impossibility: if you think something here is wrong, tell us at info@probitysciences.com and say what and why. We read every message sent to that address about a correction. If you are right, we correct the page, say on the page that it changed, and credit you by name if you want the credit. If we think it stands, we explain why.
If you send us a correction, a suggestion or any other feedback about the site, you are giving us permission to use it, to act on it and to publish a corrected page, without any obligation to you and without payment. We will not identify you as the source unless you ask us to. Please do not send us anything you consider confidential or proprietary in a correction; sections 4.1 and 5.5 apply.
Verify anything that matters against the standard itself and against your own regulatory requirements before you act on it. That is not us hedging our arithmetic. It is the ordinary discipline of using any external source in a regulated file, and your quality system almost certainly requires it of you already.
5.5If you put something from this site into a controlled file
Pages on this site are not controlled documents in the sense your quality system means. Where a page carries a review date, that is a date, not a revision number. Pages are revised without notice, they are not under change control, and we do not issue change notifications or maintain a distribution list. Section 9 applies: a page you relied on may be revised or withdrawn.
So if you print a page, or a calculator's output, and put it in a design history file, a validation file or a submission, treat it as an uncontrolled external reference on the date you took it. Record the date, record the version of the standard you checked it against, and satisfy yourself that it is right for your device. Your quality system almost certainly requires that of any external source already.
6Standards, regulations and other people's material
The site discusses standards and regulations published by others, including ISO 11607, ASTM F1980, and the FDA's regulations and guidance.
- We do not reproduce those documents. Standards published by ISO, ASTM, AAMI and similar bodies are copyright works sold by those bodies. Nothing on this site is a substitute for holding a current, licensed copy of the standard you are working to, and you should read the standard rather than our description of it.
- Where we describe or summarize a standard, that is our reading of it. It is not the text, it is not authoritative, and it does not bind anyone. Where our reading and the standard differ, the standard is right.
- Regulations and official guidance are the controlling text, in whatever version applies to your product in your market. We cite where we can so you can go to the source.
- Names, marks and standard numbers belonging to others are used to identify the documents they refer to. That use does not imply any affiliation with, sponsorship by or endorsement from ISO, ASTM, AAMI, the FDA or any other body.
7Who owns what, and what you may do with it
The underlying facts are not ours. The requirements in a published standard, the text of a regulation, the Arrhenius relationship and the arithmetic that follows from it are public, and we do not claim to own any of them. We point you to the sources so you can check us.
What is ours is the way we have selected, organized, worked through, dated and written it up: the explanatory text, the worked examples, the tables, the structure of the guides, the diagrams, the site design, and the way any calculator we publish presents its working. Those are protected by copyright and by other rights, and they belong to us or to people we have licensed from. "Probity Sciences" is our trading name and we claim rights in it as a mark.
7.1What you may do without asking
- Read the site, print pages, and save copies for reference inside your own organization.
- Quote a sentence or two with attribution and a link back.
- Cite or link to any page, in an internal document, a report or a submission.
- Use a figure you calculated here in your own documents. You do not need our permission, and we do not want a credit line in your file. Section 5.3 applies: once you use it, it is yours.
- Circulate inside your own organization any document we send you for supplier qualification, and keep it in your qualification file. Please do not republish it outside your organization.
7.2What you may not do without written permission
- Republish, redistribute or sell our text, tables, worked examples or guides, in whole or in substantial part, in any medium.
- Present our material as your own, or strip attribution from it.
- Build any calculator we publish into your own product, service or template pack, or reimplement it from this site as something you offer to others.
- Bulk-download or mirror the site, or reproduce it as a dataset that you distribute or sell, other than as any robots.txt or llms.txt we publish permits.
- Use the Probity Sciences name or marks in a way that suggests we endorse, reviewed or produced something we did not.
If you want to do something this section does not allow, ask, at info@probitysciences.com. The answer is often yes, and we would rather be asked than find out.
8Links to other sites
Where we link to another site, such as a regulator, a standards body or an official database, that site is independent and we do not control it. We link a source because it is the place to check something, not because we vouch for everything on it, and we are not responsible for its content, its accuracy or its privacy practices. When you follow a link off this site, that site's terms and privacy policy apply, not ours.
A link is a citation. It is not a recommendation, an endorsement, or a statement that we have assessed whoever is on the other end of it.
9Availability of the site
We may change, suspend, withdraw or restrict any part of the site at any time, including pages, guides and any calculators, without notice. We do not promise the site will always be available, that it will be error-free, or that a page you relied on will still be there. If you need to keep a copy of something, keep one.
10Privacy
Our privacy policy, published at probitysciences.com/privacy, explains what the site collects, where it goes and who processes it. It sits alongside these terms. If you use the contact form, read it first.
Section 3 of that policy is a dated list of everything this site actually does, kept deliberately short and deliberately checkable. Section 5 of it explains what you are agreeing to when you send us something, and works together with section 11 below.
Privacy policy11Messages from us: email and text
This is the section a mobile carrier or a messaging provider will read. It is written to be found and read on its own, so it repeats a few things said elsewhere. These are the messaging terms for Probity Sciences.
11.1What is running today
As at the date at the top of this page, Probity Sciences operates no text message program. We collect no phone number through this site, we send no text messages, and we are not registered with the United States mobile carriers to send business text messages. Nothing on this site says or implies that we are.
The only messages we send today are email: a reply to an inquiry you sent us, and a small number of follow-ups about that same inquiry, described in 11.2.
The rest of this section is the standing terms for messages we send. It applies in full to email today, and it applies to text messages if and when that program exists.
11.2Replying to you, and following up
If you write to us, we will write back. That is the point of the form and of the published address, and it does not require any separate permission.
We may also follow up about the same inquiry if you go quiet. The boundary is a number rather than a judgment call: at most three follow-ups, within 90 days of the last message you sent us, about the subject you raised and nothing else. Any new message from you restarts that window. Every follow-up carries one line telling you how to make it stop, and "please stop" in any words, by any route, stops it.
A follow-up about your own inquiry is not a marketing message and it is not a subscription. It is also not a list: nobody is added to anything by writing to us.
11.3Email that is not a reply to you
If we ever send email that is not about an inquiry you raised, three things are true of it, always:
- You will have ticked a box asking for it. It is never a condition of getting a reply, of getting a document, or of anything else, and the box is never pre-ticked.
- Every message carries a working way to stop it, and stopping takes effect immediately. You can also just tell us to stop, in any words, by any route.
- Every subject line is literally accurate. No false "Re:" or "Fwd:", no implied prior correspondence that did not happen, no urgency that is not real. We consider that a floor, not an aspiration.
We do not send mail to bought, rented or shared lists, and we do not buy contact data. Everybody we email either wrote to us first or ticked a box.
11.4Text messages, if that program ever exists
These are the terms that would govern it. They are published now so that they can be read before rather than after.
- Program and content
Text messages from Probity Sciences would be for two things only: a short reply about your own inquiry, and messages about a call you have arranged, such as a confirmation, a change of time or a reminder. There would be no promotional or marketing text messages, at all.
- Consent
You would opt in by ticking a checkbox, unticked when the page loads, next to a mobile number you typed in yourself. The full disclosure sits next to the box on the form, not behind a link. Consent is not required to contact us, to get a reply, to receive any document, or to buy anything. Consent is never bundled with acceptance of these terms, and agreeing to these terms is not agreeing to be texted.
- Frequency and cost
Message frequency varies. Message and data rates may apply, and those are between you and your mobile carrier, not us.
- How to stop
Reply STOP to any message and the messages stop. You can also tell us to stop in any other words, or by email to info@probitysciences.com, and it counts exactly the same. STOP is not the only way out. We would act on a stop request as soon as we saw it and in any case within ten business days. You would receive one plain confirmation that you had been unsubscribed, and nothing else.
- How to get help
Reply HELP to any message, or email info@probitysciences.com. Both reach the same person.
- Carrier limits
Mobile carriers are not liable for delayed or undelivered messages.
- Your number is not shared or sold
We do not sell, rent or share your mobile phone number or your text messaging consent with anyone for their own marketing or promotional purposes. No mobile information is shared with third parties or affiliates for marketing or promotional purposes. We do not share either with affiliates, lead generators or list brokers for any purpose. The only parties who would ever receive your number are the service providers that carry a message for us, named in section 3.5 of the privacy policy, and only so that the message reaches you.
- What we record, and for how long
If you ever give consent to be texted, we keep a record of what you agreed to, when, the exact wording that was on the screen at the time, the number it attached to, and, if you later stop it, when and how you told us. We keep that record for at least five years, because it is the evidence that we messaged you only because you asked and that we stopped when you said so. Section 5.6 and section 6 of the privacy policy set this out in full.
Before any of this could run, four things must be true that are not true today: a registered legal entity must exist, it must hold a federal tax identification number, the business and the messaging program must be registered with the carriers' registry, and a business line must exist to send from. Section 5.4 of the privacy policy publishes that status. We will not send a single text message before all of it is done.
11.5Phone calls
Nobody is cold-called. We do not make unsolicited sales calls and we do not intend to. If you arrange a call and want it by phone, you give us the number at that point, and it is used for that call.
12The site is provided as is (warranty disclaimer)
TO THE FULLEST EXTENT THE LAW ALLOWS, THE SITE AND EVERYTHING ON IT, INCLUDING THE GUIDES AND ANY CALCULATORS, ARE PROVIDED "AS IS" AND "AS AVAILABLE", WITHOUT WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED. THAT INCLUDES ANY IMPLIED WARRANTY OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, ACCURACY, COMPLETENESS, CURRENCY OR NON-INFRINGEMENT, AND ANY WARRANTY THAT THE SITE WILL BE UNINTERRUPTED, SECURE OR FREE OF HARMFUL COMPONENTS.
Section 5.4 says what we do when something is shown to be wrong. That commitment is how we work; it does not create a warranty, and it does not enlarge the liability set out below.
13The limits on our liability (limitation of liability)
Read this with section 4: it concerns your use of this website, and it does not cut down or replace anything in a signed agreement. TO THE FULLEST EXTENT THE LAW ALLOWS:
- We are not liable for indirect, incidental, special, consequential, exemplary or punitive damages, or for lost profits, lost revenue, lost data, lost time, delay to a submission, or the cost of substitute services, arising from your use of or inability to use the site, from anything on the site you relied on, or from any site we linked to.
- We are not liable for decisions you make in reliance on the site, in the absence of a signed agreement covering the specific work, including the choice of inputs to a calculator, the use of an output in a validation file or a regulatory submission, or the design of a test program.
- If, despite the above, we are found liable to you in connection with your use of this website, OUR TOTAL LIABILITY IS LIMITED IN AGGREGATE TO ONE HUNDRED UNITED STATES DOLLARS (USD 100). This limit applies to the website only. It does not apply to, and does not cap, liability under a signed agreement, which sets its own limits.
Some of these limits are not permitted everywhere. Where a limit is not permitted, it applies to you only as far as the law allows. Nothing here excludes or limits liability that cannot lawfully be excluded or limited, including liability for fraud or fraudulent misrepresentation, or for death or personal injury caused by negligence.
14When you cover us (indemnity)
If a claim is brought against us because of something you did, you agree to cover our reasonable costs of dealing with it, including reasonable attorneys' fees, to the extent the law allows. This applies to claims arising from:
- your breach of these terms;
- your use of the site in a way these terms do not permit, or in a way that is unlawful;
- information you submit to us that is false, that you had no right to send, or that infringes someone else's rights; or
- your infringement of someone else's intellectual property, confidentiality or privacy rights.
This is proportionate and it cuts both ways. You are responsible only to the extent the claim is actually caused by your conduct, and not to the extent it is caused by our own act, omission or breach. We will tell you promptly if such a claim arises, we will not settle it in a way that admits fault on your part without your agreement, and you may take part in the defense at your own cost.
15Governing law and how disputes are handled
These terms, and any dispute arising out of them or out of your use of the site, are governed by the laws of the State of Washington, without regard to its conflict-of-laws rules.
Talk to us first. If you have a complaint, email info@probitysciences.com and set out the problem. Most things can be sorted out that way. Please give us 30 days to respond before starting proceedings.
If that does not resolve it, the dispute will be handled in the state or federal courts located in the State of Washington, and you and we each consent to the jurisdiction and venue of those courts.
The exception: where the law where you live gives you rights that cannot be waived or displaced by an agreement like this one, including consumer protection rights and the right to bring a claim locally, those rights are preserved and nothing here removes them.
16Changes to these terms
We may update these terms, for example when the site changes or the law changes. When we do, we change the "last updated" date at the top, and where a change is significant we note it on this page.
A change applies to your use of the site after the date it is made. It does not change the terms that applied to anything you did before then. If you submitted the contact form, the version in force on the day you submitted it is the one that applies to that submission.
A change to section 11 never widens a permission you already gave. If you opted in to something, changing this page does not change what you opted in to. Widening it takes a fresh, separate act by you.
17The rest of it (general)
- These terms are the whole agreement between us about your use of the site, and nothing more. They replace anything said before about it, and they are not altered by any other document you send us.
- A signed agreement wins. If you and we have signed an agreement, as defined at the top of this page, its terms are part of your agreement with us, and where it conflicts with these terms, the signed agreement controls.
- If any part of these terms is found unenforceable, the rest still applies, and the unenforceable part applies as far as it lawfully can.
- If we do not enforce something straight away, we have not given up the right to enforce it later.
- Sections 5.3, 5.5, 6, 7, 11, 12, 13, 14 and 15 continue to apply after you stop using the site.
- Notices to us must be in writing, by email to info@probitysciences.com. Notices to you will be sent to the email address you gave us, if any. Headings are there to help you navigate and do not change the meaning of a section.
- This site has no accounts, no logins and no payments. We will never email you asking for a password or for payment details, and any message that does is not from us.