ISO 11607 Validation · ISO 17025 Accredited Lab · FDA-Registered Facility
Don't let packaging validation delay your FDA submission.
Send us your protocol or your timeline — within one business day a packaging engineer responds with a plan to hit your submission or audit date. Seal integrity, accelerated aging, transit simulation, sterile barrier — all under one ISO 17025–accredited roof.
One business day. A packaging engineer, not a salesperson.
FDA-Registered
Manufacturing Facility
ISO 13485:2016
Certified Quality System
ISO 11607 Validation
Sterile Barrier Standard
ISO 17025
Accredited Packaging Lab
12 Cleanrooms
Class 5–8
3 Facilities
CA · NH · Costa Rica
Packaging is where submissions slip.
You've nailed device design and clinical. Then packaging validation pushes your timeline a quarter because the accelerated-aging protocol needs a redo, the transit simulation requires a different ASTM cycle, or your seal-strength data won't survive an FDA reviewer's question.
Most CMOs treat packaging as an afterthought. We treat it as a separate gating workstream and staff it with engineers whose only job is getting it through QA and into your submission on schedule.
What you get.
Not a sales call — a packaging validation workstream that produces audit-ready, submission-grade documentation against your timeline.
ISO 11607 validation protocol
Designed from scratch or reviewed against your existing protocol — sterile barrier system and packaging process validation, structured for FDA review.
Seal integrity & burst testing
Seal strength, burst, and visual inspection per ASTM F88 / F1140 / F2096, with data packaged to withstand a reviewer's questions.
Accelerated-aging plan
ASTM F1980 accelerated aging with real-time correlation to support your shelf-life claim — scoped to your submission date, not a generic cycle.
Distribution & transit simulation
Distribution simulation per ASTM D4169 / ISTA to prove the package survives real-world shipping, not just the lab bench.
Sterile barrier verification
Dye penetration and microbial barrier verification confirming the sterile barrier holds through aging, transit, and the point of use.
Submission-ready validation report
A complete, defensible validation report formatted for FDA 510(k) and EU MDR technical files — ready to drop into your submission.
25+
Years FDA-Registered
820+
Product Launches Supported
$4B+
Client Acquisition Value Created
12
Cleanrooms, Class 5–8
Consolidated assembly, packaging validation, and EO sterilization for a Class II sterile orthopedic device — reducing their vendor count from four to one and cutting 14 weeks from their launch timeline.
Best fit
Class II/III sterile medical devices heading into an FDA 510(k) or EU MDR submission, or facing an audit or packaging change with a real deadline.
Not a fit
Non-medical, consumer, or food packaging, and devices with no regulated sterile barrier or submission requirement.
What we need from you to move fast.
You don't need every item below. The more we have when you fill out the form, the more concrete the response is — typically within one business day from a packaging engineer, not a salesperson.
- Device classification (Class I, II, or III) and current packaging format (pouch, tray, blister, custom).
- Whether you have an existing validation protocol or are starting from scratch.
- Target submission or audit date — even a rough quarter helps us scope the workstream against your critical path.
- Specific concern areas: seal integrity, accelerated aging, transit simulation, sterile barrier verification, or all of the above.
- If you already have a protocol you'd like reviewed before the call, attach it and we'll come prepared with specific feedback.
Get a packaging validation plan reviewed.
One business day. Packaging engineer, not a salesperson.
You submit
Send your protocol or timeline through the form — attach a protocol if you have one.
An engineer reviews
A packaging engineer — not a salesperson — reviews it within one business day.
You get a plan
You receive a written validation plan mapped to your submission or audit date.
No cost, no obligation. Your information stays internal to LSO and is used only to respond to your inquiry. No newsletters, no third-party sharing.