Container Closure Integrity Patents: Who Leads, Where Gaps Are 2026
- One filer dominates the ranked field. The leading assignee holds 8 of the ranking's entries against a fifth-place count of 2 and a tenth-place count of 1 — a steep drop-off after the top spot.
- Filing peaked in 2022, then cooled. Records rose from 0 in 2017 to a peak of 7 in 2022, with the 2026 count of 2 still partial under the roughly 18-month publication lag.
- Testing and delivery-device claims overlap heavily. A61M (body-fluid devices) and G01M (testing machines) each cover 47.4% of the 19 records in scope, showing most filings sit at the intersection of the drug-delivery device and the leak-test method.
What container closure integrity patenting actually covers
Container closure integrity (CCI) testing verifies that a sealed drug container — vial, syringe, cartridge — keeps out contamination and keeps in sterility across its shelf life, including through cold chain and deep cold storage handling. The patent activity in this dataset sits at the junction of two disciplines: physical test methods such as helium leak testing, headspace analysis and vacuum decay, and device and material engineering for closures that must survive low-temperature elastomer stress and shipping vibration without losing seal integrity. Because publication lags actual filing by roughly 18 months, the most recent year in any trend line here understates real filing activity.
This scope covers 19 published records dated from 2015 through the 2026-07-31 cut-off, indexed against a search string built around container closure integrity and cold chain drug packaging test methods. The dataset is small enough that single filings move percentages meaningfully — read the shares as directional signals of where claim space is occupied, not as market-size figures.
Filing trend and technology composition
The record set is small, so single-year swings and single-filer counts carry more weight than in a larger corpus. Read the trend and the IPC composition together: a testing-heavy filing pattern is consistent with a field where the closure hardware is largely settled and the open questions are in method validation.
Filing trend, 2017–2026
Records climbed from 0 in 2017 to a peak of 7 in 2022, the highest count in the window, before easing. The 2026 figure of 2 is a partial year and will revise upward as later publications land.
IPC subclass composition (19 records)
A61M and G01M each appear on 47.4% of the 19 records in scope, reflecting devices and their integrity test methods filed together. G01N (material analysis) reaches 15.8% and B65D (containers and packaging) 10.5% — both classes carry fewer records, one indicator of where claim density is lighter.
Shares are the percentage of the 19 records in scope. A patent can carry several IPC classes, so the shares add up to more than 100%.
Go deeper on Container Closure Integrity and Cold Chain with Eureka
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Try EurekaThe most-cited records in this space
Method and apparatus for performing container closure integrity testing (US20220128431A1)
The method submerges a sealed container in a pressure chamber filled with a liquid saturated by a test gas, pressurises the chamber with a gaseous mixture containing that gas, then removes the container and runs a laser-based headspace analysis to measure the test gas's partial pressure inside the container. That measurement determines whether a defect exists and can help locate it on the container body, closure, or seal interface.Cited 3 times in this corpus — the most-cited record in the dataset.
| # | Publication no. | Patent title | Citations |
|---|---|---|---|
| 1 | US20220128431A1 | Method and apparatus for performing container closure integrity testing | 3 |
| 2 | US20240269388A1 | Method of Making a Low-Silicone Oil System for a Medical Injection Device | 2 |
| 3 | WO2022254007A1 | Method of making a low-silicone oil system for a medical injection device | 2 |
| 4 | WO2025133221A1 | A method for CCI testing | 1 |
Citation counts are drawn from the searched corpus only and skew toward older filings; treat them as a signal of influence within this dataset, not a ranking of current commercial importance.
Publication numbers are shown where the record carries one (4 of 4 rows); clicking a row searches Eureka by that number.
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Browse MCP servers →What the numbers mean for filing strategy
Three patterns stand out once the ranking, the trend and the IPC composition are read together: one filer's dominance, a 2022 filing peak that has not repeated, and a testing-versus-hardware split that maps to where new claims still have room.
One filer, then a long tail
The ranked field has 11 companies, but the leader holds 8 entries against a fifth-place count of 2 and a tenth-place count of 1. That gap suggests most competitors here are defending a single method or device family rather than building a portfolio.
Activity peaked, then cooled
Filings rose from zero in 2017 to a peak of 7 in 2022 before easing off. Given the roughly 18-month publication lag, the apparent slowdown after 2022 should be read cautiously rather than as a firm decline.
Devices and test methods filed together
A61M and G01M each sit on 47.4% of the 19 records in scope, meaning most filings bundle a delivery device claim with a leak-test or measurement method claim rather than filing either alone.
PCT is the preferred entry route
Of the receiving offices recorded, WIPO (PCT) accounts for 8 filings, ahead of the United States at 4 and Europe at 2 — consistent with applicants seeking broad optionality before committing to national phase.
Eureka can read the same corpus for gaps instead of for coverage: under-claimed branches adjacent to container closure integrity and cold chain, with the prior art for and against each one.
Who is filing, and where they are moving
The ranked field names 11 companies. Recent-year momentum is thin across the board — most named assignees show zero filings in the latest year, and the one exception is a modest signal rather than a trend.
The dominant filer in this set
The top-ranked assignee holds 8 of the 19 records in the ranking, far ahead of the fifth-place count of 2. Its co-assignee pairing with an affiliated entity is also the strongest pairing found in the dataset, at 8 shared filings.
One recent filer is still active
Sanofi shows 2 filings in the latest year, the only named assignee with recent-year activity above zero in this dataset. Every other tracked assignee, including a Roche entity down 100% year-on-year, shows no filings in the latest year.
A specialist instrument maker holds the most-cited claim
Lighthouse Instruments, a smaller specialist rather than a pharma major, holds the most-cited record in the corpus — a laser-headspace-analysis method for detecting container defects. That points to test-method IP sitting outside the large device manufacturers as often as inside them.
| Assignee | Recent year | YoY |
|---|---|---|
| Sanofi SA | 2 | — |
| Becton Dickinson France SAS | 0 | — |
| Becton Dickinson & Co | 0 | — |
| Novo Nordisk A/S | 0 | — |
| F. Hoffmann-La Roche Inc | 0 | -100% |
| LIGHTHOUSE INSTRUMENTS LLC | 0 | — |
| Merck Sharp & Dohme | 0 | — |
| F. Hoffmann-La Roche & Co AG | 0 | — |
Where to take this analysis
The dataset points to specific next steps depending on whether the goal is filing strategy, freedom-to-operate, or competitive tracking.
Scope a freedom-to-operate check
Before drafting claims in headspace analysis or low-temperature elastomer formulations, check the specific claim language on the most-cited records — citation counts here concentrate on a handful of filings.
Run a claim check in EurekaTrack the leading filer's next moves
With one assignee holding 8 of the 19 ranked records and a strong co-assignee pairing with an affiliate, watching its continuation filings is more informative than watching the field broadly.
Set up assignee monitoring in EurekaRevisit the 2025-2026 window later
The most recent filing year is structurally undercounted due to publication lag; a re-pull in 6-12 months will give a truer read on whether the 2022 peak was a one-off or the start of a new plateau.
Schedule a refreshed pull in EurekaCommon questions on CCI and cold chain patents
Container closure integrity (CCI) testing checks whether a sealed drug container — a vial, syringe, or cartridge — maintains its seal against contamination and leakage throughout its shelf life, including during cold chain transport. Patents in this area typically cover a specific test method, such as helium leak testing, vacuum decay, or laser-based headspace analysis, or a specific apparatus for running that method. Companies patent these methods because a validated, defensible test method can become a regulatory and commercial standard, and because the underlying instrumentation can be licensed or sold separately from the drug product itself.
In this dataset the ranked field covers 11 companies, with one filer holding 8 of the 19 records in the ranking and a sharp drop to 2 records at fifth place. That pattern indicates a market with one clearly dominant portfolio holder and a long tail of companies each defending a narrower slice of the technology. Recent-year momentum is thin across nearly all tracked assignees, with only one showing active filing in the latest year captured.
The dataset shows filings rising from zero in 2017 to a peak of 7 in 2022, the highest single-year count in the window. Because patent publication typically lags filing by around 18 months, the apparent decline after 2022 is partly an artefact of that lag rather than necessarily a real drop in R&D activity. A fuller picture of 2024-2026 filing levels will only be visible once those applications finish publishing.
US20220128431A1 describes a method that submerges a sealed container in a pressure chamber filled with a test-gas-saturated liquid, pressurises it, then measures the test gas's partial pressure inside the container using laser-based headspace analysis to detect a defect. It is the most-cited record in this dataset, cited 3 times, which signals it is a frequently referenced reference point for later filings in this specific submersion-and-headspace approach. It does not block every CCI test method — vacuum decay, dye ingress, and other headspace configurations sit outside its specific claim elements — but anyone designing a submersion-based helium or gas-headspace test should review its claims closely.
The IPC composition shows heavy overlap between device claims (A61M, 47.4% of the 19 records) and testing-machine claims (G01M, also 47.4%), while material-analysis (G01N, 15.8%) and container/packaging (B65D, 10.5%) classes carry noticeably fewer records. That lighter density in materials and packaging-specific claims, combined with no single dominant assignee in sub-areas like low-temperature elastomer formulation or shipping-vibration test validation, suggests those branches are less crowded than the core leak-test method space.
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Disclaimer. This page is generated from Patsnap Eureka data drawn from a limited snapshot of global patent and scientific-literature records, and is provided for general information and reference only.
Patent data carries inherent limitations: recent filings (typically the most recent 18–24 months) are under-counted due to standard publication lag; counts may be reported at either a patent-family or a patent-record basis and are not always directly comparable; classification, applicant-name, and citation data may contain errors, duplicates, or omissions; and the underlying search query defines and constrains the scope shown. As a result, the analysis may be incomplete or inaccurate and may not reflect the full technology landscape.
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Machine translation. Assignee and organisation names originally recorded in Chinese, Japanese or Korean have been rendered into English by an AI translation step so that the tables stay readable. These renderings are best-effort and may not match a company’s registered English name; the original name is what the underlying patent record carries, and it is what any Eureka query launched from this page uses.