manufactured · input

0.22-Micron Sterilizing-Grade Membrane Filters

Single-use PVDF or PTFE membrane filters validated to achieve sterile effluent from bulk solution. FDA 21 CFR requires integrity testing of each filter before and after use. Dominated by Merck (Millipore), Pall (Danaher), and Sartorius. Long lead times for validated pharmaceutical grades (6–18 months for novel formats).

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Source countries

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Companies

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Goods affected

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Claims on record

What depends on it

Goods that need this input

1 essential American goods rely on 0.22-micron sterilizing-grade membrane filters somewhere upstream in their supply chain.

Where it comes from

Source countries

Share of global supply, by country.

CountryShare of supply
DEGermany45%
USUnited States30%
JPJapan10%
CNChina8%

Who makes it

Supplier companies

3 companies produce 0.22-micron sterilizing-grade membrane filters.

MilliporeSigma (Merck KGaA)

HQ DE38% share

German science and technology company (Darmstadt; family-owned since 1668; €22B revenue); life science division (MilliporeSigma in US/Canada, Millipore globally) is the world's leading producer of pharmaceutical sterilizing-grade membrane filters under the Durapore® (PVDF), Millipak®, and Express® SHC brands. Durapore 0.22 μm PVDF filters are the industry benchmark for IV fluid sterilizing filtration — validated by virtually every major IV fluid manufacturer globally. Merck KGaA has been family-controlled since 1668 — making it the world's oldest operating pharmaceutical company (predating most European nations in their current form). The Merck family still controls >70% of shares through their foundation. The same 350-year-old German family company that supplied dyes to the First World War German army now makes the sterilizing filters that make every IV bag sterile. Note: US Merck (MSD/Merck & Co.) is a separate company that split from Merck KGaA after World War I when its US subsidiary was seized as enemy property and sold.

Pall Corporation (Danaher subsidiary)

HQ US32% share

American filtration, separation, and purification technology company (Port Washington, NY; Danaher Corporation subsidiary since 2015 acquisition for $13.8B); world's second-largest pharmaceutical sterilizing filter manufacturer under the Supor® (PES), Fluorodyne® EX (PVDF), and Emflon® (PTFE) brands. Pall Corporation was founded in 1946 by Dr. David Pall, a British-born scientist who invented the first practical fluid filtration membrane for aircraft jet fuel systems during WWII — technology originally developed for military aviation now forms the basis of pharmaceutical sterile filtration. Pall's acquisition by Danaher — which also owns Cytiva (former GE Healthcare Life Sciences, bioreactors and chromatography) — means a single US conglomerate controls approximately 35-40% of the critical tools and materials used in both IV fluid manufacturing and biopharmaceutical drug production.

Sartorius AG(SRT.DE)

HQ DE18% share

German laboratory and bioprocessing equipment company (Göttingen; XETRA: SRT; ~€3.4B revenue) that manufactures Sartopore 2 (PES — polyethersulfone) and Sartopore Platinum (modified PES) sterilizing membranes — the primary European alternative to Merck/Pall membrane platforms. Sartorius holds an estimated ~15% share of the pharmaceutical sterilizing filtration market, with particular strength in European biologics manufacturing. Sartorius also makes Sartocon cassette systems for tangential flow filtration (TFF), Stedim biocontainers (single-use bags), and Biowave bioreactor systems — making it, like Danaher, a vertically integrated supplier across multiple critical biopharmaceutical manufacturing unit operations. Sartorius acquired Stedim (France) in 2007 and has organically grown its bioprocessing portfolio. Göttingen primary manufacturing; additional production in Yauco, Puerto Rico (acquired via Sartorius Stedim Biotech).