The tariff classification of Isolators from Ireland

N361448May 29, 2026CLA-2-84:OT:RR:NC:N1:105
CATEGORY: Classification
TARIFF NO.: 8421.39.0115
Shannon BryantTrade-IQ, LLC485 Smokey Lake RoadIron River, MI 49935RE: The tariff classification of Isolators from IrelandDear Ms. Bryant:In your letter dated
May 11, 2026
, on behalf of your client, ProSys Group, you requested a tariffclassification ruling. Descriptive literature was provided for our review.The first item under consideration is described as the EOLAS Series positive-pressure aseptic isolator, whichis device engineered to establish and sustain a Grade A (ISO 5) sterile micro-environment, crucial forpharmaceutical tasks such as sterility testing and manual aseptic manipulations. This active environmentalcontrol system integrates dual H14 HEPA filtration, ProSgen vapor-phase hydrogen peroxide (VHP)decontamination, PLC-managed differential pressure control, and real-time environmental monitoring, allhoused within a stainless steel/powder-coated steel frame. User interaction is facilitated by an Allen BradleyHMI touchscreen, RFID-enabled glove ports with chlorosulfonated polyethylene (CSM) gauntlets, and LEDstatus indicators. The operational cycle comprises five phases: aeration, VHP decontamination (includingpreconditioning, conditioning, and a 6-log SAL 10 kill), production mode where the PLC confirmsenvironmental integrity, a use phase for sample introduction and sterility testing with continuous monitoring,and glove integrity testing recorded per 21 CFR Part 11/Annex 11. The isolator maintains the main processchamber (C1) at +50 Pa above ambient pressure via PID (Proportional, Integral, Derivative) fan speedcontrol.The second item under consideration is described as the CORUS Series positive-pressure aseptic isolator,which is a device built on the same environmental control architecture as the EOLAS, and is specificallyengineered for seamless integration with medium-to-high-speed pharmaceutical filling lines and cell andgene therapy process equipment. Its primary function is to establish and maintain a Grade A (ISO 5) sterileenvironment around the integrated ancillary machinery, as the CORUS itself does not perform fillingoperations. Featuring a modular frame of 316L stainless steel and powder-coated steel, the system includesmultiple Allen Bradley HMI stations, RFID-enabled glove ports, and rapid transfer ports (RTPs) for materialtransfer. Internally, it comprises an extended enclosure with distributed dual H14 HEPA filters and multiple
EC centrifugal fans, utilizing an identical ProSgen VHP decontamination system and Allen BradleyCompactLogix PLC control as the EOLAS. Operational phases include a comprehensive VHPdecontamination cycle, production mode with confirmed Grade A zones, material introduction via sterilizingtunnels or VHP-decontaminated transfer chambers, the filling or cell and gene therapy processing phase, andcontinuous environmental monitoring at all critical ISO 5 points.The third item under consideration is described as the ProTectus standardized OEB-5 negative-pressurecontainment isolator, which is designed to protect operators and the environment from highly potent activepharmaceutical ingredients (HPAPIs) and other hazardous drug substances by maintaining a sealednegative-pressure barrier. Constructed with a stainless steel/powder-coated steel frame, it features a SiemensTP900 HMI, safe-change glove ports, lift-up polycarbonate windows, and a continuous liner/bag-out port,with exhaust air directed to a facility hazardous waste scrubber. Internally, it includes a transfer chamber anda working chamber, both equipped with H14 HEPA filters and a variable-speed extract fan, controlled by aSiemens S7-1500 PLC, and capable of nitrogen inertion and integrated weighing. Operational phasesencompass startup with cascading negative pressure, a leak rate test to confirm containment integrity,optional nitrogen inertion, material introduction, processing (e.g., weighing, dispensing) under negativepressure with filtered exhaust, material removal, and a breach response system that activates alarms andmaximizes fan speed. Similar to the first two items, this unit is imported complete but disassembled.In your submission, you suggest that the subject Aseptic Isolators and Containment Isolator are classifiable inheading 8419, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Machinery,plant or laboratory equipment, whether or not electrically heated (excluding furnaces, ovens and otherequipment of heading 8514), for the treatment of materials by a process involving a change of temperaturesuch as heating, cooking, roasting, distilling, rectifying, sterilizing, pasteurizing, steaming, drying,evaporating, vaporizing, condensing or cooling, other than machinery or plant of a kind used for domesticpurposes; instantaneous or storage water heaters, nonelectric; parts thereof.” We disagree, as neither unit usesa change in temperature to treat materials. Instead, both units are designed to maintain controlledenvironments that enable separate operations, such as testing, handling, mixing, and other processes, to beconducted within the chamber. While the Aseptic Isolators can perform a decontamination cycle, this cycleis intended to clean interior surfaces, not to treat pharmaceutical products or equipment. The ContainmentIsolator is designed to create a sealed barrier between hazardous products and the operator and does not haveany heating or cooling capabilities. Therefore, both categories of isolators are not classified in heading 8419.The applicable subheading for the subject Aseptic Isolators and Containment Isolator will be 8421.39.0115,HTSUS, which provides for “Centrifuges, including centrifugal dryers; filtering or purifying machinery andapparatus, for liquids or gases; parts thereof: Filtering or purifying machinery and apparatus for gases: Other:Dust collection and air purification equipment: Other.” The general rate of duty will be free.The duties cited above are current as of this ruling’s issuance. Duty rates are provided for your convenienceand are subject to change. The text of the most recent HTSUS and the accompanying duty rates are providedat https://hts.usitc.gov/.This ruling does not address the applicability of any additional duties, taxes, fees, exactions and/or othercharges, which may apply to the goods discussed herein. This includes, but is not limited to, tariffs and otherduties as provided for in Subchapter III to Chapter 99, HTSUS. Thus, for example, in addition to theclassification stated above, the merchandise covered by this ruling may also need to be reported with eitherthe Chapter 99 provision under which an additional tariff applies or one of the Chapter 99 provisionscovering exceptions to such tariffs.For further information to assist with the importation process, please refer to the frequently updated CargoSystems Messaging Service (CSMS) messages at https://www.cbp.gov/trade/automated/cargo-systems-messaging-service and the Trade Remedies page at https://www.cbp.gov/trade/programs-administration/trade-remedies.
The holding set forth above applies only to the specific factual situation and merchandise description asidentified in the ruling request. This position is clearly set forth in Title 19, Code of Federal Regulations(CFR), Section 177.9(b)(1). This section states that a ruling letter is issued on the assumption that all of theinformation furnished in the ruling letter, whether directly, by reference, or by implication, is accurate andcomplete in every material respect. In the event that the facts are modified in any way, or if the goods do notconform to these facts at time of importation, you should bring this to the attention of U.S. Customs andBorder Protection (CBP) and submit a request for a new ruling in accordance with 19 CFR 177.2. Additionally, we note that the material facts described in the foregoing ruling may be subject to periodicverification by CBP.This ruling is being issued under the provisions of Part 177 of the Customs and Border ProtectionRegulations (19 C.F.R. 177).A copy of the ruling or the control number indicated above should be provided with the entry documentsfiled at the time this merchandise is imported. If you have any questions regarding the ruling, please contactNational Import Specialist Jason Christie at [email protected].
Sincerely,
(for)James P. ForkanDirectorNational Commodity Specialist Division