CLA-2-84:OT:RR:NC:N1:101

Esther Y. Noel, Sr., Trade Analyst
Robert Bosch, LLC
2800 S. 25th Avenue
Broadview, IL 60155-4594

RE: The tariff classification of sterilizer assembled in Germany

Dear Mr. Noel:

In your letter dated March 11, 2014, you requested a tariff classification ruling on behalf of your client Robert Bosch Packaging Technology of Broadview, Illinois.

The item under consideration has been identified as Sterilization Tunnel HQL (“HQL”) used for the production of safe and reliable sterilization and depyrogenation of pre-cleaned containers. You state that the HQL series includes about 40 standard tunnel sizes and 20 tunnel types with sterilizable cooling sections. The HQL utilizes a dry-heat sterilization process, which follows the Laminar Flow Principle. The HQL series is imported solely for medical/pharmaceutical use and is not used in the sterilization or packaging of food items.

Depyrogenation tunnels are used in pharmaceutical filling lines to sterilize glass containers before they are aseptically filled. These tunnels use unidirectional hot air at temperatures up to 600°F (350°C) and can be used to sterilize and depyrogenate glass vials, ampoules, and cartridges.

The standard features for the HQL are as following:

Laminar air flow for temperature stability and uniform heat distribution; Variety of belt widths, ranging in sizes from 400mm to 1200mm (12”-48”); Safe zone pressure balance; Automatic density control for better temperature stability; Friction-free container transport; Easy access to tunnel interior for cleaning and maintenance; Output range: up to >90,000 per hour, depending on container size; Optional sterilizable cool zone for ensured container sterility and Ability to be used to sterilize glass vials, ampoules and cartridges

The HQL is semi-assembled in a German facility, but is completed, upon import, according to customer specifications in Minnesota. The semi-assembled machine consists of three (3) separate pieces:

Section 1: Tunnel Infeed Zone Section 2: Tunnel Heating Zone Section 3: Cooling Zone

Finally, you state that generally the three sections will arrive in a single shipment. However, you state that, in the case of missing or broken parts, additional replacements will be imported. This ruling letter does not cover any additional parts or accessory items imported.

The applicable subheading for the Sterilization Tunnel HQL will be 8419.20.0010, 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 other equipment of heading 8514), for the treatment of materials by a process involving a change of temperature such as…sterilizing,…, other than machinery or plant of a kind used for domestic purposes; instantaneous or storage water heaters, nonelectric; parts thereof: Medical, surgical or laboratory sterilizers: Medical or surgical sterilizers.” The rate of duty will be Free.

Duty rates are provided for your convenience and are subject to change. The text of the most recent HTSUS and the accompanying duty rates are provided on World Wide Web at http://www.usitc.gov/tata/hts/.

This ruling is being issued under the provisions of Part 177 of the Customs Regulations (19 C.F.R. 177).

A copy of the ruling or the control number indicated above should be provided with the entry documents filed at the time this merchandise is imported. If you have any questions regarding the ruling, contact National Import Specialist Matthew Sullivan at [email protected].

Sincerely,

Gwenn Klein Kirschner
Acting Director
National Commodity Specialist Division