Written and maintained by CASRAI Editorial Board
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This page describes products and general use; it is not medical advice.
A sterilization container is a reusable, rigid, lidded case that holds surgical or laboratory instruments during steam sterilization and keeps them sterile until the case is opened. People who read this page are usually sterile processing staff, clinic and lab managers, buyers and students who need to know what a container is made of, how the FDA classifies it, and how it differs from a tray or a wrap.
Who uses it: sterile processing departments, surgical and dental clinics, and research facilities that sterilize reusable instrument sets.
What a sterilization container is
The FDA describes a rigid sterilization container as a device "intended to be used to enclose another medical device that is to be sterilized by a healthcare provider", to allow that device to be sterilized, and to maintain sterility until it is used. In the FDA’s product-code database the type is listed as a Class II device. Searchers also call it a rigid sterilization container or a sterilization tray; the first name is the regulatory one, and the second is often used for the inner tray that sits inside the case (see the comparison below).
How it is built: parts and materials
The parts below come from the FDA 510(k) summary for one cleared system, K162600 (decision 2016-12-09). They describe that single product, not every container on the market.
- Base and cover. The cover has a sealing gasket and is secured to the base with latches that lock in place.
- Filter retainers and single-use paper filters. The filter lets sterilant gas in and out while acting as a microbial barrier. In that summary the filter media is single use only.
- Inner trays and support brackets. These hold the contents so the sterilant can reach them.
- Data cards and tamper-evident arrows. The same summary describes data cards for recording information about a sterilization load, and tamper-evident arrows that show the case has not been opened; each arrow carries an external process indicator. Data cards, filters and arrows are single use.
Materials listed in that summary include aluminum alloys 5052 H32 and 6061 and SAE 304 stainless steel. The summary states that the container does not come into direct patient contact while in use.
Types and how the FDA tracks them
The FDA groups rigid containers under two regulations. Standard containers sit with wraps and trays under 21 CFR 880.6850 (product code KCT, "Sterilization Wrap Containers, Trays, Cassettes & Other Accessories"). A newer type, the rigid sterilization container with electronic monitoring or software, has its own regulation, 21 CFR 880.6855 (product code QJT).
| Type | FDA code and regulation | Key difference (as stated by FDA) |
|---|---|---|
| Standard rigid sterilization container | KCT, Class II, 21 CFR 880.6850 (older clearances were filed under FRG, "Wrap, Sterilization") | Cleared through 510(k) against an earlier container; each clearance sets that product’s sterilization method and sterile-storage claim |
| Rigid sterilization container with software / electronic monitoring | QJT, Class II, 21 CFR 880.6855; first listed under De Novo DEN210004 (decision 2022-06-17) | Designed for high-vacuum or pulse-vacuum steam systems; the regulation lists special controls including sterility status reporting and a minimum 30-day sterile storage period |
openFDA’s 510(k) records list many cleared container systems: the earliest, from 1983 to 2015, include several filed under FRG, and clearances from 2005 through 2025 are filed under KCT.
What the regulation requires of the newer type
The rule for containers with software, 21 CFR 880.6855, lists special controls that a manufacturer must meet. They include non-clinical testing of sterilant penetration, sterility assurance and seal integrity, a minimum 30-day sterile storage period, microbial barrier performance, corrosion resistance and dryness of contents, along with biocompatibility, software and human-factors work and labeling that states warnings, limitations and the validated sterility duration. The regulation also lists labeling for replaceable components and compatible products.
Sterile storage time differs by product
The same 510(k) record shows why you read the labeling of the container you own. The K162600 container was validated to maintain sterility for a maximum of 30 days after sterilization, with containers that had already gone through more than 100 sterilization cycles. Its predicate, the system cleared as K142529, is described in the same document as maintaining sterility for a maximum of 180 days and as suitable for pre-vacuum steam, immediate-use steam and 100% ethylene oxide sterilization. A claim made for one product is not a claim for all containers.
Container, tray and wrap compared
A container is a closed case with a gasket and filters. A tray is the open carrier inside it; read autoclave trays for that item. A wrap is a disposable sheet folded around a tray or set; read sterilization wrap, which also covers the CDC’s list of packaging options. Small single items are packed in sterilization pouches. All of these are sterilization packaging that must let the sterilant in and keep microorganisms out.
Safe use and handling basics
- Use a container only with the sterilization method named in its own instructions for use; the FDA records above show that cleared methods vary by product.
- Replace the single-use filter media as that manual directs; the K162600 summary states the filter is single use only.
- Chemical indicators are used with packs to show exposure to a sterilization process; see chemical indicators for sterilization. The CDC steam-sterilization page (dated 2023-11-28) discusses indicators for packs.
- For how storage time and handling affect sterility, see event-related sterility and sterile storage.
Common mistakes
- Assuming one container’s storage-time claim (30 days, 180 days) applies to every container.
- Reusing a paper filter because the case looks clean.
- Treating "sterilization tray" and "rigid sterilization container" as the same item when ordering or writing a procedure.
- Using a container with a sterilizer cycle its labeling does not name.
FAQ
What is a rigid sterilization container?
It is a reusable lidded case that encloses instruments for steam sterilization and maintains their sterility until use. The FDA regulates standard containers under 21 CFR 880.6850 and containers with software under 21 CFR 880.6855, both as Class II.
What is the difference between a sterilization tray and a sterilization container?
A tray is an open carrier for instruments and needs a wrap, pouch or container around it. A container is the closed case, with a sealed lid and filter, that can enclose that tray.
Is a sterilization container reusable?
Yes. In the K162600 summary the container was tested after more than 100 sterilization cycles, but its single-use paper filters are replaced. Check each product’s instructions for its limits.
Sources
- openFDA device classification, product codes QJT and KCT, https://api.fda.gov/device/classification.json (checked 2026-10-30).
- 21 CFR 880.6855, Rigid sterilization container with electronic monitoring, https://www.law.cornell.edu/cfr/text/21/880.6855 (checked 2026-10-30).
- FDA 510(k) K162600 clearance letter and summary, https://www.accessdata.fda.gov/cdrh_docs/pdf16/K162600.pdf (checked 2026-10-30).
- openFDA 510(k) database, device name "sterilization container", https://api.fda.gov/device/510k.json (checked 2026-10-30).
- CDC, Steam Sterilization, https://www.cdc.gov/infection-control/hcp/disinfection-sterilization/steam-sterilization.html (page dated 2023-11-28, checked 2026-10-30).
