Cold Sterilization Solution: FDA-Listed Contact Times and What to Check

General product and regulatory information for laboratory, clinic and supply staff. It is not medical advice and not a reprocessing procedure; always follow the labelled instructions of the product and the device manufacturer.

Short answer

A cold sterilization solution is a liquid chemical sterilant used at or near room temperature, usually for heat-sensitive reusable devices. On the FDA list of cleared sterilants, the labelled contact time for sterilization runs from 6 minutes in a heated, automated system to 12 hours in a room-temperature soak. That is far longer than the contact time for high-level disinfection of the same product.

Definition and scope

“Cold sterilization” is trade shorthand, not a regulatory category. FDA maintains a list titled FDA-Cleared Sterilants and High Level Disinfectants with General Claims for Processing Reusable Medical and Dental Devices. Each entry gives the 510(k) number, the active ingredient and the contact conditions for sterilization and for high-level disinfection. A product is a sterilant only when its entry carries an indication for device sterilization; some entries on the same list are high-level disinfectants with no sterilization indication.

This page covers liquid chemical products for reusable devices. For the wider disinfectant ladder, see types of disinfectants; for heat-free alternatives that are not liquid soaks, see ultraviolet sterilization.

Sterilant versus high-level disinfectant: the same bottle, two contact times

Many products on the FDA list carry two claims. The shorter high-level disinfection time kills most microorganisms but not necessarily all bacterial spores; the sterilization time is the longer one that was supported by sporicidal testing. Treating a soak at the short time as sterile is the central error this page exists to prevent.

The CDC disinfection and sterilization guideline gives a disinfection-level example for glutaraldehyde, a figure of tens of minutes at room temperature to reliably kill mycobacteria and other vegetative bacteria, while the FDA-cleared sterilant labels in the table below run from about 7.5 to 12 hours for the glutaraldehyde products. Disinfection-level times are not sterilization times.

Active ingredients and FDA-listed contact conditions

The table reproduces selected entries from the FDA list (FDA page checked 2026-11-01). It identifies products only so each row can be traced to its 510(k) entry; it is not a ranking or endorsement.

Product (510(k))	Active ingredient(s) on the list	Sterilization contact condition	High-level disinfection condition	Maximum reuse on the list
Acecide-C (K091210)	3100-3400 ppm peracetic acid	2 hrs at 20ºC	7 min at 20ºC	5 days
Steris S40 Sterilant Concentrate (K090036, K173256)	≥1820 mg/L peracetic acid	6 min at 46-55°C	No high-level disinfection indication	Single use, diluted by the system
EndoSpor Plus (K972708)	7.35% hydrogen peroxide, 0.23% peracetic acid	180 min at 20°C	15 min at 20°C	14 days
Sporox (K970230)	7.5% hydrogen peroxide	6 hrs at 20°C	30 min at 20°C	21 days
Cidex Activated Dialdehyde Solution (K060618)	2.4% glutaraldehyde	10 hrs at 25°C	45 min at 25°C	14 days
Aldahol V (K113015)	3.4% glutaraldehyde, 20.1% isopropanol	8 hrs at 20ºC	10 min at 20ºC	14 days
Sporicidin (K003087)	1.12% glutaraldehyde, 1.93% phenol/phenate	12 hrs at 25°C	20 min at 25°C	14 days
Rapicide (K993042)	2.5% glutaraldehyde	7 hrs 40 min at 35°C	Automated endoscope reprocessor: 5.0 min at 35°C	28 days
Rapicide OPA-28 (K120306)	0.575% ortho-phthalaldehyde	No indication for device sterilization	10 min at 20ºC manual; 5 min at 25ºC in an automated reprocessor	28 days

Three patterns stand out from these entries. Sterilization times at room temperature range from 2 to 12 hours. The only minutes-scale sterilization entry is a heated, single-use system cleared for use with a specific processing system. And ortho-phthalaldehyde appears as a high-level disinfectant without a sterilization indication; see ortho-phthalaldehyde (OPA).

When heat is the CDC-preferred route

CDC states that medical devices in contact with sterile body tissues or fluids are critical items, and that if such items are heat resistant, the recommended sterilization process is steam sterilization. Heat- or moisture-sensitive items require a low-temperature sterilization technology. A liquid chemical sterilant is therefore a route for items that cannot take heat, not a convenience substitute for the autoclave. For the instrument workflow, see cleaning and sterilizing surgical instruments.

What to verify before relying on a product

This checklist is built only from the FDA list and the CDC guideline. Each item has a sourced reason.

• Find the 510(k) entry. The FDA list is organised by 510(k) number, active ingredient and contact conditions; a product that is not on it with a sterilization indication has no listed sterilant claim.
• Read the sterilization line, not the disinfection line. Every row above has two different times, and one row has no sterilization claim at all.
• Match temperature. The contact condition is tied to a stated temperature, and some entries apply only in an automated endoscope reprocessor that holds that temperature (see automated endoscope reprocessors and washer-disinfectors).
• Check the reuse period and monitoring. The FDA list gives a maximum reuse period per product, and notes that for EndoSpor Plus the reuse period is limited to 14 days because test strips for its active ingredients are lacking. CDC notes that glutaraldehyde is commonly diluted in use, so concentration is checked with test strips; for hydrogen peroxide, CDC says dilution must be monitored by regularly testing the minimum effective concentration.
• Check material compatibility. CDC describes peracetic acid as unstable, particularly when diluted, and able to corrode copper, brass, bronze, plain steel and galvanized iron.
• Plan the rinse. CDC links residual solution to patient harm that careful rinsing prevents: colitis believed to be caused by glutaraldehyde exposure from residual disinfecting solution in endoscope channels, and corneal damage from a tonometer tip that was not properly rinsed after hydrogen peroxide.

Common misunderstandings

“A short disinfection soak sterilizes the instrument.”

CDC’s glutaraldehyde figure of tens of minutes is a disinfection exposure. Listed sterilization claims for glutaraldehyde products are many hours.

“Any high-level disinfectant is a sterilant.”

No. CDC classes OPA as a high-level disinfectant, not a sterilant, and the FDA list shows its entry without a sterilization indication.

“Cold means no equipment.”

Some sterilant claims require heating to 46-55°C or 35°C, a processing system, or an automated reprocessor that maintains temperature.

“A soaked device stays sterile on the shelf.”

Rinse-water and storage rules for liquid-sterilized items are set by the device and product labels and are not covered here.

FAQ

What is a cold sterilization solution?

A liquid chemical sterilant, usually peracetic acid, hydrogen peroxide or glutaraldehyde based, that has an FDA-cleared indication for device sterilization at a stated contact time and temperature.

Is a cold sterilant the same as a disinfectant?

Not necessarily. One product can carry both a sterilization time and a much shorter high-level disinfection time, and some products have only the disinfection claim.

Where do I look up whether a product is FDA-cleared as a sterilant?

On FDA’s list of cleared sterilants and high-level disinfectants, searching by product name or 510(k) number.

Sources

• U.S. FDA, FDA-Cleared Sterilants and High Level Disinfectants with General Claims for Processing Reusable Medical and Dental Devices, checked 2026-11-01.
• CDC, Chemical Disinfectants, Guideline for Disinfection and Sterilization in Healthcare Facilities, checked 2026-11-01.
• CDC, Sterilization, Guideline for Disinfection and Sterilization in Healthcare Facilities, checked 2026-11-01.