CHL Chapter 20: Technical Essentials: Steam Sterilization

Major Repair

Outside the scope of normal maintenance on a sterilizer; such as well repairs of pressure vessel, replacement of the chamber door or vacuum pump, a major piping reassembly, or rebuilds or upgrades to the sterilizer's controls.

Any point

Passed result

Qualification Testing

Special monitoring required after sterilization installation, relocation, malfunction, process failure or repair in following changes in connections to maintenance of utilities.

97%-100%

Steam saturation of a steam sterilizer

Wet Packs

Trays or containers with moisture visible on the inside after the sterilization process is completed

Process indicators (type1)

also referred to as external CIs and are intended for use with individual packages to designate that the packages have been exposed to the sterilization process. This includes (tape, label or container lock).

Single critical process variable indicators (type 3)

are designated to indicate exposure to a sterilization process at a specific single variable. They are placed inside the sterilized packages in an area that is least accessible to the sterilant and inspected for a color change when the package is opened.

Chemical Indicators (CI's)

are designed to detect potential sterilization failures that could occur from improper packaging, incorrect loading or sterilizer malfunctions. They do NOT prove that an item is sterile, but rather the sterilization conditions for which the sterilization were met.

Emulating indicators (type 6)

are designed to react to all critical process variables for specified sterilization processes.

Integrating indicators (type 5)

are designed to react to all critical process variables.

Multi-critical process variable indicators (type 4)

are designed to react to two or more variables and is intended to indicate exposure to a sterilization process at a single variable of the chosen critical process variables.

Indicators for use in specific tests (type 2)

are intended to verify functionality. The most popular is the Bowie Dick test.

Stated Values

are specific critical variables where the CI must reach the endpoint or show a pass result.

Air that is too dry

can contribute to superheating

Steam that is too wet

can contribute to wet packs

Non-Condensable Gas (NCG's)

cannot be liquefied by compression under the conditions of temperature and pressure used during the sterilization process. This creates air in the steam supply, resulting in sterilization failures.

Biological Indicator (BI)

is a sterilization test that contains viable (live) spores that are most resistant to sterilization modality (method) being monitored.

Water

is the main ingredient for steam sterilization.

Biobarrier

A package system that allows sterilant to enter a pack and after sterilization, creates a barrier to contamination.

Extended Sterilization Cycle

A sterilization cycle that falls outside of the traditional cycles used in the Sterile Processing Department, because a device's IFU mandate and exposure time that exceeds standard steam sterilization times.

Critical Variables

Characteristics of sterilization or disinfection processes that have the largest influence on the effectiveness of that process.

Validation

Documented procedures performed by the medical device manufacturer to establish that a process consistently yields a product complying with predetermined specifications.

Verification

Documented procedures performed in the user environment to establish that predetermined specifications have been met.

Lot (Load) Control Number

Numbers and or letters by which a specific group of products can be traced to a particular manufacturer or sterilization operation.