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Sterile U

Exposure Control
Methods for determining at a glance whether each pack or item has been exposed to the sterilization process, without the need to open the pack.

Application

In most cases, sterilizer operators will not inspect inside sealed packs since they will be opened in the Operating Room (OR), or another department. Exposure Control monitoring products are a way for sterilizer operators to know at a glance whether sealed packs have been exposed to the sterilization process.

Exposure Control monitors are Class 1 Process Indicators (ISO 11140). They are used to indicate that the unit (i.e. packs, containers) has been directly exposed to the sterilization process and to distinguish between processed and unprocessed items. They undergo a colour change when they have been exposed to the sterilizing agent.

It assures the operator handling the processed items that the pack has been exposed to the sterilization process without the need to open the pack or check Load Control records. Exposure Control involves the use of Class 1 chemical indicators that are externally visible.

They can be on tapes or other devices used to seal packs, on load cards or on PCD labels. The most common Class 1 Process Indicator used for Exposure Control is indicator tape.

The nice thing about tape is its dual purpose. It is used as an indicator and as a mean to secure packages for sterilization. Indicator tapes come in a variety of formats. Some are made for disposable wraps and contain stronger adhesive. Others are made for reusable wraps. Their adhesive is strong enough to hold the wrap, but light enough to leave no adhesive residue on the wrap when it’s cleaned.

Externally visible chemical indicators for Exposure Control should be used with every package. For unwrapped trays or peel pouches, Pack Control monitoring may eliminate the need for exposure indicators since their result is externally visible. As with other chemical indicators, Exposure Control indicators (UK, English) are available for steam, EO, hydrogen peroxide gas plasma, ozone, and liquid peracetic acid.

Learn More

For detailed information on exposure control procedures and product usage, please refer to the following documents:

ISO 11140 Sterilization of health care products - Chemical indicators

Tutorial: Introduction to the Decontamination Cycle in a hospital environment (PDF, 668 KB)
Tutorial: Steam Chemical Indicator Classifications (PDF, 573 KB)