Frequently Asked Questions
What is a normal process of sterilization?
- A normal process of sterilization implies 3 stages: The pre-conditioning time, the sterilization exposure time, and the cool down time (also commonly referred to as “drying time”).
- At 132/134oC, the sterilization exposure time is usually 4 minutes (although can be longer for special applications). At this temperature, we know that biological indicators will be de-natured (rendered non viable) before 2 minutes of exposure to saturated steam.
- 2 minutes is considered the time required to attain a 6 log reduction using biological indicators. Sterility assurance is 2X the time it takes to get a 6 log reduction, or about 4 minutes in a standard cycle.
What are the different classes of indicator?
There are 6 classes of indicators
- Class 1: Process indicators are intended for use with individual units (e.g. packs, containers) to indicate that the unit has been directly exposed to the sterilization process, and to distinguish between processed and unprocessed units. They shall be designed to react to one or more of the critical process variables. (ISO 11140-1:2005, 4.2)
- Class 2: (typically a Bowie Dick air removal test or test pack) indicators are intended for use in specific test procedures as defined in relevant sterilizer/sterilization standards. (ISO 11140-1:2005, 4.3)
- Class3: is a single variable indicator designed to react to one of the critical variables and is intended to indicate exposure to a sterilization process at a stated value (SV) of the chosen variable. (ISO 11140- 1:2005, 4.4)
- Class 4: is a multi-variable indicator designed to react to two or more of the critical variables and is intended to indicate exposure to a sterilization cycle at stated values (SVs) of the chosen variables. (ISO 11140- 1:2005, 4.5)
- Class 5: Integrating indicators are designed to react to all critical variables. The stated values (SVs) are generated to be equivalent to, or exceed the performance requirements given in the ISO 11138[8][9][10] series for BIs. The stated values for steam class 5 integrating indicators are required over the typical temperature ranges of the steam sterilization process. (ISO 11140-1:2005, 4.6)
- Class 6: Emulating indicators are cycle verification indicators which shall be designed to reasafesealct to all critical variables for specified sterilization cycles. The stated values (SVs) are generated from the critical variables of the specified sterilization process. (ISO 11140-1:2005, 4.7)
What are they used for?
Used to sterilize instruments, burs, diamonds, mayo trays and any item that a dentist would re-use that can be steam, chemically vapor or ETA sterilized.
What does a Self-seal mean?
The pouches have a self-seal adhesive strip on one end of the pouch, which eliminates the need for tape or a heat sealer.
What does triple Chevron seal mean?
Each of the three seals are heat-sealed three times and chilled back to room temperature. This produces a seal, which provides extra strength in the auto-clave and contributes to a better peel performance upon opening.
Why are pouches blue-tinted?
To help identify any punctures or tears, which darkens to show seal strength, providing clear visibility of unacceptable seals.
What does it mean when the indicator arrow does not change color?
The indicator arrow only changes color if sterilization conditions have been achieved during the sterilization cycle.
Can SafeSeal sterilization pouches be used in dry-heat?
No, they cannot.
How long do the instruments stay sterile after sterilization?
Up to 1 year after sterilization.
Are our sterilization pouches recyclable?
The pouch is a medical grade kraft paper (recyclable), and film (also recyclable). However it is recommended that the paper not be recycled as the indicator ink is solvent based for the steam ink and may not be appropriate for recycling. Therefore the packaging and the film can be recycled while the paper should be disposed of in the chemical waste bin or hazardous material if there is one. Otherwise, they should be disposed of in the regular trash.
Are the pouches a class 4 or class 5 indicator?
The pouches are equipped with internal multi-parameter indicators (meeting the requirements of a Type 4 chemical indicator) as well as Type 1 external process indicators for steam and EtO sterilization. Please note, since 2014, the International Standards Organization (ISO) has replaced the use of ‘Class’ with ‘Type’ when referring to 6 different types of chemical indicators.
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