SafeSeal Quattro Sterilisation Pouches

SafeSeal® Quattro sterilisation pouches are made from high-quality porous medical paper and mechanically sealed with TruePress™ technology. The perforated fold facilitates precise folding of a wide self-adhesive strip to form an airtight seal. Internal and external multiparameter process indicators for steam sterilisation respond to three variables: time, temperature and saturated steam. The multiparameter process indicators printed directly on the pouch confirm sterilisation parameters. The blue-tinted film makes it easy to view instruments and detect punctures or tears. A convenient thumb notch makes it easy to open the pouch without contaminating the contents.

Available in:

• 89 x 229mm - hand tool & equipment (nipper, clipper etc.)
• 254 x 356mm - multiple tools & equipment (trays, dishes, etc.)

Colour Chart Guide

Below is a colour change guide that should help in the interpretation of the colour change that occurs when the pouches are processed in an autoclave, or ethylene oxide sterilisation chamber.

Caution: the chemical indicators are only used as a sterilisation process indicator. The indicators should be used in conjunction with biological indicators (spore strips) to ensure the devices within the pouches are sterile. Each strip has a starting colour and a finishing colour. Ideally, the indicator should change from the first box to the last box, but this is often not the case due to the large variation in sterilisation chambers. Therefore, an acceptable range of colour changes is recommended as below:

FAQs

• A normal process of sterilisation implies 3 stages: The pre-conditioning time, the sterilisation exposure time, and the cooldown time (also commonly referred to as “drying time”).
• At 132/134 degrees C, the sterilisation 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 indicators?

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 sterilisation 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 sterilisation 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 sterilisation 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 sterilisation 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 sterilisation process. (ISO 11140-1:2005, 4.6)
• Class 6: Emulating indicators are cycle verification indicators that shall be designed to all critical variables for specified sterilisation cycles. The stated values (SVs) are generated from the critical variables of the specified sterilisation process. (ISO 11140-1:2005, 4.7)