General information about chemical indicators monitoring sterilization processes

Depending on local regulations, all sterilization processes have to be validated, especially after start-up each repair of equipment and using new versions of instruments. For daily routine monitoring biological indicators are not suitable due to their long response time between 2 and 5 days. Chemical indicators can monitor the result of a sterilization cycle with the advantage of having the result of the sterilization process available immediately. Several chemical indicators or indicator systems (indicator in a process challenge device [PCD]) are available for different sterilization processes: - Steam at 121C and 134C - Dry Heat 160C - 180 C - Ethylene Oxide at several temperatures and concentrations - Formaldehyde at several temperatures - and radiation Chemical indicators or indicator systems have several functions: Functional check of the sterilizer air removal and steam penetration test, called Bowie-Dick-Test (only for steam sterilization processes with air removal prior to sterilization) Sterility test Use of a cycle or batch control system or indicators placed inside of each individual sterilization pack or container. Logistic information Process indicators are placed on the surface of a package or container and provide pure handling information if goods passed a sterilization process or not. Process indicators placed outside on a package are unable to monitor the efficacy of a sterilization cycle. Unfortunately, many manufacturer on the market do not describe the function of their indicators. New European Standards (EN 867 series) and International Standards (ISO 11140 series) demand from the indicator manufacturer to specify what the chemical indicators is intended to be used for. gke-Steri Record chemical indicators have been tested for their functionality. Their application is described in the attached directions for use. All batches are tested with a permanent quality control system to fulfill the determined gke specifications. The pharmaceutical and medical device industry are used to produce sterile goods according the GMP rules (Good Manufacturing Practice) or the ISO 900X standards. For hospitals the same rules apply. They have to demonstrate that their sterilization processes guarantee a certain sterility assurance level (SAL) of the produced sterile goods. This procedure is called validation. The validation can be carried out by checking physical parameters (parametric release), using biological indicators and methods and/ or chemical indicators or indicator systems. ../2

Side 1

next --->

General information about chemical indicators for the monitoring of sterilization processes
-2Besides validation a permanent routine monitoring has to be carried out during production to assure sterile production, i.e.: steam: temperature, time, air removal, steam penetration ethylene-oxide: temperature, time, gas concentration, humidity, gas penetration dry heat: temperature of the surface of the instruments inside the package, time, individual packaging, heat transfer through packaging Therefore it is a must to validate all sterilization cycles in hospitals and industry before start-up of the process. The European Medical Device Directive (MDD) which is mandatory for all EU countries has been implemented in 1995 with a transition period until 13.06.1998. All sterile goods applied on human beings are defined as Medical Devices (MD). All MD's produced require the validation of the sterilization process according to the European Standards: EN 550 for the EO-gas sterilization process EN 552 for the radiation sterilization process EN 554 for the steam sterilization process
-6

to demonstrate a sterility assurance level (SAL) of 10 CFU per part according to EN 556. Industrial suppliers and hospitals require that the validation is carried out by an European Notified Body, if they bring sterile goods to the market. If they do not bring the MD's to the market, they require the same validation process without a Notified Body involved. Sterilization cycles used in hospitals require the same sterilization standards like in industry. Usually sterilizer manufacturers have validated their processes under worst case conditions. If the critical parameters are controlled, a save production is assured. Some parameters may be controlled by physical

means some others, like air removal, are best monitored by chemical indicator systems with a PCD. Details of the individual indicator types are available on attached table and described below: Bowie-Dick-Test to monitor air removal and steam penetration The original Bowie-Dick-Test is used each day to monitor air removal and steam penetration of the steam sterilization process in the start-up phase. A cotton package of 7 kg contains a chemical indicator sheet which is in compliance with EN 867-3. A description of this test pack is given in the European Standard EN 285. However, this original test package has got three disadvantages: High manpower-effort to produce the package. The cost to wash the cotton material. The type of cotton, ingredients of washing powders and the density of packing influences the reproducibility of the results. ../3 <--- back side 2 next --->

General information about chemical indicators for the monitoring of sterilization processes
-3 The original Bowie-Dick-Test package provides only correct results, if the sterilization time of 3,5 minutes at 134C (274 F) is not exceeded. A special BD-test-program in the sterilizer is required. However, many already installed sterilizers do not contain this specific test programs.

A moist cotton pack gives misleading results. To reduce the package production effort, several Bowie-Dick simulation tests have been developed by various companies. The gke-Steri-Record BDS-Test Chemo-D-BDS-1A-CR offers a quick and safe information about air removal and steam penetration according to EN 867 part 4. Most of the Bowie-Dick simulation tests and also the original Bowie-Dick cotton package require a special test programs (134C/274F at 3.5 minutes holding time). The gke-Steri-Record Bowie-Dick simulation test consist of a metal test device (PCD) containing a test strip with a chemical indicator. The test device is connected to a teflon tube. If there is any air in the sterilizer, corresponding amounts will remain in the tubing of the test device. Steam pressure will push the remaining air back into the test device and will partially or totally fill it up and block steam penetration. Corresponding to the air filling the color change of the chemical indicator will happen, where steam penetration is allowed. Our BDS-Test Chemo-D-BDS-1 is used also for normal Bowie-Dick-Test programs of 134C (274F) for 3,5 minutes.

Opposite to the normal cotton package the gke-Steri-Record -BDS-Test may be alternatively used in

normal sterilization cycles at 134C (274F) up to 9 minutes. This is an advantage if a standard BD-Test program in the sterilizer is not available. The gke-Steri-Record BD simulation test has been tested against EN 867-4 and ISO 11140-4 and is equivalent to the original BD-cotton package of 7 kg according to EN 285. Do not compare the gke-Steri-Record BD simulation test with the US-AAMI cotton package or similar BDS tests of 4 kg 5% tested with the ISO-Standard draft ISO 11140-5, which is less sensitive.

The gke-Steri-Record BD simulation test is loaded with a chemical indicator strip and placed in a sterilizer without any other material. After the sterilization cycle is over, remove the test strip. If all bars of the chemical indicator turn from yellow to black, the sterilization cycle is free of non-condensable gases. If parts of the chemical indicators remain yellow the steam penetration is faulty. Reasons may be: insufficient air removal, a leak in the sterilizer (door seals or valves). Very often non-condensable gases in steam transfer large amounts of air and/or CO2 into the sterilization process.

The Bowie-Dick air removal test in the morning does not guarantee efficient sterilization cycles during the whole day. Especially inert gases in steam may negatively influence the sterilization process during the day. Therefore monitoring of each batch with the gke-Steri-Record batch monitoring system, Chemo-DCH-1HA, is recommended. (See 2.1.) ../4 <--- back side 3 next --->

General information about chemical indicators for the monitoring of sterilization processes
-4Integrating Indicators and Batch Monitoring Systems to monitor whole sterilizer load Batch or cycle monitoring

gke has developed different Batch Monitoring Systems to check all relevant parameters like temperature,
pressure, time, concentration of gas etc. for steam, ethylene oxide and formaldehyde. The color change varies with each type of indicator-system. For detailed information please read the directions for use in each package. The batch control set consists of a process challenge device (PCD) where the indicator is inserted. The test device replaces a cotton pack or container and simulates the most difficult place to sterilize. The result is available immediately after the sterilization process has finished. If the test device simulates the most difficult sterilization conditions in the loading, it is assumed, that the

whole batch has reached sterility. Clear advantages of the test system are obvious: Package monitoring Integrated indicators are used to control packs, containers or pouches. They must be placed at the worst case inside of each pack.. The result is only available after opening the package or container before use. Indicators placed on the surface of packs, containers or pouches are unable to control the efficiency of a sterilization process. Process Indicators These indicators are available for all sterilization processes and are placed on top of packs, containers or pouches. The indicators are not designed to offer information about the efficacy of a sterilization process but to distinguish between sterilized and non-sterilized goods. In general indicators outside of packs positioned are unable to monitor sterility independent of the type. Process indicators are available as selfadhesive points, data labels, strips and container labels. Sometimes customers believe that a color change of a process indicator on a container or package is equal to a sterile content. Referring to the above information this is not automatically the case! If there is e.g. air in the steam sterilizer, a process indicator changes the colour without having sterile conditions in the packs. ../5 <--- back side 4 next ---> The result is available immediately without opening the packs. No complicated packaging of cotton packages. An individual control for every package is not necessary. Economic monitoring in comparison to single batch control in each pack. The documentation is reduced to a batch control strip.

General information about chemical indicators for the monitoring of sterilization processes
-5The enclosed table presents an overview of all gke-Steri-Record chemical indicators, also enclosed is the gke-Steri-Record chemical indicator product overview.

Remark The chemical composition and color change of indicators is different from manufacturer to manufacturer. Therefore it is recommended, to use only one indicator type for all types of tests to prevent confusion and misinterpretation of results.

gke-Steri-Record-Documentation System
The GMP and ISO 900X regulations require a definite documentation of all control procedures. The regulations are originally designed for industrial production. The same requirements, however, apply in hospitals, where sterile goods are produced. In case of internal or external requests the gke-Steri-Record documentation system allows the documentation of all sterilized goods from the day of production until the day of use in a operating room.

gke-Steri-Record self-adhesive labels with special printing devices, offer the opportunity to print
production and expiry date as well as special lot information. Double self-adhesive labels may be used twice, being transferred from a sterilization package to a documentation page for a patient. All available products are described in more detail later on and in their directions for use. If you have further questions please do not hesitate to contact your gke distributor or the gke application lab.

<--- back

side 5