Bowie-dick simulation test

1. Chemical Indicators (steam sterilization processes)

1.1. Bowie-Dick Simulation Test (BDS-Test)

Used in vacuum steam sterilization processes checking leaks, non condensable gases (NCG) and/or insufficient air removal and to assure steam penetration. The BDS indicator strip is placed into the BDS test device and sterilized in an empty chamber at 121 °C, 15 min or 132 – 134 °C, 3-3.5 min (BD test program). Please refer to the gke colour reference chart. There are three different versions available.

Process / batch monitoring

1.2. Process and Batch Monitoring Systems (Hollow load test systems)

Batch Monitoring Systems (BMS) are validated according to the load configuration and are used for routine monitoring of each batch. Process Monitoring Systems (PMS) are used to check the air removal characteristics of sterilizers. Those tests are so-called type tests that are described in the sterilizer standards (e.g. BD Test and Helix Test according to EN 285 and EN 867-5). PMS are sometimes designed to be more challenging than type tests and exceed the penetration performance in order to assure sterilization of complex loads.
Process Monitoring Systems can also be used as Batch Monitoring Systems. It is recommended to always use the PMS with the highest test requirements that has just passed in a validated process.
The indicator strip is placed into the process challenge device (PCD). The test device is sterilized together with the load. More PCDs and test sets can be found in section 5.

1.2.1. Compact-PCD®, colour: green, with less demanding requirements than EN 867-5

1.2.2. Compact-PCD®, colour: orange, Hollow Load Test according to EN 867-5

1.2.3. Compact-PCD®, colour: red, with higher requirements than EN 867-5

1.2.6.1. for standard steam sterilization processes (121 °C, 15 min / 134 °C, 3 min)

1.2.6.2. for prion steam sterilization processes (134 °C, 18 min)

Package monitoring

1.3. Package Monitoring Indicators for steam sterilization processes

The indicators are used inside packs or containers to monitor all relevant parameters of steam sterilization processes. These indicators should only be used if solid instruments and porous goods (no hollow devices) are sterilized. Package monitoring indicators only provide sterility information at the position inside the chamber where they are located. If only cross contamination on surfaces of the instruments should be prevented the instruments are sterilized without being packaged. In special combination autoclaves that clean, lubricate and sterilize dental instruments, the indicator is also placed unpacked into the indicator holder inside the chamber. All indicators fulfil the requirements according to EN ISO 11140-1 Type 4, 5 or 6 and test the critical variables (temperature, time and condensate/water) with different defined pass/fail windows. They are self-adhesive and can be used for documentation.

1.3.1. Type 4 Indicators (wide pass/fail window)

Process indicators

1.4. Process indicators for steam sterilization processes

Process indicators according to EN ISO 11140-1 Type 1 are adhered on each sterilization package on plastic, paper, (non) woven and change their colour during sterilization to provide logistical information if the pack has passed a sterilization process or not. Process indicators do not inform about the quality of the sterilization process.
There are single self-adhesive labels to be adhered or slipped on containers and double self-adhesive labels to be adhered on packs. They can be removed off the second layer and adhered again for documentation.
Plastic inserts to reduce the core diameter to 2“ or 1“ are available free of charge.

If larger amounts of labels are ordered, labels with other dimensions, different number of labels per roll and other core diameter can be produced. All gke process indicators for steam sterilization processes change their colour from blue to brown/black as shown:

1.4.1. Double self-adhesive 3-layer labels, on roll

They can be used for documentation due to extra layer.

1.4.1. Double self-adhesive 3-layer labels, on roll

1.4.1.2. Labels 58 x 35 and 78 x 35 mm, for non-woven materials

1.4.1.3. Labels 102 x 56 mm, for the Getinge documentation system

1.4.1.4. Labels 38 x 39 mm, for non-woven materials

The single self-adhesive container labels are put into packs, pouches or slipped on containers which have to be sterilized. After sterilization they are adhered onto the patient documentation sheet. It can be labelled with expiry date or a 3-line documentation label can be adhered onto the container label. Colour change see 1.4.

1.4.4. Autoclave tape

The self-adhesive container seal seals the container and contains a process indicator. It can be manually labelled or labelled with a 3-line documentation label (see 6.).

2.2. Self-adhesive indicator strips for process monitoring

to be used in all gke BMS/PMS process challenge devices. Those indicator strips are used inside a gke-PCD so this combination becomes a type 2 indicator system according to EN ISO 11140-1.

2.2. Self-adhesive indicator strips for process monitoring2.3. Self-adhesive type 4 package monitoring indicators according to EN ISO 11140-1

The indicators are placed into packages or containers to monitor the relevant variables of sterilization processes. Those indicators should only be used if solid instruments or porous goods (no hollow devices!) are sterilized. Pack-

2.2.2.4. Indicator tape

The indicator tape with ethylene oxide process indicator is available on roll with 50 m length and 19 mm width and is used to seal packs. It can be replaced by packing tape and EO documentation labels (see 6.2.3).

Indicators for fo processes

3. Chemical Indicators for formaldehyde sterilization processes

3.1. Process Challenge Device (PCD)

to be used in Low Temperature Steam Formaldehyde (LTSF) sterilizers to test sufficient formaldehyde penetration. The indicator strip is placed into the PCD. The test device is sterilized together with the load. More PCDs can be found in 5.

1.4.4. Autoclave tape

The self-adhesive container seal seals the container and contains a process indicator. It can be manually labelled or labelled with a 3-line documentation label (see 6.).

3.2. Self-adhesive indicator strips for process monitoring

To be used in all gke PMS (available in start-up kit and refill packs). Those indicator strips are used inside a gke-PCD so this combination becomes a type 2 indicator system according to EN ISO 11140-1.

3.3. Type 4 self-adhesive package monitoring indicators

The indicators are placed into packages or containers to monitor the relevant variables of sterilization processes. Those indicators should only be used if solid instruments or porous goods (no hollow devices!) are sterilized. Package monitoring indicators only provide sterility information at the position inside the chamber where they are located. After sterilization they can be adhered for documentation.
The indicators are available on card with 16 self-adhesive indicators.

Indicators for H2O2 processes

4. Chemical Indicators for hydrogen peroxide (H2O2) / plasma sterilization processes

All indicators and labels for hydrogen peroxide (H2O2) sterilization processes have a plastic foil carrier since paper must not be used in those processes. They can also be used for disinfection.
gke has changed the indicator colour change from purple → pink to blue → green to get a better contrast.

4.1. Process Challenge Devices (PCD) and Testset

The indicator strip is placed into the PCD. The test device is sterilized together with the load. The penetration charac-teristics of all hydrogen peroxide/plasma sterilization processes into hollow devices are less compared to steam sterilization processes. Therefore, it is not reasonable to use the “steam” PCDs in those processes. For this reason less sensitive Helix-PCDs with shorter tube lengths and larger tube diameter have been developed to check the limits of hydrogen peroxide sterilization processes. In contrast to steam sterilization processes tubes with small diameters are more difficult to penetrate than with large diameters. More PCDs in Compact-PCD design can be found in 5.1.

4.2. Self-adhesive indicator strips for process monitoring

to be used in all gke BMS/PMS process challenge devices. Those indicator strips are used inside a gke-PCD so this combination becomes a type 2 indicator system according to EN ISO 11140-1.

Indicators for H2O2 processes

4.3. Type 4 self-adhesive package monitoring indicators

The indicators are placed into packages or containers to monitor the relevant variables of sterilization processes. Those indicators should only be used if solid instruments or porous goods (no hollow devices!) are sterilized. Pack-age monitoring indicators only provide sterility information at the position inside the chamber where they are located.
Alternatively those indicators can also be used to monitor disinfection processes (e.g. in rooms or isolators). After sterilization they can be adhered for documentation.

The indicators are available on card with 16 self-adhesive indicators.

4.4. Double self-adhesive labels to be used in printers

The labels with process indicator according to EN ISO 11140-1 type 1 are used in printers with and without cutting device. After the information is printed the label can be adhered on sterilization packs or pouches and after opening them for medical treatment they can be transferred to the patient documentation. The chemical indicator provides logistic information if the package has passed a sterilization process.

4.4.1. Labels 78 x 35 mm4.4.1. Labels 78 x 35 mm

4.4.2. Endless label with 7 cm width to be used in printers with cutting device

4.4.3. Labels 78 x 48 mm

4.4.4. Labels 102 x 56 mm, for Getinge documentation system

Testsets and PCDs

5. Testsets and PCDs

TTestsets are used to test the penetration limits of the sterilant in different sterilization processes. The testsets contain PCDs with different penetration characteristics. All PCDs can be used with gke biological or chemical indicators, available for steam, ethylene oxide, formaldehyde and hydrogen peroxide sterilization processes. Please order the corresponding biological or chemical indicator strips a PCD or testset, see 1.2.6 (steam), 2.2 (ethylene oxide), 3.2 (formaldehyde) or 4.2 (hydrogen peroxide/plasma).

5.1. Compact-PCD-Testset, consisting of 10 Compact-PCDs, grey

5.2. Helix-Testsets

Documentation system

6. Documentation System

6.1. Hand labelling devices

The gke Steri-Record® documentation system is used for batch and patient related traceability after sterilization of medical devices.
By using a gke labelling device a label of the same content including production and expiry date, batch number and responsible person is adhered on each pack and on the documentation sheet. After opening the sterile pack in the operation room the label can be removed from the package and adhered into the patient file. Thus all information provided on each pack can be traced back from the patient to the processing and approval.
The labels are available in different colours, optionally with or without indicator.

gke offers two versions of hand labelling devices:

The following example shows a printed label by using a hand labelling device:

6.2.1. without indicator

6.2.2. with process indicator for steam sterilization processes

6.2.3. with process indicator for different sterilization processes

6.3. Double self-adhesive 3-line ECO labelss

6.4.1. without indicator

6.4.2. with process indicator for steam sterilization processes