GKE Australia Indicators for Hydrogen Peroxide Processes

Hydrogen peroxide (H2O2) is not commercially available as a pure liquid, but only as an aqueous solution between 30-60%, as it can suddenly explode in pure form in contact with catalytic metal surfaces with release of oxygen (O2), water (H2O) and heat. H2O2 / H2O, mixtures are vaporized and used in the gas phase for sterilization of medical devices in healthcare or are used for room disinfection procedures. The reaction products oxygen (O2) and water (H2O) are non-toxic and are therefore used instead of toxic sterilization processes with EO or LTSF. Furthermore, these methods have the advantage to be carried out at low temperatures 20-60 ° C.

Room or isolator or incubator disinfection procedures

Room disinfection processes are performed by spraying / evaporating aqueous hydrogen peroxide solutions throughout the room or inside an incubator at room temperature. Before the humidity is reduced to below 10% RH. Thereafter, hydrogen peroxide mixtures of 30-50% are evaporated as an aerosol and sprayed into the room. In this case, the hydrogen peroxide gas concentration increases and until the desired concentration of e.g. 200-2,000 ppm is reached, the aerosol concentration is reduced and kept constant over time. During fumigation, it must be ensured that no water condenses on cold spots, otherwise hydrogen peroxide will dissolve in the condensate and disappears out of the gas phase. For this reason, the room including all equipment requires temperature stabilization beforehand in order to prevent condensation. If rooms are not rectangular, but designed in L- or T-shapes, or if machine installations obstruct natural convection, there is a risk that partial areas of the room may have insufficient H2O2 concentrations. In order to find out where the worst-case locations with low H2O2 concentration are, biological indicators with G. stearothermophilus 10E6 are used on different carriers packaged in Tyvek envelopes. To validate the cleanroom disinfection process, 100-200 biological indicators (BI) are used. For routine monitoring, 20-30 BI are placed at the worst-case locations.

Hydrogen Peroxide Sterilization Processes

In the meantime there are more than 40 manufacturers producing H2O2 sterilizers on the world market with chambers of 20 – 200 liters. The sterilization takes place at temperatures of 30-60 °C. The material to be sterilized should also have the sterilization temperature before the addition of H2O2 in order to avoid condensation. After venting <1 mbar, H2O2-H2O mixtures (30 – 60% H2O2) are evaporated on hot plates into the chamber. With the intention of a better distribution of the gas mixture generated in the chamber air is added afterwards. However, it is an open question whether the existing H2O2 / H2O gas mixture mixes homogeneously with the air injected later on, which is very much related to the point of air addition and the type of loading. Air bubbles can be created that do not contain any H2O2 gas.

Since the H2O2v concentration in the gas phase is relatively low (2-10 mg/l), depletion of H2O2 on the material to be sterilized quickly occurs, when H2O2 is consumed and no sterilization can continue. Thereafter, remaining air, steam, H22O2, O2 mixtures are sucked off. Several cycles can be connected in series to obtain a better penetration and sterilization in the hollow devices. However, the penetration characteristics of these processes are much poorer compared to fractionated steam sterilization processes. For this reason, biological and/or chemical indicators must always be placed within the load having the most difficult penetration characteristics. Since BI cannot be placed inside packages (no evaluation before using the MP is possible), Process Challenge Devices (PCD) are used with biological or chemical indicators outside the load, which simulate the “worst-case“ load configuration. These PCDs must be validated with a worst-case load.

Advantages of H2O2 Processes:

  • The sterilizer does not require complex installation, an electrical connection is sufficient.
  • The process velocity is quicker than other low temperature sterilization processes.
  • At the end of the sterilization process H2O2 is decomposed in the non-toxic components water and oxygen.
  • No air removal cycles are necessary, just one deep vacuum is sufficient.
  • No toxic substances remain in the load, except small amounts of absorbed H2O2.
  • No special rooms with flow-through aeration are required in comparison using EO sterilization processes.

Disadvantages of H2O2 Processes:

  • H2O2 is an oxidation agent and can react with the materials of the instruments and the packaging materials.
  • Sterilization velocity of the same alive germ is not only depending on the process conditions and load but additionally on the material of the instruments being sterilized.
  • Cellulose materials/fibres of paper, cotton and linen decompose H2O2 into water and oxygen. Plastics with free OH-groups can cause similar reactions. They are not allowed to be used in this process.
  • Low temperature sterilization processes typically sterilize tubes and MIS instruments with narrow lumens. The penetration characteristics of the H2O2 processes are limited and quite different depending on the processes available on the market.
  • Due to the low H2O2 concentrations of 2-10 mg/l, the consumption in the sterile material may cause areas in which no H2O2 is present any longer since no H2O2 is supplied continuously like steam in steam sterilization processes.
  • In the diffusion phase by injection of air is not sure whether a homogeneous dilution of air takes place or air bubbles are created inside the load or tubes creating non sterile spots.
  • The critical variables of killing germs are not completely published and/or understood. Therefore, a validation of the processes according to EN ISO 14937 cannot be carried out until today with biological indicators.
  • Biological indicators necessary for the validation and routine monitoring are not standardized until today. The identical strain, e.g. G. Stearothermophilus may have completely different characteristics from batch to batch when located on different carriers. Therefore, no standard reference biological indicator is available to test this process.
  • So far, no test method for biological indicators has been published in national or international standards. Therefore, there is currently no standard reference biological indicator available to test this process.
  • Special expensive packaging materials without cellulose materials are required.
  • The biological indicators for monitoring H2O2 sterilization processes that are currently available on the market are not comparable.

Chemical Reaction kinetics

H2O2 is a very good oxidant and decomposes without stabilization explosively into water (H2O) and oxygen (O2):

(1)

H2O2 is not available in pure solution and requires H2O for stabilization and transportation. Typically it is available in aqueous solutions, e.g. in cartridges with the maximal allowed concentration based on safety precaution: H2O2 : H2O ~ 60 : 40

(2) The hydrate solvent complex allows the H22O2 to be safely stored


H2O2 solutions decompose over time, also the diffusion of H2O2 through the plastic cartridges is possible. Chemical and biological indicators should not be stored together with H2O2 cartridges or bottles, since they react with the H2O2-vapour over time!

In the gas phase H2O2 dissociates in several very reactive OH-radicals, which rapidly kill the germs in the sterilization process

(3)

The free radicals inactivate the germs very fast, however only small amounts are present which also recombine again. Water stabilizes the H2O2 molecule by solvation and therefore decreases the concentration of the free radicals, which are responsible for sterilization.
The presence of water vapour in the gas phase reduces the concentration of free radicals and the sterilization efficacy. Water is introduced into the process at the beginning (equation 2) and additionally water is formed during the sterilization process (equation 4).

(4)

The NX-versions of the Sterrad series concentrate the H2O2 by vaporization. Water evaporates faster than H2O2 (100°C, 100 kPa) and concentrates the H2O2 (150°C, 100 kPa) concentration to over 90%.
Alternatively to H2O2 peracetic acid can be used.

(5)

Peracetic acid also splits off a•OH-radical. Also the sodium salt of the peracetic acid is used in liquid solutions in the Steris-1-process for high-level disinfection.

Also there are processes which use peracetic acid and H2O2 in the gas phase. Disadvantageous is that the peracetic acid is immediately converted into acetic acid which may corrode stainless steel instruments.

Physical relationships in describing the penetration of Hydrogen Peroxide in hollow devices

Introduction

VHPO (vaporized hydrogen peroxide oxide) / plasma sterilization processes are increasingly being used in the healthcare sector as low-temperature sterilization processes and replace ethylene oxide sterilization processes. Their problem is that residual EO absorbed in plastic and on plastic surfaces takes longer to desorb and thereby instruments being sterilized in EO sterilization processes are not available for a long time after sterilization, because they require a long quarantine time for EO desorption.

It is known that VHPO sterilization processes have limited penetration characteristics of the sterilizing agent in hollow devices and tubes compared to steam sterilization processes. Therefore, the efficiency of the processes are very different depending on the processes used.

Physical basic information

1. VHPO Concentration inside the sterilization chamber:

H2O2 dissolved in water is the basis for the production of the VHPO gas in the sterilizer chamber in all processes. Concentrations of 35-60% VHPO / water are used. In some processes, the solution is concentrated prior to evaporation, as water evaporates much faster (H2O boiling point 100 °C and H2O2 boiling point 150 °C under normal conditions) and thus the concentration of VHPO can be increased up to 90% (Sterrad NX). However, the concentration of the starting liquid phase is only secondary to the concentration of H2O2 in the gas phase. It depends on the amount of liquid injected, the concentration of the solution and the volume of the sterilizer chamber.

Sterilization methods with H2O2 are usually low pressure methods. Almost all known sterilization processes initially use a vacuum < 1 mbar and inject the liquid mixture into the chamber, which then evaporates immediately. This is followed by a holding time where no further VHPO is replenished. Essentially, a VHPO and steam mixture is formed. VHPO is very reactive and there are several chemical approaches to inactivate germs. The reaction consists of the oxidation of proteins to form oxidation products, steam and oxygen O2. As a result of these reactions, VHPO is consumed and quickly lowers the relatively VHPO concentrations of 2-10 mg / l, since it can react with all objects in the sterilizer (chamber wall, packaging material, instruments).

VHPO is stabilized with H2O in the liquid phase. However, to which extent it plays a role in the inactivation of germs in the gas phase is currently still under discussion, especially as the VHPO concentration is decreasing and the water concentration is increasing during the reaction in all those processes.

Examples of H2O2 sterilization processes

Biological Indicators

  • Biological indicators must be more difficult to kill in a sterilization process than any pathogenic germs. In EN ISO 14937 16 of different pathgenic germs are listed. The selected BI must be more difficult to be killed than those 16 pathogenic germs.
  • These tests have to be carried out with all materials of instruments and BI carriers.
  • For testing a special test sterilizer (resistometer) is required, however, not yet available on the market.
  • Therefore this test procedure is currently carried out only under individually defined conditions in a defined H2O2 sterilization process, not from a general H2O2 process point of view.
  • Only in liquid H2O2 / H2O such tests can already be carried out in all laboratories worldwide, but are not directly comparable for the gas phase.
    A lot of germs, also cells in the human body, use the enzyme catalase which is a catalyst to split H2O2 into water and oxygen.
    Catalase is used to stop sterilization in the liquid phase.
  • Biological indicators spores of G. Stearothermophilus, B. Atrophaeus and B. Pumilus have been tested. They also have the catalase enzyme on the surface and protect themselves partially from being inactivated by H2O2.
  • The resistance of biological indicators heavily depends on their carriers (the same spore of G. Stearothermophilus is killed much more difficult using a Tyvek carrier in comparison on a glass fiber, stainless steel or PET carrier).

In the submerged fermentation process, gke produces large batches of biological indicators with homogeneous resistance. Conventional “solid state” fermentation processes on petri dishes where the spores are scraped off and indicate inhomogeneous resistance values. These generate non-linear semilogarithmic survival curves. The semilogarithmic survival curves of the gke BIs are linear.

By using the fermenter method, gke is able to adjust the resistances of the BI in a certain range according to the requirements of the customers and has batch sizes in the range of 10E10 – 10E12 CFUs. For monitoring of H2O2 processes gke produces purified spore suspensions which are applied to the carriers in a reproducible monolayer.

All gke biological indicators comply with the standard EN ISO 11138 series, European and American Pharmacopeia (EP + USP). The specifications for population and D-value are documented in the certificate for each batch included in every package.

The biological indicators (spore discs, strips and SCBIs) contain G. Stearothermophilus spores, that are immobilized on different carriers (e.g. glass fiber, Tyvek, stainless steel, PET). For evaluation a microbiological laboratory is necessary. Growth medium tubes for incubation of biological indicators are also available at gke. gke self-contained biological indicators already contain a growth medium and don‘t need a microbiological lab for evaluation.

BIOLOGICAL INDICATORS

1. gke Steri-Record® Self-contained biological indicators

Mini-Bio-Plus self-contained biological indicator (SCBI) uses a plastic vial containing a spore plate and glass ampoule with a growth medium and pH-indicator inside. It is used for validation and routine monitoring of hydrogen peroxide sterilization processes without using a microbiological laboratory.

The SCBI are available with different carrier materials.

They can also be used inside gke process challenge devices (Bio-PCDs), All SCBI fulfil the requirements according to EN ISO 11138-1.

1.1. Standard SCBIs
G. Stearothermophilus available with population 106 CFU/SCBI

Indicators for Hydrogen Peroxide Processes | VH2O2 | BMSS
Art.-No. Quantity Product Code Carrier Colour of cap
327-601 10 B-V-G-MBP-10-6 Glass fiber Light Grey
327 -605 50
327-610 100
337-601 10 B-V-T-MBP-10-6 Tyvek Colourless
337-605 50
347-601 10 B-V-ST-MBP-10-6 Stainless steel Dark Grey
347-605 50
357-601 10 B-V-P-MBP-10-6 PET Light Green
357-605 50

BIOLOGICAL INDICATORS

1. gke Steri-Record® Self-contained biological indicators

Mini-Bio-Plus self-contained biological indicator (SCBI) uses a plastic vial containing a spore plate and glass ampoule with a growth medium and pH-indicator inside. It is used for validation and routine monitoring of hydrogen peroxide sterilization processes without using a microbiological laboratory.

The SCBI are available with different carrier materials.

They can also be used inside gke process challenge devices (Bio-PCDs), All SCBI fulfil the requirements according to EN ISO 11138-1.

1.1. Standard SCBIs
G. Stearothermophilus available with population 106 CFU/SCBI

Indicators for Hydrogen Peroxide Processes | VH2O2 | BMSS
Art.-No. Quantity Product Code Carrier Colour of cap
327-601 10 B-V-G-MBP-10-6 Glass fiber Light Grey
327 -605 50
327-610 100
337-601 10 B-V-T-MBP-10-6 Tyvek Colourless
337-605 50
347-601 10 B-V-ST-MBP-10-6 Stainless steel Dark Grey
347-605 50
357-601 10 B-V-P-MBP-10-6 PET Light Green
357-605 50

1.2. Instant-SCBIs for immediate release

G. Stearothermophilus available with population 106 CFU/SCBI

The Instant-Mini-Bio-Plus SCBI contains a type 4 chemical indicator allowing that the result of hydrogen peroxide sterilization processes can be instantly evaluated at the end of the process. Therefore, it is not necessary to wait for the result of the SCBI incubation since the type 4 indicator provides equivalent or better information about the result of the sterilization process according to EN ISO 11140-1

Indicators for Hydrogen Peroxide Processes | VH2O2 | BMSS
Art.-No. Quantity Product Code Carrier Colour of cap
327-651 10 B-V-G-I-MBP-10-6 Glass fiber N/A
327 -655 50
327-650 100

1.2. Instant-SCBIs for immediate release

G. Stearothermophilus available with population 106 CFU/SCBI

The Instant-Mini-Bio-Plus SCBI contains a type 4 chemical indicator allowing that the result of hydrogen peroxide sterilization processes can be instantly evaluated at the end of the process. Therefore, it is not necessary to wait for the result of the SCBI incubation since the type 4 indicator provides equivalent or better information about the result of the sterilization process according to EN ISO 11140-1

Indicators for Hydrogen Peroxide Processes | VH2O2 | BMSS
Art.-No. Quantity Product Code Carrier Colour of cap
327-651 10 B-V-G-I-MBP-10-6 Glass fiber N/A
327 -655 50
327-650 100

2. gke Steri-Record® Incubators and accessories

The incubation temperature is visible in the display. All incubators are either available with an aluminium block to incubate SCBIs or alternatively without aluminium block. In this case an aluminium block available for different applications has to be ordered separately. The plug contains a CE conformity for the low voltage directive.

2.1. Dry Bath Incubators

Indicators for Hydrogen Peroxide Processes | VH2O2 | BMSS
Art.-No. Product Code Temperature Application
With aluminium block for SCBIs
610-120 I-57-AB-MBP 57 to incubate G. stearothermophilus biological indicators
6610-121 I-V-AB-MBP 30 – 60 variable temperature selection
610-122 I-V-T-AB-MBP variable temperature selection and programming of the incubation time
Without aluminium block
610-110 I-57 57 to incubate G. stearothermophilus biological indicators
610-111 I-V 30 – 60 variable temperature selection
610-112 I-V-T variable temperature selection and programming of the incubation time

2.2. Accessories

Aluminium blocks to insert SCBIs (12 pcs each).

Indicators for Hydrogen Peroxide Processes | VH2O2 | BMSS
Art.-No. Product Code Diameter Application
610-113 I-AB-MBP 10 mm for all gke Steri-Record® Mini-Bio-Plus SCBIs

2.3 Crusher for SCBIs

to activate all gke SCBIs. The gke incubator already includes a crusher.

Indicators for Hydrogen Peroxide Processes | VH2O2 | BMSS
Art.-No. Product Code Material Application
224-002 I-C Stainless steel 1
224-004 I-PC Plastic 10

2. gke Steri-Record® Incubators and accessories

The incubation temperature is visible in the display. All incubators are either available with an aluminium block to incubate SCBIs or alternatively without aluminium block. In this case an aluminium block available for different applications has to be ordered separately. The plug contains a CE conformity for the low voltage directive.

2.1. Dry Bath Incubators

Indicators for Hydrogen Peroxide Processes | VH2O2 | BMSS
Art.-No. Product Code Temperature Application
With aluminium block for SCBIs
610-120 I-57-AB-MBP 57 to incubate G. stearothermophilus biological indicators
6610-121 I-V-AB-MBP 30 – 60 variable temperature selection
610-122 I-V-T-AB-MBP variable temperature selection and programming of the incubation time
Without aluminium block
610-110 I-57 57 to incubate G. stearothermophilus biological indicators
610-111 I-V 30 – 60 variable temperature selection
610-112 I-V-T variable temperature selection and programming of the incubation time

2.2. Accessories

Aluminium blocks to insert SCBIs (12 pcs each).

Indicators for Hydrogen Peroxide Processes | VH2O2 | BMSS
Art.-No. Product Code Diameter Application
610-113 I-AB-MBP 10 mm for all gke Steri-Record® Mini-Bio-Plus SCBIs

2.3 Crusher for SCBIs

to activate all gke SCBIs. The gke incubator already includes a crusher.

Indicators for Hydrogen Peroxide Processes | VH2O2 | BMSS
Art.-No. Product Code Material Application
224-002 I-C Stainless steel 1
224-004 I-PC Plastic 10

3. Spore Suspensions

All spore suspensions are delivered in 10 ml glass bottles with a septum, suspended in 40% ethanol/water and comply with EN ISO 11138-1.

Indicators for Hydrogen Peroxide Processes | VH2O2 | BMSS
Art.-No. Product Code Population[CFU/ml] Population per bottle Characteristics
228-107 B-S-F-V-SUS-10-7 107 108 purified
228-108 B-S-F-V-SUS-10-8 108 109
228-997 Determination H2O2

3. Spore Suspensions

All spore suspensions are delivered in 10 ml glass bottles with a septum, suspended in 40% ethanol/water and comply with EN ISO 11138-1.

Indicators for Hydrogen Peroxide Processes | VH2O2 | BMSS
Art.-No. Product Code Population[CFU/ml] Population per bottle Characteristics
228-107 B-S-F-V-SUS-10-7 107 108 purified
228-108 B-S-F-V-SUS-10-8 108 109
228-997 Determination H2O2

4. gke Steri-Record® Growth medium

Test tubes (diameter: 16,1 mm) with CASO-Boullion (TSB) with pH-indicator and aluminium screw cap with seal. The test tubes have optimized dimensions and volume to fit all kind of spore strips. If germs are growing the pH-indicator changes its colour and allows a quick evaluation of the result

Indicators for Hydrogen Peroxide Processes | VH2O2 | BMSS
Art.-No. Quantity Product Code Process Germ
223-010 10 B-S-V-CM steam, hydrogen peroxide G. stearo-thermophilus
223-100 100

4. gke Steri-Record® Growth medium

Test tubes (diameter: 16,1 mm) with CASO-Boullion (TSB) with pH-indicator and aluminium screw cap with seal. The test tubes have optimized dimensions and volume to fit all kind of spore strips. If germs are growing the pH-indicator changes its colour and allows a quick evaluation of the result

Indicators for Hydrogen Peroxide Processes | VH2O2 | BMSS
Art.-No. Quantity Product Code Process Germ
223-010 10 B-S-V-CM steam, hydrogen peroxide G. stearo-thermophilus
223-100 100

CHEMICAL INDICATORS

5. Batch and Process Monitoring

The chemical indicators only provide the information about the quality of the sterilization and disinfection process with hydrogen peroxide on the location where the indicator is placed.

Several Process Challenge Devices (PCD) can be selected to monitor the process. gke will help you to select the appropriate PCD for routine monitoring.

After sterilization the self-adhesive indicator can be used for documentation.

The gke chemical indicators comply with EN ISO 11140-1.

All indicators and labels for hydrogen peroxide sterilization processes have a plastilc foil carrier since paper must not be used in those processes.

5.1. Process Challenge Devices and Testsets

The H2O2 Batch Monitoring System (BMS) ensures that the hydrogen peroxide gas penetrates into the most-difficult areas inside the load or all locations in the isolator. The air removal and penetration characteristics of hydrogen peroxide are very different depending on the sterilizer model and program and very much dependent on the material to be sterilized. Therefore, gke does not offer a fixed combination of indicator and PCD, the selection of the PCD depends on the performance of the hydrogen peroxide process on the one hand and the requirements of the load and material properties on the other hand. It must be ensured that the selected PCD simulates the load to be sterilized. After selecting the appropriate PCD, it can be ordered separately and used with biological or chemical indicator strips.

5.1.1. Helix-Testset and PCDs

Art.-No. Product Code tube Quantity
Diameter [mm] Length [cm]
200-016 PM-HPCD-TS-10 Testset with 10 PCDs 10
200-525 PM-HPCD-5-25 5 25 1
200-550 PM-HPCD-5-50 5 50
200-575 PM-HPCD-5-75 5 75
200-510 PM-HPCD-5-100 5 100
200-425 PM-HPCD-4-25 4 25
200-450 PM-HPCD-4-50 4 50
200-475 PM-HPCD-4-75 4 75
200-325 PM-HPCD-3-25 3 25
200-350 PM-HPCD-3-50 3 50
200-025 PM-HPCD-2-25 2 25

5.1.2 Compact-PCD-Testset and Compact-PCDs, grey

The testsets contain PCDs with different penetration characteristics. All PCDs can be used with gke biological or chemical indicators

Indicators for Hydrogen Peroxide Processes | VH2O2 | BMSS
Art.-No. Product Code Comparable with PCD Quantity
200-211 PM-RCPCD-1 200-071 (Tattoo) 1
200-212 PM-RCPCD-2
200-213 PM-RCPCD-3 200-081 (Dental)
200-214 PM-RCPCD-4
200-215 PM-RCPCD-5
200-216 PM-RCPCD-6 200-091 (Ophthal)
200-217 PM-RCPCD-7 200-020 (green)
200-218 PM-RCPCD-8 200-021 (orange)
200-219 PM-RCPCD-9 200-029 (red)
200-220 PM-RCPCD-10 200-030 (brown)
200-210 PM-RCPCD-TS Testset with 10 CPCDs 10

5.2. Self-adhesive Indicator Strips for Process Monitoring

To be used in all gke BMS/PMS process challenge devices. EN ISO 11140-1 Type 2 Indicator in combination with a PCD.

Indicators for Hydrogen Peroxide Processes | VH2O2 | BMSS
Art.-No. Product Code Quantity Content
214-202 C-V-PM-2 250 Indicator strips

CHEMICAL INDICATORS

5. Batch and Process Monitoring

The chemical indicators only provide the information about the quality of the sterilization and disinfection process with hydrogen peroxide on the location where the indicator is placed.

Several Process Challenge Devices (PCD) can be selected to monitor the process. gke will help you to select the appropriate PCD for routine monitoring.

After sterilization the self-adhesive indicator can be used for documentation.

The gke chemical indicators comply with EN ISO 11140-1.

All indicators and labels for hydrogen peroxide sterilization processes have a plastilc foil carrier since paper must not be used in those processes.

5.1. Process Challenge Devices and Testsets

The H2O2 Batch Monitoring System (BMS) ensures that the hydrogen peroxide gas penetrates into the most-difficult areas inside the load or all locations in the isolator. The air removal and penetration characteristics of hydrogen peroxide are very different depending on the sterilizer model and program and very much dependent on the material to be sterilized. Therefore, gke does not offer a fixed combination of indicator and PCD, the selection of the PCD depends on the performance of the hydrogen peroxide process on the one hand and the requirements of the load and material properties on the other hand. It must be ensured that the selected PCD simulates the load to be sterilized. After selecting the appropriate PCD, it can be ordered separately and used with biological or chemical indicator strips.

5.1.1. Helix-Testset and PCDs

Art.-No. Product Code tube Quantity
Diameter [mm] Length [cm]
200-016 PM-HPCD-TS-10 Testset with 10 PCDs 10
200-525 PM-HPCD-5-25 5 25 1
200-550 PM-HPCD-5-50 5 50
200-575 PM-HPCD-5-75 5 75
200-510 PM-HPCD-5-100 5 100
200-425 PM-HPCD-4-25 4 25
200-450 PM-HPCD-4-50 4 50
200-475 PM-HPCD-4-75 4 75
200-325 PM-HPCD-3-25 3 25
200-350 PM-HPCD-3-50 3 50
200-025 PM-HPCD-2-25 2 25

5.1.2 Compact-PCD-Testset and Compact-PCDs, grey

The testsets contain PCDs with different penetration characteristics. All PCDs can be used with gke biological or chemical indicators

Indicators for Hydrogen Peroxide Processes | VH2O2 | BMSS
Art.-No. Product Code Comparable with PCD Quantity
200-211 PM-RCPCD-1 200-071 (Tattoo) 1
200-212 PM-RCPCD-2
200-213 PM-RCPCD-3 200-081 (Dental)
200-214 PM-RCPCD-4
200-215 PM-RCPCD-5
200-216 PM-RCPCD-6 200-091 (Ophthal)
200-217 PM-RCPCD-7 200-020 (green)
200-218 PM-RCPCD-8 200-021 (orange)
200-219 PM-RCPCD-9 200-029 (red)
200-220 PM-RCPCD-10 200-030 (brown)
200-210 PM-RCPCD-TS Testset with 10 CPCDs 10

5.2. Self-adhesive Indicator Strips for Process Monitoring

To be used in all gke BMS/PMS process challenge devices. EN ISO 11140-1 Type 2 Indicator in combination with a PCD.

Indicators for Hydrogen Peroxide Processes | VH2O2 | BMSS
Art.-No. Product Code Quantity Content
214-202 C-V-PM-2 250 Indicator strips

6. Self-adhesive Package Monitoring Indicators

The indicators according to EN ISO 11140-1 Type 4 are placed into packages or containers to monitor the relevant variables of sterilization processes. Package 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 with different specifications, dose = 2.3 mg/l H2O2, 50 °C, alternative: 2 min, 4 min, or 6 min. The indicator can also be used for longer sterilization times, higher temperatures and concentrations.

Indicators for Hydrogen Peroxide Processes | VH2O2 | BMSS
Art.-No. Product Code Quantity Dose at 50 °C
214-221 C-V-P-6 400 2.3 mg/l H2O2 /6 min
214-223 3.200
214-231 C-V-P-4 400 2.3 mg/l H2O2 /4 min
214-233 3.200
214-241 C-V-P-2 400 2.3 mg/l H2O2 /2 min
214-223 3.200

7. Labels with process indicators 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.

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

Indicators for Hydrogen Peroxide Processes | VH2O2 | BMSS
Art.-No. Product Code Length Outside roll diameter Roll core
214-390 C-V-L-1-70-DA 60 m 14,7 cm 3“

6. Self-adhesive Package Monitoring Indicators

The indicators according to EN ISO 11140-1 Type 4 are placed into packages or containers to monitor the relevant variables of sterilization processes. Package 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 with different specifications, dose = 2.3 mg/l H2O2, 50 °C, alternative: 2 min, 4 min, or 6 min. The indicator can also be used for longer sterilization times, higher temperatures and concentrations.

Indicators for Hydrogen Peroxide Processes | VH2O2 | BMSS
Art.-No. Product Code Quantity Dose at 50 °C
214-221 C-V-P-6 400 2.3 mg/l H2O2 /6 min
214-223 3.200
214-231 C-V-P-4 400 2.3 mg/l H2O2 /4 min
214-233 3.200
214-241 C-V-P-2 400 2.3 mg/l H2O2 /2 min
214-223 3.200

7. Labels with process indicators 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.

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

Indicators for Hydrogen Peroxide Processes | VH2O2 | BMSS
Art.-No. Product Code Length Outside roll diameter Roll core
214-390 C-V-L-1-70-DA 60 m 14,7 cm 3“