Indicators and Indicator Systems

for Hydrogen Peroxide Processes

VH2O2

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Table of Contents

Hydrogen Peroxide Processes

General Information ........................................................................................................... 4

Description of existing processes .................................................................................... 4

Advantages and Disadvantages ....................................................................................... 5

Chemical reaction kinetics ................................................................................................ 6

Process characteristics ..................................................................................................... 7

Physical relationships of penetration ............................................................................... 8

Examples of H2O2 sterilization processes ........................................................................ 9

Monitoring Products

BIOLOGICAL INDICATORS (BI)

General Information ......................................................................................................... 11

Self-contained Mini-Bio-Plus Indicators (SCBI) ............................................................. 12

Bio-Compact-PCDs and Accessories ............................................................................. 13

Example Test Results in Bio-Compact-PCDs with SCBI ............................................... 13

Incubator and Accessories ............................................................................................. 14

Spore Strips ..................................................................................................................... 15

Spore Discs ...................................................................................................................... 15

Suspensions .................................................................................................................... 16

Growth Medium ................................................................................................................ 16

CHEMICAL INDICATORS (CI)

Testsets and Process Challenge Devices (PCD) .......................................................... 17

Compact-PCD Test and Indicator Strips ........................................................................ 18

Example Test Results CI in Helix– and Compact-PCDs ............................................... 19

Package Monitoring Indicators ....................................................................................... 20

Process Indicators ........................................................................................................... 20

Documentation System ................................................................................................... 22

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General Information

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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. 1. 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 and as an aerosol 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. 2. Hydrogen Peroxide Sterilization Processes in Healthcare facilities and Industrial applications 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

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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 chemically react (oxidize) with the materials of the instruments,

packaging and incubator.

• 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 properties of H2O2 processes are limited and very different depending on the processes available on the market, the geometry and the material of hollow devices.

• Since only small amounts of H2O2 are vaporized, these are completely consumed by the load de-pending on the load quantity, so that at the end of the process no more H2O2 is remaining. H2O2 is not supplied as steam is 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 for killing germs are not fully published and/or known by the manufacturers. Therefore, a validation of the processes according to the requirements of EN ISO 14937 with bio-indicators is only possible to a limited extent.

• 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.

• No test method has yet been published in the standard. Therefore there is no standard reference bioindicator to test this process.

• Biological indicators required for the validation and routine monitoring are missing and have not yet been standardized until today.

• The biological indicators for monitoring H2O2 sterilization processes that are currently available on the market are not comparable.

• Special expensive packaging materials without cellulose materials are required.

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Chemical Reaction kinetics H2O2 is a very good oxidant and decomposes without stabilization explosively into water (H2O) and oxygen (O2) especially under high pH conditions:

(1) 2 H2O2 2 H2O + O2

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 H2O2 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 1).

The NX-versions of the Sterrad series concentrate the H2O2/H2O2 mixture by vaporization. Water evapo-rates 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. Peracetic acid also splits off a OH-radical. Also there are processes which use peracetic acid and H2O2 in the gas phase. Disadvantageous is that the peracetic ac-id is immediately converted into acetic acid which may corrode stainless steel instruments.

Also the sodium salt of the peracetic acid is used in liquid solutions in the Steris-1-process for high-level disinfection.

(5)

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(4)

OH-

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Process characteristics

The sterilization process depends on the following process variables over time:

When plasma is generated, it does not sterilize in the sterilization processes (Plasma could be used only as a sterilizing agent, with significant higher energies which can damage the load. Therefore, it is not used in H2O2 processes).

The sterilization efficacy even in low concentrations of H2O2 is very high. During the sterilization process H2O is generated which slows down the sterilization velocity, the more water is present. Therefore the process slows down during successive sterilization. When larger loads are sterilized, the sterilization may stop because the H2O2 concentration diminishes to zero. As a result the validation of a process can only be carried out with a clearly defined load configuration. The general “worst-case” load configuration procedure as used in steam sterilization processes cannot be used, but each load configuration requires individual validation, since the kill heavily depends on the materials of the instrument and individual H2O2 consumption as well.

Dependence on the Material of the Goods to be sterilized

It is published1 that the resistance (D-values) of the same Stearothermophilus batch on different carriers can substantially differ. Materials with OH--groups, like cellulose, decompose H2O2. The speed of a sterili-zation process depends on the materials where the instruments are made from. Therefore cellulose pack-ing materials cannot be used in H2O2 sterilization processes because they decompose H2O2 quickly.

The efficacy of a sterilization process depends not only on the design, but individually on the material of the instruments used, the load configuration and the H2O2 sterilization program of the sterilizer. This difficulty is not existent to this extent in any other sterilization process.

1 Volker Sigwarth & Alexandra Stärk: „Effect of Carrier Materials on the Resistance of Spores of Bacillus Stearothermophilus to Gaseous Hydrogen Peroxide”, PDA Journal of Pharmaceutical Science & Technology 2003 Jan-Feb; 57(1), S. 3-11

Variables Influence speed to the process

Temperature increasing

H2O2 concentration in the gas phase increasing

H2O concentration in the gas phase (H2O is injected together with H2O2 and generated during the sterilization process cecreasing the sterilization efficacy)

decreasing

Carrier materials of the spores, e.g. instruments or carrier materials decreasing or increasing

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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 proces-ses. 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 steriliza-tion, because they require a long quarantine time for EO desorption. It is known that VHPO sterilization processes have limited penetration characteristics of the sterilizing gas in hollow devices and tubes compared to steam sterilization processes. Therefore, the efficiency of the processes varies greatly depending on their methods, especially for hollow devices, and must therefore be validated indi-vidually. 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 ap-proaches 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 rela-tively 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.

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2. Penetration of sterilization agents The sterilizing agent is only effective if it reaches all surfaces of instruments in packages and inside of hollow devices. It is important to design the sterilization process so that areas inside of hollow devices can be securely sterilized as well. In steam sterilization processes vaccuum pressure cycles connected in series are used and sufficient quantities of the sterilizing agent (steam) is provided. In VHPO sterilization, after a vacuum of less than 1 mbar, the evaporation of the solvent mixture produces the sterilizing agent. However, the used H2O2 is not replenished in the exposure phase. In terms of process technology, this is not easily possible, since a constant concentration as in steam sterilization is not possible. The formation of steam and oxygen gas during H2O2 consumption causes an increase of the total pressure in the chamber, whereas in steam sterilization, "used" steam causes the pressure in the chamber to drop by condensation. Consequently, in order to maintain the desired exposure conditions in steam sterilization, it is only necessary to maintain the desired pressure by feeding more steam while in H2O2 processes the H2O2 concentration may go to zero, without any H2O2 replace-ment, but the total pressure is increasing. Therefore, a pressure constant process does not make sense. Intensive experiments with Helix PCD tubing systems have shown that the traditional air removal characteris-tics, as known in steam sterilization processes, are not transferable 1:1 in VHPO processes. Firstly, in addition to the geometric relationships (length, inner diameter), the materials of the tubes/pipes play a significant role, so that e.g. stainless steel PCDs of the same length and diameter are much more difficult to penetrate than e.g. Teflon tubes. Furthermore, penetration tests sometimes show different results. Obviously, the different absorption and desorption speed on the walls of the tubes/pipes play a considerable role, so that the absorption of H2O2, H2O and O2 gas proceeds at different speeds and thus no clear pass/fail conditions can be found in the end com-pared to steam sterilization processes (same effect as with separation in gas chromatography). Further tests on different materials still have to be carried out. If the sterilizer gas mixture (VHPO, steam, oxygen, air) passes through tubes/pipes, absorption and desorption phenomena occur at different rates on the tube walls for the individual gases. This can lead to separation effects of the individual gases as in gas chromotography. Further experiments are planned. In order to ensure the reproducibility of the process in VHPO routine monitoring, all critical process parameters must therefore be checked with a Type 2 indicator system independent of the sterilizer. Direct monitoring of the H2O2 concentration is technically only possible with high efforts due to low concentration in the gas phase. The penetration of the sterilizing agent depends on the instrument design and the packaging. The structure of the pressure difference depends on the amount of H2O2 and water, but is often not sufficient to ensure penetration inside of hollow devices. Due to the relatively small amount of H2O2 it quickly implements on the surfaces of the instruments into steam and oxidation product and is no longer available. This is completely different in steam sterilization processes since almost unlimited amounts of steam is available to condense. In steam sterilization which is pressure controlled, condensed steam is simply replenished to maintain the intended pressure. The converted H2O2 is not replaced within one cycle, and the H2O2 concentration goes back to zero, and therefore no further kill can occur. To circumvent this problem, there is a variety of processes sterilizer manufacturers have introduced using consecutive H2O2 injections behind each other. Depending on the method, different results in the penetration and inactivation occur. 3. Validation of VHPO sterilization processes Individual validation of each VHPO process is necessary because:

• Different materials of instruments influence the kill speed.

• Large amounts of load may consume all H2O2, so no H2O2 is left before the sterilization is completed.

• This process has limited penetration characteristics into lumen instruments.

Consequences: Direct inoculation of complex instruments is necessary, if no BIs with the same carrier of the instrument materi-al can be placed at the most difficult penetration position of complex lumen instruments.

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Examples of H2O2 sterilization processes

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Biological Indicators

Biological Indicators

• Biological indicators must be more difficult to kill in a sterilization process than any pathogenic

germs. In EN ISO 14937 a series of 16 different pathgenic germs is listed.

• Tests in all individual H2O2 processes have to be carried out to prove all pathogenic germs are easier to kill than the BI.

• 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 H2O2 sterilization processes, which are not comparable.

• Currently only in liquid H2O2 / H2O such tests can already be carried out but are not directly compa-rable in 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.

• Biological indicators spores of G. Stearothermophilus, B. Atrophaeus and few B. Pumilus have been tested. They also have the catalase enzyme on the surface and protect themselves from being quickly inactivated by H2O2 and thus have a high resistance.

• The resistance of biological indicators heavily depends on their carriers (the same spore of G. Stea-rothermophilus is killed much more difficult using a Tyvek carrier in comparison to a glass fiber carri-er).

gke produces large batches of biological indicators with homogeneous resistances in fermentation processes. Conventional "petri dish" fermentation processes where the spores are scraped off produce inhomogeneous resistance values. They 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 with batch sizes in the range of 10E10 - 10E12 CFUs. For monitoring H2O2-processes gke produces purified spore suspensions which are inoculated on carriers in a reproducible monolayer procedure. 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 a 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. gke self-contained biological indicators al-ready contain a growth medium and do not require a microbiological lab for evaluation.

Monolayer inoculation of biological indicators for VHPO processes 1. BI suspension production In fermenters vegetative germs are produced and converted into spores, which stop biological activity and have a long survival time. After sporulation large amounts of protein from the vegetative form adhere on the spore protecting spore kill in H2O2 processes. Those processes require BIs where the proteins are re-moved. 2. BI inoculation on a carrier If BI suspensions are normally inoculated on a carrier, a multi-layer agglomeration of spores is created. Spores on the upper layer of the agglomeration are inactivated, protecting spores underneath to be killed. Therefore VHPO BIs require a monolayer inoculation on the carrier.

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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), see 2. All SCBI fulfil the requirements ac-cording to EN ISO 11138-1.

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

G. Stearothermophilus available with population 106 CFU/SCBI

1.1. Standard SCBIs

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.

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 (under development)

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 Purple

357-605 50

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Biological Indicators

2. gke Steri-Record® Process Challenge Devices (PCD) for SCBI

Bio-C-PCDs, colour: green, to be used with all Mini-Bio-Plus SCBIs described before, for validation and routine moni-toring of hydrogen peroxide sterilization processes. A PCD with SCBI placed inside is called a type 2 indicator according to EN ISO 11140-1.

Each PCD contains 5 seal rings in addition for replacement in the screw cap. VHPO Sterilization Processes have a lower penetration characteristics than steam sterilization processes. Therefore, until now only PCD no 0, 1, 2 and 3 may pass depending on the process.

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Examples for Test Results using Bio-C-PCD and SCBI (The tests have been carried out in German hospitals in commercial sterilizers.)

Art.-No. Product Code PCD-

Version Penetration

characteristics

300-031 B-PM-OCPCD-0 oval

300-032 B-PM-RCPCD-0 round

300-033 B-PM-OCPCD-1 oval

300-034 B-PM-RCPCD-1 round

300-035 B-PM-OCPCD-2 oval

300-036 B-PM-RCPCD-2 round

300-037 B-PM-OCPCD-3 oval

300-038 B-PM-RCPCD-3 round

Increasing Difficulties For details see table below

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Biological Indicators

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

3.3. Crusher for SCBIs

The incubation temperature is visible in the display. All incubators are either available with an aluminium block to incubate up to 12 SCBIs including a crusher or alternatively without aluminium block. In this case an aluminium block available for different applications (see 3.2. accessories) has to be ordered separately. The plug contains a CE conformity for the low voltage directive.

3. gke Steri-Record® Incubators and accessories

3.1. Dry Bath Incubators

Art.-No. Product Code Temperature Application

With aluminium block for 12 SCBIs

610-119 I-37-AB-MBP 37 to incubate B. atrophaeus

biological indicators

610-120 I-57-AB-MBP 57 to incubate G. stearothermophilus

biological indicators

610-121 I-V-AB-MBP variable

temperature selection 30 - 60

610-122 I-V-T-AB-MBP variable temperature selection and programming of the incubation time

Without aluminium block, see 3.2.

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

3.2. Accessories

Art.-No. Product Code Diameter Application

610-113 I-AB-MBP 10 mm for all gke Steri-Record®

Mini-Bio-Plus SCBIs

610-115 I-AB-CM 16.5 mm for all gke Steri-Record®

growth medium tubes

Aluminium blocks to insert SCBIs or growth medium tubes (12 pcs each).

Art.-No. Product Code Quantity Material

224-002 I-C 1 Stainless steel

224-004 I-PC Plastic 10

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Biological Indicators

4. gke Steri-Record® Biological Indicators

The biological indicators consist of G. Stearothermophilus bacteria spores inoculated on different carriers with the size of 6 x 38 mm and packaged individually (in Tyvek envelope of 94x65 mm) or in bulk in a blister box. They also contain a certificate which states nominal population and D-value. All spore strips can be also used inside of process challenge devices (PCD), see 6.1.1 and 6.1.2)

The G. Stearothermophilus bacteria spores are inoculated on discs with 7 mm diameter (available with different carriers) and are packaged individually (in Tyvek envelope of 60x65 mm) or in bulk in a blister box.

4.1. Spore Strips

4.2. Spore Discs

For monitoring of hydrogen peroxide sterilization and disinfection processes gke produces very homogenous spore suspensions with a uniform D-value in a fermenter that are specially purified afterwards.

Art.-No. Quantity Packaged Carrier Product Code Population

332-601 100 individually PET B-V-P-SS-10-6

106

332-604 40 bulk

332-602 100 individually Glass fiber

B-V-G-SS-10-6 332-605 40 bulk

332-603 100 individually Tyvek B-V-T-SS-10-6

332-606 40 bulk

332-607 100 individually Stainless steel

B-V-ST-SS-10-6 332-608 40 bulk

Art.-No. Quantity Packaged Carrier Product Code Population

332-612 100 individually PET B-V-P-DIS-SP-10-6

106

332-614 110 bulk

332-616 100 individually Glass fiber

B-V-G-DIS-SP-10-6 332-611 110 bulk

332-618 100 individually Tyvek B-V-T-DIS-SP-10-6

332-613 110 bulk

332-617 100 individually Stainless steel

B-V-ST-DIS-SP-10-6 332-615 110 bulk

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Biological Indicators

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.

Art.-No. Product Code Population [CFU/ml]

Population per bottle

Characteristics

229-107 B-V-SUS-10-7 107 10

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specially purified 229-108 B-V-SUS-10-8 10

8 10

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5. 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.

Art.-No. Quantity Product Code Process Germ

223-010 10 B-S-V-CM

steam, hydrogen peroxide

G. stearo-thermophilus 223-100 100

4.3. Spore Suspensions

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Chemical Indicators

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6. Batch and Process Monitoring

6.1. Process Challenge Devices and Testsets

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.

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 per-oxide 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 de-pends 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.

6.1.1. Helix-Testset and PCDs

Art. No. Product Code

Tube

Quantity Diameter

[mm] Length [cm]

200-016 PM-HPCD-TS-10 10 Testset with 10 PCDs

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

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Chemical Indicators

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6.2. Self-adhesive Indicator Strips for Process Monitoring

Before Sterilization After successful Sterilization

Art. No. Product Code Quantity Content

214-202 C-V-PM-2 250 Indicator strips

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

6.1.2 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.

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

7. Indicator Tape

Art. No. Product Code Quantity Content

214-351 C-V-L-1-AT 4 rolls à 25 m

Indicator tape, Self-adhesive, 24 mm widths

The indicator tape with process indicator is used to wrap packages.

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Chemical Indicators

Examples for Test Results using Helix-PCDs and Compact-PCD (The tests have been carried out in German hospitals in commercial sterilizers.)

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Chemical Indicators

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

9. 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.

Art.-No. Product Code Length Outside roll

diameter Roll core

214-390 C-V-L-1-70-DA 60 m 14,7 cm 3“

8. 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.

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

214-243 3.200

Before Sterilization After Sterilization

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.

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Chemical Indicators

9.4. Labels 78 x 35 mm

Art. No. Product Code Labels/

Roll Outside roll

diameter Roll core

214-349 C-V-L-1-80x40-

SC-DA 800 12 cm 3“

9.2. Labels 78 x 48 mm

9.3. Labels 102 x 56 mm, double self-adhesive for Getinge Documentation System

Art. No. Product Code Labels/

roll Outside roll

diameter Roll core

214-369 C-V-L-1-SL-

DDOC 800 12 cm 1,5“

horizontal and vertical splits, separation in 3 segments

Art.-No. Product Code Labels/

roll Outside roll

diameter Roll core

214-373 C-V-L-1-80x50-

SU-DA 750 12,5 cm 3“

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Documentation System

10. Documentation System

10.1. 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. gke offers two versions of hand labelling devices:

10.2. 3-line labels, double self-adhesive

The labels consist of 3 layers and can be directly adhered onto the packages. Each package contains 2 or 12 rolls with 750 labels and an ink roll for the gke labelling device.

Art.-No. Product Code 1. Printing line 2. + 3. Printing line

240-820 D-G-NL 3 alpha-numeric and 9 numeric digits 12 numeric digits

240-830 D-G-AL 12 alpha-numeric digits

240-892 Ink roll for all gke hand labelling devices

Art. No. Product Code Colour Quantity

244-883 C-V-L-1-DA-R red

2

244-873 12

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gke-GmbH Auf der Lind 10 65529 Waldems Germany T +49 6126 94320 F +49 6126 943210 info@gke.eu www.gke.eu 710-012 EN V04