gke Steri-Record ® Process Monitoring System for ethylene oxide sterilization processes

Application

The process challenge device (PCD) can be used with biological indicator strips (B. atrophaeus 106) and afterwards incubated by a microbiological laboratory. Self-contained biological indicators (SCBI) may be incubated directly after sterilization inside an incubator. For routine monitoring chemical indicators also can be used with the advantage that they can be checked immediately after the sterilization process has finished. In opposite to steam sterilization processes different ethylene oxide sterilization processed are used which differ in temperature, pressure, ethylene oxide concentration and inert gas mixtures, e. g. CO2.
Biological and chemical indicators have been tested at 55°C under the following sterilization conditions:

EO/l[mg] Pressure[bar] CO2 [%]

EO

[%]

Time [min]
500 1,7 85 15 90
600 5,5 94 6 60
250 1,7 94 6 180
1200 5,5 85 15 30
600 0,5 0 100 60

During the sterilization process it is absolutely necessary to monitor the relative humidity in addition, which should be above 30%. The ideal relative humidity during sterilization is between 60% and 70% RH.

gke offers a Compact-PCD®-Testset where PCDs with different penetration characteristics can be selected. Initially all PCDs can be used and checked which are penetrated and which are not and the most difficult one can be selected which is still able to pass. The validation of this process should be checked also with biological indicators.

Alternatively 6 different Bio-C-PCDs can be selected by using self-contained biological indicators SCBIs for ethylene oxide sterilization processes, see separate data sheet.

Sterilization processes which are carried out with ethylene oxide, the PCD should only be used if sufficient diffusion time for the penetration is guaranteed. Is there no penetration of the ethylene oxide gas in the PCD, put the indicators (depending on the packaging-material) of the other sterilizing goods in one or more tyvek pouches to assure difficult sterilizing conditions. In this case sterilizing of longer hollow-types cannot be detected.

Product Description

The PCD consists of a 4.55 m long stainless steel tube of 3 mm diameter connected with a capsule holding the indicator strip or self-contained biological indicator (SCBI) sealing one end.

Best Process Challenge Device | GKE Indicators for Hydrogen Peroxide

Process Monitoring Systems (Helix-PCDs)

Performance Characteristics

The combination of a PCD and a biological or chemical indicator is a type 2 indicator system according to EN ISO 11140-1 consisting of a “specific test load” (PCD) and “indicator strip”.
Sterilization programs are not standardized. Therefore, a validation with biological indicators (B. atrophaeus 106) according to EN ISO 11138-1 + 2 is required before chemical indi-cators may be used for routine monitoring.
The validation of the load configuration (PQ = Performance Qualification) according to EN ISO 11135-1 ensures that the sterilization process meets the requirements to sterilize the load configuration.

General Benefits

  • The use of this EO PMS allows the monitor-ing of sterility inside hollow instruments, tubes and porous goods not provided by recording pressure, temperature and EO concentration in the chamber and/or using exposed indicator strips.
  • Easy interpretation of the results due to pre-cise colour change.
  • Environmentally friendly, no unnecessary waste. The test device can be used for an unlimited number of cycles. All important parts are made of stainless steel.

  • Continuous reproducibility of the results over the lifetime of the PCD.
  • For validation biological indicators are avail-able according to EN ISO 11138-1 + 2
  • Assurance that only sterile released packs are used.
  • No microbiologic laboratory needed.
  • Cost effective. Only one indicator strip or one SCBI is required for each sterilization process instead of one in each pack.

Benefits for PCD to be used with chemical indicators

  • The batch can be released without opening the pack to check the internal packing indi-cator.
  • All information relevant to release the load is supplied on completion of the process so that the person authorized can release the batch.
  • The graduated colour change of the indica-tor bars shows the level of the penetration into the PCD.
  • The indicator colour chemistry is a non-reversible chemical reaction. The indicator strip can be documented proof for several years without changing back to its original colour.
  • gke self-adhesive labels simplify recording with the gke Steri-Record® documentation system.
  • All gke chemical indicators are protected from bleeding by a polymer binder and sur-face coating and can be disposed with nor-mal garbage.

Order Information

Art.-No.* Product code Quantity Content Application
200-028 C-E-PM-HPCD 1 Stainless steel helix test device to be used with chemical or biological indicator strips
300-028 B-E-PM-HPCD 1 to be used with self-contained biological indica-tors (SCBIs)
212-202 C-E-PM 250 Chemical integrating indicator strips, 1 seal ring for all EO sterilization processes (for art.-no 200-028)
221-601 B-E-H-SS-10-6 100 B. atrophaeus spore strips on paper carrier, 106
326-605 B-E-MBP-10-6 50 Self-contained biological indicators (SCBI), 106 for all EO sterilization processes (for art.-no 300-028)
326-610 100
336-605 B-E-MBP-10-6-EP 50
336-610 100

CLEANING PROCESS MONITORING

Cleaning process monitoring indicators and accessories

Self-adhesive cleaning process monitoring indicators (CPI) can be used in washer-disinfectors (WD) (7.1), in ultra-sonic cleaning baths (7.2), in bedpan washers (7.3) and in textile washing machines (7.4). The indicator that has been washed off at the latest, should basically be used to check the cleaning process. There are five different indica-tors available with increasing wash-off characteristics.
The suitable indicator can be selected during a test run. If the WD is equipped with a glass door the indicators can be placed so that the wash-off characteristics are visible through the window and the indicator that has been washed off at the latest can be determined. In WD without glass doors the indicator that has just been fully washed off should be selected for process monitoring.

1. for washer disinfectors (WD)

The cleaning process monitoring indicators are available on cards with 16 double-sided indicators. The indicators can be used as indicator pair and afterwards the indicator can be adhered for documentation. The indicators are placed in a holder or inside a Hollow Flow PCD.

1.1. Cleaning Process Monitoring Indicators, Indicator pair

Best Process Challenge Device | GKE Indicators for Hydrogen Peroxide
Art. No. Product Code Quantity
810-101 W-CPI-Y
(Cleaning process
indicators, yellow)
160
810-102 480
810-103 960
810-201 W-CPI-G
(Cleaning process
indicators, green)
160
810-202 480
810-203 960
810-301 W-CPI-B
(Cleaning process
indicators, blue)
160
810-302 480
810-303 960
810-351 W-CPI-P
(Cleaning process
indicators, purple)
160
810-352 480
810-353 960
810-401 W-CPI-R
(Cleaning process
indicators, red)
160
810-402 480
810-403 960
810-901 W-MC-CPI
(Cleaning process
indicators, green, blue, red)
160
810-902 480
810-903 960

1.2. Cleaning Process Monitoring Indicators for CSD, single indicator

The cleaning process monitoring indicators are available on cards with 16 single indicators. The indicators can be touched on the side with the hand icon without touching the indicator. Afterwards the indicator can be adhered for documentation. The indicators are placed in a holder or inside a Hollow Flow PCD.

Best Process Challenge Device | GKE Indicators for Hydrogen Peroxide
Art. No. Product Code Quantity
811-101 W-CSD-CPI-Y
(colour: yellow)
160
811-201 W-CSD-CPI-G
(colour: green)
811-301 W-CSD-CPI-B
(colour: blue)
811-351 W-CSD-CPI-P
(colour: purple)
811-401 W-CSD-CPI-R
(colour: red)

1.3. Holder and Hollow Flow (PCD) for cleaning process monitoring indicators

Best Process Challenge Device | GKE Indicators for Hydrogen Peroxide
Art. No. Product Code Content Quantity
800-100 W-HO Stainless steel holder 1
800-102 W-PHO Plastic holder 10
800-111 W-HF-PCD Hollow Flow PCD
with 2 adapters: 2 and 4 mm split width, 2 LL adapters and a 0.3 m silicone tube (2x)
1

2. for ultrasonic cleaning baths

Self-adhesive cleaning process monitoring indicators to test ultrasonic cleaning baths, on card with 4 indicators each. The indicators are placed horizontally or vertically in the clip holder (see 2.2) and put in the liquid volume to check the cleaning efficacy inside the baths.

2.1. Ultrasonic cleaning process monitoring indicators

Best Process Challenge Device | GKE Indicators for Hydrogen Peroxide
Art. No. Product Code Quantity
810-111 W-U-L1 (Ultrasonic cleaning process indicators: yellow) 40
810-112 120
810-211 W-U-L2 (Ultrasonic cleaning process indicators: green) 40
810-212 120
810-311 W-U-L3 (Ultrasonic cleaning process indicators: blue) 40
810-312 120
810-411 W-U-L4 (Ultrasonic cleaning process indicators: red) 40
810-412 120

2.2. Holder for ultrasonic cleaning test sheets

Holder consisting of a bottom plate and a stainless steel bar (available in 3 different lengths) with cross connector and two height adjustable clips to fix the indicator horizontally and/or vertically inside the basin volume. Two holders can be connected by using a stainless steel bar and the cross connectors.

Best Process Challenge Device | GKE Indicators for Hydrogen Peroxide
Art. No. Product Code Content Quantity
800-115 W-U-HO-7 Holder with 7 cm stainless steel bar 1
800-116 W-U-HO-20 Holder with 20 cm stainless steel bar
800-117 W-U-HO-40 Holder with 40 cm stainless steel bar

3. for bedpan washers

gke has designed a special cleaning process indicator to monitor the cleaning efficacy in bedpan washers. The indi-cator can be directly adhered onto the test position.

Best Process Challenge Device | GKE Indicators for Hydrogen Peroxide
Art. No. Product Code Quantity double-sided indicators Quantity single indicators
810-000 W-BP-L0 64 128
810-001 160 320

4. for washing machines (laundry)

Cleaning process indicators are used for monitoring of cleaning processes in washing machines (laundry). The indi-cator is placed into a Laundry-Check® ball and the ball is placed into the washing drum together with the load. Indica-tors (see 1.1.) can be used, alternatively a cleaning process indicators with other wash-off characteristics (see 4.1.) can be used.

4.1. Cleaning process indicators

Best Process Challenge Device | GKE Indicators for Hydrogen Peroxide
Art. No. Product Code Quantity
810-501 W-WA-L5
(Cleaning indicators, pink)
160
810-601 W-WA-L6
(Cleaning indicators, grey)
160

4.2. Laundry-Check® Ball

The Laundry-Check® Ball can be opened by unscrewing two parts. The indicator can be inserted in a holder inside the ball. Both parts are closed and put into the drum together with the laundry (load). A red cord is attached to the ball which makes it easier to find the ball in the washing drum after the process.

Best Process Challenge Device | GKE Indicators for Hydrogen Peroxide
Art. No. Product Code Quantity
800-130 W-LA-CHECK 1