for process monitoring of steam sterilization processes.
gke Steri-Record® Process Monitoring Systems (PMS) are described as process challenge devices (PCD) in the standard and are used to check sterilizers, so-called type tests. They proof if a sterilizer fulfils the standard specification (e.g. BD-Test and Hollow Load Test according to EN 285 and EN 867-5) and are used for routine monitoring in steam sterilization processes in each cycle to detect insufficient air removal, leaks and/or non condensable gases (NCG) in steam. Batch Monitoring Systems (BMS) are validated according to the load configuration and are used for routine monitoring of each batch. A PMS can also be used as a BMS, if the penetration performance of the sterilizer exceeds the penetration performance of the load to be sterilized. If this process is validated according to a sterile load and a suitable BMS, this verification ensures the sterilization at the most difficult positions inside of the sterilization load. Monitoring temperature and pressure alone do not provide sufficient information to ensure steam penetration. After validation the BMS simulates the penetration requirements of simple instruments up to complex hollow, minimal invasive surgical (MIS) instruments, tubes, solid instruments and porous loads. Similar PCDs also allow monitoring of low temperature sterilization processes. Further information see data sheet “Testsets and PCDs“.
gke Steri-Record® Compact-PCD® consists of an external plastic casing with an internal stainless steel tube and capsule holding the indicator. The PCDs (green and orange) are available with round and oval cross section having the same performance characteristics:
- - round version with stainless steel bracket. This PCD can be put vertically on a loading rack or placed horizontally on the bracket.
- - oval version: This PCD can be placed horizontally on the flat side of the PCD, suitable for small sterilizers (2.5 cm height).
All PCDs are re-usable and can be used for a considerable number of sterilization cycles.
The gke PMS is a class 2 indicator according to EN ISO 11140-1, consisting of a „specific test load“ (Process Challenge Device = PCD) and „indicator system“ (indicator strip).
The PMS have been validated from a laboratory accredited according to the standard EN ISO 17025 (test reports on request).
The daily use as a process monitoring system has to be validated according to the reference load configuration during the performance qualification (PQ).
The technical gke team supports you by comparing the requirements of a test system with the load configuration.
1. Compact-PCD® , colour: green
This PMS represents a challenging test concerning air removal and steam penetration that can be used for routine monitoring of simple hollow devices, tubes, porous loads and solid instruments. However, this PMS is less demanding regarding air removal and steam penetration that the hollow load test described in EN 867-5.
2. Compact-PCD® , colour: orange
The PMS simulates the hollow load test according to EN 867-5. This standard which will be modified into EN ISO 11140-6 (available as draft, 07/2010) is included in the standard for large sterilizers (EN 285) as well as in the standard for small class B sterilizers (EN 13060) as type tests and make high demands on the sterilization process concerning air removal and steam penetration.
3. Compact-PCD® , , colour: red
Thegke-HDH-PMS (High Demand Hollow) is used for routine monitoring of extreme complex instruments or long tubes, whereas the hollow load test according to EN 867-5 is not anymore sufficient. The gke Steri-Record®HDH-PMS test requires a sterilizer with extremely high air removal and steam penetration characteristics. The standard EN 867-5 describes a test cycle with 9 injections of steam to 950 mbar. In this test cycle the hollow load test will be successfully penetrated, if a vacuum of 450 mbar will be reached in between each steam pulse. To successfully penetrate the gke -HDH-PMS in the same test cycle a vacuum of at least 210 mbar is necessary.These data are only valid under laboratory conditions using a reproducible process in a test sterilizer according to EN ISO 18472. All other parameters that affect the air removal and steam penetration are strictly defined in such a program and must remain unchanged in all test cycles.
Under real sterilization conditions the differences in performance between type test according to EN 867-5 and the gke HDH-PMS may change considerably because day-to-day programs differ from the above mentioned test cycle. Usually less but deeper vacuum cycles are used.
Two indicator strips can be selected according to the program used and are available with different stated values:
- 1. 134°C, 3.5 min or 121°C, 15 min(standard cycle)
- 2. 134°C, 18 min (prion cycle)
If all four bars of the chemical indicator turn from yellow (standard cycle) /pink (prion cycle) to black it is an indication of sufficient steam penetration inside the PCD.
|Sufficient temperature, time and steam penetration|
|Insufficient air removal and steam penetration|
|Temperature achieved, but no air removal and no steam penetration|
|Insufficient temperature, no air removal and no steam penetration|
This result ensures air removal and steam penetration into the whole load under the condition that the PCD is representing the load configuration.
- Indicator strips for standard and prion sterilization cycles are available.
- Only the use of a PMS allows the monitoring of sterility inside of complex hollow instruments, tubes and porous goods not provided by recording pressure, temperature and steam quality in the chamber and/or using exposed indicator strips.
- Cost effective due to multiple use. Only one indicator strips is required for each sterilization process instead of one in each pack.
- Ease interpretation of the results due to precise colour change.
- Continuous reproducibility of the results.
- All information relevant to the process is supplied on completion of the process so that the authorized person can release the batch without opening the packs.
- Environmentally friendly, no unnecessary waste.
- The indicator colour chemistry is a non reversible chemical reaction and remains colour-fast over time.
- The graduated colour change of the indicator bars informs about the kind and magnitude of air removal and steam penetration inside the sterilizer and non-condensable gases in steam.
- 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 surface coating can be disposed with normal garbage.
- Selection between three different versions of Compact-PCD®- ideal handling for each chamber size and load.
- The screw cap consists of a highly thermal resistant material and stainless steel sandwich construction that protects hands from high temperatures. The chemical indicator may be easily removed and evaluated on completion of each cycle.
- The Compact-PCD® can be used for a considerable number of cycles. All important parts are made of stainless steel or thermal resistant polymers.
Each start-up kit contains of a Compact-PCD and 100 integrating indicator strips for standard steam sterilization processes as well as a documentation sheet to be copied before daily use. All test devices are also available separately. The indicator strips are available as refill packs for standard and prion steam sterilization processes and also contain a sealing kit for the screw cap.
1. Start-up kit and process challenge devices
2. Refill packs indicator strips