FAQs

Close to the walls you get superheation, which is detected by Gke labels and Gke class 6 indicator. Inside the packs and in the PCD you compensate overheation with created condensate.
First of all you have to test, if our proposal of superheation close to the walls was correct. Please measure with thermo-sensors at the wall. The reason could be superheated steam being introduced or the pressure in the jacket is higher than the pressure in the chamber. The jacket pressure should be almost identical to the chamber pressure, otherwise the walls are warmer than the steam inside the sterilizer chamber creating superheation close to the walls.

The second reason could be centralized steam supply with reduction valves without cooling possibilities between reduction valve sterilizer inlet..

The BMS strip shows a proper colour change when placed in the same load in the worst load case.

We would not recommend to use flash sterilizers for implants. The risk of recontamination is too high. Normal sterilization with double packing is recommended.

As per EN ISO 111450 part 1, an indicator should not change color to the end color in the absence of steam. The recommended practice is to put the said indicator in a bakery oven or a dry heat sterilizer at 140 C and keep a holding time of 30 mts. At the end of the process the indicator strip is allowed to change color. However the color change of the indicator should not be to the end color.

The goods remain sterile until they are contaminated from outside. This depends on the handling of non-wrapped goods. 1

In Europe in washer disinfectors cleaning is done with cleaning solutions, the disinfection is carried out by thermal disinfection (water 90

Cleaning solution has the job to dissolve non water soluble proteins to clean the surfaces, the disinfection solution has the job to kill the germs. However most of the cleaning/disinfection solutions do both.

According to the definition type A hollow objects are instruments with an open cavity on only one side where the ratio of length to diameter of the cavity is greater than or equal to 1 and less than or equal to 750 (1 = L/D = 750) and where the length of the cavity is not greater than 1500 mm (L = 1500 mm); or, alternatively, instruments with an open cavity on both sides where the ratio of length to diameter of the cavity is greater than or equal to 2 and less than or equal to 1500 (2 = L/D = 1500) and where the length of the cavity is not greater than 3000 mm (L = 3000 mm). Type B hollow objects, on the other hand, are instruments with an open cavity on only one side where the ratio of length to diameter of the cavity is greater than or equal to 1 and less than or equal to 5 (1 = L/D = 5) and where the diameter of the cavity is greater or equal to 5 mm (D = 5 mm); or, alternatively, instruments with an open cavity on both sides where the ratio of length to diameter of the cavity is greater than or equal to 2 and less than or equal to 10 (2 = L/D = 10) and where the diameter of the cavity is greater or equal to 5 mm (D = 5 mm).

The Cavity diameter (D) / Length (L) chart below shows the areas relating to type A (in blue) and type B (in orange) hollow bodies with an open cavity on only one side (for those with an open cavity on both sides, for any given cavity diameter, double the length to obtain the equivalent diagram). The space above these areas relates to those bodies where the ratio of length to diameter of the cavity is too big for them to be sterilized even with B cycles; the space below relates to bodies that are not hollow but solid.

Its purpose is to check the degree of steam penetration in the case of hollow objects and the efficacy of the air removal system. The test uses a Teflon tube open at one end only (length 1.5 m, internal diameter 2 mm), ending with a Teflon capsule, containing a chemical process indicator. EN 13060 requires for purposes of approval the employment of this apparatus to test cycles for sterilizing hollow load A (for example B cycles). The test is positive if the chemical indicator changes colour in line with the information given by the producer.
The thermometer test described in the answer to F.A.Q. What is the sterilization temperature band? is not required for hollow load A, in that it is not possible to make a precise measurement of the temperature reached at the back of the cavity of the apparatus described above.

EN norms require the presence of a process evaluation system and/or recorder. The former must automatically monitor the factors essential to ensuring sterilization and must indicate to the operator if the cycle is acceptable or not. In particular, a process evaluation system should answer the same questions as those a well-trained operator would pose when examining the record of the cycle to say whether it has been completed correctly or not:

These are necessary for the removal of air from the autoclave chamber, given that at any given pressure and temperature the density of air is around 1.5 times that of steam, such that any air present during sterilization settles in the lower part of the chamber and creates so-called

EN norms lays down that during sterilization the following nine temperatures

Heat is the best and most used sterilization method and pressurized, saturated water vapor is the most efficient method of heat transmission. That is why steam sterilization reduces the time and the temperature needed for the treatment: at 134

Disinfection destroys all the micro-organisms present in a given environment apart from spores: an object that has been disinfected properly may still transmit a pathogenic micro-organism. Sterilization, on the other hand, is the complete elimination of all micro-organisms including spores.

One has to remember the data recorder that actually creates the print out does NOT control the cycle, but just records the data generated by sensors and air detectors located throughout and around the chamber.

The cycle is controlled by the solenoid valve which controls the steam charges and vacuum pulses and the entire cycle including time temperature / pressure. In a sterilizer if an abort occurs, a micro chip over rides everything and takes the cycle immediately into the exhaust phase and then into the drying phase to finish the process, however, if the abort takes place during the holding time, the micro chip will stop the cycle and go to exhaust and drying, but BI

Chemical Indicators with the correct stated value (temperature) and end point (time) can only recognize entrapped air if they can simulate the inside of the instrument therefore, in their current format, Chemical Indicators can only give information at the point at which they are placed within the pack. Class 4-5-6 chemical indicators are NOT Process Challenge Devices, as they cannot simulate worst case situations in validation load, nor do they have x-ray vision, so they cannot replicate a Process Challenge Device.

No, the air detector cannot recognize entrapped air inside a pack but only monitors condition in the free space of the chamber. The quantity levels at which non condensable (air) gases become critical depend on the goods to be sterilized. For example, a Bowie Dick 7kg linen pack signals an error by means of an inserted indicator sheet or by growth of inserted biological Indicators, if 150-200ml of air has a total inner volume of only 3.14ml. Therefore 0.314ml of non-condensable gases will block 10cm of the tube length to steam penetration, thus preventing effective sterilization of this instrument or tubing at this location.

Poor quality of contaminated steam can generate wet steam, and more importantly, non-condensable gases like air. Non-condensable gases will impede the sterilization process and prevent sterilization from taking place.

If air is not removed from inside

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