Some guidelines from Getinge AB

Getinge AB 1997

STERILIZATION WITH STEAM

Version 9709

CONTENTS
Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5 INTRODUCTION Popular introduction to steam . . . . . . . . . . . . . . . . . . . . . . . . .7 Steam sterilization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9 The moisture content of the goods . . . . . . . . . . . . . . . . . . . . . . 11 MEDIA QUALITY Steam . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 Water . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 PACKING MATERIAL Wrappings of paper . . . . . . . . . . . . . . Wrappings of textile . . . . . . . . . . . . . . Bags or peelable reels of paper or paper mixes Peelable reels of plastic foil . . . . . . . . . . Goods carriers . . . . . . . . . . . . . . . . . PACKAGING Single items . . . . . . . . . Plastic items . . . . . . . . . Textiles . . . . . . . . . . . . Instrument set . . . . . . . . Containers . . . . . . . . . . Baskets . . . . . . . . . . . . Loading . . . . . . . . . . . . Fold instruction for wrappings PROGRAM MODIFICATION General advice . . . . . . Modification procedure . Post treatment . . . . . . Pre treatment . . . . . . .

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THE STERILIZER Pre heating the sterilizer . . Doors . . . . . . . . . . . . The sterilizer condition . . . The sterilizer and the steam Replacement of sterile filter Air purging . . . . . . . . . Leakage . . . . . . . . . . .

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Preface
A result of a sterilization where steam has been used as the sterilizing agent, is usually judged from two criteria, the STERILITY and the REMAINING MOISTURE CONTENT of the goods. The sterility which is dependent on physical, chemical and biological parameters is naturally the most important one. The physical parameters can be verified by means of the sterilizer recording instrument and/or by using chemical indicators. By means of biological indicators packed together with the goods, the intended bacterial killing result can be proved. Moisture content is more difficult to judge because the permissible limits are more widely spread and will vary with the great variety of articles being sterilized. Both the above criteria are recommendations or demands associated in respective countries. These are often issued by the authority responsible for public health and sick care or with organisations associated to these.

The controllable key factors

The sterilizing result is directly influenced by such key factors as MEDIUM QUALITY, PACKING MATERIAL, PACKING TECHNIQUE, STERILIZER CONDITION and TYPES OF PROGRAM. With this reference book GETINGE AB will show the individual user the possibilities available to influence these factors depending on hi own conditions, to achieve the best result in each specific case. To begin with the background is given to the conceptions of sterility and moisture content.

INTRODUCTION
Popular introduction to steam
Steam beyond all comparison is the cheapest and most suitable medium for thermal sterilization, because its energy content is very large and self emitting, while heating the micro organisms, the moisture necessary to kill these. At the appropriate temperature and pressure, all agents can exist in the three states of aggregation, gaseous, liquid and solid, provided they do not decompose at high temperature. The conversion from one state to another is accompanied by absorbing or emitting heat (and usually also a change of volume). To illustrate this the diagram below shows what happens when heat is added to 1 kg ice at -50oC. The unit for heat is the joule (J). The most common unit for technical use is the thousand times larger kilojoule (kJ). An elderly unit was BTU (British Thermal Unit).
C +200 G +150 +100 +50 0 -50 A
95 335 420 2250

-100

kJ

Fig 1.

At the initial point A, the temperature of the ice is -50oC. Heat which is transferred to the ice increases its temperature. At point B, when the temperature is 0oC the temperature rise suddenly stops in spite of heat being continuously admitted. This is because all heat is consumed by melting the ice. The admitted amount of heat is absorbed in the conversion when the water goes from solid to liquid state and is therefore called the melting (fusion) heat of the ice. As can be seen from the diagram the heat amount comes to about 335 kJ. The water temperature will not increase until all ice is melted, but at 100oC (this fictitious laboratory experiment is assumed to take place at

atmospheric pressure) the temperature becomes constant again. Another state conversion temperature is attained. The heat amount which has been admitted to the water of 0oC and caused its temperature rising from C to D is called sensible heat and comes to about 420 kJ. The not occurring temperature rise at point D in spite of heat being continuously admitted depends on all supplied energy being consumed by converting water from liquid state to steam. The energy consumed until all water has boiled off from D to E in fig. 1 is called latent heat and is at 100oC of the order 2250 kJ. The steam produced from the boiling water is called wet steam because minor water particles are carried away by the bubbling water. At point E where all water is converted into steam, the latter is called dry saturated. Such steam is invisible like atmospheric gases and i characterized by being free from suspended water drops, but it is neither superheated, i.e. not heated to a higher temperature than the water had from which it was created. The state dry saturated is an ideal state of steam which is in practice difficult to maintain, but for sterilization purpose the very best. On continued heat admittance at E when all water is converted into steam, the steam temperature increases along the line E - F. The steam is then superheated. At F the heat supply is supposed to be removed. On the diagram the pressure has been assumed to stay constant a atmospheric pressure why the temperature of the saturated steam is 100oC. If the heating of the water takes place in a closed vessel, the steam pressure and thereby the temperature increases along the line D G. It is also possible to create steam with lower temperature than 100oC, but in that case the steam production has to take place at subatmospheric pressure. The deeper vacuum the lower steam temperature as can be seen from fig. 2.

There exists always a known relationship between temperature and pressure with saturated steam which can be seen on fig. 2.
4 BAR

C 1 20 40 60 80 100 120 140

Fig. 2

Steam sterilization
Sterilization means total killing of all microorganisms such as spores, virus, bacteria etc. The most difficult killing objects are bacteria in the spore state. The sterilization is made cheaper and safer using moisture heat. The time required depends on the temperature at which the sterilization process is performed. The killing of spores demand that: 1. The spores must become moistened. 2. The spores must be hot (above 115oC). The sterilization process consists usually of three main phases (see fig. below)
bar

Pretreatment

Sterilizing

Posttreatment

The pretreatment
The task of the pretreatment is to replace all air with steam in the chamber and in the blind space of the packings as well as in cavities and pores in the goods to be sterilized. If this replacement is not successful, a spore may be surrounded by air, in which case it may become hot enough but not humidified and therefore survives. In the pretreatment stage therefore a gradual replacement of the air takes place by repeatedly pumping out the chamber atmosphere, and at each evacuation replace it with steam. This first phase also aims at preheating the goods.

Sterilization
During the second phase the actual sterilization takes place. The goods are heated from room temperature to sterilizing temperature (say 134oC) by the admitted steam condensating on all surfaces which are colder than 134oC. When the steam reverts into water all heat once required to produce it, is given back and this is why heating with steam is outstandingly efficient. It has also the advantage of fulfilling one additional of the main conditions above, to humidify the spores. The disadvantage is however that there is much more steam (condensate) required for heating purpose than is needed for humidification. This is why the goods may become more moisturized than wanted. When the chamber- temperature and pressure has reached the desired level, usually minimum 121oC respectively 134 oC, this is maintained for a certain minimum time, the sterilizing time, which is minimum 15 respectively 3 minutes. The relationship time - temperature is covered in standards.

Post treatment
The process is finished with a third phase during which the chamber steam is emptied by evacuation to a deep vacuum. This is often called the drying phase because at this stage, in the best case, all water condensed to steam should boil off in order to enable for the vacuum pump to take it away. This is however not possible if the water has been collected in for instance a wrinkle in a plastic bag, as there is no amount of heat available to evaporate the water. This is sometimes the reason why it becomes difficult to reduce the moisture content of the goods.

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The moisture content of the goods

As said earlier, the heating of the goods is made by steam emitting its heat content to the surfaces on which it condenses to water. This condensation continues until all all objects have attained the temperature of the steam itself. Therefore more condensed steam is required the heavier an object is. To increase the temperature to 134oC of a mallet the weight of which is 0, 5 kg, there will be formed about 10 ml condensate. This water will most probably flow together to drops which are collected somewhere in the parcel or the package material. If the water can later on be removed or not depends on whether it is in contact with any heated object or not. If the water is collected in a wrinkle in a plastic bag where it has no contact with an object like instrument, bowl or similar the water will hardly be removed by any dryingor post treatment cycle acceptable from the time point of view. The heat content of the the water itself is sufficient to evaporate only about 14% of it. If on the other hand the condensate is collected where it is in contact with metal surfaces like in the bottom of a bowl or absorbed in a textile surrounding an instrument practically all condensate will evaporate with a dry load as result. A specific problem are articles made of plastic. A comparison between two bowls, one made of steel and the other of plastic shows that nearly the same amount of steam will be required to heat the objects to sterilizing temperature. For a common kidney bowl the quantity is a few millilitres. The water flows together to a pool on the bottom of the bowl. After the drying stage all water has evaporated from the metal bow while almost all is left in the plastic one. This happens in spite of the same amount of heat being accumulated in both objects. The reason is the good heat conductivity with steel making practically all accumulated energy available in one small spot when evaporating the pool. With the plastic bowl the total amount of heat remains spread out and therefore not available where it is needed. There is a difference in heat conductivity of about 50100 times, which means that if there was one minute required to evaporate the water in the metal bowl, it would take about one hour with the plastic one. This illustrates the importance of combining goods types and packing material in the right way. More about this later. Does not the sterilizer design and function have any influence on the sterilizing result? Yes it has, and in two ways. Technical malfunction resulting in a wet load may occur with the sterilizer itself or with the steam supplied from a central plant. The sterilizer itself can be checked by means of its own instruments and by weighing the goods before and after a sterilization process. The weight should due to moisture should normally not exceed 1%1 with textiles.
1. Often stipulated in standard

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Another circumstance which has influence on the moisture content of the load is the degree of preheating which takes place during the pretreatment stage of the process. This preheating can be made in different ways but they all aim at increasing the temperature of the load without making use of condensation. In this way the temperature rise, which shall take place later during the sterilizing phase, will be reduced and this is also the case with the amount of condensate. In the ideal case that small amounts of condensate is required that it appears only as dew on the goods. This will however be attained only with small instruments. An additional factor influencing the result is the post treatment phase. During this stage can with a suitable process shaping that part of the excess moisture be evaporated which was necessary to add during the pretreatment stage.

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MEDIA QUALITY
Steam
The result of a sterilization process is greatly influenced by the quality of the sterilization medium which can be either steam from a centra steam production plant or steam produced by the sterilizer own electric steam generator. In both cases the feed water quality indirectly influences the quality of the produced steam. Certain demands are therefore raised on the steam supplying a sterilizer. The values referred to in this booklet are based upon Getinge's own experience and can where appropriate be replaced by values and measuring methods given in different standards.

Cleanness
1. Solid particles such as welding pearls, graphite, rust flakes, sand etc. must not be present since the steam comes in direct contact with the sterilizing goods. 2. Liquids, except water, must not be found for the same reason as above 3. Gases prevent the required close contact between the steam and the microorganisms to be killed and shall be limited as below Hydrazine (N2H4) max. 0,01 mg/kg steam Ammonia (NH3) max. 5 mg/kg steam Air and/or non condensable gases max. 3,5% V/V, formed by the gas-air-mixed steam. 4. Chemicals, others than listed below, like residuals from water softening and similar must not occur in sterilization steam.

Salt content max. 1 mg/kg steam Analysis of condensate

An analysis of the condensate from the steam gives an idea about it cleanness regarding additional agents. These should not, according to

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the standard EN285, occur in concentrations exceeding the values given in mg/kg condensate in the table below.
Evaporation residuals 1,0 from which: SiO2 Iron Cadmium Lead Other heavy metals Chloride Phosphate Other desirable properties: Conductivity PH-value Hardness < 3S/cm (at 20 oC) 5-7 < 0,1 dH 0,01 0,1 0,005 0,05 0,1 0,1 0,1

Pressure
1. Getinge sterilizers should be supplied with steam having a pressure of 2,5 - 2,7 bar(g), indicated by the sterilizer pressure gauge Steam supply. 2. Permissible pressure variations max. 0,1 bar. 3. With built in steam generators, the pressure may drop to 2,2 bar(g).

Moisture content
Sterilizers should be supplied with dry saturated steam. The physica state dry saturated is difficult to maintain in a practical application, and measurements followed by control of the moisture content is an awkward procedure. Practising the advice later given which are based upon practical experience, will generally result in a steam with satisfactory moisture content. This means that nor will it be superheated, a state of the steam which is hazardous in connection with sterilization because it does not contribute with the humidification necessary when destructing microorganisms. The superheating in a sterilizer loaded with one standard textile pack must not exceed 5 oC during the first five minutes of the sterilization period.

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Checking-up the piping

A Check that the building steam distribution pipes do not slope up in the flow direction so as to enable for condensate pools to be formed and that steam traps, strainers, chokes etc. are in good working condition. See recommended pipe arrangements under the headline below. The main principle in avoiding condensate pools to be formed is to fit the pipe sloping minimum 1:50 in the flow direction, arrange with steam traps enabling for the condensate to be discharged and avoid fitting any chokes in horizontal pipes. B Check the steam traps! A continuously leaking steam trap may cause a too low supply pressure. C The dewatering devices (see illustration on page 17) should be placed not further than 1 m away from the sterilizer steam intake. If this is not possible for practical reasons, a steam separator can be arranged before the sterilizer steam intake. This will remove condensate formed between the system dewatering devices and the sterilizer.

Steam supply via distribution system

Dimensioning, dewatering and laying of pipes which are to distribute steam of the high quality required for sterilizing purpose belongs to a special group of technique. Getinge AB recommends work in this field being carried out in accordance with advice given by Spirax-Sarco, a world wide well known company with many years experience of steam distribution systems. An arrangement according to the following description normally satisfies the demand for dewatering, filtration and supervision facilitie when supplying a sterilizer with steam from a main steam supply line. 1. Connect the sterilizer to a live steam line, not to an inadequately drained or inadequately vented dead leg. Long branch connections to sterilizers should be avoided. 2. Dimension the piping for a steam velocity of 38 m/s at the pressure 250 kPa. If several sterilizers are connected to the same pipe, calculate with a simultaneity factor 0.8. 3. The steam supply pipes should fall minimum 1:50 in the flow direction. 4. Introduce reducing valve(s) in the supply line if the pressure is higher than specified in the installation drawing. The steam pressure upstream the reducing valve should not fluctuate more than 10%. Do not reduce the pressure with a factor smaller than 0,5 in each stage. Use a second reducing valve for greater reduction ratio.

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Each reducing valve must be followed by a safety valve. If the steam in the supply pipe is wet, include dewatering as shown in Figure A just before the reducing valve, as shown in the sketches below.

The safety valve exhaust pipe should have at least the same dimension as the valve exhaust connection and must not contain chokes or shut off devices. Water pockets formed in the piping, must be drained. 5. There must be no chokes or restrictions placed in horizontal pipes. 6. Fit the last reducing valve not more than 6 m pipe length away from the sterilizer, but not closer than 4 m if maximum reducing ratio (2:1) is utilized. If the reducing valve is positioned much more than six metres from the sterilizer, include dewatering as shown in Figure A just before the sterilizer.

7. The last dewatering device (see figure below) should not be placed further than 1 meter away from the sterilizer steam intake. 8. No steam consumers other than sterilizers should be connected down-streams the last reducing valve. 9. Branch pipes should be connected on top of horizontal main pipe. 10. A connection should be provided between reducing valve and sterilizer on the steam supply line to enable sampling steam for quality check up. 11. Because of its daily use, the shut off valve should be of the easy-to-handle type for instance a remote controlled ball valve.

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12. Insulate steam pipes up to the sterilizer steam intake

6 3 1 4
4 - 6 Meter

8 7

7 11
, , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , ,

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, , 13

>400 mm

4 2
100 mm

3 9

A
9

10

10

Supply line in ceiling

7 11
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13 , ,

>400 mm

4
10

A
9

10

100 mm

6 3 5

1 4

Supply line in floor or in the storey below 1 2 3 4 5 6 7 High-pressure line Labyrinth diverter / separator Shut-off valve Filter Reducing valve Safety valve Pressure gauge 8 9 10 11 12 13 Vent Ball valve Steam trap Remote-controlled valve Non-return valve Sterilizer

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Steam supply from built in steam generator

The design pressure for built in steam generators is 3,5 bar(g). See plate on the vessel. The variation of 10% in opening pressure, shown by all safety valves, will not permit the vessel working pressure being almost the same as the design pressure. To make sure the valve does not leak, the working pressure must be kept about 0,3 bar below the design pressure. The steam generator pressure is controlled in two steps by a pressure switch equipped with two contacts. 1. Check all elements for continuous circuit. Use a current clamp while in use and an ohmmeter when disconnected. 2. Set the pressure switch as described below. Set the switch controlling the higher pressure to switch off power at the pressure stated in the electric wiring diagram. The setting is to be done at rising pressure.

Set the other switch to turn on power at the lower pressure given
on the electric wiring diagram. This setting should be done at dropping pressure.

Water
Pump service liquid
Temperature Maximum permissible water temperature for maximum pump capacity and depth of vacuum is 15 oC. Water with higher temperature may be used provided lower pump ratings are accepted. Hardness In order to minimize the sterilizer maintenance- and service expenses the water hardness should not exceed 4 dH (0,7 mmol/l). The installation of a water softener is recommended should the water be harder.

Water supply common steam generator and sterilizer

Usually the steam generator is supplied with water from one common water source (intake) on the sterilizer, why the values of temperature and hardness will be common for all consuming units of the sterilizer. The feed water should be colourless and free from solid particles such as rust flakes, graphite etc. The content of other matters may vary depending on water quality. The content of iron should, however, be 0,2 mg/l or less to avoid stains on sterilized goods.

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Separate feed water supply for steam generator

If there is a separate water system supplying the steam generator, this water is usually treated through a filter or some other kind of water treatment device and then connected to a separate tank on the sterilizer. In such cases values deviating from the ones given below may be accepted. Temperature. Separate feed water If there is a separate supply and tank for the steam generator feed water, the water temperature should not exceed 60oC. Deionized water Deionized water may only be connected if the steam generator is designed for this. Should the steam generator be intended for deionized water, the conductivity must not be less than 0,5 S/cm. Other components The chemical composition of deionized water may vary depending on the water treatment method used. Sterilizer standard EN285 states guideline values for evaporation deposits in deionized water. These values may serve as a guide when assessing water quality, but need no necessarily be complied with for reliable operation.

Guideline values to EN285: Evaporation deposits 10,0 mg/l, of which: Silicon in the form of SiO2 Iron Cadmium Lead Other heavy metals Chlorides Phosphates Recommended pH: 5 to 7 Suitable conductivity 15 S/cm Suitable hardness 0,1 dH 1,0 mg/l 0,2 mg/l 0,005 mg/l 0,05 mg/l 0,1 mg/l 2,0 mg/l 0,5 mg/l

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PACKING MATERIAL
Packing materials and goods carriers are important parts in the system which shall lead up to a sterile and dry load. It is not possible to use any piece of paper, cloth or container for packing up the goods to be sterilized. Certain demands have to be satisfied. The traditions and standards in different countries often guides the choice of and demand for wrapping material and it is therefore difficult to specify nothing but generally desirable qualities. For countries associated with EEC or EFTA there is a common standard, which has replace earlier standards in the these countries. The demands presented in several of the following sections are thereby sharpened for countries associated with EEC or EFTA.

Wrappings of paper
Paper used as wrapping material for goods to be sterilized must meet certain requirements. To be suitable for packing purposes shall: the barrier layer of the paper envelop

be strong, also when wet. allow penetration of air and steam. serve as an effective barrier against micro organisms. preferably have a colour making it possible to see if it is wet. withstand heat to 137oC without becoming brittle.

the water absorbing layer of the paper envelop

be able to absorb, disperse and keep condensate. be able to surround at least bottom and sides of the instrument tray.
The goods should normally be wrapped in several layers of paper where the inner should have the qualification to absorb and disperse the condensate formed, while the outer should be treated to serve as a barrier for microorganisms. Both functions are just as important. The look and properties of the packing materials available on the market can vary widely. Following main groups exist: Plain paper Crepe paper

Nonwoven

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How these types should be combined in order to obtain the result earlier specified ought to be decided by the paper supplier in consultation with the Sterile Services Manager. Plastic which is integrated in the fibre structure with some paper qualities renders the paper deteriorated penetration and drying abilities, why this material should be avoided.

Wrappings of textile
Envelops of textile should when coming to use:

be made of cotton or a mixture of cotton and a synthetic fibre, resistant to sterilization without destroying its strength and penetration facilities.

act as an effective stop for micro organisms. preferably have a colour indicating if it is wet. withstand repeated use without changing its properties.

Bags or peelable reels of paper or paper mixes

The two most common packing types are:

Bags made entirely of plain paper Bags/rolls having a paper backing and front side of clear heat labile
plastic foil. The demand raised on paper is valid also for bags and rolled hoses of paper mixes when applicable. In addition to this there is a demand for sealing the bags or hoses with heat (welding). The bond between paper / paper or plastic / paper must be stron enough to resist the sometimes very fast pressure variations occurring during sterilization.

Peelable reels of plastic foil

On markets where plastic foil hoses are still used, it must be observed that all foil qualities can not be used as packing material. This is because the porosity in some of these is lost when heated up. A bag of such a material can also subtract during the post treatment which causes the content to crush.

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Goods carriers
Baskets

Baskets used as carriers for sterilizing goods should:

Be made of stainless steel. Conform with SPRI-, ISO- or DIN-standard. Containers

Containers used as goods carriers should:

Be made according to ISO- or DIN-standard. Be vented through filters or sterile filters preferably arranged in the
lid. Containers having the ventilation arranged through openings controlled by thermal- or pressure difference-based devices should be avoided because of their worse ventilation abilities

Preferably be made entirely of an aluminium alloy (also the lid)

which will, compared to other materials, show outstanding thermal conductivity abilities. See also moisture content on page 14. Stainless steel and plastic have opposite abilities and should therefore be avoided.

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PACKAGING
The condition in obtaining a sterile and dry load is, as earlier stated, that the steam used is of a good quality and that the sterilizer works faultless. If this is the case, it is most often possible to achieve a good result by adapting the packaging method to the goods to be sterilized. Of course the demands and recommendations raised by the health- and sick care authorities in different countries must be considered. Besides these basic conditions, some general recommendations may promote obtaining the best result.

Single items
Single items and small sets containing only a few instruments are preferably packed in bags. Remember that:

larger bags than necessary should not be used. Follow instructions

given by the bag manufacturer. the bag should not be overloaded with heavy instruments. The bag has limited capability to keep and disperse the condensate. If too large condensate quantities are formed, these can not be retained on the instrument but will be collected as drops rolling away from the instrument. This kind of condensate is difficult to get rid off during the post treatment and will consequently remain in the bag. the bags should be leaning towards the side of a basket. Place a water absorbing paper at the bottom of the basket. This sucks up the condensate formed on the outside of the bag, and stops it from pouring down on the basket below.

bags of paper mixes shall be placed with with the paper side towards
the paper side of the next bag, since plastic foils towards paper may make the latter as tight as to jeopardize the penetration.

Plastic items
Plastic items often give rise to wet packings since they do not emit their heat content fast enough to make the condensate evaporate during the available time.

Avoid as far as possible the use of reusable items of plastic, or sort

out the instruments on the basis of their material.

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 The result may be improved by arranging the bags in one layer so

that the condensate as far as possible will remain on the spot where it was created thereby avoiding forming of pools.

Place a water absorbing paper at the bottom of the basket. This sucks
up the condensate formed on the outside of the bag. In some cases it may be necessary to wrap the plastic item in a water absorbing paper which retains the condensate.

Arrange the bags in the basket in such a way that the condensate if
possible remains on/close to the instrument. Water collected in a wrinkle or a corner will remain when the goods are taken out. If the shape of the instrument is such that the condensate can not be retained on or close to the instrument, or if it is that heavy that large quantities of condensate are formed, one should consider using another packing method. Place bags containing bowls to make the condensate remain in the bowl. The old rule saying that bowls should be placed in the sterilizer to make all water escape is no longer valid. The aim of this rule was to facilitate the air removal at a time when efficient vacuum pumps were rare subjects on the market. To day's pumps and the modern sterilizing processes with several prevacuums can easily remove the air from an upright standing bowl.

Arrange therefore the bowls leaning backwards to such an extent that

the condensate formed remains in the former.

Textiles
To enable adequate air removal and steam penetration, the weight of textile parcels should not exceed 6 kg.

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Instrument set
Instrument sets should preferably be packed on instrument trays.

Select the size of the tray so that the instruments can preferably be
placed in one single layer. If a moisture absorbing- and distributing layer is missing in the outer wrapping, the bottom and sides of the tray should be covered with a water absorbing paper preventing the condensate from flowing out to the outer wrapping.

Spread the goods evenly by weight over the tray surface thereby
avoiding condensate flowing together

Instruments having a flat surface should be laid down on this. Place bowls with the opening facing upwards. Do not lay cotton or compresses in a bowl since these suck up condensate which will then not come in contact with hot metal for evaporation.

Distribute plastic items evenly over the tray surface and avoid collecting them in one corner. The result can be improved by laying an OP-towel on top of the instruments and in good contact with these.

Divide very heavy sets into two and place them on one tray each.
Weights above 6 kg should be avoided if possible. When sterilizing heavy goods such as orthopedic instruments, should not more than 30% of the total load consist of trays with a weight of up to 10 kg.

Pack preferably the instrument tray in several layers of paper of

which the internal should be the moisture absorbing type. Wrapping material of textile could also be used. (See also wrapping material paper textile). Certain material for orthopedic operations are sold in boxes where the different parts hang on stands. This looks very neat but is directly reprehensible from sterilizing point of view. All condensate formed wil flow to the bottom of the box where it will be impossible to remove in spite of the total weight of the items not being larger than it could be expected to become dry. Sterilize this kind of goods distributed on trays so that the weight of each tray is kept within given limits.

27

Containers
Containers should be packed according to the container manufacturer recommendations:

If the container is equipped with sterile filter and therefore no wrapping of the instrument trays are required, the bottom and inner sides of the container should be covered with a high absorbing paper or an OP-towel to disperse the condensate.

If the instrument tray is to be wrapped in paper instead of textile, it

is important that the paper nearest the tray is of water absorbing type. See also packing material.

Plastic items requiring 121C sterilization temperature should not be

placed in containers where the drying will be time-consuming, but should be packed in bags of paper mixes placed in baskets. See also wrapping methods single items.

The process time can be shortened if condensate from high situated

containers can be prevented from falling in drops on the lid of the underlaying ones. This is achieved by placing a moisture absorbing paper under each container, especially when it comes to stainless lids.

Containers should be loaded on special made Shelf trolleys such that

an air space is formed between each container layer

28

Baskets
Wire baskets intended for sterilizing purposes are the most suitable load carriers since these permit a good steam penetration- and drying effectiveness to the same extent for most kind of goods and types of packings.

Adapt the height of the baskets that there will always be a few centimetre air gap between the goods and the basket above.

Loading
The dryness of the load depends on the way the baskets/containers are situated in the sterilizing chamber.

Always place heavy goods below the light goods to avoid the condensate wetting the light baskets.

Never let the goods come in contact with the chamber walls since it
will then become wet.

29

Fold instruction for wrappings

Folding the inner wrapping 1.
Put two sheets of wrapping on the table. Place the instrument tray (parcel) diagonally on the centre of the wrapper.

2.
Fold your nearest corner of the top wrapper over the tray.

3.
Fold back the tip of the corner.

4.
Fold the right corner over the parcel and fold back that much of the tip that the parcel remains covered.

5.
Fold the left corner accordingly.

30

Folding the inner wrapping 6.

Fold the remaining corner over the parcel.

7.
Turn the parcel half a turn on top of the outer wrapper.

8.
Fold the corner and push it into the wrapping close to the parcel. Arrange for the outmost tip to protrude about 5 cm.

Folding the outer wrapping 9.

Place the parcel diagonally on the centre of the wrapper and fold it in the same manner as used with the inner wrapping sheet.

10.
Seal the wrapping with two strips of adhesive tape without indicator. Attach a 5 cm long indicator tape on top of one of the tapes.

31

32

PROGRAM MODIFICATION
On delivery, Getinge sterilizers are set and tested to enable a reliable sterilizing process in the shortest possible time. As can be seen from the earlier parts MEDIA QUALITY, PACKING MATERIAL and PACKING, the circumstances can vary considerably. It would therefore be impractical to use a single process which would enable sterile and dry load at all events. Getinge sterilizer control system comprises of a number of possibilities to make alterations and additions in the sterilizing program according to certain preformed patterns. This enables for a program to be adapted to such groups of products which may be difficult to get dry after sterilization. The different types of modifications, which should be made by a skilled technician in consultation with with the Sterile Services Manager, are described further in the text.

General advice
Adapt if possible one program for one type of goods and next program for another etc. By doing this the most effective drying method for each type of goods will result in shortest possible process times.

If a mixed load is to be sterilized, select a drying method suitable for

all types of goods and set the time to match the most trying goods (see table for Basic settings).

Sterilize all temperature stable goods at 134oC since this gives the
best result in the shortest time.

When sterilizing easily damaged goods like certain empty glass containers which do not resist fast temperature changes, the change-step 3 of the pretreatment can be used separately to make heating up more careful.

When changes are made to the process, the result of validations that
have been done is affected. Always consult the person in charge of hygiene as to what changes can be made and whether existing validations must be redone.

33

Modification procedure
All process alterations are made by changing the program parameters for the appropriate program. How this is made is described under the headline Changing parameters with OP2 in chapter General advice in the service manual. See also menu descriptions in the chapter about the control system It is only with steam sterilization programs that the pre- and post treatment can be modified as follows. With formaldehyde and ethylene oxide sterilizers these parameters are already occupied for other purposes. All of the Getinge sterilization programs can not be modified according to this advice. Which are the changeable ones of all parameters appears from the program phase list and the program combination. Adjustable parameters are marked on the program combination list by informing on the range within the parameter may be set.

Post treatment
The post treatment is the best part of the process to start with. This is because the process remains in its origin up to and including the sterilizing cycle and the sterility of the product will therefore not be jeopardized. One must remember that goods which are too dry during the sterilizing cycle will not keep the spores sufficiently humidified, which is a basic condition when sterilizing with steam. If goods of different material and sets with very much varying weight are to be sterilized in one and the same process, the post treatment is the one that should be modified.

Push program selector button for the program to be changed. Follow the advice found in the service manual to program the different parameters.

Select DRYING VACUUM when needed by programming Postvacuum time.

Select DRYING WITH STERILE AIR when needed by programming Postpuls. air.

Select DRYING WITH STEAM when needed by programming

Postpuls. steam. The different post treatments give varying result, mainly depending on type of goods, packing material and packing technique.

Prolonging the drying vacuum

What is called a drying vacuum is the most common drying method for most types of goods. For textiles is this the most time-saving drying

34

method. It is also this drying method which is preprogrammed on delivery from the factory.

Select DRYING VACUUM when needed by programming the

desired duration in hours, minutes and seconds in Postvacuum time. Always start by prolonging the drying vacuum by 5 - 10 minutes. Try with 15 or 20 minutes should this not be sufficient (see table Basic settings for drying processes on page 37)

Drying with sterile air

This alternative is particularly efficient on ordinary goods packed in baskets where the moisture is evenly dispersed. Always program a three minutes long drying vacuum before the air pulses. Suitable steps for trials are 11, 15 and 20 minutes. Note! If this post treatment method is to be used to a large extent, it is recommended that the sterile filter is replaced with an absolute filter with the casing made of polypropylene with thread-attachment (article number 470 22 45-01). If the origin filter is used, its condition and attachment should be checked weekly. Recommended replacement interval will be found under the headline THE STERILIZER.

Drying with steam

If the previous methods should prove insufficient, drying with stea can be programmed. Always program a three minutes long drying vacuum before the steam pulses. Recommended steps are 11, 15 and 20

35

minutes. In very difficult cases 24 minutes of steam pulses may be required (see the basic settings table on page 37).

Note! With sterilizers where the process is controlled by common pressure switches, the pressure switch controlling the depth of the pre vacuum should be set to close at -0,85 bar(g). Wrong setting can jeopardize the drying and also rehumidify the goods. Drying with steam is particularly efficient on instrument trays sterilized in containers at 135oC.

36

Basic settings for drying processes

Symbols for suitability: Very good = -#Good = .#Unsuitable = / Shortest recommended time*1 in minutes using Total process time*2 in minutes approx. 43 32 18 20 15 15 15 20 22 22 20 25 54 45 52 43 52 43 61 50 60 58 42 48 58 63 No Type of load temperature oC Sterilizing drying vacuum 3 min. drying vacuum + drying with air pulses 3 min. drying vacuum + drying with steam pulses

121 134

Textiles

. . . . . . . . . . . . . . . .

5 5 20 20 20 20 20 20 25 30 30 22 20 25 27 30 27 30 35 35

. . / / / / / / / /

5 5 13 15 11 13 11 13 20 20 22 18

/ / . . . . . . . . . / / / / 35 00: xx: 00 30 20 14

121 134

Instruments in paper mixes bags 1 kg

121 134

Instrument trays 3 kg in paper wrapping

121 134

Instrument trays 6 kg in paper wrapping

121 134

Instrument 10 kg in paper wrapping

6 7 8

121 121 121 134

Plastic items in paper mixes bags Plastic and metal items in paper mixes bags Instrument tray in aluminium container 6 kg Instrument tray in aluminium container 10 kg Instrument tray in stainless steel container 6 kg Instrument tray in stainless steel container 10 kg

121 134

10

121 134

11

121 134

Programming the parameter xx = No. of minutes as stated above

00: xx: 00

00: xx: 00

*1. Select the time for the most time requiring gods when sterilizing mixed loads. *2. The process time is based on the shortest of the setting times in the row.

The table values refer to a fully loaded GETINGE sterilizer with chamber dimensions 660 X 660 x 1250 mm, equipped with a built in steam

37

generator. Steam supplied from a central steam plant, other chamber volumes and smaller loads may give somewhat deviating process times.

Pre treatment
In some cases modifying the post treatment method is not sufficient. A possibility is then to heat the goods more sufficiently by altering the pre treatment. All such pre heating which is meant to take place withou condensation taking place is based on the use of the super heat energy in steam of a higher temperature. Be observant on the fact that too intense warming up with super heat energy can lead to a dehydration of the goods which will jeopardize its sterility. Select therefore one or two programs where such goods should be separately sterilized which can not be satisfactorily dry with a modified post treatment.

A program, the pre treatment of which has been altered, must be validated once more by sterilizing biological indicators packed with the actual goods.

It is important that the size and composition of the load is equal at each sterilisation. A much diminished load cannot absorb the super heat as the load will not be humidified enough to ensure sterility.

Summing-u Select one or two programs for treatment of difficult loads in particular.

Combine one or more type-loads for this (these) program(s). Do not make more program modifications than necessary. Do not change the composition or size of the type-loads while performing the test runs.

Incomplete pre-pulses may indicate too powerful overheating. Change the modified program curves in the sterilizer manual using
the curves found at the end of this booklet.

Always re-validate the sterilizer after a change in the pre-treatment.

The programming password is needed in order to alter parameters influencing the pre treatment.

38

A suitable tool for programming the control system is an OPC or an OPH.

Modification step 1
A Reprogram the parameter HIGH PULS AP4/1 from 1 to 2 bar on sterilizers equipped with an analog pressure transducer (showing pressures on the display). Reprogram the parameter HIGH PULS AP4/1 from 0 to 120 oC on all other sterilizers. B Change the parameter STEAM PULS AP4/2 from 5 to 2 seconds and the parameter VAC + STEAM AP4/3 from 30 seconds to 2 minutes. The pre pulses will now appear in a pressure diagram as shown below. The changes has prolonged the total process time by about 8 minutes.

Modification step 2
Retain modifications made in step one and change the parameter PREVACUUM AP2 from 3 to 4. By doing this one pulse is added to the pre treatment. This alteration prolongs the process time by about another 5 minute and makes the pressure diagram look as shown below.

Modification step 3
Keep the changes in step one and two while the parameter STEA RAMP AP5 is changed from 5 to 2. The modification leads to a reduced flow-speed with the steam and consequently a reduced risk for a sagging steam supply pressure. This alteration prolongs the process time by about another 12 minutes. STEAM RAMP AP5 can be programmed from 5 to 2 on sterilizers without analog pressure indication. On sterilizers with analog pressure

39

indication, AP5 changes from 2.5 bar/min. till 0.3 bar/min. The lower value, the lower steam speed.

Combining the changes

The described program modifications can be set together that any of the pre treatments can be combined with any desired post treatment.

40

THE STERILIZER
Pre heating the sterilizer
After the sterilizer has been started it should be given plenty of time to heat up with closed door. When the light in the control panel start button illuminates, the temperature in the jacket has attained the programmed value. Allow if possible the sterilizer to heat up for another 20 minutes to enable for the entire metal mass to get warm straight through. An alternative, and a most efficient way is to ensure pre heating by performing a complete sterilization process with an empty chamber.

Doors
THE STERILIZER DOORS SHOULD BE KEPT CLOSED when the sterilizer is not in use. The doors should be opened only when loading and unloading whereupon these should be closed immediately. An open door will quickly be cooled down and may therefore cause not desired condensation during the subsequent process.

41

The sterilizer condition

The sterilizer working condition is a primary factor for the sterilizing result, both with regard to the sterility and moisture content of the goods. If problems suddenly arise with an earlier correct functioning sterilizer, the fault is usually to find with the supply mediums or an occurring sterilizer malfunction. Regarding medium faults, see under the headline MEDIA QUALITY. Any kind of fault in the sterilizer or the supplied steam which makes it possible for air or other gases to be collected in the goods pack may lead to the two conditions heat and moisture not being safely fulfilled. The sterilizer function must therefore be checked with following intervals if otherwise is not stated:

The chamber- pressure and temperature should be checked after each

process using the recording instrument.

The efficiency of the humidification should be checked by means of

standardized chemical indicators able to react upon time, temperature and humidity, for instance sterility integrators.

The tightness of the sterilizer chamber should be checked once a

week. The easiest way to do this is starting the sterilizer leak test program. The test will fail if air is let into the chamber to such an extent that temperature homogeneity and/or steam penetration is jeopardized.

The condition and rigid attachment of the sterile filter should be

checked weekly. A further indication of the sterilizer condition with regard to is ability to remove and make the steam penetrate porous loads is obtained through a so-called Bowie-Dick test. The pattern of the Bowie-Dick indicator paper has to show the same saturation with colour all over its surface after completed sterilization. Pale parties indicate the presence of air or non condensable gases which have stopped the steam penetration and jeopardized humidification and attaining of the correct temperature.

42

An indicator paper for an ordinary Bowie / Dick test should be packed in a porous parcel of a standardized composition. There are on the market also several types of ready made test parcels of Bowie/Dick test type having somewhat varying qualities. These are intended for sterilization without any further wrapping which saves time. Use a make type-approved by Getinge. See the sterilizer manual or contact Getinge AB.

The sterilizer and the steam

Check that the sterilizer is horizontal in all directions. Check that the sterilizer steam distribution pipes are not slanting
backwards to prevent for condensate to be collected and that steam traps, strainers, chokes etc. are faultless. The main principle for avoiding condensate collecting pockets to be formed is to arrange the pipes sloping in the flow direction. Further that strainers are mounted with the screen pointing upwards to avoid condensate being collected in the strainer housing and that no chokes are mounted in horizontal pipes.

During peak consumption the steam pressure must fall not below 2,2
bar(g). Check the function of the steam traps on jacket and door seal groove. A continuously leaking steam trap may cause too low steam supply pressure.

Check that the jacket drain pipe filters are not clogged thereby causing ineffective heating of the jacket.

Thequalityofexternalwaterandsteamsupplyshouldbecheckedmonthly.
The sterilizer function should simultaneously be checked by means of biological indicators.

Replacement of sterile filter

The condition of the sterile filter can be deciding for the sterility of the goods since a defect filter may cause renewed contamination on end of the process. It is therefore important to:

check the condition of the sterile filter and its attachment with regard
to tightness.

replace the filter at recommended intervals.

The sterile filter life time is influenced by:

43

The cleanness of the air passing through the filter With increased number of particles in the air admitted to the chamber, which is usually taken from the sterilizer surrounding service compartment, the filter will stop up quicker. This is shown as an increased pressure difference across the filter but becomes most obvious by the prolonged airing times. This does no deteriorate the filter ability to separate particles but to large a pressure fall may cause the filter burst and give free access for all kind of contaminants. The humidity of the air passing through the filter The air in the service compartment usually holds a higher degree of humidity than the surrounding atmosphere. How much depends on the ventilation of the compartment. In tropical climate one must alway count with a high degree of humidity in the air. A fault with the sterilizer can also expose the filter for extreme humidity in the state of steam from the chamber. With a wet filter the pressure difference across the filter rises tremendously, and besides breakage in the filter material it can be destroyed by bacteria growing through. The sterile filter should be replaced after the number of sterilization cycles shown by the table below.
GE 2044 GE 2606 GE 2609 GE 2612 GE 2617 GE 6912 600 300 275 250 200 200

When the air is heavily mixed with particles or is very damp, the values above should be reduced.

Air purging
Where sterilizers without analog pressure measurement are installed at high altitudes, the lower reversal point of the pre-pulses can be adjusted to -0.75 to -0.8 bar. Simultaneously the pre treatment should be set for 4 pre-pulses using PREVACUUM AP2 change the settings in the control system to tropic. On certain models with analog pressure measurement it is sufficient to set the control system to tropical. NOTE: These changes require the sterilizer to be revalidated.

44

Leakage
Chamber
On sterilizers having a special program for this, perform a leak rate test, according to instructions in the USER-manual. Permissible leak rate is 13 bar/ 10 minutes. If a pressure gauge is available with better resolution than the one on the sterilizer, the accuracy of the reading can be improved. Note tha there is no demand for the pressure gauge being of the barometric compensated type but this can be a help in determining deepest achievable vacuum. Some places which can be suspected for leakage are: Tape sealed threads The door seal The gland seal of the recorder sensor Drain non return valves

Plug seals on strainers

Note that steam leaking into the chamber from a valve or from the door seal is registered as a leak, in spite of not being a catastrophe for the sterilizing process.

Evacuation system
Check the vacuumpump ability to create a deep subatmospheric pressure by closing the hose for the pump anti-cavitation air at the end of a drying vacuum cycle. Provided the chamber is tight, the pump should start cavitating with accompanying characteristic noise. If not, there is a leak between the chamber drain valve and the pump. Some places which can be suspected for leakage are: Tape sealed threads Hose claps Plug seals on strainers

Condensor drain valve

45

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