Getinge GEE User manual

BAX001 . . . . . GEE General

Ethylene oxide is a poisonous and explosive agent. This manual therefore has to be thoroughly studied before the sterilizer is put into operation!

BAX002 . . . . . All manuals

Attention symbols

Some of the war nings, instruct ions and advice in this manual are so important that we used the following special symbols to draw attention to them:

Warnings

This symbol indi cates a wa rning . Injury or even death may result if you do not heed it. This symbol is also used to mark out safety components etc. See section ”Safety devices, a survey” in chapter ”Introduction” in the OPERATOR MANUAL or chapter ”Maintenance” in the SERVICE MANUAL

Instructions

Advice

This symbol indicates instructions which are important, for example to preve nt damage to the sterilizer an d/or the load

This symbol indicates important advice and hints that make it eas ie r to work with the sterilizer.

INTRODUCTION

CAX016 . . . . . GEE General

Introduction GEE

The GETINGE sterilizer type GEE is intended for sterilization of heat sensitive goods which may be damaged by the temperature in a conventional steam sterilizer. The active sterilizing agent is ethylene oxide, used in a process at temperatures about 50 oC.

The sterilizing agent is stored in liquid state under pressure in gas bottles. The liquid ethylene oxide is transformed into gas in a heated evaporator before it enters the sterilizer chamber.

Both the sterilizer chamber and the door(s) are equipped with jackets in which temperature controlled water is circulated. This keeps chamber walls and door(s) at a uniform temperature, thereby preventing condensate from forming on the walls.

A computerized control unit, thoroughly described in a separate section of this manual, controls the process from start to end. The operator will not be able to alter any variables in the control unit program while a process is in progress.

Parameters such as jacket and chamber temperature as well as elapsed sterilizing time may be displayed by the operator at any time during the process.

CAX017 . . . . . GEE - Explosion proof

Owing to t he g eneral dangerousn ess of t he sterilizi ng agen t, some ster ilizer main compone nts are placed in separate rooms, diff erently classified with regard to the risk of explosion. The sterilizer pressure vessel with its executing components and the gas bottle storage room are classified as explosive area. Electric components in this area therefore are of the explosion proof type.

Electric temperature sensors are equipped with zener barriers while valve actuators and signal transmitters are of the pneumatic type in this zone. To enable for the pneumatic signals to be processed by the computer, they are converted outside the explosive area to electric signals.

CAX018. . . . . . GEE General

Guidelines of using ethyl ene oxid e as sterilant

Ethylene oxide properties

Ethylene oxide has its boiling point at 10,7 oC (51,3 oF) at atmospheric pressure and is at room temperature a colourless, flammable gas which is somewhat heavier than air.

Ethylene oxide is characterized by being readily reactive with many chemicals, soluble in most organic solutions as well as solid state organic materials and completely soluble in water at 10 oC (50 oF).

Polymerization of liquid state ethylene oxide is initiated at room temperature by acids, bases or such catalysts as dehydrated metal chlorides or -oxides. Rust may consequently serve as a polymerization starter. The polymerization is associated with a considerable heat production. Uncontrolled rise of the temperature may result in evaporation of ethylene oxide and ultimately risk of explosive decomposition. A temperature rise of a few degrees only may be indicative of risk of polymerization.

In contrast to the liquid state of ethylene oxide, which is relatively stable to detonating agents, gaseous ethylene oxide is highly explosive and flammable when mixed with air. Gaseous ethylene oxide in air is readily ignited by an electric spark, sta tic electricity, an open flame or by similar means. If heated to 571 oC (1059,8 oF) in the absence of air or oxygen , ethy lene o xide vapour will dec ompose wi th exp losive violence. In an air mixture self ignition takes place at 429 oC (806 oF).

The health hazards when handling ethylene oxide are many.

In gaseous state the agent affects the mucous membranes already

•

below 100 ppm. The lower odour detection limit for ethylene oxide is as high as about

•

700 ppm and for this reason it can not serve as a risk-indicator for human exposition. Ethylene oxide has a fatiguing effect on the organs of smell even at low concentrations.

For higher concentrations one feels sick with long periods of vomit-

•

ing. The gas also works narcotically. At high gas concentrations the cornea of the eye may be injured as

•

well as the mucous membranes of the throat and the pulmonary alveoli.

After repeated contact there often appear an allergic hypersensitive-

•

ness.

• Severe inhalation poisoning causes, besides sickness and vomiting

also mental aberration, weakness, cramp, difficulty in breathing, unconsciousness and occasionally pulmonary oedema.

• Ethylene oxide in liquid state is eating and causes b listers on the skin.

The eating is not immediate but longer contact time causes deeper tissue decomposition.

• Liquid ethylene oxide is one of the most destructive agents to eyes.

• Ethylene oxide solved in water to 40-80% will cause more severe

injuries than pure ethylene oxide. This circumstance has caused eat injuries on the human body on spots where ethylene oxide has dissolved in perspiration.

• Ethylene oxide is a readily reactive agent and an efficient solvent

which must be taken into consideration when selecting material for articles and wrapping which are to be sterilized in this medium.

· Carbon steel, stainless steel, glass, rubber, acrylic, polyamide,

PVC, PTFE and polythene are not affected by ethylene oxide during the sterilization.

· Rubber, leather, polythene, polymetylmetacrylate and PVC may

absorb small quantities ethylene oxide which can be removed by exposing the goods to vacuum for some time.

· Packing material like paper, wood, cotton, paint, ink and enamel

is usually unaffected by the gas.

ETO- steri li zation gene rally

The reason for the very rigorous directions for use and handling of ethylene oxide is that the substance, which from several points of view is very dangerous also in low concentrations, can be spread to the work area by a ccident, carelessnes s, unexpect ed malfunction of the equipment etc.

In the daily use of a gas sterilizer no gas escapes to the operato premises. The only occasion when very small quantities may be detected close to the sterilizer is when the sterilized goods is taken out from the chamber, because some of the material has absorbed a certain quantity of gas. No matter how small the amount might be, it must never be neglected.

Ethylene oxide is po isonou s, exp losi ve, canc ero genic and suspiciously mutati ng.

GETINGE AB has devoted great care in the design of the ethylene oxide sterilizer in order to obtain entire personal and material safety, not

only in the regular use of the sterilizer, but also in such extraordinary situations as can reasonably be predicted.

An indispensable condition in achieving the safety aimed at, is that the written advise regarding installation and operation of the sterilizer and accessory equipment is strictly followed and that its original technical performance is maintained by regular service as long as the steri lizer is in use.

There is concentrated ethylene oxide in:

THE GAS CYLINDER

The ethylene oxide is stored as a liquid under pressure in gas bottles or cylinders, each one containing a gas quantity sufficient for several sterilisation processes.

THE STERILIZER CHAMBER AND EVAPORATOR

The ethylene oxide is withdrawn from the cylinder not until a defined stage in the sterilization process is reached. The fluid ethylene oxide is converted into gas state in a heated evaporator before it enters the sterilizing chamber.

THE VACUUM PUMP AND THE EXHAUST SYSTEM

After the gas has influenced the goods for a stipulated time, it is pumped out of the sterilizer chamber by a water ring type vacuum pump. The gas is collected in a tank which also holds the recirculating sealing water for the pump. Gas and water are separated in the tank from which the gas is lead through an exhaust pipe to a destruction unit or into the open air. The exhaust pipe must, if led into the open air terminate minimum 3 m above ground level at a minimum distance of 7,5 m from human whereabouts, windows, air intakes etc.

There is ethylene oxide residuals in:

THE SEVICECOMPARTEMENT

During the humidification stage, steam is admitted to the chambe where it condensates. This increases the water content of the tank why the excess water is allowed to escape through an overfl ow wit h g a s trap. This escaping water contains solved ethylene oxide which continuously evaporates. Close above the floor drain should therefore be arranged a ventilation hood, sized so as to be able to ventilate the whole service compartment with an air change of 10 times per hour. The air inle should be placed near the ceiling.

THE UNLOADING SIDE ROOM

In spite of the use of an efficient post-treatment process there remain unacceptable gas quantities in the sterilized goods. The goods has to be

degassed for a period of time which depends on the type of material in goods and wrapping as well as the ambient temperature. The air should, in this room, be changed 10 times per hour in diagonal direction from the ceiling towards the floor, so arranged that the air is moved away from the operator. With this arrangement, airing the goods for a longer period of time is allowed to take place in the same room as the unloading side of the sterilizer.

Ethylene oxide free is:

THE LOADING SIDE ROOM WITH DOUBLE ENDED STERILIZERS

Under regular operating conditions, there is no free ethylene oxide present in this room. There are however the same requirements on the ventilation here as on the unloading side, because if a process has to be aborted, access to the goods has to be gained from the loading side. (Only sterilized goods should be handled on the clean side).

Ventilation system

Exhaust from different rooms has to be made through a separate ventilation system. Alternatively the exhaust could be connected to an existing ventilation system, prov ided this does not wor k according to the recirculation principle.

Work-room

Warnin g posters

Gas storage

Start of a sterilization process should be blocked as long as the ventilation system is not working.

Any room opened for ethylene oxide sterilization should be used exclusively for this purpose and must not be used as a common working area or be u tilize d as a bre ak-room for employee s. Post ed not ice should allow authorized personnel only admission to the sterilizer room.

At the entrance or door to rooms where ethylene oxide is handled, a warning poster with information about the kind of room-activity should be posted. The sterilizer should be equipped with poster(s) informing about risk- , handlin g- and pro tectiv e in structio ns a ccordi ng to local rules.

Not more g as than the every-day need sh ould be stored in the room where the sterilizer is situated. For storing larger quantities of gas cylinders or bottles, take advice from the local fire authorities.

Requirement on the operator

The ethylene oxide sterilizer must be operated by specially educated personnel only. The education should besides the ”push button information” comprise:

• General information about ethylene oxide properties

• Knowledge about the sterilizer principle function

• Knowledge about the ventilation system

• Knowledge about the symptoms at the beginning of an ethylene

oxide poisoning

• First aid to an ethylene oxide exposed person

• Measures in case of an ethylene oxide leak

• Knowledge about how to fight an ethylene oxide fire

Data for fire fighting

Explosive mixture with air 2,6-100% of volume

•

• Ignition temperature 429

C (806 oF)

• The gas is somewhat heavier than air

In case of accidents

•

Do not use open flame

• Smoking is not allowed

• Use sparkless tools and explosion proof electric equipment

Leaks

• Make tight if possible

• Use atomizing water nozzle to damp formation of gas

• Drains should be covered and floors below the sterilizer floor evac-

uated

Fire

• Keep the gas bottles cool by spraying atomized cold water if they are

in a fire

• Do not extinguish burning gas if it is not absolutely necessary

• Extinguish with atomized water or powder if absolutely necessary

First aid

• Rinse eyes in copious quantities of water for at least 15 min. if the

agent has come in contact with the eyes

• Pull off contaminated clothes

• Wash contaminated skin with copious quantities of water

• Do not apply artificial respiration

• Call for a doctor when symptom arise which could result from con-

tact with ethylene oxide in eyes or on skin

The sterilization gas

The sterilant is a mixture consisting of:

CAX042 . . . . . GEE General

Ethylene oxide as a sterilizing agent

Properties of ethylene oxid e

Ethylen e oxi de boi ls at 10.7°C at a tmospher ic press ure an d at room temperature is a colourless and combustible gas which is slightly heavier than air.

Ethylene oxide is characterised by r eactivity wit h many che micals, solubility in most organic solutions as well as in organic solids and complete solubility in water at 10°C.

The polymerisation of ethylene oxide in liquid form is initiated at room temperature by acids, bases or catalysts such as dehydrating metal chlorides or oxides. Rust can consequently give rise to polymerisation. The polymerisation is associated with significant heat production. A rise in temperature of just a few degrees may be a sign of a risk o polymerisation.

Unlike ethylene oxide in liquid form, which is relatively stable in relation to explosion initiators, gaseous ethylene oxide which is mixed with air is extremely explosive and combustible. Gaseous ethylene oxide is readily ignited by electric sparks, static electricity, naked flames etc. If ethylene oxide is heated to 571°C in the presence of air or oxygen, the ethylene oxide vapour disintegrates explosively. Spontaneous ignition occurs in an air mixture at 429°C.

The handling of ethylene oxide poses many health hazards.

• In gaseous form the substance already affects the mucous mem-

branes at concentrations below 100 ppm.

• The lower odour limit for ethylene oxide is very high - 700 ppm - and

therefore cannot be used as an indicator of exposure hazard. Ethylene oxide strains the olfactory organs even at low concentrations.

• People exposed to higher concentrations suffer from nausea and

vomiting over long periods. The gas also has a narcotic effect.

• At high ethylene oxide concentrations the cornea of the eye, the

mucous membranes of the throat and the alveoli of the lungs may be damaged.

• Allergic hypersensitivity often occurs after repeated contact.

• Severe poisoning through inhalation in addition to nausea and vom-

iting also causes mental confusion, a state of weakness, convulsions, respiratory difficulties, unconsciousness and in some cases pulmonary oedema.

• Ethylene oxide in liquid form is corrosive and causes blisters on the

skin. The corrosive reaction does not occur immediately, but prolonged contact leads to disintegration of the deeper tissues.

• Ethylene oxide in liquid form is an extremely hazardous substance

for the eyes.

• A 40 percent aqueous solution of ethylene oxide causes more severe

damage than pure ethylene oxide. Corrosive damage has occurred in cases where ethylene oxide has been dissolved in sweat.

• Ethylene oxide is an extremely reactive substance and an effective

solvent, which must be borne in mind when choosing the material of items and packaging sterilized in this medium.

· Carbon steel, stainless steel, rubber, acrylic, polyamide, PVC,

PTFE and polyethylene are not affected by ethylene oxide during sterilization.

· Rubber, leather, polyethylene, polymethyl methacrylate and PVC

may absorb small quantities of ethylene oxide, which can be removed by keeping the material under vacuum for a time.

· Packaging materials such as paper, wood, cotton, paint, ink and

enamel are generally not affected by the gas.

General information on ETO sterilization

The reason for the extremely strict instructions on the use and handling of ethylene oxide is that this substance, which is many ways is very hazardous even at low concentrations, may be spread within the workroom by accident, through carelessness, unexpected equipment faults and so on.

No discharges of gas in the operator room occur in the daily operation of a gas sterilizer. The only occasion when small quantities of gas may be detected close to the sterilizer is when the sterilized items are removed from the chamber, as the material may have absorbed a certain

amount of gas. Regardless of how small the quan tities in volved are, they must never be ignored.

Ethylene oxide is toxic, explosive, carcinogenic and suspected of causing mutations.

GETINGE AB has put great emphasis on personal and material safety in designing the ethylene oxide sterilizer, not just with routine operation in mind but also to deal with exceptional situations that can be reasonably predicted.

It is an essential requirement, for the intended level of safety to be achieved, that the writ te n instru cti ons for installation and ope ration o f the steriliz er and add itional equipment are strictly complied with and that technical performan ce i s main tai ned by re gula r s erv icin g duri ng t he time the sterilizer is in use.

There is concentrated ethylene oxide in:

THE GAS CONTAINER

Ethylene oxide is stored in the form of liquid under pressure is gas bottles or cylinders, which contain a quantity of gas sufficient for several sterilization processes.

THE STERILIZATION CHAMBER AND THE EVAPORATOR WITH ASSOCIATED PIPE SYSTEM

Ethylene oxide is not taken from the cylinder until the sterilization process has reached a particular point. Liquid ethylene oxide is gasified in a heated evaporator and is then conveyed into the sterilization chamber.

THE VACUUM PUMP AND THE OUTLET SYSTEM

After the gas has acted on the items for the specified time, the gas is pumped out of the sterilization chamber by a vacuum pump of the water-ring type. The gas is collected in a tank which also contains the circulating sealing water for the pump. Gas and water are separated in the tank and the gas is conveyed through an outlet pipe to the cleaning unit or outside the building. The mouth of an outlet pipe discharging into the atmosphere must be at least 3 m above ground level and at least

7.5 m from areas where people spend time or where there are windows, air intakes and so on.

There are ethyle ne oxide residues in:

THE SERVICING ROOM

During the moistening phase vapour is released into the chamber. The vapour condenses on the load until the load has reached the correct tem-

perature. This increases the liquid level in the gas separator tank. This liquid contains ethylene glycol and dissolved ethylene oxide which continuously evaporates. Liquid is drained off from the tank when the liquid level becomes too high. The tank is emptied through the valve in the bottom.

This liquid must be disposed of in accordance with local safety regulations.

Because of the potential risk of leaks, the whole servicing room must be ventilated, with the air changed at least 10 times an hour. The extraction point must normally be located at the floor drain and the air intake close to the ceiling.

THE UNLOADING ROOM

Despite an effective post-treatment process, unacceptable quantities of gas remain in the sterilized items. The items therefore have to degassed during a time which depends on the type of item and p ackaging concerned and the ambient temperature. The complete quantity of air in the room should be changed 10 times an hour in a diagonal direction from the ceiling to the floor so that the air moves in the direction away from the operator. With this arrangement it is permissible to air the items for a longer time in the room serving as the discharge side for the sterilizer.

There is no ethylene oxide in:

THE CHARGING ROOM (STERILIZER WITH TWO DOORS)

Under normal operating conditions there is no free ethylene oxide in this room. The ventilation requirements are nevertheless the same as on the discharge side, as the items have to be handled from the charging side if the process stops. (Only sterilized items may be handled on the clean side.)

Ventilation system

The discharge from different rooms must be conveyed via separate ventilation systems. The discharge can alternatively be connected to an existing ventilation system, provided this operates according to the recirculation principle.

The start of the process must be blocked for the time the ventilation system is not working.

Workrooms

The rooms used in connection with the ethylene oxide sterilization must be dedicated to this purpose, and must not be used as general workrooms or rest rooms for t he personnel. A notice stat ing that only authorized personnel have access to the sterilizer room must be posted up.

Warning notice

A warning notice must be posed up at the entrance or on the doors to the rooms where ethylene oxide is handled, containing information on the type of activity taking place in the rooms. The sterilizer should be provided within one or more notices containing hazard, handling and protection instructions in accordance with local regulations.

Gas storage

No more gas than is required to meet the daily requirement may be kept in the sterilizer room. Local fire safety authorities must be consulted on the storage of larger quantities of gas cylinders or bottles.

Requirements to be met by the operator

Only specially trained personnel may handle the ethylene oxide sterilizer. The training must go further than "press the button" information and cover the following:

• general information on the properties of ethylene oxide

• knowledge on the basic function of the sterilizer

• knowledge on the ventilation system

• knowledge on the symptoms of incipient ethylene oxide poisoning

• first aid for persons exposed to ethylene oxide

• action to be taken in the event of an ethylene oxide leak

• knowledge on how to control an ethylene oxide fire

Firefighting information

Explosive mixture with 2.6-100% a i r

•

• Ignition temperature 429°C

• The gas is slightly heavier than air.

If an acciden t happ ens

Do not use a naked flame

•

Leaks

• Smoking is prohibited

• Use non-sparking tools and explosion-proof electrical equipment

Seal the leak if possible

•

• Stop the formation of gas using water through a nozzle

• Cover the outlets and evacuate the storeys of the building below the

floor of the sterilizer room

Fire

• If the gas bottles are exposed, cool them by spraying cold water

• Do not extinguish burning gas unless absolutely necessary

• If it is necessary to extinguish, use sprayed water or powder.

First aid

• If the agent has entered the eyes, rinse with very copious amounts of

water for at least 15 minutes

• Take off clothes contaminated with gas

• Wash exposed skin with very copious amounts of water

• Go not give artificial respiration

• Contact a doctor if symptoms occur which may be due to ethylene

oxide having come into contact with the eyes or skin

Sterilization gas

The sterilizing medium is a mixture of:

CAX019. . . . . . 10/90 ETO/CO2

10% ethylene oxide C2H4O 90% carbon dioxide CO2

The gas mixtu re is stored as a li quid in gas bo ttles wi th a pressure about 51 bar (740 psig) at room temperature. The gas has to be taken out as a liquid which usually is done via a dip pipe from the bottom of the bottle. This arrangement calls for an upright position of the bottle while withdrawing the gas.

Consult your gas supplier regarding how to place the bottle to ens ure tha t only t he liq uid stage is withdrawn from the bottle.

CAX023. . . . . . 20/80 ETO/CO2

20% ethylene oxide C2H4O 80% carbon dioxide CO

The gas mixtu re is stored as a li quid in gas bo ttles wi th a pressure about 49 bar (700 psig) at room temperature. The gas has to be taken out as a liquid which usually is done via a dip pipe from the bottom of the

bottle. This arrangement calls for an upright position of the bottle while withdrawing the gas.

Consul t your gas su pplier regarding how to place the bottle to ensure that only the liquid stage is withdrawn from the bo ttle.

CAX025 . . . . . 30/70 ETO/CO2

30% ethylene oxide C2H4O 70% carbon dioxide CO

The gas m ixture is stored as a liquid in gas bottles with a pressure about 40 bar (600 psig) at room temperature. The gas has to be taken out as a liquid which usually is done via a dip pipe from the bottom of the bottle. This arrangement calls for an upright position of the bottle while withdrawing the gas.

Consul t your gas su pplier regarding how to place the bottle to ensure that only the liquid stage is withdrawn from the bo ttle.

CAX027 . . . . . 90/10 ETO/CO2

90% ethylene oxide C2H4O 10% carbon dioxide CO

The gas m ixture is stored as a liquid in gas bottles with a pressure about 7 bar (100 psig) at room temperature. The gas has to be taken out as a liquid which usually is done via a dip pipe from the bottom of the bottle. This arrangement calls for an upright position of the bottle while withdrawing the gas.

Consul t your gas su pplier regarding how to place the bottle to ensure that only the liquid stage is withdrawn from the bo ttle.

CAX029 . . . . . 10/90 ETO/Freon

10% ethylene oxide C2H4O 90% dichlorodifluoromethane CCl2F

The gas m ixture is stored as a liquid in gas bottles with a pressure about 4 bar (60 psig) at room temperature. The gas has to be taken out as a liquid which usually is done via a dip pipe from the bottom of the

bottle. This arrangement calls for an upright position of the bottle while withdrawing the gas.

Consult your gas supplier regarding how to place the bottle to ens ure tha t only t he liq uid stage is withdrawn from the bottle.

CAX031. . . . . . 12/88 ETO/Freon

12% ethylene oxide C2H4O 88% dichlorodifluoromethane CCl2F

The gas mixtu re is stored as a li quid in gas bo ttles wi th a pressure about 3,5 bar (51 psig) at room temperature. The gas has to be taken out as a liquid which usually is done via a dip pipe from the bottom of the bottle. This arrangement calls for an upright position of the bottle while withdrawing the gas.

Consult your gas supplier regarding how to place the bottle to ens ure tha t only t he liq uid stage is withdrawn from the bottle.

CAX020. . . . . . GEE general

It is important that the sterilant is withdrawn as liquid from the containers and that the liquid is completely vaporised prior to introduction of the vapour into the sterilizing chamber. The mixture fed into the sterilizing chamber will then have the specified ethylene oxide content and the dangers associated with flammable vapours will be re du ced.

CAX021. . . . . . 10/90 ETO/CO2

If, on th e other han d, vapour is withdrawn from the contai ner top, fractioning of the two components of the mixture will take place and initially the vapour will contain more carbon dioxide than the liquid, since CO2 being the more volatile component. Such vapour will have reduced steri lizing propert ies since t he propor tion of eth ylene ox ide will be reduced. As evaporation of the liquid progresses the remaining liquid will be enriched with ethylene oxide and ultimately the vapour off-take from the container will have an ethylene oxide content in excess of 10% and hence will be more flammable.

CAX024. . . . . . 20/80 ETO/CO2

will be enriched with ethylene oxide and ultimately the vapour off-take from the container will have an ethylene oxide content in excess of 20% and hence will be more flammable.

CAX026 . . . . . 30/70 ETO/CO2

If, on the other hand, vapour is withdrawn from the container top, fractioning of the two components of the mixture will take place and initially the vapour will contain more carbon dioxide than the liquid, carbon dioxide being the more volatile component. This vapour will have reduced sterilizing properties since the proportion of ethylene oxide will be reduced. As evaporation of the liquid progresses the remaining liquid will be enriched with ethylene oxide and ultimately the vapour off-take from the container will have an ethylene oxide content in excess of 30% and hence will be more flammable.

CAX028 . . . . . 90/10 ETO/CO2

If, on the other hand, vapour is withdrawn from the container top, fractioning of the two components of the mixture will take place and initially the vapour will contain more carbon dioxide than the liquid, carbon dioxide being the more volatile component. This vapour will have reduced sterilizing properties since the proportion of ethylene oxide will be reduced. As evaporation of the liquid progresses the remaining liquid will be enriched with ethylene oxide and ultimately the vapour off-take from the cont ainer will h ave an ethy lene oxid e con tent in e xcess of 90%.

CAX030 . . . . . 10/90 ETO/Freon

If, on the other hand, vapour is withdrawn from the container top, fractioning of the two components of the mixture will take place and initially the vapour will contain more dic hlorodifluoromethane tha n the liquid, since CCl2F2 being the more volatile component. Such vapour will have reduced sterilizing properties since the proportion of ethylene oxide will be reduced. As evaporation of the liquid progresses the remaining liquid will be enriched with ethylene oxide and ultimately the vapour off-take from the container will have an ethylene oxide content in excess of 10% and hence will be more flammable.

CAX032 . . . . . 12/88 ETO/Freon

CAX022. . . . . . GEE general

The pressure within a container gives an inaccurate information about the quantity of liquefied gas held by the container. The only satisfactory way of checking the contents of cylinders and drums is by weighing, and this method should be used to determine whether a container is empty. A simple means to get continuous informat ion about the ga s content of the bottle is to keep it standing on a scale while withdrawing the gas.

The gas bottle storage room has to be well ventilated with change of air at least ten times per hour in the direction from ceiling towards floor.

CAX002. . . . . . GEC general

Introduction GEC

Sterili zer type GEC is the coll ective desi gnation of a ra nge of GETINGE high pressure sterilizers usi ng c irculating process water as heat transfer media. GEC-sterilizers are available with vertically or horizontally sliding automatic doors. Both single and double ended types exist.

The GEC-sterilizers are intended for sterilization of liquids contained in pressure tigh t glass or plastic containers which resist pouring with water. If the sterilizer is equipped with a vacuumpump it may also serve as an ordinary steam sterilizer suitable for sterilization of utensils, containers, textiles etc.

Adaptation to respectively task is made mainly by selecting type of software for the control unit. The sterilizer control unit is computerized and provides possibilities for a large number of processes, all characterized b y a very go od acc uracy in c ontrolling the p rocess p arameters.

Both instantaneous and set values for a proceeding process may be displayed on request.

The software which controls the processes can be fixed programmed in the control unit to combine quickness with safety in the production lines. When it comes to odd type of works, most process parameters can be set from time to time by the operator. Reprogramming of the control unit can be made at site.

The automatic doors are provided with safety devices to protect the operator.

The sterilizer chamber, made of acid proof stainless steel is covered externally to about half its area by seal-welded u-profiles which serve both as stiffening bars for the pressure vessel and, for vacuum-cycles, as a steam jacket containing temperature con trolled steam heating for the chamber walls.

The GEC-type steri lizers should be sup plied with el ectrici ty, cold water, process water, compressed air and steam. If central steam is not avai la b le o r t h e r e are rea son s not to use i t , sma l l GEC-u nits can be equipped with an electric steam generator.

CAX014 . . . . . GEV general

Introduction GEV

The GEV sterilizer is characterized by one or more ventilators, arranged at the sterilizer chamber ceiling, to keep the chamber atmosphere in violent circulation.

The utilized compartment is made of comparatively thin stainles steel sheet and is centrically located in a surrounding pres sure v essel. The space between the utilized compartment and the pressure vessel is filled at each sides with a pack of tubes which are flown through by cold water, or in some cases by steam.

The ventilators make the chamber atmosphere pass through the pipe pack in direction from the ceiling towards the floor, thereby being cooled or heated depending on the medium passing through the pipes.

The flow through the load will consequently go in the dire ction from below and upwards.

The special feature of the ventilator sterilizer renders it unique properties. Besides the sterilizer functioning as a common steam sterilizer, it also works excellent with support pressure, created through the admission of compressed air into the chamber. The turbulent flow caused by the ventilators will efficiently homogenize the chamber atmosphere so as to create a uniform temperature all over the chamber. Without the ventilator stirring effect a stratification between steam and air would easily take place with big temperature gradients as a consequence.

Sterilizing products being sensitive to moisture can be treated in ventilator sterilizers which are heated by steam passing through the packs of pipe. The heat produced is transferred to the goods when the ventilator circulates the air trapped in the chamber. The process can be complemented with support pressure created by compressed air.

The principle described in the paragraph above is also used as a drying procedure, for instance if an extremely dry load is required after a steam sterilization.

By letting cold water through the pipe-pack an efficient cooling of the load will be obtained. Also the cooling process can be complemented with support pressure created by compressed air.

CAX035. . . . . . GEVC general

Introduction GEVC

Sterilizer type GEVC is the collective designation of a range of GETINGE high pressure sterilizers capable of using either circulating process water or circulating air as heat transfer media. GEVC-sterilizers are available w ith vertically or horizon tally sliding autom atic doors. Both single and double ended types exist.

The GEVC-sterilizers are designed for sterilization of most types of

products. The sterilizer can run both GEC-cycles and GEV-cycles.

GEC-cycles are often intended for sterilization of liquids contained in pre s s u r e tigh t g l a s s or plast i c conta i ners whi c h resist p o ur i ng with water. In this case circulating water is used as heat transfer media. A centrifugal pump is used for circulating the water.

GEV-cycles are used when the re is a d emand for a package for the product. Also this type of cycles can be used for sterilization of liquids in sealed containers. For GEV-cycles air and steam are used as heat transfer media. One, or several, fans are used to keep the chambe atmosphere in violent circulation.

If the sterilizer is equipped with a vacuumpump it may also serve as an ordinary steam sterilizer suitable for sterilization of utensils, containers, textiles etc.

Adaptation to respectively task is made mainly by selecting type of software for the control unit. The sterilizer control unit is computerized and provides possibilities for a large number of processes, all characterized by a very good accuracy in controlling the process parameters. Both instantaneous and set values for a proceeding process may be displayed on request.

Reprogramming of the control unit can be made at site. The a utomatic doors ar e provided with safety devi ces to protect the

operator.

The GEVC-type sterilizers should be supplied with electricity, cold water, process water, compressed air and steam. If central steam is not available or there are reasons no t to use it, smal l GEVC-units can be equipped with an electric steam generator.

CAX015 . . . . . GE Ph.div. general

Introduction GE

Sterilizer type GE is the collective designation of a range of GETINGE high pressure sterilizers using steam and v acuum in the process for ster-

iliz ation. GE-ster ilizers are avai lable w ith v ertica lly or hor izontally sliding doors. Both single and double ended types exist.

The GE-sterilize rs are intended for steriliz ation of materia ls in the health service as well as in the pharmaceutical industry. The type o materials include: instruments, utensils, glass, plastic, leather and textiles. Some sterilizers have special programs for sterilization of hot and cold liquids. The all dominating sterilizing agent is steam with a temperature of 120-135 °C.

Reprogramming of the control unit can be made at site. The automatic doors are provided with safety devices to protect the

operator.

The sterilizer chamber, made of acid proof stainless steel is covered externally to about half its area by seal-welded u-profiles which serve

both as stiffening bars for the pressure vessel and as a steam jacket containing temperature controlled steam heating for the chamber walls.

The GE-type sterilizers sho uld be supplied with electricity, cold water, compressed air and steam. If central steam is not available or there are reasons not to use it, GE-units can be equipped with an electric steam generator.

CAH017 . . . . . Introduction to GE sideways-opening, Hospital

Autoclave type GE

Getinge Autoclave type GE is the designation of a series of high-pre ssure autoclaves with horizontal, automatic sliding doors in single-door and double-door versions..

The autoclaves are intended for the sterilization of equipment both in hospitals and industry. Adaptation to the particular functions concerned is done through the selection of control equipment. This is based on a microprocessor and consequently offers a very large number of types of process, all characterized by exception al accuracy in the regulation of the process parameters. The operator can call up on a display information on the current process, current process phase and the actual values of the parameters while the process is in progress.

The totally dominant sterilization medium is steam with a temperature of 121 - 134 °C. Material which is damaged by this temperature may be sterilized, in certain autoclave models, in formalin vapour at 65 - 80 °C.

Mos t types of items ca n be steri lized i n the GE au toclaves , using adapted programs: Instruments, machine parts, glass, plastic, rubber, leather, textiles, cold and hot liquids in open or ventilated containers and small pressure-tight liquid-filled containers of stable shape.

European standard EN 285 specifies the use of fixed programs only. However, the control equipment of GE autoclaves allows the programs to be made variable during the time testing is in progress.

If the autoclave is not covered by European standard EN 285, all the programs are variable.

As door operation is controlled automatically as well as the processes, it is not a long step to automation of the handling of items for sterilization. The control unit is therefore prepared for the control of autoclaves with automatic loader and/or unloader.

As in other Getinge double-jacketed autoclaves, the external surface of the chamber is half-covered with all-welded U-sections. These stiffen the flat walls of the pressure vessel, and at the same time accommodate the steam which keeps the chamber walls warm in order to minimize condensation in the chamber. The design principle means that all welds are available for visual inspection after the thermal insulation has been removed.

A vacuum pump of the water-ring type removes air, steam and condensate from the chamber and door-gasket groove. The sealing wate r of the pump is taken from an open pump which in some cases also supplies the feed-water pump with water on autoclaves with a built-in steam generator.

The condenser between the chamber and the vacuum pump converts waste steam to water. The decrease in volume contributes substantially to increasing the efficiency of pump operation an d protecting the pump and discharge lines against high temperatures.

A well-damped d ischarge system after the vacuum pump and welldimensioned thermal insulation around the chamber mean that the auto-

clave has a minimal effect on the surroundings where it is installed, making it easy to position.

GE autocl aves have to be supplied with ele ctricity, col d water, compressed air and steam. When steam is supplied from a central steam-production plant, its distribution is required to be well insulated and dewatered. The pressure in the line has to be reduced to the correct level and the line has to be fitted with a safety valve. In addition, the steam plant must produce a quality of steam which is suitable in the context of sterilization.

If there is no steam network or there are reasons for not using the steam network, the autoclave can be fitted with a built-in electric steam generator (certain models only) or a stand-alone steam generator which is installed in the service room.

CAX036 . . . . . GED general

Introduction GED

Steril izer type GED is t he collective de signation of a ra nge of GETINGE high pressure disinfection autoclaves using steam and vacuum in the process for disinfection.

The GED operate at the temperature 105 oC, or for heat sensitive goods at 75 oC. In both cases steam serves as a disinfection agent, in the latter case under vacuum. Very heat sensitive material can be disinfected in specially designed GED´s by means of formaldehyde at 65 oC.

Since the process include vacuum stages, the control unit is equipped with a process for automatic leak rate test.

Jacket tempe ratures below 100 oC are enabled by using subat mospheric steam, produced by intermittent evacuation of the jacket.

The processes are based upon the GETINGE principle with pulsating

prevacuum, known for its air purging abilities.

Reprogramming of the control unit can be made at site. The automatic doors are provided with safety devices to protect the

operator.

The sterilizer chamber, made of acid proof stainless steel is covered externally to about half its area by seal-welded u-profiles which serve both as stiffening bars for the pressure vessel and as a steam jacket containing temperature controlled steam heating for the chamber walls.

The GED- type sterilize rs should be supplied w ith electr icity, cold water, compresse d air and st eam. If centr al steam is no t available o there are reasons not to use it, GED-units can be equipped with an electric steam generator.

CAX033. . . . . . GEE general

The sterilizer

The ster ilizer cham ber, made of acid proof stainless steel is covered externally to about half its area by seal-welded u-profiles which serve both as stiffening bars for the pressure vessel, and as a double jacket

containing the medium heating the chamber walls. The design principle makes all weld seams a ccessible for visual inspection after removal of the heat insulation.

The gas sterilant is drawn as a liquid from bottles or cylinder containers. It is converted into a gas in a heated evaporator which is designed to serve also as a cleaner for the gas.

Steam required for the processes should be taken from a well drained steam supply line, or when not available from a steam generator.

The vacuum pump of water ring type takes its sealing water from a vented tank to which it also delivers the used water. The gas leaving the pump escapes through a exhaust pipe, connected to the water tank.

With double ended sterilizers the doors are interlocked, enabling for one door only to be opened at a time. After an error has occurred or whenever manual interference has taken place in the process, the unloading door remains closed and the loading door will be the only one giving access to the chamber.

The steri lizer should be supplied with electri city, cold water, compressed air (or nitrogen when explosion proof) and steam. When the latter is taken from a central production plant, it is essential that the distribution piping is properly drained. If central steam is not available or there are reasons not to use it, an electric steam generator may be supplied.

CAM007 . . . . . Introduction GE 2044

GE 2044

Sterilizer type GE 2044 is the collect ive denominatio n for a range of GETINGE high pressure sterilizers with vertically sliding manual doors, all with the door opening 430 x 430 millimetre

Both single and double ended types exist.

The sterilizers are intended for sterilizat ion of materials in the health servic e as well as in the ind ustry. Adap tation to resp ective ly task is made mainly by selecting type of control unit. This is built up around a micro processor and therefore provides an almost endless number of processes, all characterized by a very good accuracy in controlling the process parameters. Both instantaneous and set values for a proceeding process may be displayed on request.

The al l dominating s terilizing ag ent is stea m with a temperat ure of 120 - 135 °C. Material which may be damaged at this temperature can, in some sterilizer models, be sterilized in formaldehyde vapour at 60 80 °C.

The 2044-sterilizers are intended for processing a great variety o goods such as: instruments, utensils, glass, plastic, leather, textiles, hot or cold liquids in open or ven ted containers and small ri gid pressure tight liquid ampoules. This is done with dedicated programmes.

European Standard EN 285 prescribes the use of fixed programs only. The control equipment of the 2044 sterilizers allows the programs to be varied during testing.

The sterilizer chamber, made of acid proof stainless steel is covered externally to about half its area by seal-welded U-profiles which serve

both as stiffening bars for the pressure vessel, and as a steam jacket containing temperature controlled steam heating the chamber walls.

A vacuumpump of the water ring type removes air, steam and condensate from the chamber. Its seal ing water i s t aken from an open tank which also serves the feed water pump on sterilizers equipped with a built in steam generator.

The condenser between chamber and v acuum pump converts all wa ste steam to water. This reduction of the pump handling volume speeds up the vacuum producing process and will save the pump and waste piping from high temperatures.

A well silenced drain system after the vacuum pump and the well sized thermal chamber insulation makes the sterilizer an environmentally pleasing unit, easy to locate.

The type 2044 sterilizers should be supplied with electricity, cold water, steam and, for LAB- and for maldehyde sterilizers, also compressed air. When steam is taken from a central production plant, it is essential that the distribution piping is properly drained.

If central steam is not available or there are reasons not to use it, an electric steam generator, contained within the cabinet volume may be supplied.

CAM011 . . . . . Introduction to GEF-449 perFORMer

GEF-449 perFORMer

GEF-449 perFORMer is the designation of a series of GETINGE highpressu re steriliz ers with a v ertical manual sliding door, all of w hich

have a charging opening of 430 x 430 mm and a chamber depth of 940 mm.

There are both stand-alone and built-in versions.

The sterilizers a re intended for the sterilization of items in hospitals. They are adapted to the items concerned through the choice of control equipment. This control equipment is based on a microprocessor and consequently offers a number of types of process, all of which are characterized by exceptional accuracy in the regulation of process parameters. The operator can call up information on the current process, current process phase and the actual values of parameters on a display while the process is in progress.

There are two variants of sterilizers, one for a combination of steam

and formalin sterilization and the other for formalin alone.

The sterilizing medium of the combined sterilizer is principally steam at a temperature of 121 - 134°C. Materials which are damaged by this temperature are sterilized in formalin vapour at 50 - 80°C.

Most types of items can be treated in the GEF-449 sterilizers, using adapted programs: Instruments, machine parts, glass, plastics, rubber, leather, textiles and temperature-sensitive materials.

European Standard EN 285 for steam sterilizers spe cifies the use of fixed programs only in steam sterilization. However, the control equipment of the GEF-449 sterilizers allows the programs to be made variable during the time testing is in progress.

As with Getinge's other double-jacketed sterilizers, the external surface of the chamber and doors is half-covered with all-welded U sections. These stiffen the flat walls of the pressure vessel, as well as holding the steam that keeps the chamber walls and doors wa rm to minimize condensation in the chamber. (The doors are only heated in the

+ 760 hidden pages