Subject : Introduce Systec company and autoclave Presented...

• Subject : Introduce Systec company

and autoclave

• Presented by : Vahid Totonchi

• Mehr 1393

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The concept of sterilization

Astrylyzyasyvn or sterilization means elimination of all forms of life in or on a

medium or substance. The different forms of living cells, bacteria and eukaryotes,

Andvspvr bacteria, spores, fungi, virus particles, smaller than the virus.

Sterilization process is complete, meaning that it is sterile or non-sterile

environment and a term or provision or part-sterile or nearly sterile there.

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Sterilization Methods

• Different sterilization procedures are performed in the microbiology laboratory can

be used in both physical and chemical methods.

• Physical methods: incineration, autoclaving, use the oven (oven), filtration and

radiation

Chemical methods: the use of chemical disinfectants and disinfectant Burning in

the microbiology laboratory culture after culture and transfer using a wire loop or

ounces (needle) to catch and fry them on the flames killed the tools are sterile.

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Sterilizing autoclave method

• An autoclave is a pressure chamber used to sterilize equipment and supplies by

subjecting them to high pressure saturated steam at 121 °C for around 15–20 minutes

depending on the size of the load and the contents.[1] It was invented by Charles

Chamberland in 1879,[2] although a precursor known as the steam digester was

created by Denis Papin in 1679.[3] The name comes from Greek auto-, ultimately

meaning self, and Latin clavis meaning key—a self-locking device.[4]

• Other types of autoclave are used in the chemical industry to cure coatings, vulcanize

rubber and for hydrothermal synthesis, growing crystals under high temperatures and

pressures. Synthetic quartz crystals used in the electronic industry are grown in

autoclaves.

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Systec Company

• Systec develops, produces and markets laboratory autoclaves and devices for media preparation and handling worldwide

• The company was founded in 1994

• It employs about 115 persons

• Two main sites in Germany

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• Systec is absolutely committed to the laboratory autoclave market

We make steam sterilization processes in laboratories

safe, accurate, reproducible and validatable

• Systec educates the market, customers as well as distributors, about state-of-the-art steam sterilization techniques and developments

• Systec provides innovations in design, quality and solutions for various steam sterilization applications in laboratories

• We want to strengthen our position as a leading company in the global laboratory autoclave market

INTRODUCTION | company mission

6 © Systec GmbH , Wettenberg | www.systec-lab.com

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SYSTEC D-SERIES – BENCH-TOP, FRONT-LOADING AUTOCLAVES

• 7 models, 23 to 200 liter chamber volume


INTRODUCTION | product range

SYSTEC V-SERIES – VERTICAL, TOP-LOADING AUTOCLAVES


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• Systec V-Series and D-Series autoclaves are available in three different performance categories

– Systec DX|VX For all laboratory applications even for state-of-the-art sterilization processes. With all possibilities to add options for process optimization to meet highest process accuracy and to carry out validatable sterilization cycles.

– Systec DE|VE For basic laboratory applications and media sterilization. With limited possibilities to add additional options for process optimization.

– Systec DB|VB For simple process applications. No options available for process optimization.



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SYSTEC H-SERIES – HORIZONTAL, FLOOR-STANDING AUTOCLAVES

• 16 models, 65 to 1.580 liter chamber volume



SYSTEC H-SERIES 2D – DOUBLE-DOOR, PASS-THROUGH AUTOCLAVES


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• Further Directives:

– 2006/95 EC Low Voltage Equipment

– 2004/108 EC Electromagnetic Compatibility

– 2006/42 EC Machinery Directive

• All steam sterilizers and mediapreparators come with CE Mark

• Marking permission for CE mark issued by a notified body proving that pressure vessels are calculated and checked by an independent authority

INTRODUCTION | quality


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• Certified according to newest ISO-Norm DIN EN ISO 9001:2008

• Certified for design, development, production, sales and service for laboratory autoclaves

INTRODUCTION | quality management


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• Systec offers the widest range of laboratory steam sterilizers and mediapreparators in the world

– 73 autoclave models, 23 to 1.580 liter chamber volume

– 7 mediapreparator models, 10 to 120 liter chamber volume

– Manual and fully automatic media dosing, filling and handling devices

– Modularity and a vast variety of options and accessories provide a maximum of flexibility and allows to meet even the highest customer’s requirements

– Custom solutions where applicable

• A strong focus to steam sterilization applications in laboratories

• About 20 years of experience in the design and construction of steam sterilizers and mediapreparators

THIS MAKES SYSTEC A UNIQUE AND RELIABLE PARTNER FOR YOUR STEAM STERILIZATION APPLICATIONS

INTRODUCTION | a unique and reliable partner


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• Research laboratories at universities and other research institutes

– Medical science

– Biology

– Environmental protection

– Biotechnology

INTRODUCTION | our customers


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• Microbiological diagnostic laboratories

– Human-Medicine

– Veterinary-Medicine



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• Cosmetic industry

– Research

– Quality Control

– Production / Pilot production



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• Biotech companies and laboratories

– Research

– Quality Control

– Production



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• Service laboratories



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STERILIZATION OF LIQUIDS (PREPARATION)

• Culture media in bottles to selectively grow specific microorganisms

• Instruments

• Empty glassware

• Tubes and hoses

• Pipettes, pipette tips

• Filters, Textiles

BASIC PRINCIPLES | steam sterilization in laboratories

STERILIZATION OF SOLIDS (PREPARATION)


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STERILIZATION OF WASTE (DECONTAMINATION)

• Solid waste in waste bags

• Liquid waste in bottles

• Biohazard waste

BASIC PRINCIPLES | steam sterilization in laboratories


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Sterilization is a term referring to any process that eliminates or kills all forms of microbial life, including transmissible agents (such as fungi, bacteria, viruses, spore forms, etc.) present on a surface, contained in a fluid, in medication, or in a compound such as biological culture media

• Steam sterilization is carried out at

– a steam pressure of 1 to 5bar

– a sterilization temperature between 100 to 150°C

– a sterilization time between 3 and 20 minutes

• Commonly used steam sterilization parameters are

– 121°C, 15 to 20 minutes

– 134°C, 3 to 5 minutes

BASIC PRINCIPLES | what is steam sterilization?


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STEAM GENERATION BY INTERNAL HEATING ELEMENTS

• Heating elements inside the pressure vessel of the autoclave

• Steam is generated in a steam generator which is separated from the pressure vessel but integrated into the housing of the autoclave

BASIC PRINCIPLES | how is steam produced in steam sterilizers

STEAM GENERATION BY SEPARATE STEAM GENERATOR


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• For steam generation in a steam sterilizer, demineralized water must be used

• The water quality has a direct influence to the steam quality

• Normal tap water contains minerals, in particular carbonates, and other ingredients which can contaminate the product during sterilization

BASIC PRINCIPLES | how is steam produced in steam sterilizers


DIN 58951-2 Sterilization - Steam sterilizers for laboratory use Part 2: Apparatus requirements, requirements on services and installation

Demineralized water conductivity (at 20 °C)

< 15 μS/cm and Σ alkaline earth ions < 0.02 mmol/l

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• Kinetic heat energy (heat) is transferred from the heating elements into the liquid (demineralized water)

• The liquid (demineralized water) has the tendency to evaporate due to the kinetic energy (heat)

• As higher the kinetic energy the more molecules are released from the surface of the liquid due to evaporation

• The aggregate state changes from liquid to gaseous (steam)

BASIC PRINCIPLES | evaporation


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• When steam condenses e.g. on cold surfaces, steam releases its kinetic energy (heat)

• Due to condensation, the aggregate state changes from gaseous (steam) to liquid

BASIC PRINCIPLES | condensation


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BASIC PRINCIPLES | air release phase | internal heating elements vs. steam generator


Valve

Air

Water

Heating element

Water reservoir with heating element

for steam generation

Air must be replaced by steam

through air release valve

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air

steam

heating of water

heating element

Air removal by suppression

against the natural gravitation

of the air

Not an optimal process, as air is

heavier than steam

Steam rises up and air gravitates

down

valve open

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valve closed

heating element

air

steam

sterilizing effect

if temperature is reached

no sterilizing effect

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Steam inlet from top

Air release at the bottom with the

natural gravitation of the air

Suppression of the remaining air

and steam injection to sterilization

temperature / pressure

Remaining air sediments down to

the bottom

Steam-

generator

Steam created by a steam generator

outside of the sterilization chamber

Second air release phase

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Steam-

generator

No remaining air left in the chamber

100% steam atmosphere (steam

pressure)

Temperature equals exactly the

pressure depending boiling point

The temperature depends only on the

steam pressure

Direct correlation between pressure

and temperature

Pressure and temperature monitoring

ensures a redundant process control

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• Steam is generated directly in the pressure vessel of the autoclave

• Steam is created on the bottom of the chamber

• Air must be suppressed to the top of the chamber

• Suppression of air against its natural gravitation

• Air physically is heavier than steam and gravitates down while steam rises up

Ineffective air release causes a reduction of the biological efficiency

of a steam sterilization process

• Steam is generated in a steam generator outside pressure vessel

• Steam inlet from top of the pressure vessel

• Air is suppressed to the bottom of the pressure vessel

• Suppression with the natural gravitation of the air

Separate steam generator and steam generation outside the pressure vessel

allows much better process control


STEAM GENRATOR INTERNAL HEATING ELEMENTS


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• Heating elements on the bottom of the pressure vessel

• Dirty water swamp on the bottom of the pressure vessel

Not easy to clean the pressure vessel

• No heating elements on the bottom of the pressure vessel

• Not dirty water swamp on the bottom of the pressure vessel

Easy to clean the pressure vessel


STEAM GENRATOR INTERNAL HEATING ELEMENTS


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STERILIZATION OF LIQUIDS (PREPARATION)

STERILIZATION OF LIQUIDS | general

• Culture media in bottles to selectively grow specific microorganisms

• Steam sterilization can influence media quantity and quality (e.g. heat sensitive additives)

• Most critical sterilization process as far as safety, cycle time and productivity are concerned


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H: Heat-up

S: Sterilization

C: Cooling

Blue: Pressure in the chamber

Red: Temperature

in the media

STERILIZATION OF LIQUIDS | cycle phases


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• The pressure vessel of the autoclave is heated by steam

• Steam condenses on the cold walls of the bottles and releases its energy

• The heat radiates into the liquid

The liquid is heated up with a delay time compared to the

pressure vessel of the autoclave

STERILIZATION OF LIQUIDS | heat-up phase


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H: Heat-up

S: Sterilization

C: Cooling


Red: Temperature

in the media

• When the autoclave is heated up to sterilization temperature, the liquids in the bottles have by far not yet reached the wanted sterilization temperature

• The overall time required to attain equilibrium between chamber and liquids is hence much longer



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• Temperature must be measured in a reference vessel using a PT-100 temperature load sensor

– To ensure that the wanted sterilization temperature is really reached inside the liquid

– To ensure a safe cooling temperature

The reference vessel must be as large and the filling volume as

high as the volume of the biggest vessel filled with culture media



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H: Heat-up

S: Sterilization

C: Cooling


Red: Temperature

in the media

• Increased temperature in the pressure vessel during the heat-up time

• Improved heat transfer – Liquid media in the bottles heats up faster

• Heat-up time reduced by up to 50%



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• When sterilizing liquids, not only achieving the sterilization temperature in the heat-up phase is important

• It is also important to cool the liquids to a save temperature before it is allowed to open the autoclave

STERILIZATION OF LIQUIDS | cooling phase


TRB 402 – Technical Regulations for Pressure Vessels (clause 3.2.4)

If there is a given danger of delayed boiling of the sterilization product, e.g. when sterilizing liquids, it must be ensured that the pressure vessel can only be opened when the temperature of the liquid is cooled well below the boiling point

DIN 58950 – Steam sterilizer for pharmaceutical products (clause 8.4)

The program control must be designed that opening of the door during operation is not possible

When using a liquid sterilization program, it must be ensured that the temperature in the product is lower than 0.8 times the boiling temperature

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STERILIZATION OF LIQUIDS | cooling phase | delayed boiling


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• Delayed boiling can result in heavy injuries

• To prevent delayed boiling, it is to ensure that liquids in steam sterilizers are cooled down to a temperature well below the boiling point at atmospheric pressure

• A thermal protection has to ensure that the autoclave cannot be opened as long as the liquid is not cooled down to a save temperature

• The temperature has to be measured in the liquid (reference vessel)

• A cooling temperature of 80°C is safe

Because of the high risk of accidents there should not be any compromise

STERILIZATION OF LIQUIDS | cooling phase | delayed boiling


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EVAPORATION COOLING

• Cooling by evaporation (boiling) of the culture media in the cooling phase

Only for open vessels

• Cooling without evaporation (boiling) of the culture media in the cooling phase

• Cooling by radiation

For open and hermetically closed vessels

STERILIZATION OF LIQUIDS | cooling phase

NON-EVAPORATION COOLING


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• Evaporation cooling is achieved by evaporation (boiling) of the sterilized liquid

• Evaporation can only take place in open vessels - never in closed vessels as in closed vessels a gas exchange is not possible

• Evaporation out of closed vessels cannot take place and the liquid does not cool off

• Caps of closed vessels must at least be vented

How can it be assured that bottles are always open (caps are vented) given the fact that more and more bottles with screw caps are used in laboratories nowadays?

At the opening of the autoclave, the temperature of the liquid in closed bottles is still above 100°C and the bottles are still under pressure

DANGER! GLASS BOMB

STERILIZATION OF LIQUIDS | cooling phase | evaporation cooling


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• Conventional cooling, no active cooling system

• Slow steam release

• Boiling and evaporation of liquid media out of the vessel due to pressure drop in the pressure vessel

• Cooling by evaporation down to 100°C / 100kPa

Liquid product loss of 3 to 5%

No cooling effect on hermetically closed vessels

Risk of over boiling – protein containing liquid can foam over

STERILIZATION OF LIQUIDS | cooling phase | conventional cooling


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• Below 100°C/100kPa, evaporation cooling discontinues

• Atmospheric pressure is reached, no more pressure that can be released from the pressure vessel

• Further cooling to 80°C by radiation through the stainless steel and insulation of the pressure vessel and the autoclave housing is very slow

All heat that radiates out of the autoclave is given to the room in

which the autoclave is installed and heats the room – special air condition

in the room might be needed



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OPEN VESSEL (1000ml water) CLOSED VESSEL (1000ml water)


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• Hermetically closed and open vessels in autoclave chamber

• Both, the closed and the open vessels, are filled with 1000ml of water



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H: Heat-up

S: Sterilization

C: Cooling


Red: Temperature

in the media

• Cooling by evaporation down to 100°C is reasonably fast

• Further cooling by radiation down to 80°C is very slow

Cooling time up to 10 hours (depending on load volume)



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• Cooling by ambient air ventilation

• Condensation of steam at the cold spot causes a pressure drop

• Boiling and evaporation of liquid media out of the vessel due to pressure drop in the pressure vessel

• Down to 80°C = vacuum ~ 50 kPa

Liquid product loss of 7 to 10%


Risk of over boiling – protein

containing liquid can foam over

Heat radiates into the room where the autoclave is installed

STERILIZATION OF LIQUIDS | cooling phase | ambient air ventilation


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OPEN VESSEL (1000ml water) CLOSED VESSEL (1000ml water)


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• Hermetically closed and open vessels in autoclave chamber

• Both, the closed and the open vessels, are filled with 1000ml of water



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H: Heat-up

S: Sterilization

C: Cooling


Red: Temperature

in the media

• Cooling by evaporation down to 80°C

Cooling time between 1 hour and 5 hours (depending on load volume)



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• Cooling by water cooling with cooling coils around the pressure vessel

• Condensation of steam at the cooled walls of the pressure vessel

• Quick pressure drop

• Fast Boiling and evaporation of liquid media out of the vessel

• Effective down to 80°C


Risk of over boiling – protein containing liquid can foam over

STERILIZATION OF LIQUIDS | cooling phase | water cooling


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• Cooling by water cooling with cooling coils around the pressure vessel

• Prior to cooling, replacement of steam pressure by sterile filtered air pressure (support air pressure)

• Air is a non-condensable gas , pressure remains throughout the whole cooling phase

• Cooling by radiation of heat to the cooled walls of the pressure vessel

Non-evaporation cooling No boiling of the liquids

Effective for hermetically closed vessels

STERILIZATION OF LIQUIDS | cooling phase | water cooling with support air pressure


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H: Heat-up

S: Sterilization

C: Cooling


Red: Temperature

in the media

• Non-evaporation cooling down to 80°C

Cooling time between 30 minutes and 3 hours (depending on load volume)



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STERILIZATION OF LIQUIDS | cooling phase | water cooling systems

COOLING COILS DOUBLE JACKET (MANTLE COOLING)


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• Double jacket is produced by point welding two metal sheets and inflating these by air pressure

• Double jacket has very tiny capillaries through which the cooling water is led

• Using tap water or softened water for cooling would block the capillaries with carbonates

Because of the tiny capillaries, expensive demineralized water

has to be used for cooling

• Half-pipe cooling coils to increase the cooling surface

• Cooling water is led all around the pressure vessel

• Cooling coils provide a bigger diameter compared to the capillaries of a double jacket which reduces the risk of blocking the cooling system by carbonates

Inexpensive tap water or softened water can be used

STERILIZATION OF LIQUIDS | cooling phase | water cooling systems

COOLING COILS DOUBLE JACKET (MANTLE COOLING)


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• Add-on: Radial Ventilator

• Internal ventilator for further reduction of the cooling time

• Supports water cooling with support air pressure by ventilation forced convection of the heat to the cooled walls of the pressure vessel

Does not reach into the chamber, does not reduce the usable space

(except Systec V-40 and V-55)



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H: Heat-up

S: Sterilization

C: Cooling


Red: Temperature

in the media


• Water cooling with support air pressure and Radial Ventilator

Cooling time between 20 minutes and 2 hours (depending on load volume)



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• Add-on: Ultra Cooler

• Additional heat exchanger for further reduction of the cooling time

• Supports water cooling with support air pressure and radial ventilator

Does not reach into the chamber, does not reduce the usable space

(except Systec V-40 and V-55)



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H: Heat-up

S: Sterilization

C: Cooling


Red: Temperature

in the media


• Water cooling with support air pressure, Radial Ventilator and Ultra Cooler

Cooling time between 10 minutes and 60 minutes (depending on load volume)



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• Spray cooling

• Heating by steam

• Steam is condensed in the cooling phase and recirculated through a heat exchanger as cooling water

• Cooling by spraying cold water to the vessels

• Includes support air pressure


Only for hermetically closed vessels

STERILIZATION OF LIQUIDS | cooling phase | spray cooling


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• Spray cooling with laminar plate

• Laminar plate prevents direct spraying of water to the bottles


Only for hermetically closed vessels

STERILIZATION OF LIQUIDS | cooling phase | spray cooling with laminar plate


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H: Heat-up

S: Sterilization

C: Cooling


Red: Temperature

in the media


• Spray cooling with or without laminar plate

Cooling time between 5 minutes and 20 minutes (depending on load volume)

STERILIZATION OF LIQUIDS | cooling phase | spray cooling


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• Conventional cooling (no active cooling system)

• Ambient air ventilation

• Water cooling without support air pressure

• Water cooling with support air pressure

• Spray cooling with support air pressure

STERILIZATION OF LIQUIDS | cooling phase | evaporation vs. non-evaporation cooling

NON-EVAPORATION COOLING EVAPORATION COOLING


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• Cooling without support air pressure

• Boiling of liquids during cooling phase

– Loss of liquid out of vessels due to boiling process

– Risk of over boiling

– Danger of delayed boiling

Not effective on

hermetically closed bottles

• Cooling with support air pressure

• Replacement of steam pressure by sterile filtered air pressure for cooling (support air pressure)

• Non evaporation cooling

– No boiling, no product loss

– No risk of over boiling

– No risk of delayed boiling

Effective on open and hermetically closed vessels

STERILIZATION OF LIQUIDS | cooling phase | evaporation vs. non-evaporation cooling

NON-EVAPORATION COOLING EVAPORATION COOLING


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• Closed bottles and cans, etc. must always be sterilized with support air pressure in the cooling phase

• There is danger of explosion without support air pressure as the temperature and pressure in closed bottles drops much slower than in the pressure vessel of the autoclave when using a cooling system without support air pressure

How can it be assured that bottles are always open (caps are vented) given the fact that more and more bottles with screw caps are used in laboratories nowadays?

Systec strongly recommends to use a cooling system with support air pressure for safety reasons!!!

STERILIZATION OF LIQUIDS | closed bottles


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• Temperature and pressure dependent door-locking device prevents opening of the door whilst there is too high temperature or pressure

• PT-100 temperature load sensor for measuring the temperature in a reference vessel

• Water cooling with cooling coils and support air pressure

– Add-on: Radial ventilator

– Add-on: Ultra Cooler

• Compressor for support air pressure if on-site compressed air supply is not available

STERILIZATION OF LIQUIDS | standard features and recommended options

RECOMMENDED OPTIONS STANDARD FEATURES


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STERILIZATION OF SOLIDS | general

• All kind of tools and utilities that are needed for research

– Instruments

– Empty glassware (bottles, cans, …)

– Tubes and hoses

– Pipettes, pipette tips

– Filters, Textiles

• Critical process as far as the biological efficiency is concerned


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• Important factors

– Temperature

– Time

– Most important: Sterilization agent (steam)

• Steam contains 3600 times more heat energy than dry air at the same temperature

• Important for the biological efficiency of a steam sterilization process is not only the temperature but particularly the heat capacity of the sterilizing agent (steam)

An accurate, reproducible and validatable sterilization can only be ensured

if the steam penetrates to all outer and inner surfaces of the product

STERILIZATION OF SOLIDS | preconditions


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• Air displacement by simple heat-up

• Steam atmosphere in the pressure vessel

• Air inside the product (pipette tip box)

No sterilizing effect in the pipette tip box

STERILIZATION OF SOLIDS | heat-up phase | inefficient air release


Air Steam

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• Two pipette tip boxes

• In both boxes, temperature sensors and bio-indicators are placed



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• Pipette tip box wrapped with aluminum foil



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• Pipette tip boxes and two empty bottles placed into the autoclave

• Each box and bottle contains a temperature sensor and a bio-indicator

• Temperature mapping and using bio-indicators in the pressure vessel of the autoclave and in the product itself during the sterilization cycle allows to exactly determine the biological efficiency of the process in different areas of the autoclave and the load



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STERILIZATION OF SOLIDS | general

• All kind of tools and utilities that are needed for research

– Instruments

– Empty glassware (bottles, cans, …)

– Tubes and hoses

– Pipettes, pipette tips

– Filters, Textiles

• Critical process as far as the biological efficiency is concerned


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– Temperature

– Time






STERILIZATION OF SOLIDS | preconditions


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• Air inside the product (pipette tip box)

No sterilizing effect in the pipette tip box



Air Steam

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STERILIZATION OF SOLIDS | heat-up phase | fractionated / pulsed pre-vacuum


First pre-vacuum - air removal 90-95% First steam injection - remaining air gravitates down Second pre-vacuum - air removal 99-100% Second steam injection - remaining air gravitates down Third pre-vacuum - air removal 100% Third steam injection - heat up to sterilization temperature and start of sterilization time

Steam-

generator

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• Efficient air release by fractionated / pulsed pre-vacuum

• Steam can penetrate to all inner and outer surfaces of the product

• Steam atmosphere in both, the pressure vessel and the product

• No remaining air inside the product (pipette tip box)

Sterilizing effect in the pipette tip box



Air Steam

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• Pipette tip boxes and two empty bottles placed into the autoclave

• Each box and bottle contains a temperature sensor and a bio-indicator




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Location of bio-indicator Test result

Chamber No growth

10L bottle No growth

1L bottle No growth

pipette tip box 1 No growth

pipette tip box 2 No growth

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• When sterilizing solids, after sterilization, the steam will be released from the pressure vessel

• It is allowed to open the autoclave as soon as atmospheric conditions are reached in the pressure vessel

• During steam release, steam condenses in the product

• The product is wet after sterilization

STERILIZATION OF SOLIDS | steam release phase


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• Surface drying by opening the door of the autoclave after the sterilization cycle is finished

• Not a good drying result, still much condense in the products

Standard feature: Systec autoclaves

provide an automatic door-opening at the end of the sterilization cycle

(triggered through a parameter)

STERILIZATION OF SOLIDS | drying


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• Drying with fractionated post-vacuum

• During vacuum, the boiling point is lowered which causes that the hot condense evaporates

• As much as the condenses cools off, the drying effect gets less

• Not a good drying result, still much condense in the product especially on difficult products (such as textiles) and high load volumes



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• Drying by fractionated post-vacuum and Suprdry

• Drying by fractionated post-vacuum

• Additional heating by Superdry heating coils

• Heating adds energy to the pressure vessel which keeps the condense hot

• Ensures an optimal drying result even for difficult products and high load volumes



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• Separate steam generator (Systec VX, DX and HX autoclaves)

• Vacuum system

– Fractionated pre-vacuum for efficient air removal

– Fractionated post-vacuum for drying

• Superdry for efficient drying even on difficult loads and high load volumes

STERILIZATION OF SOLIDS | standard features and recommended options



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STERILIZATION WASTE (DECONTAMINATION)

STERILIZATION OF WASTE | general

• Solid waste in waste bags

• Liquid waste in bottles

• Biohazard waste


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– Temperature

– Time






STERILIZATION OF WASTE | preconditions


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• Air inside the waste bag

No sterilizing effect in the waste bag

STERILIZATION OF WASTE | heat-up phase | inefficient air release


Air Steam

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• Waste bag with petri dishes placed into the autoclave

• Three temperature sensors with each a bio-indicator in different levels in the waste bag




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Chamber No growth

Waste bag top Growth

Waste bag middle Growth

Waste bag bottom Growth

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• Air displacement by steam through simple heat-up is not sufficient to ensure a 100% steam atmosphere not only in the pressure vessel of the autoclave but also in the product that should be sterilized

• If air is left inside the product that should be sterilized, the air will prevent that steam can penetrate to all surfaces of the product

• Remaining air inside the product reduces the biological efficiency of the sterilization process considerably





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• Heat-up and air release through over pressure pulses, pulsed heat-up

• Steam pulses are given into the pressure vessel of the autoclave followed by releasing the steam again

STERILIZATION OF WASTE | heat-up phase | over pressure pulses / pulsed heat-up


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• Some water must be added into the bag to support the air release out of the destruction bag

• By evaporation out of the destruction bag during steam release the air release will be improved

• Difficult to standardize – in particular when the out gassing plastic suppresses the steam out of the destruction bag.

• Over pressure pulses procedure is better than simple heat up but it is not a reproducible or validatable method

STERILIZATION OF WASTE | heat-up phase | over pressure pulses / pulsed heat-up


Air Steam

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STERILIZATION OF WASTE | heat-up phase | fractionated / pulsed pre-vacuum


First pre-vacuum - air removal 90-95% First steam injection - remaining air gravitates down Second pre-vacuum - air removal 99-100% Second steam injection - remaining air gravitates down Third pre-vacuum - air removal 100% Third steam injection - heat up to sterilization temperature and start of sterilization time

Steam-

generator

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• Efficient air release by fractionated / pulsed pre-vacuum

• Steam can penetrate to all inner and outer surfaces of the product

• Steam atmosphere in both, the pressure vessel and the waste bag

• No remaining air inside the waste bag

Reproducible and validatable sterilizing effect in the waste bag



Air Steam

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• Waste bag with petri dishes placed into the autoclave

• Three temperature sensors with each a bio-indicator in different levels in the waste bag




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Chamber No growth

Waste bag top No growth

Waste bag middle No growth

Waste bag bottom No growth

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• Air leaving the autoclave is filtered through a 0.2µm HEPA-filter

• Condense is kept in the pressure vessel and steam is injected to the condense to ensure sterility of the condense prior to draining

STERILIZATION OF WASTE | air exhaust filtration


steam

air

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• Filter is inline sterilized during the sterilization process by steam injection

• Temperature in the filter controlled by PT-100 temperature sensor

• Filter can be exchanged by operator, no service intervention needed

STERILIZATION OF WASTE | air exhaust filtration


steam

air

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• Separate steam generator (Systec VX, DX and HX autoclaves)

• Over pressure pulses

• Vacuum system

– Fractionated pre-vacuum for efficient air removal

– Single post-vacuum to reduce bad smell of the waste

• Air exhaust filtration for save sterilization of even biohazard waste

STERILIZATION OF LIQUIDS | standard features and recommended options



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• Vertical, top-loading autoclaves


SYSTEC AUTOCLAVES | Systec V-Series


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Link: Technical Drawings



Systec V-40 V-55 V-65 V-75 V-95 V-100 V-120 V-150

Chamber dim. Ø x depth (mm)

344x450 344x600 400x500 400x600 400x750 500x500 500x600 500x750

Chamber volume total / nominal (l)

45/40 60/65 70/65 80/75 100/95 110/100 130/120 160/150

Heating (kW) 3.6 3.6 9.0 9.0 9.0 9.0 9.0 9.0 Faray

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Technical Drawings

Technical Drawings

• Optimized loading capacities

• Slim housing, small footprint

• Extended chamber dimensions

• Excellent loading capacities Systec V-95 and Systec V-150 optimized for three layers of 1 liter Schott bottles



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• Horizontal, bench-top autoclaves


SYSTEC AUTOCLAVES | Systec D-Series


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SYSTEC AUTOCLAVES | Systec D-Series


Systec D-23 D-45 D-65 D-90 D-100 D-150 D-200


260x420 344x500 400x500 400x700 500x500 500x750 500x1000


25/23 50/45 70/65 95/90 110/100 160/150 210/200

Heating (kW) DX DE and DB

2.8 2.3

2.8 3.0

9.0 4.5

9.0 4.5

9.0 4.5

9.0

7.25

9.0

7.25

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Technical Drawings

• Systec V-Series and D-Series autoclaves are available in three different performance categories

– Systec DX|VX For all laboratory applications even for state-of-the-art sterilization processes. With all possibilities to add options for process optimization to meet highest process accuracy and to carry out validatable sterilization cycles.

– Systec DE|VE For basic laboratory applications and media sterilization. With limited possibilities to add additional options for process optimization.

– Systec DB|VB For simple process applications. No options available for process optimization.

SYSTEC AUTOCLAVES | Systec V- and D-Series | performance categories


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• Systec VX and DX autoclaves with steam generator

• Steam generator separates the heating (steam generation) from the pressure vessel of the autoclave

• Steam generator integrated into the housing of the autoclave



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• Systec VE|VB and DE|DB autoclaves with heating elements inside the pressure vessel of the autoclave

• Steam generator inside the pressure vessel of the autoclave



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• Horizontal, floor-standing autoclaves

• 16 models, 65 to 1.580 liter chamber volume

SYSTEC AUTOCLAVES | Systec H-Series


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Systec HX-65 HX-90 HX-100 HX-150 HX-200


400x500 400x700 500x500 500x750 500x1000


70/65 95/90 110/100 160/150 210/200

Heating (kW) 9.0 9.0 9.0 9.0 9.0 Far

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Technical Drawings




Systec HX-210 HX-320 HX-430 HX-540 HX-650


740x500 740x750 740x1000 740x1250 740x1500


280/210 385/320 495/430 602/540 710/650

Heating (kW) 18.0 18.0 18.0 18.0 18.0 Far

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Technical Drawings




Systec HX-580 HX-780 HX-980 HX-1180 HX-1380 HX-1580


1000x750 1000x1000 1000x1250 1000x1500 1000x1750 1000x2000


755/580 950/780 1150/980 1345/1180 1541/1380 1735/1580

Heating (kW) 36.0 36.0 36.0 36.0 36.0 36.0 Far

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Technical Drawings

Technical Drawings

• Double-door, pass-through autoclaves

• Build into a wall between to divide a sterile and an unsterile area

• For clean-rooms and biological safety laboratories


SYSTEC AUTOCLAVES | Systec H-Series 2D


Sterile side Unsterile side

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Systec HX-90 2D HX-150 2D HX-200 2D


400x750 500x750 500x1000


98/95 155/150 205/200

Systec HX-320 2D HX-430 2D HX-540 2D HX-650 2D


740x750 740x1000 740x1250 740x1500


370/320 480/430 590/540 700/650


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Systec HX-580 2D HX-780 2D HX-9802D


1000x750 1000x1000 1000x1250


670/580 870/780 1070/980

Systec HX-1180 2D HX-1380 2D HX-1580 2D


1000x1500 1000x1750 1000x2000


1270/1180 1470x1380 1670x1580


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• LCD Screen with multi-function keys

• Displays all relevant sterilization parameters in real-time

• Shows the cycle stage

• Customizable sterilization parameters for each program

• Four access levels secured by numeric code

SYSTEC AUTOCLAVES | control panel Systec V- and D-Series


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SYSTEC AUTOCLAVES | available programs Systec V- and D-Series


Available programs VX|DX Available programs VE|DE Available programs VB|DB

1-3 Solids 4-5 Waste in waste bags 6 Liquid waste with regulated steam exhaust for cooling 7 Liquid waste with self cooling 8-10 Liquids with regulated steam exhaust for cooling 11 Liquids with self cooling 12 Cleaning 13 Vacuum-Test** 14 Bowie-Dick-Test** 15-25 Free for individual programming

1-3 Solids 4-5 Waste in waste bags 6 Liquid waste with regulated steam exhaust for cooling 7 Liquid waste with self cooling 8-10 Liquids with regulated steam exhaust for cooling 11 Liquids with self cooling 12 Cleaning

1 Solids 2 Waste in waste bags 3 Liquids with regulated steam exhaust for cooling

**Requires the optional vacuum system

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• Standard for Systec H-Series, optional for Systec VX autoclaves from 65 liter chamber volume

• Full color touch-screen

• Up to 100 sterilization programs self-programmable

• Self-programmable description for each program in the program list

• Sterilization parameters customizable for each program

• Displays all relevant sterilization parameters as well as the cycle stage in real-time

• Real-time graph view

• User administration

– User names

– Passwords

– Access and operating rights

SYSTEC AUTOCLAVES | touch-screen


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TEMPERATURE AND PRESSURE RANGE X | E | B

• Maximum temperature 140°C

• Maximum pressure 4bar

• Systec D-23: 136°C, 3.8bar

• Maximum temperature 150°C

• Maximum pressure 5bar

• For autoclaves from 65 to 650 liter chamber volume and more

• Later upgrade possible

SYSTEC AUTOCLAVES | standard features

OPTIONAL EXTENSION OF TEMPERATURE AND PRESSURE X | E


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SAFETY DOOR-LOCK X | E | B

• Temperature and pressure dependent door-lock

• Prevents opening of the door whilst there is too high temperature or pressure in the autoclave

• Automatic door opening at the end of the sterilization cycle

• Programmable for each program individually


AUTOMATIC DOOR OPENING X | E | B


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ADJUSTMENT OF STERILIZATION TIME X | E

• Sterilization time adjustable between 1 and 300 minutes

• Programmable for each program individually

• Programmable timer for automatic, delayed start of a sterilization cycle


START BY CLOCK X | E


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TEMPERATURE AND PRESSURE REGULATION X | E | B

• Class A PT-100 temperature sensor

• Electronic pressure sensor

• Redundant process control of both, temperature and pressure

• Water cooled steam exhaust condensation to protect drain against high temperature

• Thermostatic controlled


STEAM EXHAUST CONDENSATION X | E


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STANDARD FEATURE: AUTOFILL X | E

• Autofill, connection to demineralized water line for automatic filling of demineralized water

• Systec DX-23 and 45: build-in tank filled automatic or manual

• Systec DE-23 and 45: build-in tank filled manual (optional automatic)

• Manual filling of demineralized water direct into the pressure vessel of the autoclave

• Systec DB-23 and 45: manual filling of demineralized water into build-in tank

SYSTEC AUTOCLAVES | standard features and options | steam generation

MANUAL FILLING E | B


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STANDARD FEATURE: LOW WATER LEVEL PROTECTION X | E | B

• Protection against low water level in steam generator (X autoclaves)

• Protection against low water level in chamber (E and B autoclaves)

• Over-heating protection

• Over-temperature protection

• Over-pressure protection


STANDARD FEATURE: FULL PARAMETER LIMIT CONTROL X | E | B


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OPTION: DEMINERALIZATION CARTRIDGES X | E

• Produces demineralized water from tap water

• Demineralized water quality consistently checked by conductivity meter

• Feed water vessel for feeding demineralized water from a separate (external) vessel

• Condensate collection vessel to collect condense


OPTION: FEED WATER VESSEL AND CONDENSATE COLLECTION VESSEL X


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STANDARD FEATURE: CONTROLLED MEDIA TEMPERATURE X | E | B

• Flexible PT-100 temperature probe for reference bottle

• Start of sterilization time depending on the temperature of the media

• Calculation of F0-Value

• To reduce the sterilization time for heat sensitive culture media

SYSTEC AUTOCLAVES | standard features and options | sterilization of liquids

STANDARD FEATURE: F0-CALCULATION X | E


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OPTION: COOLING OF LIQUIDS X | E

• Ambient air ventilation (without support air pressure)


• Water cooling (without support air pressure)



OPTION: COOLING OF LIQUIDS X | E


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OPTION: FOR FAST AND SAFE COOLING OF LIQUIDS X | E

• Water cooling (with support air pressure)


• Addon: Radial ventilator

• Addon: Ultra Cooler

• Spray cooling (with support air pressure)


OPTION: FAST AND SAFE COOLING OF LIQUIDS X | E


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OPTION: FOR FAST AND SAFE COOLING OF LIQUIDS X | E

• Closed cooling circuit for water cooling

• Magnetic stirrer for homogeneous mixing of culture media in big flasks


OPTION: MAGNETIC STIRRER X | E


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• Feed water softener Needed if tap water used for cooling is harder than 300µS / 10°dH

• Compressor for support air pressure if on-site compressed air is not available

– Silent 40 for autoclaves Systec V- and D-Series up to 50 liter chamber volume

– Silent 50 for autoclaves Systec V- and D-Series from 65 to 200 liter chamber and Systec H-Series 65 to 200 liter chamber volume

– Silent 200 for autoclaves Systec H-Series 210 to 1580 liter chamber volume


FURTHER OPTIONS FOR WATER COOLING SYSTEMS X | E

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STANDARD FEATURE: STEAM GENERATOR X

• Separate steam generator integrated into the housing of the autoclave

• For optimized fractionated pre-vacuum

• Over-pressure pulses, pulsed heat-up for improved displacing of air out of waste bags

SYSTEC AUTOCLAVES | standard features and options | sterilization of solids and waste

STANDARD FEATURE: OVER-PRESSURE PULSES X | E | B


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OPTION: VACUUM SYSTEM X

• Vacuum system for reproducible and validatable steam sterilization of solids and waste in waste bags – Fractionated pre-vacuum for optimal air

displacement

– Fractionated post-vacuum for drying


• Superdry heating for drying of solids

• For an optimal drying result even on difficult loads and high load volumes



OPTION: SUPERDRY X


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OPTION: AIR EXHAUST FILTRATION X

• Air exhaust filtration for save sterilization of biohazard waste

• Protects the environment aginst possible contamination




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STANDARD FEATURE: RS232 INTERFACE X | E

• RS232 Interface for connection of a Windows PC

• Compatible for documentation over a network

• Internal storage for documentation of up to 500 sterilization cycles

SYSTEC AUTOCLAVES | standard features and options | documentation

STANDARD FEATURE: INTERNAL STORAGE X | E


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OPTION: PRINTER X | E | B

• Printer with standard paper (no thermal paper)

• Integrated into the housing of the autoclave


• Systec ADS for control, parameterization and documentation of up to 6 Systec autoclaves

• Either by direct RS232 connection or through a network

• Numerical and graphical processing of the data


OPTION: PC SOFTWARE X | E


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OPTION: DOCUMENTATION SD X | E

• Documentation on 1GB SD-Card

• For documentation of up to 10.000 sterilization cycles



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STANDARD FEATURE: VALIDATION PORT X | E | B

• Validation port for introducing independent temperature sensors into the pressure vessel of the autoclave

• For validation port to introduce independent temperature sensor gastight

SYSTEC AUTOCLAVES | standard features and options | qualification & validation

OPTION: VALIDATION SET X | E | B


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• Support tables for Systec D-Series autoclaves

SYSTEC AUTOCLAVES | optional accessories


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• Wire-mesh baskets for liquids and solids

• Closed baskets for waste in waste bags



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use wire mesh baskets don't use closed baskets

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don't use wire mesh baskets use closed baskets

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• Racks for Systec D-Series and Systec H-Series



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• Transport and Loading carriages for Systec D-Series and Systec H-Series

• For easy laoding and unloding even of heavy goods



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• Lifting device for Systec V-Series autoclaves



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• Heating and cooling by spraying of water

• Water is continuously recirculated

• Additional air pressure can be selected over the whole sterilization cycle

SPECIAL APPLICATIONS | hot water recirculation


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• PT-100 temperature load sensor for measuring the temperature in a reference vessel

• Hot water recirculation

• Includes: Spray heating and spray cooling

– Includes: Support pressure over the whole sterilization cycle

– Includes: Temperature and pressure extension to 150⁰C/5bar (for autoclave 65 liter to 650 liter)

• Compressor for support air pressure if on-site compressed air supply is not available

SPECIAL APPLICATIONS | hot water recirculation



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• Custom products and solutions available on request

• 2x Systec DX-2D double-door autoclave built into one housing

SYSTEC MARKETING | custom products and solutions


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• 2x Systec HX-650 2D double-door autoclave built into one housing, completely made from stainless steel



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• Systec autoclave – support table and transport carriage customized to sterilize heavy loads of soil



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• Change door opening for Systec D-Series and Systec H-Series



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• Changed door opening for Systec D-Series and Systec H-Series



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• Waste water collector



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QUALIFICATION & VALIDATION | Resistance of microorganisms


Because of its high temperature resistance, Bacillus Stearothermophilus is considered to be the reference indicator for qualification and

validation of steam sterilization processes

80°C 100°C 121°C 134°C

Plasmodia Flagellates Viruses Bacteria without spores Yeasts Moulds

1-5 min.

Spores of yeast and moulds 5-10 min. 1 min.

Spores of germs with low resistance

1-60 min.

Spores of germs with higher resistance (e.g. Bacillus Stearothermophilus)

15-20 min. 1-3 min.

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• Qualification A qualification process is used to verify whether or not a device is suitable for its intended use

• Validation (definition according to U.S. FDA) (...) the process of demonstrating, through the use of specific laboratory investigations, that the performance characteristics of an analytical method are suitable for its intended analytical use

• GMP / GLP (Good Manufacturing Practice / Good Laboratory Practice) It is required in governmental GxP regulations that (in particular in the pharmaceutical industry) devices with influence on the product quality must be validated

QUALIFICATION & VALIDATION | procedure


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• DQ – Design Qualification

– User defines his requirements to a device or a process

– According to these requirements a design of the device that fulfills the requirements will be developed

• IQ – Installation Qualification

– Verification whether the device is manufactured and installed according to the requirements developed in DQ

• OQ – Operational Qualification

– Verification whether the device operates without product according to the requirements developed in DQ

• PQ – Performance Qualification

– Verification whether the device operates with product according to the requirements developed in DQ



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OQ Operational Qualification

(carried out periodic)

IQ Installation Qualification

(carried out once)

PQ Performance Qualification

(carried out periodic)

VALIDATION

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• All steps of IQ, OQ and PQ follow a predefined qualification test plan in which the characteristics of the device, the characteristics of the product as well as the acceptance criteria of the various tests are defined

• All results of the tests carried out must be documented according to the test plan and it must be verified whether the results are within the defined acceptance criteria

• The documentation must be verified and signed by the manufacturer and the user of the device

Aim of Qualification and Validation is to have a documented proof that a device is qualified for its intended use



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• IQ/OQ templates available from Systec as

– IQ/OQ Standard Basic IQ/OQ procedure suitable for most laboratory customers

– IQ/OQ Extended Advanced IQ/OQ suitable for e.g. the pharmaceutical industry

Link: IQ/OQ templates

QUALIFICATION & VALIDATION | validation of steam sterilization processes


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IQ-OQ Templates

IQ Standard IQ Extended

Documentation User manual Declaration of Conformity

User manual RI-Schematic Wiring diagram Declaration of Conformity

RI-Schematic Check whether options are present as confirmed in order confirmation

Detailed check of all mechanical connections against a custom RI-Schematic

Wiring diagram n/a Detailed check of all electrical connections against a custom wiring diagram

Electrical test n/a Test according to VDE 0701

Software test Check of installed software version

Check of installed software version

Number of protocols 3 (7 pages) 6 (16 pages)



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OQ Standard OQ Extended

Temperature calibration 121⁰C 105, 121 and 134⁰C

Pressure calibration 210kPa 122, 210 and 305kPa

Time calibration n/a Yes, during a test run

Failure messages n/a Yes, 7 messages

Log book n/a Check whether available

Check of access rights n/a Yes

Vacuum test (only for Systec VX, DX and HX with optional vacuum system)

Yes

Yes

Test run Instrument (empty chamber with temperature/pressure mapping and bio-indicators)

1 runs with an instruments program

3 run with an instruments program

Test run Liquids (empty chamber with temperature/pressure mapping and bio-indicators)

n/a 3 runs with a liquids program

Number of protocols 4 (15 pages) 9 (34 pages)



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• IQ/OQ templates need to be adapted to the customers need (together with the customer!)

• Typically IQ/OQ documentation includes

– Description of the device tested

– Test description

– Description of the instruments used to carry the test out (e.g. temperature sensors)

– Acceptance criteria

– Test result

– Signature of the person who did the tests (e.g. service engineer) and the customer to document that the results are approved



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• PQ – Performance Qualification

– Qualification of the sterilization process with the product that is to be sterilized

– Definition of load schemes for each product / sterilization cycle (customer!)

• Simple load

• Medium load

• Worst case load

– Temperature sensors and bio-indicators are placed into the chamber of the autoclave and into the product that is to be sterilized

• Definition of the critical areas

– Carrying out of three sterilization runs per program and load scheme

– Documentation and verification of temperature/pressure mapping and bio-indicators

• Verification of bio-indicators either by customer or by accredited test laboratory



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• Which bio-indicator has to be used for which application?



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SPORE STRIPS ONY FOR STERILIZATION OF SOLIDS AND WASTE IN WASTE BAGS


• Spore strips to be used only for sterilization of solids and waste in waste bags

• Spore strips placed into the critical areas of the load give indication whether steam was in place or not

• Spore strips will only be inactivated if steam was in place to transfer the heat energy needed for the biological efficiency of the steam sterilization process


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• Right placing of bio-indicator

• Bio-indicator and temperature sensor placed in the critical area of the load



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• Bio-indicator and temperature sensor placed in the critical area of the load



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• Bio-indicators and temperature sensors placed in the critical areas of the load



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• Systec Documentation

• en.wikipedia.org/wiki/Autoclave

• http://www.astell.com/howanautoclaveworks

• en.wikipedia.org/wiki/Sterilization

• en.wikipedia.org/wiki/Sterilizationen.wikipedia.org/wiki/Sterilization_(microbiology)

• getenotes.weebly.com/uploads/1/4/1/9/.../2.1.pptx

• ksupc.com/.../Sterilization%20methods%20and%...

Reference

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http://www.astell.com/howanautoclaveworks

http://www.astell.com/howanautoclaveworks

• Thanks For Attention

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Date post:	14-Jun-2020
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