Farayand. Subject : Introduce Systec company and autoclave. Presented by : Vahid Totonchi. Mehr 1393

Transcription

1 Subject : Introduce Systec company and autoclave Presented by : Vahid Totonchi Mehr 1393

2 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.

3 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.

4 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 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.

5 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

6 INTRODUCTION company mission 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 6

7 INTRODUCTION product range SYSTEC D-SERIES BENCH-TOP, FRONT-LOADING AUTOCLAVES 7 models, 23 to 200 liter chamber volume SYSTEC V-SERIES VERTICAL, TOP-LOADING AUTOCLAVES 8 models, 40 to 150 liter chamber volume 7

8 INTRODUCTION product range 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. 8

9 INTRODUCTION product range SYSTEC H-SERIES HORIZONTAL, FLOOR-STANDING AUTOCLAVES 16 models, 65 to liter chamber volume SYSTEC H-SERIES 2D DOUBLE-DOOR, PASS-THROUGH AUTOCLAVES 13 models, 90 to 1580 liter chamber volume 9

10 INTRODUCTION quality 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 10

11 INTRODUCTION quality management Certified according to newest ISO-Norm DIN EN ISO 9001:2008 Certified for design, development, production, sales and service for laboratory autoclaves 11

12 INTRODUCTION a unique and reliable partner Systec offers the widest range of laboratory steam sterilizers and mediapreparators in the world 73 autoclave models, 23 to 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 12

13 INTRODUCTION our customers Research laboratories at universities and other research institutes Medical science Biology Environmental protection Biotechnology 13

14 INTRODUCTION our customers Microbiological diagnostic laboratories Human-Medicine Veterinary-Medicine 14

15 INTRODUCTION our customers Cosmetic industry Research Quality Control Production / Pilot production 15

16 INTRODUCTION our customers Biotech companies and laboratories Research Quality Control Production 16

17 INTRODUCTION our customers Service laboratories 17

18 BASIC PRINCIPLES steam sterilization in laboratories STERILIZATION OF LIQUIDS (PREPARATION) STERILIZATION OF SOLIDS (PREPARATION) Culture media in bottles to selectively grow specific microorganisms Instruments Empty glassware Tubes and hoses Pipettes, pipette tips Filters, Textiles 18

19 BASIC PRINCIPLES steam sterilization in laboratories STERILIZATION OF WASTE (DECONTAMINATION) Solid waste in waste bags Liquid waste in bottles Biohazard waste 19

20 BASIC PRINCIPLES what is steam sterilization? 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 20

21 BASIC PRINCIPLES how is steam produced in steam sterilizers STEAM GENERATION BY INTERNAL HEATING ELEMENTS Heating elements inside the pressure vessel of the autoclave STEAM GENERATION BY SEPARATE STEAM GENERATOR Steam is generated in a steam generator which is separated from the pressure vessel but integrated into the housing of the autoclave 21

22 BASIC PRINCIPLES how is steam produced in steam sterilizers 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 DIN 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 22

23 BASIC PRINCIPLES evaporation 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) 23

24 BASIC PRINCIPLES condensation 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 24

25 BASIC PRINCIPLES air release phase internal heating elements vs. steam generator Valve Air Water reservoir with heating element for steam generation Air must be replaced by steam through air release valve Water Heating element 25

26 BASIC PRINCIPLES air release phase internal heating elements vs. steam generator valve open air steam 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 heating of water heating element 26

27 BASIC PRINCIPLES air release phase internal heating elements vs. steam generator valve closed steam air sterilizing effect if temperature is reached no sterilizing effect heating element 27

28 BASIC PRINCIPLES air release phase internal heating elements vs. steam generator Steam- generator Steam created by a steam generator outside of the sterilization chamber Steam inlet from top Air release at the bottom with the natural gravitation of the air Remaining air sediments down to the bottom Second air release phase Suppression of the remaining air and steam injection to sterilization temperature / pressure 28

29 BASIC PRINCIPLES air release phase internal heating elements vs. steam generator 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 29

30 BASIC PRINCIPLES air release phase internal heating elements vs. steam generator INTERNAL HEATING ELEMENTS STEAM GENRATOR 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 30

31 BASIC PRINCIPLES air release phase internal heating elements vs. steam generator INTERNAL HEATING ELEMENTS STEAM GENRATOR 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 31

32 STERILIZATION OF LIQUIDS general STERILIZATION OF LIQUIDS (PREPARATION) 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 32

33 STERILIZATION OF LIQUIDS cycle phases H: Heat-up S: Sterilization C: Cooling Blue: Pressure in the chamber Red: Temperature in the media 33

34 STERILIZATION OF LIQUIDS heat-up phase 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 34

35 STERILIZATION OF LIQUIDS heat-up phase H: Heat-up S: Sterilization C: Cooling Blue: Pressure in the chamber 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 35

36 STERILIZATION OF LIQUIDS heat-up phase 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 36

37 STERILIZATION OF LIQUIDS heat-up phase 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% H: Heat-up S: Sterilization C: Cooling Blue: Pressure in the chamber Red: Temperature in the media 37

38 STERILIZATION OF LIQUIDS cooling phase 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 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 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 38

39 STERILIZATION OF LIQUIDS cooling phase delayed boiling 39

40 STERILIZATION OF LIQUIDS cooling phase delayed boiling 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 40

41 STERILIZATION OF LIQUIDS cooling phase EVAPORATION COOLING NON-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 41

42 STERILIZATION OF LIQUIDS cooling phase evaporation cooling 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 42

43 STERILIZATION OF LIQUIDS cooling phase conventional cooling 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 43

44 STERILIZATION OF LIQUIDS cooling phase conventional cooling 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 44

45 STERILIZATION OF LIQUIDS cooling phase conventional cooling CLOSED VESSEL (1000ml water) OPEN VESSEL (1000ml water) 45

46 STERILIZATION OF LIQUIDS cooling phase conventional cooling Hermetically closed and open vessels in autoclave chamber Both, the closed and the open vessels, are filled with 1000ml of water 46

47 STERILIZATION OF LIQUIDS cooling phase conventional cooling Cooling by evaporation down to 100 C is reasonably fast Further cooling by radiation down to 80 C is very slow H: Heat-up S: Sterilization C: Cooling Blue: Pressure in the chamber Red: Temperature in the media Cooling time up to 10 hours (depending on load volume) 47

48 STERILIZATION OF LIQUIDS cooling phase ambient air ventilation 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% No cooling effect on hermetically closed vessels Risk of over boiling protein containing liquid can foam over Heat radiates into the room where the autoclave is installed 48

49 STERILIZATION OF LIQUIDS cooling phase ambient air ventilation CLOSED VESSEL (1000ml water) OPEN VESSEL (1000ml water) 49

50 STERILIZATION OF LIQUIDS cooling phase ambient air ventilation Hermetically closed and open vessels in autoclave chamber Both, the closed and the open vessels, are filled with 1000ml of water 50

51 STERILIZATION OF LIQUIDS cooling phase ambient air ventilation Cooling by evaporation down to 80 C H: Heat-up S: Sterilization C: Cooling Blue: Pressure in the chamber Red: Temperature in the media Cooling time between 1 hour and 5 hours (depending on load volume) 51

52 STERILIZATION OF LIQUIDS cooling phase water cooling 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 No cooling effect on hermetically closed vessels Risk of over boiling protein containing liquid can foam over 52

53 STERILIZATION OF LIQUIDS cooling phase water cooling with support air pressure 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 53

54 STERILIZATION OF LIQUIDS cooling phase water cooling with support air pressure Non-evaporation cooling down to 80 C H: Heat-up S: Sterilization C: Cooling Blue: Pressure in the chamber Red: Temperature in the media Cooling time between 30 minutes and 3 hours (depending on load volume) 54

55 STERILIZATION OF LIQUIDS cooling phase water cooling systems DOUBLE JACKET (MANTLE COOLING) COOLING COILS 55

56 STERILIZATION OF LIQUIDS cooling phase water cooling systems DOUBLE JACKET (MANTLE COOLING) COOLING COILS 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 56

57 STERILIZATION OF LIQUIDS cooling phase water cooling with support air pressure 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) 57

58 STERILIZATION OF LIQUIDS cooling phase water cooling with support air pressure Non-evaporation cooling down to 80 C Water cooling with support air pressure and Radial Ventilator H: Heat-up S: Sterilization C: Cooling Blue: Pressure in the chamber Red: Temperature in the media Cooling time between 20 minutes and 2 hours (depending on load volume) 58

59 STERILIZATION OF LIQUIDS cooling phase water cooling with support air pressure 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) 59

60 STERILIZATION OF LIQUIDS cooling phase water cooling with support air pressure H: Heat-up S: Sterilization C: Cooling Blue: Pressure in the chamber Red: Temperature in the media Non-evaporation cooling down to 80 C Water cooling with support air pressure, Radial Ventilator and Ultra Cooler Cooling time between 10 minutes and 60 minutes (depending on load volume) 60

61 STERILIZATION OF LIQUIDS cooling phase spray cooling 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 Non-evaporation cooling No boiling of the liquids Only for hermetically closed vessels 61

62 STERILIZATION OF LIQUIDS cooling phase spray cooling with laminar plate Spray cooling with laminar plate Laminar plate prevents direct spraying of water to the bottles Non-evaporation cooling No boiling of the liquids Only for hermetically closed vessels 62

63 STERILIZATION OF LIQUIDS cooling phase spray cooling Non-evaporation cooling down to 80 C Spray cooling with or without laminar plate H: Heat-up S: Sterilization C: Cooling Blue: Pressure in the chamber Red: Temperature in the media Cooling time between 5 minutes and 20 minutes (depending on load volume) 63

64 STERILIZATION OF LIQUIDS cooling phase evaporation vs. non-evaporation cooling EVAPORATION COOLING NON-EVAPORATION COOLING 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 64

65 STERILIZATION OF LIQUIDS cooling phase evaporation vs. non-evaporation cooling EVAPORATION COOLING NON-EVAPORATION COOLING 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 65

66 STERILIZATION OF LIQUIDS closed bottles 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!!! 66

67 STERILIZATION OF LIQUIDS standard features and recommended options STANDARD FEATURES RECOMMENDED OPTIONS 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 67

68 STERILIZATION OF SOLIDS general STERILIZATION OF SOLIDS (PREPARATION) 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 68

69 STERILIZATION OF SOLIDS preconditions 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 69

70 STERILIZATION OF SOLIDS heat-up phase inefficient air release 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 Air Steam 70

71 STERILIZATION OF SOLIDS heat-up phase inefficient air release Two pipette tip boxes In both boxes, temperature sensors and bio-indicators are placed 71

72 STERILIZATION OF SOLIDS heat-up phase inefficient air release Pipette tip box wrapped with aluminum foil 72

73 STERILIZATION OF SOLIDS heat-up phase inefficient air release Pipette tip boxes and two empty bottles placed into the autoclave Each box and bottle contains a temperature sensor and a bioindicator 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 73

74 STERILIZATION OF SOLIDS general STERILIZATION OF SOLIDS (PREPARATION) 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 74

75 STERILIZATION OF SOLIDS preconditions 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 75

76 STERILIZATION OF SOLIDS heat-up phase inefficient air release 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 Air Steam 76

77 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 % Second steam injection - remaining air gravitates down Third pre-vacuum - air removal 100% Steam- generator Third steam injection - heat up to sterilization temperature and start of sterilization time 77

78 STERILIZATION OF SOLIDS heat-up phase fractionated / pulsed pre-vacuum 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 78

79 STERILIZATION OF SOLIDS heat-up phase fractionated / pulsed pre-vacuum Pipette tip boxes and two empty bottles placed into the autoclave Each box and bottle contains a temperature sensor and a bioindicator 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 79

80 STERILIZATION OF SOLIDS heat-up phase inefficient air release Location of bio-indicator Chamber 10L bottle 1L bottle pipette tip box 1 pipette tip box 2 Test result No growth No growth No growth No growth No growth 80

81 STERILIZATION OF SOLIDS steam release phase 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 81

82 STERILIZATION OF SOLIDS drying 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) 82

83 STERILIZATION OF SOLIDS drying Drying with fractionated postvacuum 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 83

84 STERILIZATION OF SOLIDS drying Drying by fractionated postvacuum and Suprdry Drying by fractionated postvacuum 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 84

85 STERILIZATION OF SOLIDS standard features and recommended options STANDARD FEATURES RECOMMENDED OPTIONS Temperature and pressure dependent door-locking device prevents opening of the door whilst there is too high temperature or pressure 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 85

86 STERILIZATION OF WASTE general STERILIZATION WASTE (DECONTAMINATION) Solid waste in waste bags Liquid waste in bottles Biohazard waste 86

87 STERILIZATION OF WASTE preconditions 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 87

88 STERILIZATION OF WASTE heat-up phase inefficient air release Air displacement by simple heat-up Steam atmosphere in the pressure vessel Air inside the waste bag No sterilizing effect in the waste bag Air Steam 88

89 STERILIZATION OF WASTE heat-up phase inefficient air release Waste bag with petri dishes placed into the autoclave Three temperature sensors with each a bio-indicator in different levels in the waste bag 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 89

90 STERILIZATION OF WASTE heat-up phase inefficient air release Location of bio-indicator Chamber Waste bag top Waste bag middle Waste bag bottom Test result No growth Growth Growth Growth 90

91 STERILIZATION OF WASTE heat-up phase inefficient air release 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 An accurate, reproducible and validatable sterilization can only be ensured if the steam penetrates to all outer and inner surfaces of the product 91

92 STERILIZATION OF WASTE heat-up phase over pressure pulses / pulsed heat-up Heat-up and air release through over pressure pulses, pulsed heatup Steam pulses are given into the pressure vessel of the autoclave followed by releasing the steam again 92

93 STERILIZATION OF WASTE heat-up phase over pressure pulses / pulsed heat-up H 2 0 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 Air Steam 93

94 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 % Second steam injection - remaining air gravitates down Third pre-vacuum - air removal 100% Steam- generator Third steam injection - heat up to sterilization temperature and start of sterilization time 94

95 STERILIZATION OF WASTE heat-up phase fractionated / pulsed pre-vacuum 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 95

96 STERILIZATION OF WASTE heat-up phase fractionated / pulsed pre-vacuum Waste bag with petri dishes placed into the autoclave Three temperature sensors with each a bio-indicator in different levels in the waste bag 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 96

97 STERILIZATION OF WASTE heat-up phase fractionated / pulsed pre-vacuum Location of bio-indicator Chamber Waste bag top Waste bag middle Waste bag bottom Test result No growth No growth No growth No growth 97

98 STERILIZATION OF WASTE air exhaust filtration steam air 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 98

99 STERILIZATION OF WASTE air exhaust filtration steam air 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 99

100 STERILIZATION OF LIQUIDS standard features and recommended options STANDARD FEATURES RECOMMENDED OPTIONS Temperature and pressure dependent door-locking device prevents opening of the door whilst there is too high temperature or pressure 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 100

101 SYSTEC AUTOCLAVES Systec V-Series Vertical, top-loading autoclaves 8 models, 40 to 150 liter chamber volume 101

102 SYSTEC AUTOCLAVES Systec V-Series Systec V-40 V-55 V-65 V-75 V-95 V-100 V-120 V-150 Chamber dim. Ø x depth (mm) Chamber volume total / nominal (l) 344x x x x x x x x750 45/40 60/65 70/65 80/75 100/95 110/ / /150 Heating (kw) Link: Technical Drawings 102

103 SYSTEC AUTOCLAVES Systec V-Series 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 103

104 SYSTEC AUTOCLAVES Systec D-Series Horizontal, bench-top autoclaves 7 models, 23 to 200 liter chamber volume 104

105 SYSTEC AUTOCLAVES Systec D-Series Systec D-23 D-45 D-65 D-90 D-100 D-150 D-200 Chamber dim. Ø x depth (mm) Chamber volume total / nominal (l) Heating (kw) DX DE and DB Link: Technical Drawings 260x x x x x x x /23 50/45 70/65 95/90 110/ / /

106 SYSTEC AUTOCLAVES Systec V- and D-Series performance categories 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. 106

107 SYSTEC AUTOCLAVES Systec V- and D-Series performance categories 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 107

108 SYSTEC AUTOCLAVES Systec V- and D-Series performance categories 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 108

109 SYSTEC AUTOCLAVES Systec H-Series Horizontal, floor-standing autoclaves 16 models, 65 to liter chamber volume 109

110 SYSTEC AUTOCLAVES Systec H-Series Systec HX-65 HX-90 HX-100 HX-150 HX-200 Chamber dim. Ø x depth (mm) Chamber volume total / nominal (l) 400x x x x x /65 95/90 110/ / /200 Heating (kw) Link: Technical Drawings 110

111 SYSTEC AUTOCLAVES Systec H-Series Systec HX-210 HX-320 HX-430 HX-540 HX-650 Chamber dim. Ø x depth (mm) Chamber volume total / nominal (l) 740x x x x x / / / / /650 Heating (kw) Link: Technical Drawings 111

112 SYSTEC AUTOCLAVES Systec H-Series Systec HX-580 HX-780 HX-980 HX-1180 HX-1380 HX-1580 Chamber dim. Ø x depth (mm) Chamber volume total / nominal (l) 1000x x x x x x / / / / / /1580 Heating (kw) Link: Technical Drawings 112

113 SYSTEC AUTOCLAVES Systec H-Series 2D Unsterile side Sterile side 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 12 models, 90 to 1580 liter chamber volume 113

114 SYSTEC AUTOCLAVES Systec H-Series 2D Systec HX-90 2D HX-150 2D HX-200 2D Chamber dim. Ø x depth (mm) Chamber volume total / nominal (l) 400x x x /95 155/ /200 Systec HX-320 2D HX-430 2D HX-540 2D HX-650 2D Chamber dim. Ø x depth (mm) Chamber volume total / nominal (l) Unsterile side Sterile side 740x x x x / / / /

115 SYSTEC AUTOCLAVES Systec H-Series 2D Systec HX-580 2D HX-780 2D HX-9802D Chamber dim. Ø x depth (mm) Chamber volume total / nominal (l) 1000x x x / / /980 Systec HX D HX D HX D Chamber dim. Ø x depth (mm) Chamber volume total / nominal (l) Unsterile side Sterile side 1000x x x / x x

116 SYSTEC AUTOCLAVES control panel Systec V- and D-Series 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 116

117 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** 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 117

118 SYSTEC AUTOCLAVES touch-screen Standard for Systec H-Series, optional for Systec VX autoclaves from 65 liter chamber volume Full color touch-screen Up to 100 sterilization programs selfprogrammable 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 118

119 SYSTEC AUTOCLAVES standard features TEMPERATURE AND PRESSURE RANGE Maximum temperature 140 C Maximum pressure 4bar Systec D-23: 136 C, 3.8bar OPTIONAL EXTENSION OF TEMPERATURE AND PRESSURE Maximum temperature 150 C Maximum pressure 5bar For autoclaves from 65 to 650 liter chamber volume and more Later upgrade possible X E B X E 119

120 SYSTEC AUTOCLAVES standard features SAFETY DOOR-LOCK 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 Automatic door opening at the end of the sterilization cycle Programmable for each program individually X E B X E B 120

121 SYSTEC AUTOCLAVES standard features ADJUSTMENT OF STERILIZATION TIME Sterilization time adjustable between 1 and 300 minutes Programmable for each program individually START BY CLOCK Programmable timer for automatic, delayed start of a sterilization cycle X E X E 121

122 SYSTEC AUTOCLAVES standard features TEMPERATURE AND PRESSURE REGULATION X E B Class A PT-100 temperature sensor Electronic pressure sensor Redundant process control of both, temperature and pressure STEAM EXHAUST CONDENSATION Water cooled steam exhaust condensation to protect drain against high temperature Thermostatic controlled X E 122

123 SYSTEC AUTOCLAVES standard features and options steam generation 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 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 E B 123

124 SYSTEC AUTOCLAVES standard features and options steam generation STANDARD FEATURE: LOW WATER LEVEL PROTECTION Protection against low water level in steam generator (X autoclaves) Protection against low water level in chamber (E and B autoclaves) STANDARD FEATURE: FULL PARAMETER LIMIT CONTROL Over-heating protection Over-temperature protection Over-pressure protection X E B X E B 124

125 SYSTEC AUTOCLAVES standard features and options steam generation OPTION: DEMINERALIZATION CARTRIDGES X E Produces demineralized water from tap water Demineralized water quality consistently checked by conductivity meter OPTION: FEED WATER VESSEL AND CONDENSATE COLLECTION VESSEL Feed water vessel for feeding demineralized water from a separate (external) vessel Condensate collection vessel to collect condense X 125

126 SYSTEC AUTOCLAVES standard features and options sterilization of liquids STANDARD FEATURE: CONTROLLED MEDIA TEMPERATURE X E B STANDARD FEATURE: F0-CALCULATION Calculation of F0-Value Flexible PT-100 temperature probe for reference bottle Start of sterilization time depending on the temperature of the media To reduce the sterilization time for heat sensitive culture media X E 126

127 SYSTEC AUTOCLAVES standard features and options sterilization of liquids OPTION: COOLING OF LIQUIDS OPTION: COOLING OF LIQUIDS Ambient air ventilation (without support air pressure) Later upgrade possible Water cooling (without support air pressure) Later upgrade possible X E X E 127

128 SYSTEC AUTOCLAVES standard features and options sterilization of liquids OPTION: FOR FAST AND SAFE COOLING OF LIQUIDS Water cooling (with support air pressure) Later upgrade possible Addon: Radial ventilator Addon: Ultra Cooler OPTION: FAST AND SAFE COOLING OF LIQUIDS Spray cooling (with support air pressure) X E X E 128

129 SYSTEC AUTOCLAVES standard features and options sterilization of liquids OPTION: FOR FAST AND SAFE COOLING OF LIQUIDS X E OPTION: MAGNETIC STIRRER Closed cooling circuit for water cooling Magnetic stirrer for homogeneous mixing of culture media in big flasks X E 129

130 SYSTEC AUTOCLAVES standard features and options sterilization of liquids FURTHER OPTIONS FOR WATER COOLING SYSTEMS X E 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 130

131 SYSTEC AUTOCLAVES standard features and options sterilization of solids and waste STANDARD FEATURE: STEAM GENERATOR X STANDARD FEATURE: OVER-PRESSURE PULSES 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 X E B 131

132 SYSTEC AUTOCLAVES standard features and options sterilization of solids and waste OPTION: VACUUM SYSTEM OPTION: SUPERDRY 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 Later upgrade possible Superdry heating for drying of solids For an optimal drying result even on difficult loads and high load volumes Later upgrade possible X X 132

133 SYSTEC AUTOCLAVES standard features and options sterilization of solids and waste OPTION: AIR EXHAUST FILTRATION X Air exhaust filtration for save sterilization of biohazard waste Protects the environment aginst possible contamination Later upgrade possible 133

134 SYSTEC AUTOCLAVES standard features and options documentation STANDARD FEATURE: RS232 INTERFACE X E STANDARD FEATURE: INTERNAL STORAGE RS232 Interface for connection of a Windows PC Compatible for documentation over a network Internal storage for documentation of up to 500 sterilization cycles X E 134

135 SYSTEC AUTOCLAVES standard features and options documentation OPTION: PRINTER OPTION: PC SOFTWARE X E B Printer with standard paper (no thermal paper) Integrated into the housing of the autoclave Later upgrade possible 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 X E 135

136 SYSTEC AUTOCLAVES standard features and options documentation OPTION: DOCUMENTATION SD X E Documentation on 1GB SD-Card For documentation of up to sterilization cycles 136

137 SYSTEC AUTOCLAVES standard features and options qualification & validation STANDARD FEATURE: VALIDATION PORT X E B Validation port for introducing independent temperature sensors into the pressure vessel of the autoclave OPTION: VALIDATION SET For validation port to introduce independent temperature sensor gastight X E B 137

138 SYSTEC AUTOCLAVES optional accessories Support tables for Systec D-Series autoclaves 138

139 SYSTEC AUTOCLAVES optional accessories Wire-mesh baskets for liquids and solids Closed baskets for waste in waste bags 139

140 SYSTEC AUTOCLAVES optional accessories don't use closed baskets use wire mesh baskets 140

141 SYSTEC AUTOCLAVES optional accessories don't use wire mesh baskets use closed baskets 141

142 SYSTEC AUTOCLAVES optional accessories Racks for Systec D-Series and Systec H-Series 142

143 SYSTEC AUTOCLAVES optional accessories Transport and Loading carriages for Systec D-Series and Systec H-Series For easy laoding and unloding even of heavy goods 143

144 SYSTEC AUTOCLAVES optional accessories Lifting device for Systec V-Series autoclaves 144

145 SPECIAL APPLICATIONS hot water recirculation Heating and cooling by spraying of water Water is continuously recirculated Additional air pressure can be selected over the whole sterilization cycle 145

146 SPECIAL APPLICATIONS hot water recirculation STANDARD FEATURES RECOMMENDED OPTIONS 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 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 146

147 SYSTEC MARKETING custom products and solutions Custom products and solutions available on request 2x Systec DX-2D double-door autoclave built into one housing 147

148 SYSTEC MARKETING custom products and solutions Custom products and solutions available on request 2x Systec HX-650 2D double-door autoclave built into one housing, completely made from stainless steel 148

149 SYSTEC MARKETING custom products and solutions Custom products and solutions available on request Systec autoclave support table and transport carriage customized to sterilize heavy loads of soil 149

150 SYSTEC MARKETING custom products and solutions Custom products and solutions available on request Change door opening for Systec D-Series and Systec H-Series 150

151 SYSTEC MARKETING custom products and solutions Custom products and solutions available on request Changed door opening for Systec D-Series and Systec H-Series 151

152 SYSTEC MARKETING custom products and solutions Custom products and solutions available on request Waste water collector 152

153 QUALIFICATION & VALIDATION Resistance of microorganisms Plasmodia Flagellates Viruses Bacteria without spores Yeasts Moulds 80 C 100 C 121 C 134 C 1-5 min. Spores of yeast and moulds 5-10 min. 1 min. Spores of germs with low resistance Spores of germs with higher resistance (e.g. Bacillus Stearothermophilus) 1-60 min min. 1-3 min. Because of its high temperature resistance, Bacillus Stearothermophilus is considered to be the reference indicator for qualification and validation of steam sterilization processes 153

154 QUALIFICATION & VALIDATION procedure 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 154

155 QUALIFICATION & VALIDATION procedure 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 155

156 QUALIFICATION & VALIDATION procedure IQ Installation Qualification (carried out once) VALIDATION PQ Performance Qualification (carried out periodic) OQ Operational Qualification (carried out periodic) 156

157 QUALIFICATION & VALIDATION procedure 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 157

158 QUALIFICATION & VALIDATION validation of steam sterilization processes 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 158

159 QUALIFICATION & VALIDATION validation of steam sterilization processes Documentation RI-Schematic IQ Standard User manual Declaration of Conformity Check whether options are present as confirmed in order confirmation IQ Extended User manual RI-Schematic Wiring diagram Declaration of Conformity 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) 159

160 QUALIFICATION & VALIDATION validation of steam sterilization processes 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) Test run Instrument (empty chamber with temperature/pressure mapping and bio-indicators) Test run Liquids (empty chamber with temperature/pressure mapping and bio-indicators) Yes 1 runs with an instruments program n/a Yes 3 run with an instruments program 3 runs with a liquids program Number of protocols 4 (15 pages) 9 (34 pages) 160

161 QUALIFICATION & VALIDATION validation of steam sterilization processes 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 161

162 QUALIFICATION & VALIDATION validation of steam sterilization processes 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 bioindicators Verification of bio-indicators either by customer or by accredited test laboratory 162

163 QUALIFICATION & VALIDATION validation of steam sterilization processes Which bio-indicator has to be used for which application? 163

164 QUALIFICATION & VALIDATION validation of steam sterilization processes 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 164

165 QUALIFICATION & VALIDATION validation of steam sterilization processes Right placing of bio-indicator Bio-indicator and temperature sensor placed in the critical area of the load 165

166 QUALIFICATION & VALIDATION validation of steam sterilization processes Right placing of bio-indicator Bio-indicator and temperature sensor placed in the critical area of the load 166

167 QUALIFICATION & VALIDATION validation of steam sterilization processes Right placing of bio-indicator Bio-indicators and temperature sensors placed in the critical areas of the load 167

168 QUALIFICATION & VALIDATION validation of steam sterilization processes 168

169 QUALIFICATION & VALIDATION validation of steam sterilization processes 169