Medline Inc. · NASDAQ:MDLN
Medline — WAGNER Sterilsysteme — Technical Presentation (October 2009)
128 slides from Medline's technical presentation, October 2009
Slide 1: Welcome - Sterilization & Packaging
HERZLICH WILLKOMMEN - WELCOME ! zu diesem Seminar über to this seminar on Sterilisation & Verpackung Sterilization & Packaging Dipl.-Ing. Peter Wagner
Slide 2: Sterilization & Packaging
Sterilization & Packaging My name is PETER WAGNER I work as now 3rd generation in the German company WAGNER Sterilsysteme, Sterilsysteme a manufacturer of sterilization containers - founded back in 1927. WAGNER specialized > 50 years ago to produce exclusively reusable sterilization contain
Slide 3: WAGNER's SteriSet container system
WAGNER’s SteriSet container system represents a awarded design to REACH & MAINTAIN STERILITY: It is VERY protective It is COMPLETELY reusable (needs no disposables for operation) Safety award Wagner‘s SteriSet has been honored in 1998 as „Exemplary product for the Safety in Medicine" in the Go
Slide 4: Sterilization & Packaging
Sterilization & Packaging A good part of my job at WAGNER is R&D, regulatory affairs and standardization But when WAGNER partnered with MEDLINE IND., INC back in 1991 in order to distribute the SteriSet system all over the US it was me who made the relations. Which is why still today I suppor
Slide 5: Sterilization & Packaging
Sterilization & Packaging In the next 1 ½ hours I will summarize recognized ways to REACH & MAINTAIN sterility: Reaching sterility... Maintaining sterility... • General introduction • Packaging: requirements • Bioburden ? • Wrap ? • Sterilization • Rigid containers ? Principles of GAS Focus o
Slide 6: For a correct Sterile Supply
… for a correct Sterile Supply We need to reach sterility maintain sterility during transport & storage, until presentation in the OR USA Oct 09 Wagner GmbH, Munich 6
Slide 7: Sterile Supply: Reaching Sterility
Sterile Supply: Reaching Sterility… STERILE is defined in international standards as: "Condition of a medical device that is free from viable microorganism". BUT: STERILIZATION does only REDUCE the population of microorganisms! Depending on the selected method: 1 Mio down to one (= SAL 6 = min
Slide 8: Extract of Steris Study guide #002
Extract of Steris Corps. “Study guide #002 – “Hot issues of Flash”
Slide 9: Reaching Sterility: Cleaning
Reaching Sterility: Cleaning … Cleaning + disinfection of contaminated devices follows 2 principles: CHEMICAL cleaning + CHEMICAL decontamination A suitable CLEANER allows REMOVAL of soiling A suitable chemical DISINFECTION solution (next step) inactivates remainig microorganism CHEMICAL c
Slide 10: Reaching Sterility: Variables - The device itself
Reaching Sterility: Variables The device itself… Modern medical equipment is no longer "simple stainless steel" but can be formed of a variety of different materials and designs ... (MIS-instruments; optics; high density equipment like drilling machines…) USA Oct 09 Wagner GmbH, Munich 10
Slide 11: Reaching Sterility: Variables
Reaching Sterility: Variables It is important to understand that there is NO universally applicable method to decontaminate a medical device: Different chemicals / methods are available, but each of them has RESTRICTIONS, can so not be applied to all devices. USA Oct 09 Wagner GmbH, Munich 1
Slide 12: Reaching Sterility: Cleaning
Reaching Sterility: Cleaning … It is therefore important to carefully select the suitable method: Used Chemicals must be: Compatible with the MATERIALS / devices Applied in the correct CONCENTRATION for the required TIME – Risks when applied „manually“... THERMAL disinfection: Can be don
Slide 13: Reaching Sterility: Cleaning + Sterilization
Reaching Sterility: Cleaning + Sterilization … And like in case of decontamination, there is also NO universally applicable method available to TERMINALLY STERILIZE a packaged medical device: Different sterilization methods / principles / cycle designs are available, but each of them has RESTR
Slide 14: Evaluation model for sterilization methods
Reaching Sterility: Cleaning + Sterilization … Evaluation model for sterilization methods USA Oct 09 Wagner GmbH, Munich 14
Slide 15: Cleaning + Sterilization & Packaging
Reaching Sterility: Cleaning + Sterilization&Packaging… It is important to understand that there is NO universally applicable method to TERMINALLY STERILIZE a packaged medical device: Different packaging materials / systems are available, offering different levels of protection - but also di
Slide 16: Variables: Device+Cleaning+Sterilization&Packaging
Reaching Sterility: Variables Device+Cleaning+Sterilization&Packaging… Depending from the device, a suitable cleaning & decontamination method, packaging system and finally sterilization method must be selected by the user USA Oct 09 Wagner GmbH, Munich 16
Slide 17: Compatibility?
Compatibility? A sterilizer manufacturer cannot evaluate all possible packaging / load configurations which might ever be formed / combined out in the field, but can only validate his sterilizer / different cycles with standardized loads (metal; fabric) in standardized packaging materials. U
Slide 18: Compatibility?
Compatibility? A instrument (device) manufacturer (specifically ortho and neuro loaner instruments which come in very compact – but “hard to sterilize” organizing sets)… might argument that he cannot evaluate all possible PACKAGING and STERILIZATION configurations which might ever be formed / co
Slide 19: Compatibility?
Compatibility? A manufacturer of a packaging material / -system cannot evaluate all possible load and cycle configurations which might ever be formed / combined out in the field. He can only validate his own packaging / container with standardized test loads / instruments against standardi
Slide 20: Validation
Validation… A specific application specific medical device... in a specific packaging... exposed to a specific sterilization cycle in the individual hospital... may be unique in the specific hospital ! European Regulations require therefore today, that HOSPITAL USERS need to validate steri
Slide 21: Standards, guidelines, recommendations
Reaching sterility: what helps us: Standards, guidelines, recommendations... Europe EN 868 part 1..8 series on „packaging materials for sterilization“ NEW: DIN EN ISO 11607-1:2006 „packaging materials“ EN 285 „Steam sterilizers“ EN 554 etc. “validation” USA AORN "Recommended practices fo
Slide 22: ANSI/AAMI ST46:2002 Abstract
Reaching sterility: what helps us: ANSI/AAMI ST46:2002 Steam sterilization and sterility assurance in health care facilities... Abstract This recommended practice covers steam sterilization in health care facilities. The recommendations are intended to promote assurance of sterility and guide
Slide 23: ANSI/AAMI ST46:2002 Introduction
Reaching sterility: what helps us: ANSI/AAMI ST46:2002 Steam sterilization and sterility assurance in health care facilities... Introduction: Need for the recommended practice Saturated steam under pressure is one of the oldest methods used in health care facilities to sterilize medical device
Slide 24: Principles
Principles… There is a pile of valuable available documents and paragraphs which helps organizing good sterile supply, but instead of going through these in detail we will now focus on the basic understanding of the processes and possible interactions during hospital sterilization, hoping that a
Slide 25: Sterilization in health care facilities %-shares
Sterilization in health care facilities %-shares Basically, sterilization in health care (not industry) can be reduced to TWO principles: • Gas / low T sterilization: 7% • EO gas • Peroxide (i.e. ASP`s Sterrad or the new AMSCO V-PRO) • Ozone sterilization (like TSO3’s 125L) • Steam sterilization •
Slide 26: Ethylene oxide (EO)
Ethylene oxide (EO) Principle chemical inactivation of microorganism at very low temperatures (42-55 oC / 107-130 oF) by impact of 100% ETO (or HCFC/EO mixtures) Advantage suitable for nearly any heat or steam sensitive device very good penetration of gas through packaging & devices Disadvanta
Slide 27: Hydrogen Peroxide (H2O2) Plasma
Hydrogen Peroxide (H2O2) Plasma Principle the application of radiofrequency energy to vaporized peroxide at low-temperatures ( < 50oC / 122 F ) converts the peroxide into a variety of active species which sterilize by chemical impact (degrades the cell enzyme katalase) Advantage fast (45-75 minu
Slide 28: Hydrogen Peroxide (H2O2) Plasma
Hydrogen Peroxide (H2O2) Plasma USA Oct 09 Wagner GmbH, Munich 28
Slide 29: Hydrogen Peroxide (H2O2) AMSCO V-PRO
Hydrogen Peroxide (H2O2) AMSCO V-PRO 1 USA Oct 09 Wagner GmbH, Munich 29
Slide 30: Ozone (O3) sterilization
Ozone (O3) sterilization (i.e. TSO3’s 125L) Principle Oxygen (O2) passes at very low-temperatures (85–95 oF = 30-35 oC) via a strong electric field into a evacuated (but humidified) chamber. The field converts oxygene into OZONE (O3) - which sterilizes by chemical impact – then O3 is withdrawn via
Slide 31: Sterilization in health care facilities %-shares
Sterilization in health care facilities %-shares Basically, sterilization in health care (not industry) can be reduced to TWO principles: Gas / low T sterilization: 7% • EO gas • Peroxide (i.e. ASP`s Sterrad or the new AMSCO V-PRO) • Ozone sterilization (like TSO3’s 125L) Steam sterilization •
Slide 32: Steam sterilization
300 50,0 45,0 T in F 250 40,0 PSI 35,0 Temperature in F 200 30,0 Steam sterilization Pressure PSI 25,0 150 20,0 15,0 100 10,0 5,0 50 0,0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 Minutes Principle fast heat transfer by condensation of saturated, hot (270 oF) water vapor THERMALY inactivat
Slide 33: Steam sterilization: Gravity displacement cycle
Steam sterilization: GRAVITY displacemet cycle Conditioning Holding Exhaust 300 50,0 45,0 T in F 250 40,0 PSI 35,0 Temperature in F 200 30,0 Pressure PSI 25,0 150 20,0 15,0 100 10,0 5,0 50 0,0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 Minutes USA Oct 09 Wagner GmbH, Munich 33
Slide 34: Slide 34
Slide 35: Steam sterilization: Principle
300 50,0 45,0 T in F Steam sterilization: Principle= 250 40,0 PSI 35,0 Temperature in F 200 30,0 Pressure PSI 25,0 Condensation… in ABSENCE of air 150 20,0 15,0 100 10,0 5,0 50 0,0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 Minutes Condensed water needed for heat up of 10 kg steel in a conta
Slide 36: Slide 36
Slide 37: Extract AORN Recommended Practice XI
Extract AORN Recommended Practice XI (for sterilization...) Flash sterilization should be used for emergency sterilization of clean, unwrapped instruments and porous items only. RATIONALE 1) Flash sterilization is defined as sterilization of unwrapped items in a gravity displacement or prevacuum ste
Slide 38: Extract of Steris Study guide #002
Extract of Steris Corps. “Study guide #002 – “Hot issues of Flash” USA Oct 09 Wagner GmbH, Munich 38
Slide 39: Extract of Steris Study guide #002
Extract of Steris Corps. “Study guide #002 – “Hot issues of Flash”
Slide 40: Better air removal: Vacuum cycle
300 50,0 45,0 T in F 250 40,0 PSI 35,0 Temperature in F Better air removal: Vacuum cycle… 200 30,0 Pressure PSI 25,0 150 20,0 15,0 100 10,0 5,0 50 0,0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 Minutes 300 50,0 45,0 250 40,0 T in F PSI 35,0 200 Temperature in F 30,0 Pressure PSI 150 25,0 20,
Slide 41: Vacuum Steam sterilization
300 50,0 45,0 250 40,0 T in F PSI 35,0 200 Temperature in F Vacuum Steam sterilization 30,0 Pressure PSI 150 25,0 20,0 100 15,0 10,0 50 5,0 0 0,0 1 3 5 7 9 11 13 15 17 19 21 23 25 27 29 31 33 Minutes Is designed for wrapped instrument sterilization... IMPORTANT to understand: the initial vacuu
Slide 42: Steam sterilization: Pulsing pre-vac cycle
Steam sterilization: (PULSING) PRE-VAC cycle =dynamic-air-removal 300 50,0 45,0 250 40,0 T in F PSI 35,0 200 Temperature in F 30,0 Pressure PSI 150 25,0 20,0 100 15,0 10,0 50 5,0 0 0,0 1 3 5 7 9 11 13 15 17 19 21 23 25 27 29 31 33 35 37 39 41 43 45 47 Minutes USA Oct 09 Wagner GmbH, Munich 42
Slide 43: Steam sterilization: Pre-vac cycle
300 50,0 45,0 250 40,0 Steam sterilization: T in F PSI 35,0 200 Temperature in F 30,0 Pressure PSI 150 25,0 PRE-VAC (pulsing vac) cycle 20,0 100 15,0 10,0 50 5,0 0 0,0 1 3 5 7 9 11 13 15 17 19 21 23 25 27 29 31 33 35 37 39 41 43 45 47 Minutes Designed for SAFE sterilization of wrapped instrument i
Slide 44: Load dryness
Load dryness The major concern is to reach and maintain sterility inside a package. A dry load is in most cases mandatory for preservation of sterility: Remaining condensation inside a pack after sterilization is sterile water, but humid (wet) porous materials (like wrap, nonwoven, filters)
Slide 45: Slide 45
Slide 46: Steam sterilization: Load dryness vacuum
Steam sterilization: Load dryness VACUUM 300 50,0 45,0 250 40,0 T in F PSI 35,0 200 Temperature in F 30,0 Pressure PSI 150 25,0 20,0 100 15,0 10,0 50 5,0 0 0,0 1 3 5 7 9 11 13 15 17 19 21 23 25 27 29 31 33 35 37 39 41 43 45 47 Minutes USA Oct 09 Wagner GmbH, Munich 46
Slide 47: Slide 47
Slide 48: Vacuum Steam sterilization
STEAM saturation curve Pressure (PSI) 50,0 45,0 40,0 35,0 30,0 25,0 20,0 15,0 10,0 5,0 0,0 275,0 225,0 Vacuum Steam sterilization 175,0 T (oF) 125,0 75,0 25,0 Is designed for wrapped instrument sterilization... IMPORTANT to understand: the final load dryness vacuum shall re-evaporize condensat
Slide 49: Pulsing vac cycle with fractionated load dryness
Steam sterilization: PULSING VAC cycle with FRACTIONATED LOAD DRYNESS 300 50,0 45,0 250 40,0 T in F PSI 35,0 200 Temperature in F 30,0 Pressure PSI 150 25,0 20,0 100 15,0 10,0 50 5,0 0 0,0 1 3 5 7 9 11 13 15 17 19 21 23 25 27 29 31 33 35 37 39 41 43 45 47 49 51 53 55 57 Minutes USA Oct 09 Wagner Gmb
Slide 50: Controls
Controls IMPORTANT to understand Once it is documented (validated) that the applied packaging / load / cycle configuration may produce sterile results, there is still the need to monitor routine operation because there is a theoretical risk that the applied cycle himself – which strongly depen
Slide 51: Biological Indicators
Biological Indicators ? Biological indicators (=Inoculated carrier contained within its primary pack ready for use and providing a defined resistance to the specified sterilization process. ) are used to make evident that a cycle does really what he is designed for – killing microorganism: Subse
Slide 52: Chemical Indicators
Chemical Indicators Chemical indicators do not verify sterility, but they do allow detection of certain equipment malfunctions, and they may assist in the identification of certain procedural errors. There are five classes of CIs and specific performance requirements for them: Process indica
Slide 53: Chemical Integrators
Chemical Integrators Integrating chemical sterilization indicators (Class 5) can give additional security that packs have been treated correctly: as, when exposed inside packs, they monitor time, temperature & humidity but only at the spot where they have been exposed ! Recommendation: Applica
Slide 54: PCD's
PCD‘s Process challenging devices The use of a (class 5) chemical integrator in a specific "worst case" test receptacle is considered to be a more sensitive alternative to batch documentation obtained by placing chemical indicators in every single sterile pack. If such a "worst case pack" signal
Slide 55: Slide 55
Slide 56: Slide 56
Slide 57: neo &
( 9 0 neo &
Slide 58: Slide 58
Slide 59: Slide 59
Slide 60: Documentation cards
ate-ID/Inst. ID | : - RePac Recor es 5 ps C3 Charge/Load No. iat 3 Gerate-ID/ in: ionskarte / BAG ea | Freigegeben von /released by Nicht erfailt/nor fulfilled Sterilisationsbedingungen/sterilizing conditions Bo setunt/furfited CJ Niche ertutit/not tulfilied ) Freigegeben vori/refeased by 5 7 5.C n/
Slide 61: Slide 61
Slide 62: Shelf life
Shelf life ANSI/AAMI ST46:2002 §5.9.4 The shelf life of a packaged sterile item is event-related and depends on: • the quality of the packaging material • the storage conditions • the conditions during transport • and the amount of handling Rationale: The contamination of a sterile item is event
Slide 63: Shelf life
Shelf life ANSI/AAMI ST46:2002 §5.9.4 Shelf life is not simply a matter of sterility maintenance but also a function of device (remark PWA: packaging…) degradation and inventory control: In general, stock rotation according to the principle “first in, first out” should be maintained (= Rationale
Slide 64: A break... What else is needed?
What else is needed ? A break... USA Oct 09 Wagner GmbH, Munich 64
Slide 65: Sterilization: Recapitulation
Sterilization: Recapitulation There is no universally applicable sterilization method steam is, depending on the cycle design, safe, fast and economic, but not applicable to all kinds of devices ETO is dangerous and time consuming Hydrogen Oxide Plasma needs specific wrapping and can either
Slide 66: Packaging systems for sterilization
Packaging systems for sterilization... What expect users / the standards from a sterile packaging system? What offer disposable wrapping concepts? What offer “rigid” sterilization boxes? And the SteriSet-System? USA Oct 09 Wagner GmbH, Munich 66
Slide 67: Packaging: ANSI/AAMI ST46 requirements
Packaging ANSI/AAMI ST46:2002 5.6.1 Selection of packaging materials An effective packaging material for steam sterilization processing should, as a minimum: a) allow adequate air removal from and steam penetration of the package contents; b) provide an adequate barrier to microorganisms or thei
Slide 68: Sterilization wrap
Sterilization wrap Concept: “wrap a tray twice” wrapping twice should provide adequate mechanical protection and reduce the risk for a pathway into the pack due to incorrect folding later, in the OR, the removal of the FIRST layer OUTSIDE the OR allows good aseptic presentation USA Oct 09 Wagner
Slide 69: Sterilization wrap
Sterilization wrap USA Oct 09 Wagner GmbH, Munich 69
Slide 70: Sterilization wrap
Sterilization wrap The tape shall “tamper evidently” close the package and avoid a “opening” (blowing up) during sterilization will in most of the cases bear a process indicator – to demonstrate a “treatment” Wrap can produce highly permeable packs, so be suitable for many sterilization method
Slide 71: Sterilization wrap
Sterilization wrap HYGIENIC SECURITY ? Protection is needed against .... mechanical stress (risk with puncture, pinholes etc.....) sedimentation of (contaminated) dust - if not used as “double layer” USA Oct 09 Wagner GmbH, Munich 71
Slide 72: Sterilization wrap
ae SMa Nie qi 7° . — al Sterilization wrap The contaminated external surface represents a risk during opening and sterile presentation of the contents: Tearing open a pack (wrap) or handling the lid of the sterilization container might spread particles fram the contaminated surface into the air of t
Slide 73: Sterilization wrap
Sterilization wrap HYGIENIC SECURITY ? Protection is needed against .... influence of humidity: risk with wetpacks (humid & warm = poor barrier !) USA Oct 09 Wagner GmbH, Munich 73
Slide 74: Slide 74
Slide 75: What offer disposable packaging concepts?
What offer disposable packaging concepts? 2. Ease of use ? forming and sealing packs is time intensive ..... control before use needed... 3. Costs ? costs per use are very high .... packaging materials, tape ... 4. Environmental sociability? immense waste volume..... USA Oct 09 Wagner GmbH
Slide 76: Cost of disposable packaging concepts?
Cost of disposable packaging concepts? USA Oct 09 Wagner GmbH, Munich 76
Slide 77: Packaging: Wrap
Packaging: Wrap … ANSI/AAMI ST46:2002 5.6.1 Selection of packaging materials An effective packaging material for steam sterilization processing should, as a minimum: a) allow adequate air removal from and steam penetration of the package contents; b) provide an adequate barrier to microorganisms
Slide 78: Sterilization wrap is not the perfect solution
Sterilization wrap… … is not the perfect solution, but what would be better ? USA Oct 09 Wagner GmbH, Munich 78
Slide 79: Rigid sterilization containers?
Rigid sterilization containers ? Because of their metal (or plastic) body, sterilization containers offer increased protection during transport and storage and therefore reduce handling risks... USA Oct 09 Wagner GmbH, Munich 79
Slide 80: Rigid sterilization containers
Rigid sterilization containers… Steam ANSI/AAMI ST46:2002 ... may however need specific STERILIZATION conditions : • The use of rigid sterilization container systems could affect come-up and exposure times in steam sterilizers, depending on the efficiency of air removal from and steam penetration
Slide 81: Rigid sterilization containers
Rigid sterilization containers… ... do in addition need DISPOSABLES (FILTERS / tamper seals), FILTERS need to be: as PERMEABLE as possible to allow unhindered penetration of the sterilant and removal of air; but on the other end as IMPERMEABLE as possible in order to form a good barrier agains
Slide 82: Do rigid sterilization containers offer protection?
Do rigid sterilization containers offer… USA Oct 09 Wagner GmbH, Munich 82
Slide 83: Unprotected, single layer filter: SEALED?
Unprotected, single layer filter: SEALED ? USA Oct 09 Wagner GmbH, Munich 83
Slide 84: Unprotected filter + Methylene Blue Powder
Unprotected filter + Methylene Blue Powder + 10 x drop shocks and cupboard closed… . USA Oct 09 Wagner GmbH, Munich 84
Slide 85: Unprotected filter: Methylene Blue penetration
Unprotected filter: + Methylene Blue Powder penetration . USA Oct 09 Wagner GmbH, Munich 85
Slide 86: Sterilization containers need tamper sealing
ANSI/AAMI ST46:2002 Sterilization containers need tamper sealing 5.6.1 Selection of packaging materials An effective packaging material for steam sterilization processing should, as a minimum: Allow a method of sealing that results in a complete seal that is tamper-evident and that provides se
Slide 87: Sterilization containers need tamper sealing
ANSI/AAMI ST46:2002 Sterilization containers need tamper sealing „State of the art“ proposes here different options to indicate the first opening: 1) Disposable plastic locks They block the latch: access only possible if you intentionally break the lock… -> Costs ! Handling ! Waste ! USA Oct
Slide 88: Rigid sterilization containers: tamper sealing
Rigid sterilization containers: tamper sealing… 2) Paper labels? These do not physically block a latch, but shall allow to note when the latch / lid was open…? USA Oct 09 Wagner GmbH, Munich 88
Slide 89: Packaging: Rigid containers
Packaging: “Rigid containers” ANSI/AAMI ST46:2002 5.6.1 Selection of packaging materials An effective packaging material for steam sterilization processing should, as a minimum: a) allow adequate air removal from and steam penetration of the package contents; b) provide an adequate barrier to mi
Slide 90: Perforated containers
Perforated containers… … are not the perfect solution, but what would be better ? USA Oct 09 Wagner GmbH, Munich 90
Slide 91: Closed containers
i g n d es e d” r s? lo s in e “ C n ta co
Slide 92: The SteriSet Sterilization Container System
The SteriSet Sterilization Container System Offers Four Unique Features 1. Protective design 2. Disposable OR stainless Re-usable barrier 3. Safe tamper sealing (no handling needed !) 4. Drain to dry heavy loads USA Oct 09 Wagner GmbH, Munich 92
Slide 93: The SteriSet Sterilization Container System
The SteriSet Sterilization Container System OUTER LID INNER BARRIER LID BOTTOM USA Oct 09 Wagner GmbH, Munich 93
Slide 94: With protective double lid closed, sterilization is possible
With the protective double lid closed, STERILIZATION is nevertheless possible The lid concept allows unproblematic stacking during transportation and storage, also inside the sterilizer (no condensate soaks the lower containers) USA Oct 09 Wagner GmbH, Munich 94
Slide 95: Inside the sterilizer
INSIDE THE STERILIZER
Slide 96: SteriSet in detail: protective double lid
SteriSet in detail The protective double lid Hygienic security: the outer lid protects the hidden biobarriers (filterplate or valveplate) AND the silicone seal against any harmful influence ..... STERILE USA Oct 09 Wagner GmbH, Munich 96
Slide 97: SteriSet in detail: protective double lid
Protection against SteriSet in detail mechanical stress and puncture The protective double lid STERILE USA Oct 09 Wagner GmbH, Munich 97
Slide 98: SteriSet in detail: protective double lid
Protection against SteriSet in detail moisture and humidity The protective double lid or sedimentation STERILE USA Oct 09 Wagner GmbH, Munich 98
Slide 99: Protected SteriSet + Methylene Blue Powder
Protected Steriset + Methylene Blue Powder + 10 x drop shocks and cupboard closed… . USA Oct 09 Wagner GmbH, Munich 99
Slide 100: Protected SteriSet after Methylene Blue Test: Clean
Protected SteriSet AFTER Methylene Blue Test: CLEAN… USA Oct 09 Wagner GmbH, Munich 100
Slide 101: SteriSet in detail: protective double lid
SteriSet in detail The protective double lid increases shelf life and eases aseptic presentation ! Surface pollution can be removed: Either by wiping down Or by removing the STERILE OUTER LID ONLY (S-Model option) USA Oct 09 Wagner GmbH, Munich 101
Slide 102: SteriSet System: Tamper sealing
The SteriSet System: TAMPER SEALING ? SteriSet`s ThermoLoc offers a REUSABLE tamper seal which is really Safe ! BLOCKS the latches and LOCKS the lid to the bottom ! USA Oct 09 Wagner GmbH, Munich 102
Slide 103: SteriSet System: The automatic seal ThermoLoc
SteriSet System The automatic seal ThermoLoc Instead By of a disposable the influence tamper of temperature, seal, ThermoLoc ThermoLoc is a color blocks the closure coded, latch heat against activated opening: accidental reusablethetamper seal container is (integrated automatically in the closure)
Slide 104: USA Oct 09 Wagner GmbH, Munich
USA Oct 09 Wagner GmbH, Munich 104
Slide 105: SteriSet in detail: the Barrier: Filter system
SteriSet in detail: the Barrier: FILTER system Barrier concept: DISPOSABLE filter system a very DURABLE, stiff (not flexible) filterholder safely presses the disposable filter against the perforated inner lid USA Oct 09 Wagner GmbH, Munich 105
Slide 106: SteriSet in detail: the Barrier: Filter system
SteriSet in detail: the Barrier: FILTER system Easy one hand exchange ONE filter size for all containers BUT: disposable filter to change… USA Oct 09 Wagner GmbH, Munich 106
Slide 107: SteriSet in detail: Barrier 2: the valve system
SteriSet in detail Barrier 2: the valve system Barrier concept: REUSABLE valve system a valve is a reusable stainless steel barrier (tortuous path concept) which: forms OUTSIDE a sterilizer a barrier against microbial penetration .... but is INSIDE a sterilizer highly permeable to steam and
Slide 108: The SteriSet Valve: inlet direction
The SteriSet VALVE INLET direction... The inner valve disk is pushed down against a spring to open a pathway for the steam, which allows the inside to reach the same Steam pressure comes as outside. through the gap… USA Oct 09 Wagner GmbH, Munich 108
Slide 109: The SteriSet Valve: outlet direction
The SteriSet VALVE OUTLET direction... When the cycle reduces pressure (i.e. pulls a vacuum): The upper valve disk is pushed up-wards against a 2nd spring and opens a path for steam to escape USA Oct 09 Wagner GmbH, Munich 109
Slide 110: The SteriSet Valve closed & protected
The SteriSet VALVE CLOSED & Protected in the absence of pressure... USA Oct 09 Wagner GmbH, Munich 110
Slide 111: SteriSet in detail: the valve system
SteriSet in detail The valve system... Allows easy handling, safety (no puncture) & cost effectiveness The patented valve is reusable, selfacting and selfcleaning thus replaces the need and the costs to exchange filters + Environmental sociability: sociability reduced garbage! No disposabl
Slide 112: SteriSet in detail: reusable stainless steel valve system
SteriSet in detail The reusable stainless steel valve system ... Is widely used for more then 25 years and meets the following standards : EN 868-1 and –8; DIN EN ISO 11607-1 DIN (German Standard Institute) 58 952 FDA (US Food&Drug association) 510K Premarketing Notification CE-mark decla
Slide 113: SteriSet options: the condensation drain
SteriSet options The condensation drain „drain“ containers have no flat bottom, but are in form of a „sink“, with a temperature activated drain VALVE at the deepest point. This drain opens when the temper- ature reaches during a cycle 130oC/ 265oF and re-closes when temperature drops below 110oC
Slide 114: Slide 114
Slide 115: Slide 115
Slide 116: Et hes ici he
Et hes ici he ws , oh ty * roe Yt ak eee tha 2 ' t : t) “wee “ ty wh le oa ee ee : ts |
Slide 117: Allow a slow and steady cool down before handling
Allow a slow and steady cool down before handling!
Slide 118: Packaging: SteriSet
Packaging: SteriSet…. ANSI/AAMI ST46:2002 5.6.1 Selection of packaging materials An effective packaging material for steam sterilization processing should, as a minimum: a) allow adequate air removal from and steam penetration of the package contents; b) provide an adequate barrier to microorgan
Slide 119: Summary
Summary utmost protection during transport and storage .... cost effective and environmentally compatible sterile supply..... NO costs for disposables NO exchange of filters necessary NO costs for waste management a safe aseptic presentation ..... by the total unperforated design by t
Slide 120: Discussion
Sterilization & Packaging DISCUSSION www.wagner-steriset.de <<<<
Slide 121: Thank you
U ! Y O NK H A T USA Oct 09 Wagner GmbH, Munich 121
Slide 122: Do SteriSet sterilization containers need special care?
Do SteriSet sterilization containers need special care ? USA Oct 09 Wagner GmbH, Munich 122
Slide 123: Valve plate inspection
Valve plates are to be subjected to visual and mechanical inspections as shown in the pictures: Neither valves nor inner valve covers may shaw visible malformations. Valves must be blank and free to move when inspected mechanically) Containers with condensate drain: The condensate valve must be scre
Slide 124: Load dryness
Load dryness Unlike wrap or perforated filter containers, SteriSet containers are sealed after sterilization. Eventually remaining condensation (humidity) does so not represent a hygienic risk, as the seamless punched, 2 mm thick aluminum - no matter if dry or wet - cannot be penetrated by mic
Slide 125: Load dryness
Load dryness Load dryness depends on many parameters, which can only partly be influenced by the manufacturer of the packaging concept : Sterilization hard- and software: you need saturated (not wet) steam, a long enough sterilization holding time (134oC / 273 F for min. 4, better 6-7 min.; 12
Slide 126: Heavy condensation (1)
Heavy condensation (1) One of the first details to check in case of heavy load dryness problems is the CYCLE design (see FAQs on "suitable cycles"): often a prolongation of the load dryness vacuum - or going down into a deeper vacuum - will solve the problem. NOTE: The SUPERDRY cycle desig
Slide 127: Heavy condensation (2)
Heavy condensation (2) In case of that due to the load weight of the container there is plenty of condensation after sterilization you can solve this “heavy condensation” problem by using a "condensation drain" type container: the bottom drain opens INSIDE the sterilizer DURING the cycle and all
Slide 128: SteriSet in detail: unique design, unique functions
SteriSet in detail Unique design has unique functions – and price... Parts for ½ size without drain: Bottom: 63 parts Inner lid: 25 parts Outer lid: 38 parts TOTAL: 126 parts Worksteps / tools for ½ size 198 worksteps ea. fully documented acc. ISO 9001 QM system 91 Tools needed for
WAGNER Sterilsysteme — Technical Presentation (October 2009) on 6ix