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Sterilization Wrap - Vereniging Sterilisatie

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1. ai ARJOWIGGINS HEALIHCARE How to consider the choice of packaging n Choice of packaging shall depend on Type ofsterilization to be used Shelflife performance to be achieved Type of material to be packed Safety of nurses patients and for hospital environment Cost n Hence the following applies Any elected item to wrap pack must fulfill the objective related to operations in CSSDs be sterilizable allow efficiency of sterilization process maintain barrier properties after sterilization all the way until use in OR proper physical protection for medical device Acareful screening of packing wrapping options should be conducted to allow this at best possible cost performance THE BACTERIAL BARRIER FOR HUMAN PROTECTION 5 How to consider the choice of packaging y Question How to be sure that the medical device placed in the wrap packaging is still sterile when introduced in operating room y Problematic There is no destructive and routine test able to determine if the barrier integrity of the pack is still valid y Answer Compliance to EN ISO 11607 part 1 amp 2 Part 1 Requirements for material and Packaging System Design Part2 Validation requirements of processes for packaging 3 requested conditions 1 Have the adequate material 2 Have a validated packaging system design 3 Follow a protocol from packaging to operating room with regular check of the integrity of t
2. compliance with ISO 11607 1 for material requirements Q Documentation provided by the supplier Microbial barrier Porous material shall provide an adequate Tests listed in EN 868 2 microbial barrier Bacterial Filtration Efficiency ASTM F2101 Germ Proofness DIN 58953 6 8 2 14 amp 2 15 Biocompatibility amp toxicological Biocompatibility ISO 10993 attributes Sensitisation Irritation Cyto toxicity ISO 10993 Bio burden control EN 11737 Chemical properties EN 868 2 Physical amp chemical properties Physical amp chemical properties follow up Tests listed in EN 868 2 Compatibility with respect to Folding EN 868 2 forming and sealing processes Drape ability EN 868 2 Compatibility with respect to the Suitability for use in sterilization EN 868 2 after sterilization intended sterilization processes processes and cycle parameters Acceptable shelf life Any shelf life limitations for pre EN 868 2 sterilization and post sterilization storage Bacterial Filtration Efficiency ASTM F2101 Germ Proofness DIN 58953 6 3 2 14 amp 2 15 on 5 years aged paper before and after sterilization THE BACTERIAL BARRIER FOR HUMAN PROTECTION 11 Ri ARJOWIGGINS HEALTHCARE EN 868 2 Sterilization wraps n Specific requirements for sterilization wrap n 4materials are listed Plain Paper cellulose base Creped paper cellulose base Non woven cellulose base with synthetics fibers wet laid non woven 100 syntheti
3. ARJOWIGGIN STERILIZATION WRAP STERISHEET user guide for the validation of the packaging THE BACTERIAL BARRIER FOR HUMAN PROTECTION si ARJOWIGGINS HEALIHCAR I ARJ OWIGGINS in few words n Alarge range of sterilization wrap from standard creped paper to non woven n Alarge range of standard or reinforced paper for sterile packaging Hospital pouches for Steam or EtO sterilization Packaging of single use Medical Devices gi ARJOWIGGINS HEALIHCARE 2 THE BACTERIAL BARRIER FOR HUMAN PROTECTION ARJOWIGGINS Different options of packaging Wraps Cellulosic paper Linen Wetlaid non woven SMS PP y mm Containers Pouches Cellulosic paper PEHD flash spun bond THE BACTERIAL BARRIER FOR HUMAN PROTECTION 3 Sterilization Wrap in details Crepe Paper 100 wood pulp material The original wrapping material and the most cost effective Reinforced Crepe Paper 80 wood pulp and synthetic surface binders The affordable combination of drape ability and softness with strength Wet Laid Non Woven M s 50 Wood pulp and synthetic fibers blend Binders reinforced material The higher fluid repellence drape ability and strength for the demanding wrapping and draping applications 10096 synthetics fibers PP SMS Spunbond Meltblown Spunbond NW The material with the highest mechanical resistance mainly tear strength amp the only material adapted to plasma sterilisation
4. FOR HUMAN PROTECTION Ri ARJOWIGGINS HEALTHCARE Guideline for packaging 2 Sterilization 2 2 y The choice of the cycle Sterilisation cycle shall be adjusted to the loading y Unloading Don t manipulate the packs before the load is fully cooled down Check the sterilization release parameters or indicators to validate the sterilization process Check there is no residual condensation on each pack when unloading Check the integrity of the protective layer ifithas been damaged sterility state could be compromised and the pack must be processed again amp Root Causes Analysis should be performed THE BACTERIAL BARRIER FOR HUMAN PROTECTION TO 39 ARJOWIGGINS HEALTHCARE Guideline for packaging 3 Transportation y shelf life of a package sterile is event related and not time related Supplies should be handled carefully Transportation in clean cabinets in bins or with trolleys are recommended Avoid dragging crushing bending compressing or puncturing the packaging Avoid multiple handling moisture penetration and exposure to airborne contaminates After each manipulation packaging should be thoroughly inspected When hand transport sterile packages should be maintained in a position parallel with the floor Written policies and procedures should be developed for the use of transport equipment and appropriate handling practices THE BACTERIAL 40 gi ARJOWIGGI
5. IN 58953 6 2 14 amp 8 2 15 is improved Guarantee aseptic opening Possibility to combine different generation wraps and offer a combination of the best characteristics and benefits of each generation of products Provide the most adapted wrapping solution and a tailored made wrapping system Possibility to have a colour coding Security Superposition of two colours allows to visualise any defect amp prevent dust cover entering the operation rooms THE BACTERIAL BARRIER 26 Validation of the double wrapping Vs single wrapping Bacterial Filtration Efficiency test ASTM F2101 Single Double Wrapping Wrapping interleaved 96 10 99 99 9 crepe paper Agowiggins 90 98 Wet laid non woven Arjowiggins o THE BACTERIAL BARRIER FOR HUMAN PROTECTION 27 ARJOWIGGINS How to validate that the design of your packaging system is adapted Condition 2 Validation of the packaging system design by real test amp good practices y Efficiency of sterilization Steam penetration testing thru activating sterilization indicators y Integrity of the SBS Maintenance of sterility integrity over time Event Related Sterility Maintenance Study Nelson laboratories This test is performed on double layer packaging after sterilization and simulates shelf storage inside a room whose humidity and temperature are regularly recorded along with weekly handling of the packaged packs The packs are inspected
6. NS HEALIHCARI Guideline for packaging 4 Storage y shelf life of a package sterile is event related and not time related Sterile items should be stored in a manner that reduces the potential for contamination Storage area dedicated to sterile supplies Temperature and humidity controlled Room temperature amp Humidity does not exceed 70 Away from direct sunlight Traffic should be controlled to limit access to sterile items e Sterile items stored far enough away from the floor the ceiling and outside walls to allow for adequate air circulation Avoid friction of packs against the shelves during handling E O Y first in first out policy hw 24 Written policies and procedures should be developed for the storage handling and rotation THE BACTERIAL BARRIER FOR HUMAN PROTECTION II 41 ARJOWIGGINS HEALTHCARE Guideline for packaging 5 Opening sterile packages y The following guidelines should be observed when opening sterile packages Before itis opened the package should be inspected for the appropriate appearance of the external sterilization indicator and the physical integrity of the packaging O Lastand more crucial inspection Place visual aids of final packaging amp refused package in this area closely linked to first step packaging preparation Remove the outer wrap before entering the OR not to introduce exterior contaminating elements Enter the OR with the inner wrap on
7. after period of 180 days and the results is given as the percentage of uncontaminated packs Microbial aerosol challenge test Nelson laboratories aerosolizing high number of Bacillus atrophaeus spores and then testing the contents of the package for ingression of that organism THE BACTERIAL BARRIER FOR HUMAN PROTECTION 28 Validation of sterility maintenance Event Related Sterility Maintenance Study Sterility Maintenance 30 days 180 days Sterisheet Reinforced Creped Paper 100 100 Sterisheet Wet Laid Non Woven 100 100 0 0 Sterisheet SMS PRONTI Tested on double sequential wrapping THE BACTERIAL BARRIER FOR HUMAN PROTECTION 29 ai ARJOWIGGINS HEALIMH CARE Topics 3 PROCESSES VALIDATION THE BACTERIAL BARRIER FOR HUMAN PROTECTION 30 Our protocol for the validation of packaging process Condition 1 Check if the product is normalized EN 1S011607 1 EN 868 2 answering the following needs Condition 2 Validation of the packaging system design by real test amp good practices Condition 3 A written protocol and visual aids for each step 1 Packing preparation 2 Sterilization Loading 3 Transportation 4 Storage 5 Opening Only a visual inspection will guarantee the integrity of the packaging Atthe end of each stage a visual inspection should be performed thru a documented quality system including recording training amp qualifying any actor of the chain Following g
8. cs fibers dry laid non woven Linen Woven textile material THE BACTERIAL BARRIER FOR HUMAN PROTECTION 12 Role of packaging Allow sterilization AND provide a high bacterial barrier performance during the storage of the sterilized packs Sterilizing agent Micro organisms Bacterial barrier against contamination coming from Air airborne micro particles dust Fluids drops aerosols THE BACTERIAL BARRIER FOR HUMAN PROTECTION 13 ai ARJOWIGGINS AEALI A CARI Microbial barrier n The principle of bacterial barrier is that bacteria die burn their energy before crossing barrier material 6 Tortuous path n Partof the non compliant materials are the ones which are not barrier enough to stop bacteria on their way Film to paper pouches poorly manufactured no sealing in some areas Materials with holes or with insufficient tortuous path THE BACTERIAL BARRIER FOR HUMAN PROTECTION 14 4 ARJOWIGGINS HEALTHCARE Microbial barrier Germ Proofness DIN 58953 6 S 2 15 dry challenge test S 2 14 wet challenge test Pass or fail test performed on sterilized sample THE BACTERIAL BARRIER FOR HUMAN PROTECTION 15 Microbial barrier Germ Proofness DIN 58953 6 S 2 15 dry challenge test Simulates exposure to airborne bacteria by placing a microorganisms powder in contact of a pressurized depressurized sample Then are counted the microorganisms passing trough the sample on a nutrient medium place
9. d on the opposite side AIR FLOW POWDER B ri MATERIAL PAPER or LINEN Sample Agar mediurrr THE BACTERIAL BARRIER FOR HUMAN PROTECTION 16 Microbial barrier Germ Proofness DIN 58953 6 S 2 14 wet challenge test Simulates exposure to liquid borne bacteria by placing few microorganisms aqueous droplets in contact of a sample After drying amp incubation are counted the microorganisms passing trough the sample on a nutrient medium placed on the opposite side DROPLETS B era act MATERIAL PAPER or LINEN Sample Agar mediurrr THE BACTERIAL BARRIER FOR HUMAN PROTECTION 17 ARJOWIGGINS REALT AH CARE Microbial barrier Bacterial Filtration Efficiency test ASTM F2101 A microorganisms suspension is dried and sprayed onto the sample A constant air flow then draws the sprayed microorganisms through the sample The number of them that have passed through the sample is counted in a nutrient medium placed on the other side 2 naim o BFE test performed on material mp after steam sterilization to simulate exposure to airborne bacteria BFE testing 100 is the best possible rating THE BACTERIAL BARRIER FOR HUMAN PROTECTION 18 Microbial barrier TR Test performed on 1 single sheet DRY STATE WET STATE Germ Bacterial Germ Proofness Filtration Proofness resitance Efficiency EN 868 2 Annex B crepe paper gt 75 min Mason J arr Arjowiggins Wetlaid non
10. he packaging sanc ARJOWIGGINS HEALIHCARE ISO 11607 Standard n SCOPE Packaging for terminally sterilized medical device manufactured industrially or assembled in a CSSD n Increased responsibilities for the CSSD n Producer z Manufacturer Producer Arjowiggins responsible for the material Manufacturer CSSD in charge of the packaging and sterilization THE BACTERIAL BARRIER FOR HUMAN PROTECTION 7 sel ARJOWIGGINS HEALIHCARE ISO 11607 Standard n Packaging system SBS Sterile Barrier System Protective packaging n Number of layers for SBS 1 layer 2 layers Minimum package that prevents ingress of micro organisms amp allows aseptic presentation of the product at the point of use n Packaging system should consist in a SBS and a protective packaging 2 possible Ways SBS made of 2 layers 1 layer for protective packaging gt Packaging system is made of 3 layers I SBS made of 2 layers outer layer playing a double part Barrier Protection THE BACTERIAL BARRIER FOR HUMAN PROTECTION 1 MATERIAL REQUIREMENT 2 PACKAGING SYSTEM DESIGN REQUIREMENTS 3 PROCESSES VALIDATION THE BACTERIAL BARRIER FOR HUMAN PROTECTION 9 ARJOWIGGINS HEALIMH CARE 1 MATERIAL REQUIREMENT THE BACTERIAL BARRIER FOR HUMAN PROTECTION 10 x ARJOWIGGINS HEALIHCARE ISO 11607 1 Material Requirements q Example of what Arjowiggins done to be in
11. ion process compatibility Acceptable shelf life Condition 2 Validation of the packaging system design un Compatibility with respect to the intended Efficiency of sterilization Appropriate Solutions sterilization processes Packaging system physical protection Adequate protection to the product REAL TESTS through the hazards of handling amp distribution and storage GOOD PRACTI CES Packaging system microbial barrier Integrity of the Sterile Barrier System Stability testing Maintenance of sterility integrity over time THE BACTERIAL BARRIER FOR HUMAN PROTECTION 24 ARJOWIGGINS F AL TT CARE How to validate that the design of your packaging system is adapted Condition 2 Validation of the packaging system design by real test amp good practices y Severalwrapping methods Envelope folding Square folding Pasteur folding Roll method y The most common and recommended folding is envelope folding y Why To create the more tortuous path which means a better barrier against penetration of micro organism Design validated by Event Related Sterility Maintenance Stud Reduce handling during opening thanks to the tab BACTERIAL BARRIER FOR HUMAN PROTECTION I 25 gi ARJOWIGGINS HEALIHMH CS R i How to validate that the design of your packaging system is adapted y Double sequential wrap is recommended y Why Bacterial filtration efficiency amp germproof ness test D
12. lder THE BACTERIAL BARRIER FOR HUMAN PROTECTION 33 ARJOWIGGINS HEALTH CARE Guideline for packaging 1 Packing preparation 2 4 y Chose the adapted material to the medical device Material adapted to the size and weight of the items to be packed THE BACTERIAL BARRIER FOR HUMAN PROTECTION 34 i ARJOWIGGINS Guideline for packaging 1 Packing preparation 3 4 Weight up to 3 kg for double i Crepe Smal and medium size rays Maw Small packs da i Small surgical trays i i So small surgical packs of medium size and weigh Medium size packs Weight up to 12 kg for double packs Surgical instrument trays orthopaedic trays and packs and large si Een cok MEE Large Packs due to nonwoven material s resistance to disinfectants Nonwoven Weight up to 15 kg en doubl A yia Lodi MA Orthopedic sets Interleaved SMS nonwoven 28 Combination of various grades and colours to suit Interleaved every type of application These weight values are indicative IER FOR HUMAN PROTECTION 35 ARJOWIGGINS HEALIHCARE Guideline for packaging 1 Packing preparation 2 4 y Chose the adapted material to the medical device Material adapted to the size and weight of the items to be packed Adapted to the shape of the medical device Sharp edge corner Adapted to the number of manipulations add protection to sharp medical devices the pr
13. ly aseptic presentation ifthe material is a non woven resistant to disinfectants it can be used as sterile field THE BACTERIAL BARRIER FOR HUMAN PROTECTION I 42 ARJOWIGGINS HEALTH CARE Guideline for packaging A new work Item for ISO TC 198 WG 7 y The crucial subject of packaging systems assembly validation taken under consideration during the last 2 plenary meeting Keys decisions Educational informative guideline to be submit to formal vote within 1 year time frame Addressing on the same levels both Medical Devices Manufacturers and healthcare facilities hospital CSSD dentists needs Covering all kind of currently used packaging systems for hospitals i e Pouches Containers WRAPS Clearly emphasizing the KEY need of the ASPETIC presentation of the packed products THE BACTERIAL BARRIER FOR HUMAN PROTECTION 43 ARJOWIGGINS HEALTHCARE 8 Thank you for your attention THE BACTERIAL BARRIER FOR HUMAN PROTECTION 4 ARJOWIGGINS
14. otections shall withstand the sterilization process Place visual aids on the packing area to chose the right material THE BACTERIAL BARRIER FOR HUMAN PROTECTION 36 gi ARJOWIGGINS HEALIHCARI Guideline for packaging 1 Packing preparation 4 4 Visual of the folding procedure in packing area Validation 00 Place sterilization indicator inside the pack to check efficiency of sterilization process Check tack and resistance of specific sterilization indicator tape designed to endure both heat amp humidity to close the pack good Wrong Visual of the aspect of the final pack to prevent gapping billowing amp air pockets from the forming First validation of the packaging by comparison With visual aids Traceability of the pack 37 THE BACTERIAL BARRIER FOR HUMAN PROTECTION gi ARJOWIGGINS HEALIH CAR i Guideline for packaging 2 Sterilization 1 2 y Loading Avoid the sterilization of different kinds of materials Textiles Sterilization wraps Plastics containers Metal sure all items are oriented in the sterilizer such that water can drip out Basins and other concave items must be placed on their sides tipped slightly downward Pouches shall be placed vertically in a way water can drip out Do not overcrowd the sterilizer Stacked packs Tear or Puncture risk Asperity on the support risk of Tear 38 THE BACTERIAL BARRIER
15. uideline is based on these 3 conditions and the results of in situ testing experience amp good practices THE BACTERIAL BARRIER FOR HUMAN PROTECTION 31 ISO 11607 2 Validation of the process y Necessity of a quality document describing at least used material its characteristics etc supplier data type of sterilization used type of Medical Device to be sterilized folding amp packing protocol acceptation criteria qualification step IQ OQ amp PQ y Qualification in 3 steps 1 Installation Qualification c training installation table light wraps rack etc 2 Operational Qualification c check etvalidation that the packing is appropriate worst case scenario 3 Performance Qualification c repeatability and reproducibility of the process THE BACTERIAL BARRIER FOR HUMAN PROTECTION 32 gi ARJOWIGGINS HEALTHCARE Guideline for packaging 1 Packing preparation 1 4 y All the items must be carefully checked before packing q Medical devices check the medical devices are clean amp dry check the medical devices are not damaged no stain no corrosion check all items for a given procedure are there q Sterilization sheets check if packaging product is clean without any holes amp tears amp secure its tracking number trace ability feature store the wraps on rack q Packing area prepare a clear amp clean area table with an adequate surface tape ho
16. woven Arjowiggins A gt 75 min SMS Mason Jarr THE BACTERIAL BARRIER FOR HUMAN PROTECTION 19 ARJOWIGGINS Sterilization processes compatibility Steam sterilization is the way the most used q Steam q Formaldehyde q EtO q Irradiation lt 2 8 anm upas Er DL isss q Plasma THE BACTERIAL BARRIER FOR HUMAN PROTECTION se ARJOWIGGINS Sterilization processes compatibility Steam sterilization is 100 steam penetration as the way the most used percentage of activated sterilization indicators according to ISO 11134 Cycles France 18 134 C 3 ripa USA 20 121 C 5282 THE BACTERIAL BARRIER FOR HUMAN PROTECTION 21 ARJOWIGGINS HE E MALTA CAR Sterilization processes compatibility Packaging STEAM Irradiation Wetlaid non woven Cellulosic paper depending of the type of filter Cellulosic crepe paper P P P sew p P P P 0 udi P P container lt ARJOWIGGINS HEALIHCARE Topics E 2 PACKAGING SYSTEM DESIGN REQUIREMENTS THE BACTERIAL BARRIER FOR HUMAN PROTECTION 23 i ARJOWIGGINS HEALIHCAKRE ISO 11607 1 Packaging System Design Requirements Condition 1 Check if the product is normalized ISO 11607 1 amp EN 868 2 answering the following needs Microbial barrier properties Biocompatibility amp non toxicity products Sterilizat

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