PMSSteripack 2010 PRODUCT DESCRIPTION & SPECIFICATIONS

Transcription

1 PMSSteripack 2010 PRODUCT DESCRIPTION & SPECIFICATIONS

2 2 S a y f a

3 CONTENTS 1. QUALITY SYSTEMS ISO 9001: ISO 13485: SAFETY INSTRUCTIONS PRODUCT DESCRIPTION PRODUCT DESCRIPTIONS, USE AND COMPLIANCE TO INTL. STANDARDS Material Composition Instructions for Use Sterilization Characteristics of the Package Compliance to International Standards MATERIALS FOR PRODUCTION PAPER Classification Properties of the Paper PRINTING Ink Printing Indicators Testing of Indicators STEAM Indicator Testing Results EO Indicator Testing Results FO Indicator Testing Results FILM (POLYESTER/POLYPROPYLENE) Properties of the film Film Color & Lamination FINAL PRODUCT TESTING SEAL STRENGTH SPECIFICATION TABLE BIOBURDEN TEST MICROBIAL BARRIER AGEING STUDIES Accelerated Ageing Natural Ageing OPERATION MANUFACTURING PROCESS Process Process Validation LOT NUMBER EXPIRY DATE / SHELF LIFE PACKAGING Packaging for delivery Reels and Pouches Packaging of Pouches Packaging of Reels Instructions for Use (IfU)... 9 p a g e 3

4 5.5 LABELS Labels of bundles and cores Labels for Shipping Carton STORAGE CONDITIONS APPENDIX I ISO 9001:2008 CERTIFICATION APPENDIX II ISO 13485:2003 CERTIFICATION APPENDIX III TABLE OF CONTENTS OF QUALITY SYSTEMS MANUAL APPENDIX IV TS EN CERTIFICATION APPENDIX V CE DECLARATION OF CONFORMITY APPENDIX VI ISO /2CONFORMITY STATEMENT APPENDIX VII ISO CONFORMITY STATEMENT APPENDIX VIII TECHNICAL DATA SHEET STERILIZATION FLAT REEL APPENDIX IX TEST REPORTS OF STEAM INDICATOR TESTING APPENDIX X TEST REPORTS OF EO INDICATOR TESTING APPENDIX XI TEST REPORTS OF FO INDICATOR TESTING APPENDIX XII BIOBURDEN TEST REPORT (FLAT REEL) APPENDIX XIII RECOVERY BIOBURDEN TEST REPORT (FLAT REEL) APPENDIX XIV MICROBIAL BARRIER TEST REPORT APPENDIX XV ACCELERATED AGEING TEST REPORT (FLAT REEL) APPENDIX XVI ACCELERATED AGEING TEST QUALITY CONTROL REPORT (FLAT REEL) p a g e 4

5 1. QUALITY SYSTEMS 1.1 ISO 9001:2008 PMSSteripack sterilization reel and pouch production facility located in Mersin/Turkey is ISO 9001:2008 certified. As a requirement for certification the facility has a Quality System Manual. The title page and table of contents from the Quality Systems Manual are included in this compilation. * Appendix I ISO 9001:2008 Certification * Appendix II Table of Contents of Quality Systems Manual 1.2 ISO 13485:2003 The Manufacturing of PMSSteripack Sterilization Reels and Pouches is done according to ISO 13485:2003. The manufacture of Sterilization Packaging (Reel & Pouch), Bowie&Dick Test Packs and Indicator Strips are validated by this certificate. * Appendix III ISO 13485:2003 Certification 1.3 Safety Instructions The company PMSMedikal, manufacturer of PMSSteripack branded products applies the valid Environmental, Health and Safety regulations of Turkey. The Environmental, Health and Safety instructions are followed when processing material, operating machinery and other equipment that is used in the production for PMSSteripack Sterilization Reels and Pouches. 2. GENERALL CRITERIAS 2.1 Product Descriptions, Use and Compliance to Intl. Standards Material Composition PMSSteripack sterilization reels and pouches are constructed from transparent PET/PP 5 layers copolymer film and Medical Kraft Paper in accordance to EN A process indicator is applied on the surface of the reel and the pouch. This products are defined as Class I product and CE certified Instructions for Use PMSSteripack pouches are ready for use. The Reels need to be cut to the required length and sealed at one end to form a pouch. Sharp ends of instruments must be covered with an instrument protector, to prevent puncturing or cutting. The medical device to be sterilized must be placed in the package and it shouldn t be filled more than 75% of its capacity. A gap of minimum 1,5cm between the material and the each seal edge of the pouch must be leave for a smooth airflow. Before sealing, as much air as possible must be removed from the pouch. The pouch has to be sealed with a calibrated and validated sealer according to the manufacturer s recommendations. Strength of the seal must assure a clean peel. During the handling heat seal stress must be avoided, e.g. by filling the pouch horizontally, working on a flat surface. When loading into the sterilizer the pouches have to be placed into the basket in a way that film faces to film and paper faces to paper. Sterilization pouches should be put upright in the basket or container and not too tight together, such that a hand can slide in between them. The load should be processed according to the established procedures. The pouches should be handled with care when removing from the sterilizer to prevent them from tearing. Pouches must be stored in an area protected from sunlight, water and other liquids. Wet pouch shouldn t be use, if it is the case repeat the sterilization process again after changing the pouch. To open pouch, the thumb and index finger should be used to hold plastic side of pouch and a thumb and index finger to pull back paper side of pouch. The pouch must be always opened from the direction of the opening arrow. For a clean peel the pouch should be opened slowly Sterilization Sealed sterilization reels and pouches can be sterilized by STEAM, EO and FO sterilizers in accordance to EN 285 and EN The sterilization packaging ensures the protection of the medical device from contamination with bacteria and chemicals from the time of sterilization until use of the sterile device Characteristics of the Package PMSSteripack Sterilization Reels and Pouches are designed, produced and distributed to provide the highest standards of quality as: - 3 seal lines for optimum resistance - Tear free 5 layers film - Easy and clean peel for aseptic presentation - Proven Microbial Barrier - Lead free water based inks - Clear indicator color change - No toxic agents - Economy - Wide range of product sizes p a g e 5

6 2.1.5 Compliance to International Standards All PMSSteripack Sterilization Reels and Pouches are produced in accordance to the following standards and international standards: - EN868 3, EN ISO ISO /42 EEC Medical Device Directive * Appendix IV - TS EN Certification * Appendix V CE Declaration of Conformity * Appendix VI - ISO /2 Conformity Statement * Appendix VII - ISO Conformity Statement 3. MATERIALS FOR PRODUCTION All raw materials are tested for compliance to PMSMedikal raw material /purchase specifications which are defined by EN ISO 11607:2006 part 1 and part 2 EN ISO part 1:2005 EN EN Any raw material, which is not in compliance with those standards are not used to manufacture PMSSteripack products. The physical properties are checked by the Quality Assurance Department on every mother roll of paper before manufacturing process. 3.2 Printing Ink Printing The Flexo printing technique is used to place the print on the paper. The ink used for text printing is water baed and black which is resistant to extreme conditions of sterilization at 140 C (284 F) for 10 minutes Indicators Indicators on the products are ISO :2005 compliant. The process indicator inks are water based inks and meet or exceed the requirements of the EN ISO :2005 standard. The color change is defined as: STEAM : from pink to brown EO : from green to yellow FO : from pink to green * Appendix VIII Technical Data Sheet Flat Reel 3.1 Paper Classification The Medikal Kraft Paper is produced according to the requirements defined by European Standard EN 868-3:1999. The paper is suitable for STEAM, EO and FO sterilization processes Properties of the Paper All requirements listed in the table below are fulfilled at any time Testing of Indicators The process indicators for STEAM, EO and FO sterilization processes are tested according to EN ISO :2005 by an independent, accredited test institute. The indicators on PMSSteripack products are in compliance to ISO :2005 at any time STEAM Indicator Testing Results The STEAM Indicator on PMSSteripack product is ISO :2005 complaint. Properties Units Standard or Test Methods Avg. min max Substance g/m2 BS EN ISO ,6 60,2 61 Bendsten Porosity ml/mm BS Tensile Strength /MD N/15mm EN ISO ,8 116 Tensile Strength /CD N/15mm EN ISO ,5 52,6 57 Wet Tensile Strength /MD N/15mm BS 2922(Part2) 30, ,9 Wet Tensile Strength /CD N/15mm BS 2922(Part2) 17,2 15,7 19 Tear Strength /MD mn EN Tear Strength /CD mn EN Burst Strength Kpa BS Wet Burst Kpa BS 2922(Part1) Bendsten Roughness FS ml/mm BS Bendsten Roughness WS ml/mm BS Water Repellency second EN (app.a) COBB Test (60s) g/m2 BS EN ,9 14,8 17,7 Sulphate Content % ISO ,25 Chloride Content % ISO ,1 Free from lead and heavy metals and toxic materials p a g e 6

7 STEAM Indicator color changes at pass, fail and dry heat cycles: 3.3 Film (Polyester/Polypropylene) Properties of the film The multilayer plastic film (polyester/polypropylene) is transparent five layers, non toxic and has heat sealing properties with medical paper. The plastic film meets and exceeds all requirements listed in the table below according to EN standard at any time. A special formula designed by PMSMedikal causes a low crystallization and increases the tear strength EO Indicator Testing Results The EO Indicator on PMSSteripack product is ISO :2005 complaint. Properties Unit Standard or Before STEAM After STEAM Test Methods Exposure Exposure Thickness Microns ASTM D ,2 51,4 COF F/M 0,18 0,16 ASTM F 1894 B/M 0,19 0,21 Thermal Seal C ASTM F Elongation at MD % ASTM D 882 Break TD Tensile Strength kgf/ MD 5,2-5,8 5,6-6,3 ASTM D 883 at Break mm2 TD 5,4-5,8 6,3-6,4 Tear G MD D 1922 TD Gloss % ASTM D Haze % ASTM D ,1 7,3 Free from lead and heavy metals and toxic materials EO Indicator color changes at pass and fail cycles: Film Color & Lamination The color of the film is given by the pre-colored adhesive during the production. Color is lightly green: TEST SPECIFICATION METHOD Lightly green color As per reference sample check [app: 0,28 g/m 2 Visual per reference sample pigment 4/* 10%] FO Indicator Testing Results The FO Indicator on PMSSteripack product is ISO :2005 complaint. Lamination Quality TEST SPECIFICATION METHOD CPP on PET film lamination check As per quality control lamination form FR-38/R 01/ Visual / Lab / Sterilizer / Thickness Gauge / Tensile Tester 4. FINAL PRODUCT TESTING * Appendix IX - Test Report for STEAM Indicator Testing * Appendix X - Test Report for EO Indicator Testing * Appendix XI - Test Report for FO Indicator Testing To provide the highest quality for PMSSteripack products at any time is the first priority of PMS Medikal Ltd. All final PMSSteripack Sterilization Reel sand Pouches are tested for compliance to ISO /2:2006 and ISO :2005 in own facility laboratory and/or in an independent and accredited test institute. 4.1 Seal Strength The seal strength of PMSSteripack Sterilization Reels and Pouches are tested in the facility laboratory. The seal strength specifications are defined as: Properties Units Value / Spec Method frequency Seal strength For film and N/15mm Target: 3,00 ± 0,5 product width <25cm EN paper change Seal strength Annex D & every N/15mm Target: 3,75 ± 0,75 product width >25cm 30min. p a g e 7

8 4.2 Specification Table The properties, test methods and the frequency of the tests for the final products are listed as below: Properties Units Value / Spec Method frequency Seal width Mm 10 ± 2 mm Bubble Test Pinhole determination Dimension Control Leakage Test Peel direction STEAM Ind. control EO Ind. Control FO Ind. Control PET/PP film laminate bond strength PET/PP film laminate delaminating Aseptic presentation pcs pcs n/a pcs pcs pcs pcs pcs No leakage acc. Standard No pinholes acc. standard Refer to internal documentation No seal leaks acc. standard No fibers remaining on the testing tape Color change from pink to brown Color change from green to yellow Color change from pink to green ASTM F ASTM F EN Annex B EN Annex F ASTM F EN Annex E Visual External check External check For film and paper change & every 30min. Paper or film change Each film roll Paper or film change Paper or film change For every printed paper roll For every printed paper roll Every incoming material lot Every incoming material lot N/15mm >2,7 N/15mm ASTM F 88 Each film roll pcs pcs None allowed No film or paper tear STEAM sterilization 134C /7min Peel off/open slow way Bioburden testing pcs Run and record ISO Particles / cleanliness pcs None allowed Visual Microbial barrier Wrinkles in films or seals pcs Must fulfill all requirement of ISO :2006 pcs None allowed Visual Jagged edges pcs None allowed Visual Stewed printing pcs ± 2 mm Visual Print image pcs According artwork readable 4.3 Bioburden Test to and In accordance ISO :2006 Visual Each film roll Every 30min. of production At least once a year Every 30min. of production At least every 6 month Every 30 min of production Every 30min of production For every printed paper roll For every printed paper roll PMSSteripack Sterilization Reels and Pouches fulfill the bioburden property requirements according to ISO :2006 * Appendix XII - Bioburden Test Report (Flat Reel) * Appendix XIII - Recovery Bioburden Test Report (Flat Reel) 4.5 Ageing Studies Accelerated Ageing A 5 years shelf life for PMSSteripack products is guaranteed under specified storage conditions. To ensure the highest quality and to determine the shelf life of products, accelerated ageing study valid for 5 years has been applied by using accelerated ageing method ASTM F * Appendix XV Accelerated Ageing Test Report (Flat Reel) * Appendix XVI Accelerated Ageing Test Quality Control Report (Flat Reel) Natural Ageing PMSSteripack products have past several developments in the last years. The new converting facility for co-extrusion, coating, laminating and modernized printing processes including design changes on the product himself caused a new Natural Ageing Study for the actual final product. The physical property tests are applied in a 6 th, 12 th, 18 th, 24th, 36 th, 48 th and 60 th month period. 5. OPERATION The manufacturing of PMSSteripack Sterilization Reels and Pouches are done according to ISO 13485:2003 guideline. 5.1 Manufacturing Process Process The manufacturing process includes the printing of the paper (artwork and chemical indicators), the lamination of PET and PP films, heat sealing of the film and paper to reels and pouches and the final packaging. 4.4 Microbial Barrier PMSSteripack sterile barrier systems are proven microbial barriers. Products are tested and documented. The test has been applied as a Package Integrity Test. This test checks the microbial barrier property of the whole package instead of only the paper. The Package Integrity Test Results confirms the microbial barrier property of the whole PMSSteripack package as effective. * Appendix XIV - Microbial Barrier Test Report p a g e 8

9 5.1.2 Process Validation The production process is validated. As a requirement of EN ISO :2006 all equipments, machines and processes used for PMSSteripack Sterilization Reels and Pouches manufacturing a process validation has been conducted. This includes: - SOP - General Validation Plan - IQ, OQ and PPQ plans and reports for used manufacturing equipments - IQ, OQ plans and reports for production areas, rooms and laboratories 5.2 LOT Number Every PMSSteripack Sterilization Reel and Pouch is provided with a LOT number printed on the product itself. This LOT number allows the traceability of the manufacturing process of the product. The LOT code is using following format: WW YY WW = week of the year YY = year of manufacturing 5.3 Expiry Date / Shelf Life The Shelf Life of PMSSteripack Sterilization Reels and Pouches are 5 years under following storage conditions. (See chapter 5.6 Storage Conditions) The product must be used within 5 years from date of manufacture. The expiry date, as well as that of manufacturing, is printed on the label of the shipping carton. 5.4 Packaging Packaging for delivery For transportation and storage of PMSSteripack Sterilization Reels and Pouches following materials are used: * Inner packaging (PP foil, PE bag) * Outer packaging (double wall corrugated cardboard box) * Pallet: 4Way wooden pallet, heat treated according to ISPM-15 * Edge protections * 12mm wide PET belt Reels and Pouches Packaging of Reels Each roll of 70/100 and 200 m reels are placed in a PE bag and then into a cardboard box Instructions for Use (IfU) An Instruction of Use is placed in every shipping carton together with the PMSSteripack product. The IfU contents the product description, instructions for use including the storage conditions and it is original translated in 11 languages. 5.5 Labels Labels of bundles and cores The labels attached on the pouch bundles and reel cores are including following details: * REF Number * LOT Number * Manufacturing date * Continuous number for each wrap/roll * Machine number used for manufacturing Labels for Shipping Carton The labels attached on the shipping cartons are including following details: * Description * Size * Product Code * Quantity * Manufacture Date * Expiry Date * Lot Number * Storage conditions (as graphics) * Barcode * Manufacturer contact details 5.6 Storage Conditions PMSSteripack Sterilization Reels and Pouches have to be stored under below listed conditions: * Stored in original packaging * Between +10/40 O C and max. 60%RH humidity * Protected from direct sunlight, moisture and excessive airflow * stored under dry and controlled conditions It is highly recommended to store PMSSteripack products under mentioned conditions to ensure the high quality and properties of the sterile barrier systems Packaging of Pouches The sterilization pouches are packed in bundles of 250/200 and 100 pieces and wrapped by using PP film. After the wrapping they are placed into a cardboard box. p a g e 9

10 Appendix I ISO 9001:2008 Certification p a g e 10

11 Appendix II ISO 13485:2003 Certification p a g e 11

12 Appendix III Table of Contents of Quality Systems Manual p a g e 12

13 Appendix III Table of Contents of Quality Systems Manual (page 2) p a g e 13

14 Appendix III Table of Contents of Quality Systems Manual (page 3) p a g e 14

15 Appendix IV TS EN Certification p a g e 15

16 Appendix V CE Declaration of Conformity p a g e 16

17 Appendix VI ISO /2Conformity Statement p a g e 17

18 Appendix VII ISO Conformity Statement p a g e 18

19 Appendix VIII Technical Data Sheet Sterilization Flat Reel p a g e 19

20 Appendix IX Test Reports of STEAM Indicator Testing p a g e 20

21 Appendix IX Test Reports of STEAM Indicator Testing (page 2) p a g e 21

22 Appendix IX Test Reports of STEAM Indicator Testing (page 3) p a g e 22

23 Appendix X Test Reports of EO Indicator Testing p a g e 23

24 Appendix X Test Reports of EO Indicator Testing (page 2) p a g e 24

25 Appendix X Test Reports of EO Indicator Testing (page 3) p a g e 25

26 Appendix XI Test Reports of FO Indicator Testing p a g e 26

27 Appendix XI Test Reports of FO Indicator Testing (page 2) p a g e 27

28 Appendix XI Test Reports of FO Indicator Testing (page 3) p a g e 28

29 Appendix XII Bioburden Test Report (Flat Reel) p a g e 29

30 Appendix XIII Recovery Bioburden Test Report (Flat Reel) p a g e 30

31 Appendix XIV Microbial Barrier Test Report p a g e 31

32 Appendix XIV Microbial Barrier Test Report (page 2) p a g e 32

33 Appendix XIV Microbial Barrier Test Report (page 3) p a g e 33

34 Appendix XIV Microbial Barrier Test Report (page 4) p a g e 34

35 Appendix XIV Microbial Barrier Test Report (page 5) p a g e 35

36 Appendix XV Accelerated Ageing Test Report (Flat Reel) p a g e 36

37 Appendix XVI Accelerated Ageing Test Quality Control Report (Flat Reel) p a g e 37

38 Appendix XVI Accelerated Ageing Test Quality Control Report (Flat Reel) page 2 p a g e 38

39 Appendix XVI Accelerated Ageing Test Quality Control Report (Flat Reel) page 3 p a g e 39

40 Appendix XVI Accelerated Ageing Test Quality Control Report (F lat Reel) page 4 p a g e 40

41 Appendix XVI Accelerated Ageing Test Quality Control Report (Flat Reel) page 8 p a g e 41