KIMTECH PURE * A5 Sterile Apparel DATA PACK

Transcription

1 KIMTECH PURE * A5 Sterile Apparel DATA PACK 1

2 Table of Contents Technical Data Sheets...3 Case Labels...6 Package Labels...11 Certificate of Conformance...16 Certificate of Irradiation...17 Validation Report...19 Product Sheets...41 Posters

3 KIMTECH PURE* A5 Sterile Cleanroom Apparel Product Information Code Description Color Size Case/Pack Coverall White Small 25/case Coverall White Medium 25/case Coverall White Large 25/case Coverall White XL 25/case Coverall White 2XL 25/case Coverall White 3XL 25/case Coverall White 4XL 25/case Coverall White 5XL 25/case Coverall White 6-8XL 25/case Hood w/ties White Universal 100/case Hood White Universal 100/case NEW! Integrated Hood & Mask White Universal 75/case NEW! Sleeve Protector, 18 White Universal 100 pairs NEW! Boots w/grasp ties & vinyl trimmed edge White SM / MD 100 pairs NEW! Boots w/grasp ties & vinyl trimmed edge White Universal 100 pairs NEW! Boots w/grasp ties & vinyl trimmed edge White XL / 2XL 100 pairs Boots w/ties White SM/MD 100 pairs Boots w/ties White Universal 100 pairs Boots w/ties White XL/2XL 100 pairs Additional Attributes 100% Polypropylene Breathable SMS Fabric Suitable for ISO Class 5 or higher cleanrooms CE Marked, Category III, PPE Manufactured in ISO9001:2000 facility Triple bagged, vacuum packaged, includes sterility indicator Folded inside out or cuffed for aseptic donning No Silicone, No Latex, No BHT preservative Certificate of Conformance available online at Certificate of Irradiation available online at Expiration date 5 years from manufacture Coveralls Bound seams & REFLEX* Design see catalog for sizing Coveralls and Sleeves - Tunneled elastics and Thumbs loops Boots Vinyl Sole, Serged Seams Boots w/grasp ties Vinyl trimmed edges; ties attached at foot for better fit. KIMTECH PURE* A5 Cleanroom Apparel Technical Data Property Units Results Standards Bacterial Filtration Efficiency (3.0μ) % 97 ASTM F2100 Particle Filtration Efficiency (0.5μ) % 94 ASTM F2299 Sterilization (SAL 1 ) Gamma Irradiated ANSI/AAMI/ISO Trap Tear, MD lbf 10.0 ASTM D5722, IST Trap Tear, CD lbf 6.0 ASTM D5722, IST Grab Tensile, MD lbf 29 ASTM D5034 Grab Tensile, CD lbf 20 ASTM D5034 Hydrostatic Head cm H2O 80 AATCC-127 Air Permeability cfm/ft ASTM D737, IST 70.1 Water Vapor Transmission Rate g/m 2 /day 29,976 ASTM D6701 Flammability -- Class 1 16 CFR 1610 Particle Shedding (Helmke Drum) -- Category 1 IEST-RP-CC003.3 Non-neutralized aerosol 1 Sterility Assurance Level Results listed are prior to sterilization Workmanship Requirement: Apparel shall be made in accordance with reasonable industry practice with respect to defects, dirt and contamination. Apparel should be packaged as specified having described size and in the appropriate quantity as listed. For additional information: or kimtech@kcc.com Kimberly-Clark warrants that its products (1) comply with K-C s standard specifications as of the delivery date to K-C s authorized distributors/direct purchasers and are warrantied for the following periods from end user s date of purchase (verified by valid sales receipt) (a) five years for Balder Technology auto darkening filters; (b) two years for all other auto darkening filters; and (c) one year for powered air purifying respirators; (2) comply with all K-C labeling representations; and (3) are manufactured in compliance with all applicable federal, state, and local laws in effect at the time and place of manufacture of the products. THIS WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. K-C is not liable for any kind of special, incidental, or consequential damages. K-C s liability for breach of contract, tort or other cause of action shall not exceed the product purchase price. Purchasers and users are deemed to have accepted the above warranty and limitation of liability, and cannot change the terms by verbal agreement or by any writing not signed by K-C. To the extent required by applicable law, K-C does not limit its liability for death/injury resulting from K-C s negligence. /*Trademarks of Kimberly-Clark Worldwide, Inc. or its affiliates. Marques déposées de Kimberly-Clark Worldwide, Inc. ou de ses filiales KCWW. Published May

4 KIMTECH PURE* A5 Cleanroom Sterile Sleeves with CLEAN-DON* Technology Code: % Polypropylene Breathable SMS Fabric Suitable for ISO Class 5 or higher cleanrooms. Cloth-like feel Tunneled elastic and bound seams Triple-bagged Product Information: Code Color Size Case Count White pairs/case; 1 pair/inner bag; 25 pairs/secondary bag Property Target Description Lint Generation (>0.5μm) Category 1 Helmke Drum IEST RP-CC003.3 Sterilization (SAL*) 10-6 Gamma Irradiation Material** 1.8 osy (61gsom) SMS Nonwoven *Sterility Assurance Level **Additional physical property data for all KIMTECH PURE* A5 Apparel is listed below. KIMTECH PURE* A5 Sterile Cleanroom Apparel Technical Data Property Units Results Standards Bacterial Filtration Efficiency (3.0 μ) % 97 ASTM F2100 Particle Filtration Efficiency (0.5 μ) % 94 ASTM F2299 Trap Tear, MD lb f 10.0 ASTM D5722, IST Trap Tear, CD lb f 6.0 ASTM D5722, IST Grab Tensile, MD lb f 29 ASTM D5034 Grab Tensile, CD lb f 20 ASTM D5034 Hydrostatic Head cm H 2 O 80 AATCC-127 Air Permeability cfm/ft ASTM D737, IST 70.1 Water Vapor Transmission Rate g/m 2 /day 29,976 ASTM D6701 Flammability - Class 1 16 CFR 1610 non-neutralized aerosol Patent-Pending Highly Visible Blue Line along the inside of the sleeve signals the proper place to grasp while donning, helping workers avoid touching the outside of the sleeve. Results listed are prior to sterilization. Attributes The sleeve is folded with top portion folded and cuffed over the bottom (wrist) portion, exposing the inside to assist in aseptic donning. Innovative Cuff Fold pattern presents the inside of the sleeves as the package is opened, reducing the risk of touching and contaminating the outside of the sleeves Integrated Thumb Loop keeps sleeve from rolling back and exposing arm or wrist. Each individually bagged pair of sleeves has a sterilization indicator as a visual indicator that it has undergone gamma sterilization. This sleeve is CE marked (CE simple). This garment is designed for cleanroom environments and is used in markets such as: -Pharmaceuticals -Biotechnology -Medical Device Manufacturing Expiration Date is 5 years after production date. For additional information: or kimtech@kcc.com Workmanship Requirement: Sleeves shall be made in accordance with reasonable industry practice with respect to defects, dirt and contamination. Sleeves should be packaged as specified having described size and in the appropriate quantity as listed. For additional information: or kimtech@kcc.com Kimberly-Clark warrants that its products (1) comply with K-C s standard specifications as of the delivery date to K-C s authorized distributors/direct purchasers and are warrantied for the following periods from end user s date of purchase (verified by valid sales receipt) (a) five years for Balder Technology auto darkening filters; (b) two years for all other auto darkening filters; and (c) one year for powered air purifying respirators; (2) comply with all K-C labeling representations; and (3) are manufactured in compliance with all applicable federal, state, and local laws in effect at the time and place of manufacture of the products. THIS WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. K-C is not liable for any kind of special, incidental, or consequential damages. K-C s liability for breach of contract, tort or other cause of action shall not exceed the product purchase price. Purchasers and users are deemed to have accepted the above warranty and limitation of liability, and cannot change the terms by verbal agreement or by any writing not signed by K-C. To the extent required by applicable law, K-C does not limit its liability for death/injury resulting from K-C s negligence. /*Trademarks of Kimberly-Clark Worldwide, Inc. or its affiliates. Marques déposées de Kimberly-Clark Worldwide, Inc. ou de ses filiales KCWW. 4

5 KIMTECH PURE* A5 Cleanroom Sterile Integrated Hood and Mask with CLEAN-DON* Technology Product Information Code Description Color Size Case/Pack NEW! Integrated Hood & Mask, Sterile White Universal 75/case Additional Attributes Suited for ISO Class 5 or higher cleanrooms CE Marked - Category III, PPE Hood and Mask sonically welded together Triple-bagged, vacuum packaged, includes sterility indicator Folded inside out for aseptic donning, blue indicator line on interior Tunneled elastic and bound seams CLEAN-DON* ties for easy gowning No Silicone, No Latex, No BHT preservative Expiration Date 5 years from manufacture Certificate of Conformance available online at KIMTECH PURE* M3 Sterile Facemask Technical Data Property Units Results Standards Binding - White Hydro entangled Polyester Nosepiece - Fully enclosed, Soft, Malleable Aluminum Outer Facing - Clear, Polyethylene Apertured Film Inner Facing - White, BICOSOF TM Fabric Filter Media - White, Meltblown Polyester Mask Width 9 in (23 cm) Bacterial Filtration Efficiency (3.0µ), Post-Sterilization % 94.2 MIL-M-36954C Particle Filtration Efficiency (0.1µ), Post-Sterilization % 92.9 ASTM F Sterilization (SAL 1 ) Gamma Irradiated ANSI/AAMI/ISO Differential Pressure, 8 LPM flow rate, Post-Sterilization mm H2O 2.37 MIL-M-36954C 1 Sterility Assurance Level KIMTECH PURE* A5 Hood Technical Data Property Units Results Standards 100% Polypropylene SMS Fabric Bacterial Filtration Efficiency (3.0μ), prior to sterilization % 97 ASTM F2100 Particle Filtration Efficiency (0.5μ), prior to sterilization % 94 ASTM F2299 Sterilization (SAL 1 ) Gamma Irradiated ANSI/AAMI/ISO Trap Tear, MD lbf 10.0 ASTM D5722, IST Trap Tear, CD lbf 6.0 ASTM D5722, IST Grab Tensile, MD lbf 29 ASTM D5034 Grab Tensile, CD lbf 20 ASTM D5034 Hydrostatic Head cm H2O 80 AATCC-127 Air Permeability cfm/ft ASTM D737, IST 70.1 Water Vapor Transmission Rate g/m 2 /day 29,976 ASTM D6701 Flammability - Class 1 16 CFR 1610 Particle Shedding (Helmke Drum) - Category 1 IEST-RP-CC003.3 Non-neutralized aerosol 1 Sterility Assurance Level Workmanship Requirement: Apparel shall be made in accordance with reasonable industry practice with respect to defects, dirt and contamination. Apparel should be packaged as specified having described size and in the appropriate quantity as listed. For additional information: or kimtech@kcc.com Kimberly-Clark warrants that its products (1) comply with K-C s standard specifications as of the delivery date to K-C s authorized distributors/direct purchasers and are warrantied for the following periods from end user s date of purchase (verified by valid sales receipt) (a) five years for Balder Technology auto darkening filters; (b) two years for all other auto darkening filters; and (c) one year for powered air purifying respirators; (2) comply with all K-C labeling representations; and (3) are manufactured in compliance with all applicable federal, state, and local laws in effect at the time and place of manufacture of the products. THIS WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. K-C is not liable for any kind of special, incidental, or consequential damages. K-C s liability for breach of contract, tort or other cause of action shall not exceed the product purchase price. Purchasers and users are deemed to have accepted the above warranty and limitation of liability, and cannot change the terms by verbal agreement or by any writing not signed by K-C. To the extent required by applicable law, K-C does not limit its liability for death/injury resulting from K-C s negligence. /*Trademarks of Kimberly-Clark Worldwide, Inc. or its affiliates. Marques déposées de Kimberly-Clark Worldwide, Inc. ou de ses filiales KCWW. 5 Revised November 2013

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11 REF * *5 year expiration XL LOT STERILE R Package Label 11

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16 Certificate of Conformance KIMTECH PURE* A5 Cleanroom Sterile Apparel Product: KIMTECH PURE* A5 Cleanroom Sterile Apparel Lot number: AR912702X Code Description Size Packaging Coveralls L 25/case Coveralls XL 25/case Coveralls 2XL 25/case Coveralls 3XL 25/case Coveralls 4XL 25/case Hoods One size fits all 100/case This document certifies that the lots listed above conform to Kimberly-Clark s internal specifications for particle counts and sterility, of which the targets are listed below. Kimberly- Clark uses a system of in-process and lot inspections to assure conformance to specifications. Characteristic Specification Target Particle Count (Helmke Drum, IEST-RP-CC003.3) Category I 1 Sterility Assurance Level 10-6 A color change from yellow to red of the indicator dots affixed to both the case and individual bags confirms that products have been irradiated. Verified by:. Date: June 1, 2009 Registered Trademark and * Trademark of Kimberly-Clark Worldwide, Inc KCWW. All Rights Reserved. Form # KP-FORM-00008/3. 1 Product is tested prior to sterilization 16

17 1 Kimberly-Clark 1400 Holcomb Bridge Rd., Roswell, GA USA, Form# KP-FORM-00052/0 17

18 2 Kimberly-Clark 1400 Holcomb Bridge Rd., Roswell, GA USA, Form# KP-FORM-00052/0 18

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20 Issued October 13, 2010 VD-Max32.5 Radiation Validation Protocol # P Rev.0 Kimberly-Clark Page 2 of 8 Terms and Conditions of Study Any and all reports and letters issued by SteriPro Consulting or SteriPro Laboratories, divisions of Sterigenics U.S., LLC (collectively referred to as Sterigenics ) are for the sole and exclusive use of Sterigenics and the sponsor to whom they are addressed. Sterigenics strictly prohibits any other use or reproduction of any reports or portions thereof, quotations from any such reports or use of Sterigenics name without Sterigenics prior written consent. Sponsor acknowledges and shall be deemed to have agreed, upon its use of Sterigenics services that the significance of any data is subject to the adequacy and representative character of the samples tendered for testing. Sterigenics warrants only that all tests are performed in accordance with established laboratory procedures and standards. Sterigenics makes no other warranties or representations of any kind, express or implied, including but not limited to anything regarding the adequacy of the samples tendered for testing for any specific use or application, such determination being the sole responsibility of the sponsor. Sponsor acknowledges and shall be deemed to have agreed, upon its use of Sterigenics services, that Sterigenics liability for any loss or damage resulting from Sterigenics acts or omissions shall in no event exceed the cost of tests performed. In no event shall Sterigenics be liable for any special, indirect, incidental, consequential, punitive or other similar damages, including but not limited to damages arising from death, bodily injury, property damage (other than as set forth herein), loss of profits or revenue or loss of use of any samples or products. Confidential 20

21 Issued October 13, 2010 VD-Max32.5 Radiation Validation Protocol # P Rev.0 Kimberly-Clark Page 3 of 8 Table of Contents Title Page 1. Scope 4 2. Objectives 4 3. Rationale 5 4. Terms and Definitions 5 5. Responsibilities 5 6. Product Specifications 5 7. Bioburden Study Method 6 8. Verification Study Method 6 9. Acceptance Criteria Routine Sterilization References 8 Confidential 21

22 Issued October 13, 2010 VD-Max32.5 Radiation Validation Protocol # P Rev.0 Kimberly-Clark Page 4 of 8 1. Scope This study will be performed to establish a 32.5-kGy minimum dose and validate the effectiveness of Gamma Radiation sterilization of the KIMTECH PURE* A5 Cleanroom Sterile Apparel. Please refer to the Product Family Members Table below for all products included in this sterilization family. This protocol describes procedures for validation of radiation sterilization of medical products in accordance with AAMI TIR 33: Sterilization of health care products Radiation Substantiation of a selected sterilization dose Method VD-Max. 2. Objectives Product Family Members Description Kimtech Pure* A5 Cleanroom Sterile Apparel - Coveralls - Size S Kimtech Pure* A5 Cleanroom Sterile Apparel - Coveralls - Size M Kimtech Pure* A5 Cleanroom Sterile Apparel - Coveralls - Size L Kimtech Pure* A5 Cleanroom Sterile Apparel - Coveralls - Size XL Kimtech Pure* A5 Cleanroom Sterile Apparel - Coveralls - Size 2XL Kimtech Pure* A5 Cleanroom Sterile Apparel - Coveralls - Size 3XL Kimtech Pure* A5 Cleanroom Sterile Apparel - Coveralls - Size 4XL Kimtech Pure* A5 Cleanroom Sterile Apparel - Coveralls - Size 5XL Kimtech Pure* A5 Cleanroom Sterile Apparel - Coveralls - Size 6XL/7XL/8XL Kimtech Pure* A5 Cleanroom Sterile Apparel - Hoods - One size fits all Kimtech Pure* A5 Cleanroom Sterile Apparel - Boots Size S/M Kimtech Pure* A5 Cleanroom Sterile Apparel - Boots Size L Kimtech Pure* A5 Cleanroom Sterile Apparel - Boots XL/2XL 2.1. Preliminary bioburden data has determined the Kimtech Pure* A5 Cleanroom Sterile Apparel - Coveralls - Size 6XL/7XL/8XL as the Dose Setting Device for this sterilization family The Dose Setting Device for the product family will be the test sample for this validation. Presterilization bioburden level will be determined to establish the appropriate verification dose Recommendation for a routine minimum sterilization dose will be based on evaluation of microbial survivors following exposure of products to the verification dose. The minimum dose of 32.5 kgy will be designed to provide a Sterility Assurance Level (SAL) of 10-6 or not more than one non-sterile unit for each one million units sterilized at that dose level This study is intended to support release of products for which exposure to the minimum required dose can be demonstrated by the use of calibrated dosimeters and without post-exposure sterility testing of each lot. Confidential 22

23 Issued October 13, 2010 VD-Max32.5 Radiation Validation Protocol # P Rev.0 Kimberly-Clark Page 5 of 8 3. Rationale 3.1. The VD-Max validation is utilized to determine the minimum effective processing dose for radiation sterilization. The validation is based on the concept that the product bioburden for the overall average or a single lot average (if greater than twice the overall average) bioburden will be less than 100,000 colony forming units The VD-Max procedure analyzes the number and resistance of the bioburden on the product. Three independent lots of product are tested for bioburden levels, and the bioburden recovery efficiency (percent recovery) is determined. The bioburden recovery efficiency and the sample item portion (percent of unit tested) are used to calculate the theoretical device bioburden on each test unit. The final bioburden estimate is used to determine the verification dose from the radiation dose tables specified in AAMI TIR The verification dose (sub-lethal) provides a SAL of A verification experiment must be performed to verify that the product bioburden resistance is less than or equal to the standard distribution of resistances used in the AAMI radiation guidelines Following completion of the study, a final report shall be generated by SteriPro, which shall be signed and approved by designated individuals from SteriPro, and Kimberly-Clark. This report shall be submitted to Kimberly-Clark and SteriPro will retain a copy as specified in the SteriPro procedure for record retention. 4. Terms and Definitions Refer to ANSI/AAMI/ISO 11137:2006, AAMI TIR 33, and ANSI/AAMI/ISO 11737:2006 for definitions of terminology. 5. Responsibilities 5.1. Contract Irradiator Sterigenics, Corona or Charlotte will be responsible for all equipment, process qualification, dosimeter calibration, and all documentation involving the ExCell irradiator s validation. A certificate of processing will be provided for the product in this study. All other Sterigenics records that are specific to this study will be available to the sponsor upon request or audit Contract Laboratory SteriPro Labs, Itasca will perform the necessary microbiological testing for this validation and will provide all necessary documentation for the Final Report. BSI Certification, certificate numbers 2005-OSL-AQ-7662 and 2005-OSL-AQ-0212 certify SteriPro Labs to ISO 9001 and ISO Product Specifications 6.1. Product Sample Amounts Forty-eight (48) finished, routine product samples will be submitted in standard, final packaging format for all testing. These units shall be pulled after all steps of production except sterilization and be produced under current good manufacturing practice conditions. From the 48 product samples, there shall be three independent lots of ten samples each for bioburden determination. The 18 remaining samples may come from one or more production lots. Confidential 23

24 Issued October 13, 2010 VD-Max32.5 Radiation Validation Protocol # P Rev.0 Kimberly-Clark Page 6 of Sample Item Portion (SIP) The SIP used for all testing will be The SIP that will be tested as the test sample will consist of different parts of the coverall for a total SIP of Sample Preparation Additional sample prep is needed prior to sterilization in order to facilitate testing. 7. Bioburden Study Method 7.1. Recovery Determination Efficiency of Recovery Factor (ERF) will be determined using a specific bioburden recovery test procedure, which will be performed on a minimum of five samples taken from one or more production lots. This test is performed to determine the percentage of microorganisms that can be recovered from a product Averaging the recovery obtained from the samples tested will derive the recovery factor. The bioburden test results for each lot will be adjusted by applying the ERF, in order to obtain a theoretical bioburden estimate. This theoretical bioburden estimate is a more accurate representation of the actual number of microorganisms on the product Recovery Test Method The bioburden recovery test method for the product will be performed using the repetitive extraction method or inoculated recovery method. The extraction method will be the same as the method used for the bioburden determination. This testing will be conducted using test parameters outlined in ANSI/AAMI/ISO Bioburden Determination Ten samples each from three independent lots will be tested for bioburden using a specific test procedure. Each lot will have the results reported in colony forming units (CFU), with the ERF applied. The bioburden test will include aerobic bacteria and fungal enumerations Bioburden Test Method The bioburden test method will be performed by immersion of the SIP. This testing will be conducted using test parameters defined in ANSI/AAMI/ISO Verification Study Method 8.1. Verification Dose Determination A verification dose will be determined using the tables specified in AAMI TIR 33. The verification dose determination will be based on the final bioburden estimate for the product Thirteen packaged verification samples will be sent to Sterigenics for irradiation at the calculated verification dose. The actual dose delivered will be measured and documented by Sterigenics. Sterigenics will send the samples directly to the contract laboratory after the verification dose has been performed. Confidential 24

25 Issued October 13, 2010 VD-Max32.5 Radiation Validation Protocol # P Rev.0 Kimberly-Clark Page 7 of Verification Dose Range If the maximum delivered dose exceeds the verification dose by more than 10%, the verification dose shall be repeated. If the maximum and minimum delivered dose is less than 90% of the verification dose, the verification dose may be repeated. If the delivered dose is less than 90% of the verification dose, and on the tests of sterility acceptable results are obtained, the verification experiment need not be repeated Test of Sterility The test of sterility requires ten of the verification dose samples. The results will be reported as number of samples with growth and/or the number of samples with negative growth for the ten verification dose samples Test of Sterility Method The test method will be performed by direct immersion. The test will be conducted using test parameters outlined in AAMI TIR 33 and ANSI/AAMI/ISO Bacteriostasis/Fungistasis Determination The bacteriostasis/fungistasis test requires three of the verification dose samples. This test is a validation of the test of sterility. This test will be conducted to verify that no bacteriostatic and fungistatic activity, which might compromise the sensitivity of the sterility test method, was exhibited by the samples, or formed by the verification dose exposure. The test results will be reported as a pass or fail Bacteriostasis/Fungistasis Test Method The testing method will be the same as the method used for the test of sterility. The test will be performed using parameters outlined in the current USP. 9. Acceptance Criteria Interpretation of results will be acceptable or unacceptable, as defined in AAMI TIR Verification is accepted if there are no more than one positive sterility test units out of the ten tested If two positives occur, perform another sterility test on ten additional units that have been irradiated at the same verification dose determined above. Upon completion of the second sterility test, add the number of positives from the two tests together. If the total number is two positives, verification is accepted If three or more positives occur, verification is not accepted. If the positive sterility units cannot be attributed to incorrect testing or dosing, an alternative dose determination method should be used unless the cause of the failure can be identified and corrected Bacteriostasis/Fungistasis test passes. Confidential 25

26 Issued October 13, 2010 VD-Max32.5 Radiation Validation Protocol # P Rev.0 Kimberly-Clark Page 8 of Routine Sterilization The routine sterilization dose is based on the acceptable results as outlined in Section 9 of this protocol. The 32.5-kGy minimum sterilization dose is considered valid for achieving a 10-6 SAL for the product listed With completion and acceptance of this validation study, subsequent batches of the product may be sterilized at a minimum dose of 32.5-kGy and released for use based only on the dosimeters indicating that the minimum SAL of 10-6 dose has been delivered to the product Dose audits must be performed according to an established schedule, as indicated in ANSI/AAMI/ISO References ANSI/AAMI/ISO :2006, Sterilization of health care products Microbiological methods Part 1: Determination of the population of microorganisms on product ANSI/AAMI/ISO :2009, Sterilization of medical devices Microbiological methods Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process ANSI/AAMI/ISO :2006, Sterilization of health care products Radiation Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices ANSI/AAMI/ISO :2006, Sterilization of health care products Radiation Part 2: Establishing the sterilization dose AAMI TIR 33:2005, Sterilization of health care products Radiation Substantiation of a selected sterilization dose Method VD-Max USP/NF, U.S. Pharmacopoeia (current version) Confidential 26

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41 KIMTECH PURE * A5 Sterile Cleanroom Coveralls We asked. You answered. We delivered. This innovative sterile coverall meets your cleanroom needs like no other. Engineered for comfort and performance, it features a design that helps reduce the risk of contamination, which ultimately reduces wasted garments in donning. Exceptional features and benefits make it simple to use and efficient to choose. 41

42 KIMTECH PURE * A5 Sterile Coveralls with CLEAN-DON * Technology CLEAN-DON * Technology reduces the risk of contamination associated with aseptic donning Built-In Thumb Loop keeps garment sleeve from rolling back and exposing arm or wrist Patent-Pending Highly Visible Blue Line along the inside of the garment signals the proper place to grasp while gowning, helping workers avoid touching the outside of the garment Patent-Pending Snap Technology features built-in snaps that automatically release as garment is put on, which lowers the risk of touching the floor SMS Fabric Built-In Thumb Loop Snap Technology Highly Visible Blue Line Technical Data Property Units Result Standard Property Units Result Standard Bacterial Filtration Efficiency (3.0 μ) Particle Filtration Efficiency (0.5 μ) % 97 ASTM F2100 Hydrostatic Head cm H 2 O 80 AATCC-127 % 94 ASTM F2299 Air Permeability cfm/ft ASTM D737, IST 70.1 Trap Tear, MD lbf 10.0 ASTM D5733, IST Water Vapor Transmission Rate g/m 2 /day 29,976 ASTM D6701 Trap Tear, CD lbf 6.0 ASTM D5733, IST Flammability - Class 1 16 CFR 1610 Grab Tensile, MD lbf 29 ASTM D5034 Particle Shedding (Helmke Drum) - Category 1 IEST-RP-CC003.3 Grab Tensile, CD lbf 20 ASTM D5034 non-neutralized aerosol Results listed are prior to sterilization Ordering Information Code Description Color Material Case Pack Small Coverall, Sterile White SMS Fabric Medium Coverall, Sterile White SMS Fabric Large Coverall, Sterile White SMS Fabric XL Coverall, Sterile White SMS Fabric XL Coverall, Sterile White SMS Fabric XL Coverall, Sterile White SMS Fabric XL Coverall, Sterile White SMS Fabric XL Coverall, Sterile White SMS Fabric XL Coverall, Sterile White SMS Fabric 25 ** Gamma Irradiated SAL:10-6 Good for your business, good for the planet. RightCycle * from KIMBERLY-CLARK PROFESSIONAL * is an innovative program that helps you mitigate waste and cross-contamination issues in current processes and reach Corporate Social Responsibility (CSR) and Sustainability goals. No more downcycling or upcycling. RightCycle * makes it easy to recycle previously hard-to-recycle products like cleanroom garments and gloves into a variety of useful, eco-friendly products. For more information, ask your distributor sales professional or contact KIMBERLY-CLARK PROFESSIONAL * directly at Reduce Today, Respect Tomorrow * is the KIMBERLY-CLARK PROFESSIONAL * approach to sustainability. It begins with the understanding that the way we use resources today shapes the world of tomorrow. And it has led us to focus on reducing consumption at every stage of the product lifecycle from design and manufacture to distribution and disposal. Reduction is the key to lowering the environmental impact of our activities as well as those of customers. To learn more, visit Our Guarantee Your total satisfaction means everything to us. If, for any reason, our products do not meet your expectations, Kimberly-Clark will reimburse you for your initial purchase, via FREE product, for up to $1,000. For more information on Kimberly-Clark Professional *, visit us online at Guarantee extended to consuming end-user accounts only. Kimberly-Clark warrants that its products (1) comply with K-C s standard specifications as of the delivery date to K-C s authorized distributors/direct purchasers and are warrantied for the following periods from end-user s date of purchase (verified by valid sales receipt) (a) five years for Balder * Technology auto-darkening filters; (b) two years for all other auto-darkening filters; and (c) one year for powered air-purifying respirators; (2) comply with all K-C labeling representations; and (3) are manufactured in compliance with all applicable federal, state, and local laws in effect at the time and place of manufacture of the products. THIS WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. K-C is not liable for any kind of special, incidental, or consequential damages. K-C s liability for breach of contract, tort or other cause of action shall not exceed the product purchase price. Purchasers and users are deemed to have accepted the above warranty and limitation of liability, and cannot change the terms by verbal agreement or by any writing not signed by K-C. To the extent required by applicable law, K-C does not limit its liability for death/injury resulting from K-C s negligence. /*Trademarks of Kimberly-Clark Worldwide, Inc. or its affiliates. Marques déposées de Kimberly-Clark Worldwide, Inc. ou de ses filiales. COLOR GREY - Trademark of KCWW KCWW. Printed in the U.S.A. K02705 K /13 42

43 KIMTECH PURE * A5 Sterile Cleanroom Apparel Focus on contamination control not damage control When your organization is facing serious challenges such as drug patent expirations and increasing government scrutiny, the last thing you need is trouble with your people or processes. and microbial contamination is big trouble. Let us help you create an exceptional Cleanroom with innovation solutions that will improve productivity, minimize the risk to your processes and people and do so in the most environmentally friendly way possible. Based on input from industry professionals like you, we developed protective apparel for superior comfort, protection, flexibility and efficiency: the KIMTECH PURE * A5 Sterile Integrated Hood and Mask, KIMTECH PURE * A5 Sterile Sleeve Protector and KIMTECH PURE * A5 Sterile Boots with Grasp Ties. Plus, our unique CLEAN-DON * technology makes donning easier, combining two steps in one, to save time and minimize the risk of contamination. Take control in your cleanroom today with KIMTECH PURE * A5 Sterile Cleanroom Apparel. 43

44 KIMTECH PURE * A5 Integrated Hood and Mask with CLEAN-DON * Technology Sterility assurance level 10-6 Latex-free Integrated hood/mask, sonically welded together Eliminates exposure gaps Vacuum-sealed packaging Pull-down ties in back to assist in the gowning process Innovative CLEAN-DON * technology makes donning easier and reduces risk of contamination Blue Line along inside of garment signals the proper place to grasp while donning, helping workers avoid touching the outside of the garment Stretch fit elastic Combines 2 donning steps into 1 Type 6 PPE Category III for parts of the body Universal size Code Description Case Pack Weight Case Dimensions Pallet Layers/Stack Universal Integrated Hood and Mask, Sterile x x x 5 = 40 Additonal Hoods Hood with Ties, Sterile x x x 5 = Hood, Sterile x x x 5 = 40 KIMTECH PURE * A5 Sterile Boot Covers with CLEAN-DON * Technology and Grasp Ties Sterility assurance level 10-6 Vacuum-sealed packaging Edge vinyl sole to reduce slipping and liquid penetration Side Grasp ties for secure fit. Type 6 PPE Category III for parts of the body Available in 3 sizes Code Description Case Pack Weight Case Dimensions Pallet Layers/Stack Universal Boots with Grasp Ties, Sterile 100 pairs x x x 5 = SM/MD Boots with Grasp Ties, Sterile 100 pairs x x x 5 = XL/2XL Boots with Grasp Ties, Sterile 100 pairs x x x 5 = 40 Additonal Boot Covers Universal Boots, Sterile 100 pairs x x x 5 = SM/MD Boots, Sterile 100 pairs x x x 5 = XL/2XL Boots, Sterile 100 pairs x x x 5 = 40 KIMTECH PURE * A5 Sleeve Protector with CLEAN-DON * Technology Sterility assurance level 10-6 Blue Line donning signal feature Thumb loop keeps sleeve from rolling back and exposing arm or wrist SMS Material for cloth-like comfort Type 6 PPE Category III for parts of the body 18 length Code Description Case Pack Weight Case Dimensions Pallet Layers/Stack Sleeve Protector, Sterile 100 pairs x x x 5 = 40 Good for your business, good for the planet. RightCycle * from KIMBERLY-CLARK PROFESSIONAL * is an innovative program that helps you mitigate waste and cross-contamination issues in current processes and reach Corporate Sustainability Responsibility (CSR) goals. No more downcycling or upcycling. RightCycle * makes it easy to recycle previously hard-to-recycle products like cleanroom garments and gloves into a variety of useful, eco-friendly products. For more information, ask your distributor sales professional or contact KIMBERLY-CLARK PROFESSIONAL * directly at Reduce Today, Respect Tomorrow * is the KIMBERLY-CLARK PROFESSIONAL * approach to sustainability. It begins with the understanding that the way we use resources today shapes the world of tomorrow. And it has led us to focus on reducing consumption at every stage of the product lifecycle from design and manufacture to distribution and disposal. Reduction is the key to lowering the environmental impact of our activities as well as those of customers. To learn more, visit Our Guarantee Your total satisfaction means everything to us. If, for any reason, our products do not meet your expectations, Kimberly-Clark will reimburse you for your initial purchase, via FREE product, for up to $1,000. For more information on Kimberly-Clark Professional *, visit us online at Guarantee extended to consuming end-user accounts only. Kimberly-Clark warrants that its products (1) comply with K-C s standard specifications as of the delivery date to K-C s authorized distributors/direct purchasers and are warrantied for the following periods from end user s date of purchase (verified by valid sales receipt) (a) five years for Balder Technology auto darkening filters; (b) two years for all other auto darkening filters; and (c) one year for powered air purifying respirators; (2) comply with all K-C labeling representations; and (3) are manufactured in compliance with all applicable federal, state, and local laws in effect at the time and place of manufacture of the products. THIS WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. K-C is not liable for any kind of special, incidental, or consequential damages. K-C s liability for breach of contract, tort or other cause of action shall not exceed the product purchase price. Purchasers and users are deemed to have accepted the above warranty and limitation of liability, and cannot change the terms by verbal agreement or by any writing not signed by K-C. To the extent required by applicable law, K-C does not limit its liability for death/injury resulting from K-C s negligence. /*Trademarks of Kimberly-Clark Worldwide, Inc. or its affiliates. Marques déposées de Kimberly-Clark Worldwide, Inc. ou de ses filiales. COLOR GREY - Trademark of KCWW KCWW. Printed in the U.S.A. K02890 K /13 44

45 KIMTECH PURE* A5 Sterile Cleanroom Apparel with CLEAN-DON* Technology Gowning Procedure Before Gowning Step 4: Open vacuumed-packed apparel. Step 6: Gently unfold coverall Step 7: Hold garment at waist Step 1: (Pre-Entry) Don Hair Net and Shoe Covers after removing all jewelry and cosmetics. Step 2: (Gowning) Wash hands and gown first pair of sterile gloves. Sanitize gloves after gowning each article if required. Step 3: Apply mask and hood assuring a snug fit. Tear at notched edge. Step 5: Grasp the blue line. Located on the inside middle back. utilizing blue indicator line. Arms and legs are pre-drawn and snapped in place. Garment is already folded inside-out and unzipped. Begin Gowning Snaps allow gathered-up arms and legs to expand during gowning Step 8: Put one leg in and point toe through opening until snap releases Step 9: Do the same with the other leg Step 10: Insert one arm and extend until snap releases Step 11: Do the same with the other arm Step 12: Slip thumbs through thumb loops Final Step: Cross legs and zip up coverall After A5 Sterile Cleanroom Apparel is Gowned: Add boot covers Complete gowning by adding goggles and a second pair of sterile gloves. 45 /* Trademarks of Kimberly-Clark Worldwide, Inc. Marques déposées de Kimberly-Clark Worldwide, Inc KCWW. Printed in the USA. K01115 K /08

46 KIMTECH PURE * A5 Sterile Integrated Hood and Mask Donning Technique Step 1 Select your integrated hood and mask; inspect package for vacuum seal; tear along notches toward the product to open Step 2 Pull out integrated hood and unfold to locate the blue signal indicator line Step 3 Center your chin just above the blue line then roll over your forehead. Step 4 Grab ties with both hands then extend arms out in a circular motion to position under armpits. Step 5 Pull ties across chest and secure as needed Step 6 Gently adjust front flap to comfortable position; pinch mask wire over bridge of nose to ensure proper fit. /*Trademarks of Kimberly-Clark Worldwide, Inc. or its affiliates. Marques deposees de Kimberly-Clark Worldwide, Inc. ou de ses filiales KCWW. K02705 K /12 46

47 KIMTECH PURE * A5 Sterile Boot Cover with Grasp Ties Donning Technique Step 1 Select your boot cover size; inspect package for vacuum seal; tear along notches toward the product to open; flex package to separate boot covers Step 2 Pull out one boot cover by the cuff Step 3 Grasp ties with one hand and make sure they don t touch the floor Step 4 Open up boot cover; point toe towards opening and pull up over calf while holding the ties Step 5 Hold up foot or rest on bench. Grasp ties at front of boot cover and wrap over cusp of shoe/boot; then wrap ties behind ankle and tie in front. Step 6 Place donned boot on the clean side Step 7 Pull the remaining boot cover out of package by the cuff and repeat Steps 3, 4 and 5. Proceed with final gowning steps /*Trademarks of Kimberly-Clark Worldwide, Inc. or its affiliates. Marques deposees de Kimberly-Clark Worldwide, Inc. ou de ses filiales KCWW. K02705 K /12 47