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Thermo Scientific™ Nalgene™ Rapid-Flow™ Filterware Certification Program Guide

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Thermo Scientific™ Nalgene™ Rapid-Flow™ Filterware Certification Program Guide Thermo Scientific™ Nalgene™ Rapid-Flow™ Filterware Certification Program Guide Testing Procedures CERTIFICATE OF QUALITY Thermo Fisher Scientific certifies that this product meets the following criteria Thermo Scientific Nalgene Disposable Filter Unit, OR Sterilization ® Nalgene Disposable Bottle Top Filter OR Product has been gamma irradiated and dosimetrically released Nalgene Disposable Filter Unit Receiver based upon ISO 11137 recommended practices. Catalog Number: Pyrogens Pore Size: µm An extract from the lot was tested and certified Lot Number: non-pyrogenic with a documented endotoxin level of < EU/ml in conformance with the Limulus Amebocyte PRODUCT CRITERIA Lysate (LAL) USP test method. Non-Fiber Releasing Membrane Flow Rate This product was manufactured using a Samples met a flow rate of < seconds for 100 ml *of deionized microporous membrane which meets the criteria for “non-fiber” water at 20°C at psig ( Bar). releasing filters as defined in 21 CFR 210.3 (b) (6) of the Food Additive *50 mL for Cat. No. 564-0020 Amendment of the U.S. Federal Food and Drug Act. Component Materials Toxicity AUDIT CRITERIA All component materials have been tested and met the requirements for United Audit criteria tests are conducted on a routine basis as States Pharmacopoeia (USP) Class VI Biological Test for Plastics, current appropriate for each product configuration manufactured. edition. The plastics meet the requirements of the United States Food and Drug Administration (FDA) for food and beverage contact in 21 CFR 177. et seq. Bioburden Heavy Metals Samples were evaluated to determine the viable microbial bioburden of the product. The resins used in the manufacture of Nalgene Disposable Filter Units do not require reporting under The Superfund Amendment and Reauthorizaton Act (SARA) Title III Section 313. They would pass Toxicity Characteristic Leaching Sterilization Dose Audit Procedure (TLCP) testing. Gamma irradiation is audited on a quarterly basis utilizing the recommended practices of ISO 11137. Membrane Gravimetric Extractable This product is not intended for use in direct patient The extractable level of the membrane was less care or diagnostic procedures. than weight percent of the meSAMPLEmbrane. Bacterial Retention Filter membranes are quantitatively retentive at organisms using HIMA and/or ASTM methodologies. Tresia O'Shea Sterilization Validation Manager, Regulatory Compliance Gamma irradiation is validated according to ISO 11137 (sterilization of health care products – requirement for validation and routine control – Manufactured under an ISO 13485 registered radiation sterilization). Quality Management System. LOT CRITERIA The manufacturing lot was sampled, tested and 8-0405-78 1013 released by Quality Assurance for the following © 2013 Thermo Fisher Scientific Inc. All rights reserved. All trademarks are the property of characteristics: Thermo Fisher Scientific Inc. and its subsidiaries. Membrane Bubble Point Integrity Asia: China Toll-free: 800-810-5118 or 400-650-5118; India: +91 22 6716 2200, India Toll-free: 1 800 22 8374; Japan: +81 3 5826 1616; Other Asian countries: 65 68729717 Samples were tested according to an established procedure to Europe: Austria: +43 1 801 40 0; Belgium: +32 53 73 42 41; Denmark: +45 4631 2000; determine the water bubble point of the product (isopropanol for France: +33 2 2803 2180; Germany: +49 6184 90 6940, Germany Toll-free: 08001-536 376; Italy: +39 02 02 95059 or 434-254-375; Netherlands: +31 76 571 4440; Nordic/Baltic PES products and 90mm 0.2µm SFCA products). This lot meets the countries: +358 9 329 100; Russia/CIS: +7 (812) 703 42 15; Spain/Portugal: +34 93 223 09 established release criteria of 18; Switzerland: +41 44 454 12 12; UK/Ireland: +44 870 609 9203 > psig ( Bar). North America: USA/Canada +1 585 586 8800; USA Toll-free: 800 625 4327 South America: USA sales support: +1 585 899 7198 Date Stamp Sequence # Countries not listed: +49 6184 90 6940 or +33 2 2803 2180 2 Section I - Introduction: Thermo Scientific Nalgene Filtration The Thermo Scientific™ Nalgene™ Certificate of Quality Table of Contents The results of 11 specific test parameters are provided on I. Introduction the Thermo Scientific Nalgene Certificate of Quality – test II. Test Specifications data that you can keep in your files. This information is particularly helpful if you are involved with products Product Criteria ...........................................................Page subject to GMP, ISO or United States FDA guidelines. Use Introduction..........................................................................3 Thermo Scientific Nalgene Filterware with confidence... it’s Toxicity Tests USP Class VI Plastic Evaluation, In Vivo .............4 certified. Toxicity Tests Cytotoxicity, In Vitro. .........................................4 Heavy Metals Status .............................................................5 Tests Performed and Testing Frequency Membrane Gravimetric Extractables ......................................5 Our product has passed the following series of stringent tests Membrane Bacterial Retention ..............................................8 and meets the specifications listed on the certificate. 1. Product Specific Criteria: Lot Criteria • Component Materials Toxicity per USP Class VI Bubble Point Determination ..................................................6 • Heavy Metal Free per SARA • Membrane Bacterial Retention Pyrogen Bacterial Endotoxin Test ...........................................6 Flow Rate.............................................................................7 2. Lot Specific Criteria: Every lot is tested • Membrane Bubble Point Integrity Audit Criteria • Sterilization: gamma irradiated and dosimetrically released per Bioburden Determination.................................................. ....8 ANSI/AAMI/ISO standards Sterilization Dose Audit...................................................... ...9 • Non-Pyrogenic: meets current USP guidelines Sterility Validation.............................................................. ...9 • Flow Rate: minimum flow rate with DI water or isopropanol per specification III. Technical Information Materials of Construction ....................................................10 3. Audit Criteria: Test is performed to support lot-specific criteria Reference Documents ........................................................10 • Bioburden: measured quarterly on product family representative Membrane Properties .........................................................10 • Sterilization Validation: Gamma irradiation validation, performed Plastic Material Properties ..................................................11 quarterly on product family representative per ANSI/AAMI/ISO Membrane Specifications ...................................................11 standards Chemical Resistance Chart .................................................12 Thermo Scientific is committed to providing the highest quality filtration products to our customers. If you have any further questions, please Thermo Scientific Nalgene Filterware contact us at the numbers listed on this publication’s back page. products are not intended for use in direct patient care or diagnostic procedures. 3 Section II - Test Specifications Product Criteria Product Criteria Toxicity Test Toxicity Test USP Class VI Plastics Evaluation, In Vivo Cytotoxicity, In Vitro Objective: To demonstrate that the materials utilized Objective: To demonstrate that the materials utilized in the in the manufacture of Thermo Scientific Nalgene manufacture of the Thermo Scientific Nalgene Certified Filterware are biologically compatible when Certified Filterware are non-cytotoxic when evaluated tested per United States Pharmacopoeia (USP) utilizing a Biological Reactivity In Vitro Diagnostic current edition Class VI Plastics Evaluation, and Procedure with a WI38 or MRC-5 cell line. are suitable as implantable materials. Though our filterware are not considered medical devices and Audit Frequency: Materials utilized in the manufacture of our filterware are not implantable, we strive to maintain the highest were evaluated once at the time of initial material quality. qualification. Materials were evaluated independently from each other. Audit Frequency: Materials utilized in the manufacture of our filterware were evaluated once at the time of initial Test Method: Materials were evaluated for their toxic effect by material qualification for compliance with USP utilizing a MEM elution technique in conjunction with Class VI requirements. Materials were evaluated a WI38 or MRC-5 cell line. independently of each other. Cell cultures were scored for their reactivity as Test Method: Three test methods were utilized to determine defined by USP, current edition, Biological Reactivity the biological response of animals to a polymeric Tests, In Vitro. or elastic material by injection of extracts intracutaneously, systemically, and direct implant of Test Results: Materials utilized in the manufacture of our filterware the material. Test methods were a Systemic Injection have been demonstrated to be non-cytotoxic by Test, an Intracutaneous Injection Test and a Muscle showing that an extract of the material does not Implant Test. cause a difference in the growth of the cells as compared to a negative control. Dosages were administered as defined by USP. Observations and scoring were conducted as defined Table 2. In Vitro Toxicity Test Results provided by by USP for each test method performed.
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