Certificate Of Compliance - ITT Industrial Products
ITT Engineered Valves, LLC33 Centerville RoadLancaster, PA 17603-2064Phone: (800) 366-1111Fax: (717) 509-2336CERTIFICATE OF COMPLIANCE / CONFORMANCEDate Issued: November 18, 2015Customer:PERRIGO CT INCQuantity:001Customer Order Number:1020649Int. Surface Finish:RA 20 MICROINCH MAXITT Order Number:916748Ext. Surface Finish:SCOTCH BRITEITT Line Number:039Electropolish Finish:INTERIOR ELECTROPOLISH ONLYITT Part Number:%EV800000962900Figure Number (Description):Customer Tag 8-1-4(B)2-N-TME-B217(C).5-N-TME-B206Serial Number(A)916748-039-001Heat Number Information:(B)(C)28005-XV-75828011-XV-716Heat / Code 630140RYL-1687BodyElbowFerruleFerruleWeld Rod316L316L316L316L316L-3"2"1/2"--A copy of the Certified Material Test Report or the Certificate of Compliance is attached for the item(s)listed above.Additional Information:34856,DIAPHRAGM WR 02.00 MC TFMCure Date: 9-15Lot No: 4000083065Expiration Date: 9-2029GR TMQuantity: 1Grade TM: Grade TM diaphragms (modified PTFE) have a LIMITED SHELF LIFE of 14 years.Grade TM diaphragms (modified PTFE) comply with the FDA Code of Federal Regulations Title 21 Section177-1550 and have been tested in accordance with and successfully passed the U.S. Pharmacopeia XXXIVClass VI @250 F (121 C) for 60 mins & 158 F (70 C) for 24 hrs, Biological Reactivity test, Section 87and Section 88.The maximum temperature rating for Grade TM diaphragms (modified PTFE) is 329 F (165 C)Grade TM diaphragms (modified PTFE) are in compliance to:10993-5: "Tests for Cytotoxicity—In Vitro Methods”10993-10: "Tests for Irritation and Sensitization.”10993-11: "Tests for Systemic Toxicity."We hereby confirm that for the production of ITT Grade TM diaphragms (modified PTFE) no material ofanimal origin has been used during the whole production process. Grade TM material is of synthetic (PTFEresin) origin.Grade TM diaphragms (modified PTFE) meets ASME BPE Part SG, Section 3.3 & 3.4This certificate is correct at the time of issue and no changes shall be made to it without the authorization of the issuing ITT Manager. Ifany unauthorized changes are made, the certificate is void.CERTIFICATE ID (167155)
Certificate of Compliance / Conformance - continuedCustomer:PERRIGO CT INCQuantity:001Customer Order Number:1020649Int. Surface Finish:RA 20 MICROINCH MAXITT Order Number:916748Ext. Surface Finish:SCOTCH BRITEITT Line Number:039Electropolish Finish:INTERIOR ELECTROPOLISH ONLYITT Part Number:%EV80000096290048041,BACKING CUSH WR 02.00 FDA B1Cure Date: 9-15Lot No: 57736Expiration Date: 9-2021GR EPDM B1Quantity: 1Grade B1: Grade B1 (EPDM) backing cushions have a LIMITED SHELF LIFE of 6 years.Grade B1 (EPDM) backing cushions comply with the FDA Code of Federal Regulations Title 21 Section177.2600 and have been tested in accordance with and successfully passed the U.S. Pharmacopeia XXXIVClass VI @250 F (121 C) for 60 mins & 158 F (70 C) for 24 hrs, Biological Reactivity test, Section 87 andSection 88.The maximum temperature rating for Grade B1 (EPDM) backing cushions is 302 F (150 C).Grade B1 (EPDM) backing cushions are in compliance to:10993-5: "Tests for Cytotoxicity—In Vitro Methods”10993-10: "Tests for Irritation and Sensitization.”10993-11: "Tests for Systemic Toxicity."Grade B1 (EPDM) complies with 21CFR 177.2600 (e) “Rubber articles intended for repeated use in contactwith aqueous food.” Exception: Grade B1(EPDM) does not comply with 177.2600 (f) “Rubber articlesintended for repeated use in contact with fatty food “.Grade B1 (EPDM) is processed with a small amount of Stearic Acid F-1000. Stearic Acid is a commonfatty acid derived from Bovine Tallow. Stearic Acid F-1000 is confirmed to be manufactured by rigorousprocesses exceeding 392 F (200 C) for greater than 20 mins. This complies with Section 6.4 TallowDerivatives of EMEA/410/01 Rev. 3, July 2011.Grade B1 (EPDM) meets ASME BPE Part SG, Section 3.3 & 3.4.Grade B1 (EPDM) is peroxide cured.34852,DIAPHRAGM WR 00.50 MC TFMCure Date: 10-15Lot No: 4000083065Expiration Date: 10-2029GR TMQuantity: 1Grade TM: Grade TM diaphragms (modified PTFE) have a LIMITED SHELF LIFE of 14 years.Grade TM diaphragms (modified PTFE) comply with the FDA Code of Federal Regulations Title 21 Section177-1550 and have been tested in accordance with and successfully passed the U.S. Pharmacopeia XXXIVClass VI @250 F (121 C) for 60 mins & 158 F (70 C) for 24 hrs, Biological Reactivity test, Section 87and Section 88.The maximum temperature rating for Grade TM diaphragms (modified PTFE) is 329 F (165 C)Grade TM diaphragms (modified PTFE) are in compliance to:10993-5: "Tests for Cytotoxicity—In Vitro Methods”10993-10: "Tests for Irritation and Sensitization.”10993-11: "Tests for Systemic Toxicity."We hereby confirm that for the production of ITT Grade TM diaphragms (modified PTFE) no material ofanimal origin has been used during the whole production process. Grade TM material is of synthetic (PTFEresin) origin.Grade TM diaphragms (modified PTFE) meets ASME BPE Part SG, Section 3.3 & 3.448037,BACKING CUSH WR 00.50 FDA B1Cure Date: 8-15Lot No: 57666Expiration Date: 8-2021GR EPDM B1Quantity: 1Grade B1: Grade B1 (EPDM) backing cushions have a LIMITED SHELF LIFE of 6 years.Grade B1 (EPDM) backing cushions comply with the FDA Code of Federal Regulations Title 21 Section177.2600 and have been tested in accordance with and successfully passed the U.S. Pharmacopeia XXXIVClass VI @250 F (121 C) for 60 mins & 158 F (70 C) for 24 hrs, Biological Reactivity test, Section 87 andSection 88.The maximum temperature rating for Grade B1 (EPDM) backing cushions is 302 F (150 C).Grade B1 (EPDM) backing cushions are in compliance to:10993-5: "Tests for Cytotoxicity—In Vitro Methods”10993-10: "Tests for Irritation and Sensitization.”10993-11: "Tests for Systemic Toxicity."Grade B1 (EPDM) complies with 21CFR 177.2600 (e) “Rubber articles intended for repeated use in contactwith aqueous food.” Exception: Grade B1(EPDM) does not comply with 177.2600 (f) “Rubber articlesintended for repeated use in contact with fatty food “.Grade B1 (EPDM) is processed with a small amount of Stearic Acid F-1000. Stearic Acid is a commonfatty acid derived from Bovine Tallow. Stearic Acid F-1000 is confirmed to be manufactured by rigorousprocesses exceeding 392 F (200 C) for greater than 20 mins. This complies with Section 6.4 TallowDerivatives of EMEA/410/01 Rev. 3, July 2011.Grade B1 (EPDM) meets ASME BPE Part SG, Section 3.3 & 3.4.Grade B1 (EPDM) is peroxide cured.Comments:This certificate is correct at the time of issue and no changes shall be made to it without the authorization of the issuing ITT Manager. Ifany unauthorized changes are made, the certificate is void.CERTIFICATE ID (167155)
Certificate of Compliance / Conformance - continuedCustomer:PERRIGO CT INCQuantity:001Customer Order Number:1020649Int. Surface Finish:RA 20 MICROINCH MAXITT Order Number:916748Ext. Surface Finish:SCOTCH BRITEITT Line Number:039Electropolish Finish:INTERIOR ELECTROPOLISH ONLYITT Part Number:%EV800000962900We certify that the components on the above referenced purchase order meet the requirements of the purchase order, applicable drawing(s), and ourISO 9001:2008 manufacturing, testing, and inspection procedures to assure an acceptable quality level applicable to the product. These items aresupplied in accordance with QMS Manual Rev 22 dated December 13, 2013.//S// Kadeem BhailaKadeem BhailaManager, Quality Assurance (or representative)(This certificate was created electronically and is valid without signature.)This certificate is correct at the time of issue and no changes shall be made to it without the authorization of the issuing ITT Manager. Ifany unauthorized changes are made, the certificate is void.CERTIFICATE ID (167155)
ITT Engineered Valves, LLC 33 Centerville Road Lancaster, PA 17603-2064 Phone: (800) 366-1111 CERTIFICATE OF COMPLIANCE / CONFORMANCE Fax: (717) 509-2336 Customer Order Number: ITT Order Number: 1020649 916748 Customer: PERRIGO CT INC 001 039
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