Eldon James (PP) Polypropylene Material  

Regulatory Package 

FHR 13R9A  

Animal Derivative Free Polypropylene 

 

Flint Hills Resources  Longview, Texas 

 

Certificate of Conformance/Traceability

626 West 66th Street, Loveland, CO 80538 Phone: 970.667.2728

Fax: 970.667.3204 www.eldonjames.com

Customer Name: Customer P.O. Number: xxxxxxxx

Pack Slip Number: xxxxxxx Ship Date:

Part Number: x-xxPP Customer Part Number: xxxxxxxxx Lot Number: xx-xxx xxxxxxx Quantity: xxxx Manufacture Date: xx/xx/xxxx Raw Material: Natural Polypropylene Material Grade: FHR 13R9A Manufacturer: Flint Hills Resources – Huston TX, Mfg. Odessa, TX; Lonview, TX These products are manufactured in the United States of America by the Eldon James Corp. Eldon James, Corp. fittings with a suffix of PP are molded from Virgin ingredients supplied by the manufacturer listed above. Eldon James, Corp. certifies that all fittings meet the specifications as stated in current catalogs and current Quality Control drawings. Eldon James, Corp. will not take responsibility for errors or changes customers make to in house drawings of Eldon James, Corp. products. Customers are urged to request samples if they are uncertain of what they are purchasing. Ultimately, customers must make their own determination that their use of our product(s) is safe, lawful (except as provided in the above statements), and technically suitable for their intended application(s). Food Contact US Food and Drug Administration (FDA) This material meets the FDA requirements outlined in the Code of Federal Regulations 21 CFR 177.1520(a)(3)(i) and (c)3.1a. According to our information, all other ingredients used in the formulation meet their respective FDA regulations and 21 CFR 177.1520(b). Specifically, this product meets the FDA requirements for food contact, except for cooking, as listed under conditions of use C through H in 21 CFR 176.170(c), Table 2. US Pharmacopoeia (USP) This product has been certified to USP Class VI Plastic (USP<88>, Biological Reactivity Tests, In Vivo) and USP <661> requirements. Certificate is available upon request. Gamma This material is gamma irradiation stable. Tallow/BSE/TSE We do not use tallow or any other animal derived materials in the manufacture or formulation of this product. This product is Animal Derivative Free. RoHs This product is RoHs compliant. For Additional information about the resin material used in this product, please request a PDF copy of the manufacturer’s Regulatory Information/Product Stewardship Data Sheet from the Eldon James Corp. Eldon James Corp. Date

United States Pharmacopoeia Polypropylene

Physicochemical Tests-Plastics <661> 2002 Edition USP25 / NF 20

Sample Type 13R9A (Lv) Sample ID 0019-7

Project #: PP-090113-0019__________________

TEST RESULT Pass/Fail

REQUIREMENT

NONVOLATILE RESIDUE 1.1 mg diff. Difference between blank and sample

does not exceed 15 mg on 20 ml of extract for each 120 cm2

RESIDUE on IGNITION Only done if the nonvolatile residue

exceeds 5mg. Sulfuric acid added to blank and sample. Difference <5mg

EXTRACTABLE HEAVY METALS

Pass

Sample is clearer than 1 ppm lead standard.

BUFFERING CAPACITY Pass

The difference of titrates or total of like titrates is <10 ml to bring solutions to 7pH.

Analyst:____Garry Lloyd_______________ DATE: _2/11/09________________

Reviewed By: ____________________ DATE: __11/30/10_________________

European Pharmacopoeia - Polypropylene

for Containers and Closures for Parenteral Preparations - 3.1.6, 2008 Sample Type__13R9A_________Sample ID___0019-7__________

Project #: PP-090113-0019 TEST RESULT

Pass/Fail REQUIREMENT

IR SCAN IDENTIFICATION Pass FTIR is consistent with standard, and it

shows maxima at 1375, 1170, 995, and 970 cm-1

APPEARANCE Pass Sample solution, S1, is less opalescent than ref.std. #2 and is colorless.

ABSORBANCE Pass Absorbance of solution 1 at wavelengths 220 to 340 nm is ≤ 0.2 Au

ACIDITY Pass It takes ≤1.5 ml of 0.01 m NaOH to

change 0.15 ml BRP indicator in 100 ml solution 1 to blue

ALKALINITY Pass It takes ≤ 1.0 ml of 0.01 m HCL to

change 0.2 ml of methyl orange to orange in 100 ml of solution 1

REDUCING SUBSTANCE Pass Titration difference of blank and sample, S1, is ≤ 0.5 ml

HEXANE SOLUBLES 3.43 wt % HS ≤ 0.1 g (5 wt %) residue on 10 g/100 ml Hexane for 4 hr at 75º C

Ext. Zinc Pass Solution 3 has ≤ 1.0 wppm Zn by ICP: Std specifies AA, ICP substituted.

Ext. Chromium Pass Solution 3 has ≤ 0.05 wppm Cr by ICP Ext. Aluminum Pass Solution 3 has ≤ 1.0 wppm Al by ICP Ext. Titanium Pass Solution 3 has ≤ 1.0 wppm Ti by ICP

Ext. Vanadium Pass Solution 3 has ≤ 0.1 wppm V by ICP SULFATED ASH .05 wt %ASH < 1.0wt.%

ADDITIVES by TLC or HPLC # AOs Total AO load

Pass/ Fail Contains additives not listed as EP acceptable.

Concentration less than specified for that the additive in 3.1.6.

Extractable Heavy Metals Pass Conc. Solution 3 is not darker than HM std.

Analyst: Garry Lloyd Date:__2/17/09_______________

Reviewed By: Date___11/30/10_______________

Flint Hills Resources

Products molded from 13R9A and radiated by gamma rays at a dose of 25-35 kGy have a shelf life of at least 3 years if stored at a temperature below 100 F.

This statement is based on the following criteria: 1. Shelf life statement is based on test specimens molded and tested per ASTM standards. 2. Elongation at break of at least 300%. 3. Yellowness Index increase is 10 units or less. 4. Other tensile properties are within 10% of original values when not exposed to radiation. I have copied Roger M. as he was integral in the development of this grade and may be able to answer any additional questions you may have or correct any statements above that may be incorrect.

<<13R9A USP Class VI Certificate.pdf>> <<13R9A TDS.pdf>> Regards, Blair ______________________________ Blair Colby Product Service Specialist Flint Hills Resources, LP Longview, Texas 75602

Eldon James Corporation 626 West 66th Street Loveland, CO 80538 e l d o n j a m e s . c o m 970 667-2728 fax 970 667-3204

9/9/2008 Shelf-life and storage – Eldon James PP products All Eldon James and EJ BioMed products with a PP suffix are manufactured from Huhtsman 13R9A. The manufacturer of this material, Flint Hills Resources, makes no declaration regarding its shelf-life or expiration; however, it has been Eldon James’ experience in the past 2 years of manufacturing products made from this resin, that no detectable degradation of product has taken place. Our experience indicates resins made from similar polypropylene grades generally have a shelf life in excess of 3-5 years Our experience is limited to small amounts of product left in inventory that have exceeded the normal turnover rate. The products have not been lab tested. Eldon James does not list an expiration date on any of its PP products. This is simply because we have never received any indication or feedback from customers that degradation related to age of the product occurs. We consider the shelf-life estimate given above to be conservative. Of course, it is highly dependent on storage conditions. Under well managed storage, the product could potentially have a shelf life that easily exceeds 5 years. Storage guidelines: (1) room temperature 70° (2) humidity < 75% (3) UV protected storage. Note: Plastics in general are very durable and these conditions are not absolute. Please feel free to contact me if you need any additional information. Kind regards,

William Shedd Marketing/Communications bill@eldonjames.com 970 461 4325

Microsoft Word - RoHS web letter 2011-65.doc - ROHSLETTER_Jan20... http://www.fhr.com/upload/ROHSLETTER_Jan2013.pdf

1 of 1 3/15/2013 9:33 AM

Flint Hills Resources

Products molded from 13R9A and radiated by gamma rays at a dose of 25-35 kGy have a shelf life of at least 3 years if stored at a temperature below 100 F.

This statement is based on the following criteria: 1. Shelf life statement is based on test specimens molded and tested per ASTM standards. 2. Elongation at break of at least 300%. 3. Yellowness Index increase is 10 units or less. 4. Other tensile properties are within 10% of original values when not exposed to radiation. I have copied Roger M. as he was integral in the development of this grade and may be able to answer any additional questions you may have or correct any statements above that may be incorrect.

<<13R9A USP Class VI Certificate.pdf>> <<13R9A TDS.pdf>> Regards, Blair ______________________________ Blair Colby Product Service Specialist Flint Hills Resources, LP Longview, Texas 75602

Page 1 of 5

REGULATORY INFORMATION DATA SHEET

PRODUCT STEWARDSHIP

13R9A POLYPROPYLENE COPOLYMER

Product Manufacturer This product is manufactured by Flint Hills Resources in Longview, Texas, U.S.A. Manufacturing Facility Certifications The Longview Polypropylene facility is certified to the ISO 9001:2008 Quality standard. Certificate is available upon request. The Longview manufacturing facility is certified as an OSHA VPP (Voluntary Protection Program) Star Site. Chemical Inventories Please see MSDS for chemical inventory listings. Food Contact US Food and Drug Administration (FDA): This material meets the FDA requirements outlined in the Code of Federal

Regulations 21 CFR 177.1520(a)(3)(i) and (c)3.1a. According to our information, all other ingredients used in the formulation meet their respective FDA regulations and 21 CFR 177.1520(b). Specifically, this product meets the FDA criteria for food contact, except for cooking, under conditions of use C through H as listed in 21 CFR 176.170(c), Table 2.

Page 3 of 5

Coalition of Northeastern Governors (CONEG) Flint Hills Resources does not use cadmium, chromium, lead, or mercury in the manufacture or formulation of this product. In addition, this product meets the CONEG limitation of 100 ppm for the total incidental content of cadmium, chromium, lead, and mercury. Restriction of Hazardous Substances (RoHS) This product conforms to the RoHS Directive (2002/95/EC) restricting the use of Heavy Metals, PBB’s, and PBDE’s. European Directive 2002/16/EC (BADGE,BFDGE,NOGE) This product conforms to the European Directive 2002/16/EC and its amendment 2004/13/EC. We do not use 2,2-bis(4-hydroxyphenyl)propane bis(2,3-epoxypropyl) ether (BADGE), bis(hydroxyphenyl)methane bis(2,3-epoxypropyl)ethers (BFDGE) or novolac glycidyl ethers (NOGE) in the manufacture or formulation of this product. We do not test this product for these substances. European Directive 2003/11/EC This product conforms to the European Directive 2003/11/EC of 6 February 2003 amending 76/769/EEC of 27 July 1976. We do not use Polychlorinated biphenyls (PCB), polychlorinated terphenyls (PCT), Vinyl Chloride, Pentabromo-diphenyl ethers (pentaBDE), Octabromo-diphenyl ethers (OctaBDE), or Decabromo-diphenyl ethers (decaBDE) in the manufacture or formulation of this product. We do not test this product for these substances. California’s Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65) Based on available information this product does not contain any components or chemicals currently known to the State of California to cause cancer, birth defects or reproductive harm at levels which would be subject to Proposition 65. Reformulation, use, or processing of this material may affect its composition and require re-evaluation. Ozone Depleting Chemicals (ODCs) Flint Hills Resources does not use Class I or Class II ODCs listed in the Resolution 2037/2000/EC in the manufacture or formulation of this product.

Page 4 of 5

Phthalates Although phthalates are not intentionally added in the formulation of this product, there are phthalates in the final resin as a result of catalyst residues. Analytical testing has been performed on several grades with specific phthalates determined to be in concentrations less than 5 ppm. Allergens Flint Hills Resources does not use allergens - as defined by FDA as Milk, Eggs, Fish, Crustaceans, Wheat, Soy, Peanuts, Tree Nuts - in the manufacture or formulation of this product. Additional Substance Information Flint Hills Resources does not intentionally use any of the following substances in the manufacture or formulation of this product: “natural rubber latex”, “dry natural rubber”, “synthetic latex”, “rubber that contains natural rubber”, Asbestos, Bisphenol A (BPA), Melamine, Perfluorooctanoic Acid (PFOA), Polyvinyl Chloride (PVC), Alkylphenols (nonyl- or octyl-) or Alkylphenol ethoxylates (nonyl- or octyl-), Polybrominated Biphenyls (PBB’s), Polychlorinated Biphenyls (PCB’s), Polybrominated Diphenyl Ethers (PBDE’s), Polybrominated Terphenyls (PBT’s), Polychlorinated Terphenyls (PCT’s), Brominated compounds, Tributyl-tin (TBT), Dibutyl-tin(DBT), Monobutyl-tin (MBT) or any other Organo-tin compounds. We do not test this product for these substances. Shelf Life Although Flint Hills Resources does not warranty our resins within any specific length of time, we recommend a shelf life of approximately two years, provided the material has been stored in dry conditions at temperatures below 50°C (122°F) and protected from UV and nitrous oxide exposure. Improper storage conditions can initiate premature degradation of color, odor and physical properties. European Directive (2004/12/EC) Packaging and Packaging Waste This product conforms to the European Commission Directive 2004/12/EC of 11 February 2004 amending Directive 94/62/EC on packaging and packaging waste. We recommend proper recycling of our plastics as opposed to dumping plastic products into landfills. This product is recyclable according to the recycle code 5.

Page 5 of 5

Use of this Regulatory Information Data Sheet The information provided as requested is intended to be used for informational purposes only. The information is provided on a without prejudice basis and should not be viewed as giving technical advice, instruction, or otherwise. The information is furnished free of charge and is based on Flint Hills Resources’ knowledge and understanding. Flint Hills Resources makes no representation or warranty as to the completeness or accuracy of the information contained herein. It is intended for use by persons having technical skill, at their own discretion and risk, who will make their own determination as to its suitability for their purposes prior to use. As with any material, evaluation of any compound under end-use conditions prior to specification is essential. Ultimately, customers must make their own determination that use of this product is safe, lawful, and technically suitable for their intended applications. This document is effective for one year. If a product formulation revision should change the information provided in this Regulatory Information Data Sheet (RIDS), Flint Hills Resources will notify customers to whom this regulatory sheet was provided by request through the Product Service Specialist. Flint Hills Resources will not notify you should a change in regulation(s) require a change to this RIDS. Flint Hills Resources recommends updating your files with a new RIDS on a yearly basis. Verified for Flint Hills Resources, LP by:

Blair Colby Product Service Specialist Flint Hills Resources, LP 118 Huntsman Way Longview, TX 75602 U.S.A. Phone – 903-239-5332 Fax – 903-234-0174 E-Mail: Blair.Colby@FHR.com Issued 3/5/12.