626 West 66th Street, Loveland CO 80538 P: 970-667-2728 F: 970-667-3204

www.eldonjames.com

ANIMAL DERIVATIVE FREE PP NATURAL POLYPROPYLENE MATERIAL CERTIFICATE

These products are manufactured in the United States of America by the Eldon James Corp. Eldon James, Corp. fittings 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. Additional Declarations stated by the resin manufacturer: 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, as listed under conditions of use C through H in 21 CFR 176.170(c), Table 2. 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). This product is RoHs compliant. Tallow/BSE/TSE We do not use tallow or any other animal derived materials in the manufacture or formulation of this product. US Pharmacopoeia (USP) This product has been certified to the USP Class VI Plastic (USP<88>, Biological Reactivity Tests, In Vivo) requirements. Certificate is available upon request. 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. Sqample Cert _____________________________ Eldon James Date

Customer Name: Customer XYZ

P.O. Number: xxxxx

Invoice Number: xxxxx

Ship Date: xx-xx-xx

Part Number(s): LM-3 PP

Customer Part #: xxxxxxx

Quantity: xxxxx

Lot Number: xxxxxxxxxxx

Job Number: xx-xxxxx

Manufacturer: Flint Hills Resources - Huston TX - Mfg Longview TX, Odessa, TX

Raw Material: Natural Polypropylene

Material Grad: Huntsman 13R9A

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: ___________________

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__________________

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

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REGULATORY INFORMATION DATA SHEET PRODUCT STEWARDSHIP

13R9A POLYPROPYLENE COPOLYMER

Product Manufacturer This product is manufactured by Flint Hills Resources, LP in Odessa, Texas, U.S.A. Manufacturing Facility Certifications The Odessa Polypropylene facility is certified to the ISO 9001:2000 Quality standard. Certificate is available upon request. The Odessa manufacturing facility is certified to the ISO 14001 Environmental Standard. Certificate is available upon request. The Odessa manufacturing facility is certified as an OSHA VPP (Voluntary Protection Program) Star Site. Chemical Inventories See the MSDS for all chemical inventory listings.

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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, as listed under conditions of use C through H in 21 CFR 176.170(c), Table 2.

European Union (EU) Food Contact:

The monomers used to produce this resin are listed in EU Directive 2002/72/EC and/or amendments 2004/19/EC, 2005/79/EC, and 2007/19/EC. No monomers with a restriction are used. This product contains additives that are subject to Specific Migration Limits (SML) of 5 and 30 mg/kg. Migration can be affected by the conversion process so only the converter to the final item can guarantee the limit is not exceeded.

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). Drug Master File (DMF) This product is listed in DMF#7478. Letters of Authorization for access to this DMF can be obtained through the Product Service Specialist (see page 6). European Pharmacopoeia (EP) This product does not pass the EP 3.1.3 or 3.1.6 monographs for Polyolefins and Polypropylenes due to the type and/or amount of additives in this product’s formulation. The resin does pass all other testing of the 3.1.3 and 3.1.6 monographs. US Pharmacopeia (USP) This product has been certified to the USP Class VI Plastic (USP<88>, Biological Reactivity Tests, In Vivo) requirements. Certificate is available upon request. Bioterrorism Act of 2002 The facility manufacturing this product is not required to register with the Bioterrorism Act of 2002 because it is not a food facility.

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Tallow/BSE/TSE We do not use tallow or any other animal derived materials in the manufacture or formulation of this product. Kosher We do not certify this resin to be Kosher or in compliance with Kosher requirements. Latex We do not use “Natural rubber latex”, “dry natural rubber”, “synthetic latex” or “rubber that contains natural rubber” in the manufacture or formulation of this product. Heavy Metals (ELV Directive 2000/53/EC) The quantity of Pb, Hg, Cd, and Cr present in this grade is deemed below the limits given in Annex II (Note) of the Decision 2002/525/EC of June 27th (amending Annex II of Directive 2000/53) which establishes: 0.1% Pb, 0.1% Cr, 0.1% Hg, and 0.01% Cd. Coalition of Northeastern Governors (CONEG) We do 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. Polybrominated Biphenyls (PBBs), Polychlorinated Biphenyls (PCBs), Polybrominated Diphenyl Ethers (PBDEs), Polybrominated Terphenyls (PBTs), Polychlorinated Terphenyls (PCTs) We do not use PBBs, PCBs, PBDEs, PBTs or PCTs in the manufacture or formulation of this product. We do not test this product for these chemical substances. Restriction of Hazardous Substances (RoHS) This product conforms to the RoHS Directive (2002/95/EC) restricting the use of Heavy Metals and PBBs and PBDEs (named above). 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.

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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 chemical substances. Polyvinyl Chloride (PVC) We do not use PVC in the manufacture or formulation of this product. We do not test this product for this chemical substance. California’s Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65) We do not knowingly use any of the cancer causing or reproductive toxicity chemicals listed on the California Proposition 65 (The Safe Drinking Water and Toxic Enforcement Act of 1986) in the manufacture or formulation of this product. We do not test this product for these chemical substances. Ozone Depleting Chemicals (ODCs) We do not use Class I or Class II ODCs listed in the Resolution 2037/2000/EC in the manufacture or formulation of this product. Bisphenol A Bisphenol A is not used in the manufacture or formulation of this product. We do not test this product for this chemical substance. Plasticizers We do not use any plasticizers in the manufacture or formulation of this product. Organo-Tin Compounds We do not use any Tributyl-tin (TBT), dibutyl-tin(DBT), monobutyl-tin (MBT) or any other organo-tin compounds in the manufacture or formulation of this product.

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Phthalates Although phthalates are not intentionally added in the formulation or manufacture of this product, there are trace phthalates in the final resin as a result of catalyst residues. These traces are theoretically less than 8 ppm. We do not test this product for this chemical substance. Alkylphenols and Alkylphenol Ethoxylates (Endocrine Disruptors) We do not use alkylphenols (nonyl- or octyl-) or alkylphenol ethoxylates (nonyl- or octyl-) in the formulation or manufacture of this product. We do not test this product for these chemical substances. Perfluorooctanoic Acid (PFOA) – a.k.a. DuPont®Zonyl or C8 We do not use PFOA, or other fluorotelomers, in the formulation or manufacture of this product. We do not test this product for this chemical substance. Asbestos We do not use asbestos in the manufacture or formulation of this product. We do not test this product for this chemical substance. Allergens We do 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. Shelf Life Although Flint Hills Resources, LP 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.

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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. As a responsible care participant, 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. Use of this Regulatory Information Data Sheet The information in this data sheet is provided independently of any sale of the product. It is provided for the purpose of communicating regulatory compliance of the resin as shipped from a Flint Hills Resources, LP location to our customers in its pellet form. Ultimately, customers must make their own determination that use of this product is safe, lawful, and technically suitable for their intended applications. The certificate 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, LP will notify customers to whom this regulatory sheet was provided by request through the Product Service Specialist. Flint Hills Resources, LP will not notify you should a change in regulation(s) require a change to this RIDS sheet. Flint Hills Resources, LP recommends updating your files with new RIDS sheets on a yearly basis. Certified 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 9/4/07.

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