DECLARATION OF COMPLIANCE Ultipor N66 Filter Cartridges

Transcription

1 DECLARATION OF COMPLIANCE Ultipor N66 Filter Cartridges AB Style "W" Code with Nylon Hardware Part Numbers: ABN 7 W Table 1 Table 2 Table 3 ABN NB 7 B W Table 1 Table 3 (for beer applications) This is a guide to the part number structure only, for availability of specific options, please contact Pall. Table 1: Length Code Description mm (10 ) mm (20 ) mm (30 ) mm (40 ) Table 2: Microbial Removal Rating Code Description Membrane Layers NF 0.2 µm 2 NB 0.45 µm 1 NK 0.65 µm 1 Table 3: O-ring Seal Material Code Description H4 Silicone Elastomer J Ethylene Propylene Rubber This product comprises Pall proprietary Ultipor N66 filter medium with integral polyester non-woven support in a disposable filter cartridge using polypropylene and nylon 6-10 hardware. For use in water up to 70 C (158 F) and bulk alcoholic beverages in low alcoholic applications at temperatures up to 49 C (120 F). The materials of construction do not contain surfactants or binder resins. Issued: 1 May 2009 Expiry: 30 April 2010 Reference: FBDCULTIPNEN Page: 1 of 3 Peg Peri Director of Regulatory Affairs Western Hemisphere Geoff Doubleday European Quality Manager

2 Issued: 1 May 2009 Expiry: 30 April 2010 Reference: FBDCULTIPNEN Page: 2 of 3 Ultipor N66 Filter Cartridges (AB style "W" Code with nylon hardware) COMPONENTS Filter Medium: Ultipor N66 nylon with integral polyester non-woven substrate Polyester Polypropylene Support/Drainage: Cage and Core: End Cap and Fin End: Unpigmented Nylon 6-10 Adapter: Unpigmented Nylon 6-10 with internal stainless steel reinforcing ring O-ring Seals: Ethylene Propylene Rubber (J) or Silicone Elastomer (H4) Ultipor N66 ABN style filter cartridges comprise of materials that our supplier states meet regulatory and legislative requirements and guidelines for food contact in that: EEC The "W" Code Ultipor ABN filters meet the requirements for food contact as detailed in European Regulation (EC) Number 1935/2004 in that: The polymeric materials used to produce "W" Code ABN N66 filters are made from monomers and additives listed in EU Directive 2002/72/EC relating to plastic materials and articles intended to come into contact with foodstuffs (excluding seals). Migration testing (excluding seals) has been performed in simulants A, B and C and met overall migration requirements in tests after flushing and in flow conditions. Component testing gave a maximum temperature limit of 70 C (158 F). USA The materials of construction meet the FDA requirements for food contact for water and bulk alcoholic beverages in low alcoholic applications up to 49 C (120 F) as detailed in Code of Federal Regulations, 21 CFR paragraphs : Nylon 66 and Nylon 6-10 to 21 CFR section (Nylon resins) Polypropylene to 21 CFR section (Olefin polymers) Polyester to 21 CFR section (Polyethylene phthalate polymers) Ethylene Propylene Rubber and Silicone Elastomeric seal material to 21 CFR section (Rubber articles intended for repeated use excluding milk and edible oils) Note: This product contains calcium stearate, which is approved as a direct food additive. PROCESS QUALITY SYSTEMS Sites of Manufacture: Pall Ilfracombe, UK - a Division of Pall Europe Ltd Pall Puerto Rico - a Division of Pall Corporation The Quality Management System at Pall Ilfracombe is certified to ISO 9001:2008 and the Quality Management System at Pall Puerto Rico is certified to ISO 9001:2000

3 Issued: 1 May 2009 Expiry: 30 April 2010 Reference: FBDCULTIPNEN Page: 3 of 3 SUPPLIED IN EUROPE BY: Pall Europe Ltd Europa House Havant Street Portsmouth Hampshire England PO1 3PD Pall Food and Beverage New York-USA telephone toll free fax Portsmouth-UK +44 (0) telephone +44 (0) fax Visit us on the Web at Pall Corporation has offices and plants throughout the world. For Pall representatives in your area, please go to Because of technological developments related to the products, systems, and/or services described herein, the data and procedures are subject to change without notice. Please consult your Pall representative or visit to verify that this information remains valid. Copyright 2009, Pall Corporation. Pall,, and Ultipor are trademarks of Pall Corporation. Indicates a trademark registered in the USA. Filtration. Separation. Solution.SM is a service mark of Pall Corporation. FBDCULTIPNEN Produced in the UK. May 2009.

4 Rev. Date: 18-Feb-2010 Ultipor N66 Particulate and Bioreduction Filter Cartridges Description Pall Ultipor N66 particulate/bioreduction filter cartridges are specifically engineered for fine filtration, prefiltration and bioburden reduction of a wide range of pharmaceutical and biological liquids. They incorporate versatile Ultipor N66 pure Nylon 6,6 membranes which are high-area pleated into single open-ended (SOE) AB style cartridges to fit in sanitary filter housings, and provide reliable, economical and efficient particulate and bioburden removal. Features and Benefits Intrinsically water wettable Fixed pores, non-shedding Resin and surfactant-free Low filter extractables High-area for long-life Broad solvent compatibility High protein recovery from most protein solutions Repeatedly steamable in situ Manufactured for use in conformance with cgmp ISO 9000 Certified Quality System Pharmaceutical P optimized Certificate of Test provided Double open-ended (DOE) available FDA-listed materials per 21 CFR Note: These filters are also available in Kleenpak Nova capsule format. Quality and Bio-Safety Biological Tests Meets USP Biological Reactivity test,in vivo, for Class VI-121 C Plastics Effluent Quality Tests (AB Style)* Meets Cleanliness per USP Particulates in Injectables

5 Non-Fiber-Releasing Non-Pyrogenic per USP Meets Total Organic Carbon and Water Conductivity per USP Purified Water, ph per USP Sterile Purified Water * Per lot sample soak or rinse-up flush aliquots. Specifications Materials of Construction Membrane Nylon 6,6 Support, Drainage and End Caps Polyester Core and Cage Polypropylene O-rings Silicone 1 Microbial Removal Ratings NK 0.65 µm particulate rated NB 0.45 µm microbial-rated (Typical Serratia marcescens TR > ) NX, NL 0.45 µm microbial-rated (Lot samples retain > 107/cm2 Serratia marcescens) NA 0.2 µm microbial-rated (Typical Brevundimonas diminuta TR > ) Nominal Dimensions Lengths 10 in. (254 mm), 20 in. (508 mm), 30 in. (762 mm), 40 in. (1016 mm) Diameter 70 mm (2.75 in.) Configuration (AB Code 7) 2 Double 226 O-ring adapter Fin end with bayonet lock. 2 Alternate adapter codes available. Operating Conditions 3 Maximum Differential Pressure and Temperature 5.5 bard (80 psid) to 50 C (122 F) 4.1 bard (60 psid) to 80 C (176 F) 0.3 bard (4.35 psid) to 125 C (257 F) 3 Using compatible liquids. Typical initial clean media P 10 in. (254 mm) element; water at 20 C (68 F); viscosity 1 cp. For assistance in filter assembly sizing and housing selection, contact your local Pall representative.

6 Autoclave and Steaming in situ 5 Cumulative Steam Exposure 16 hours (1-hour cycles) at 121 C 4 hours (1-hour cycles) at 140 C Aqueous Extractables (NVR) per 10 in. (254 mm) Element 6 Typically < mg Ordering Information Ultipor N66 Particulate and Bioreduction Filter Cartridges This is a list of typical part numbers for the product described in this catalogue. Click Part Number Configuration to access a PDF of the part numbering structure. For part numbers and configurations that are that are not listed, please contact your Pall representative. Part Number Configuration A02NF2PH4 A05NF2PH4 A05NFZ2PH4 A05NFZ2PJ A05NL2PH4 A05NLZ2PH4 A05NTZ2PH4 AB02NFZ2PH4 AB05NB2PH4 AB05NBW2PH4 AB05NF2PH4 AB05NFZ2PH4 AB05NL2PH4 AB1LV7PH4 AB1NA3EH AB1NA3EH4 AB1NA3EJ AB1NA3PH4 AB1NA7EH AB1NA7EH4 AB1NA7EH4-GI AB1NA7PH1 AB1NA7PH4 AB1NA7PJ AB1NA7PSH1 AB1NA7PSJ AB1NA7PY1H4 AB1NA7WH4 AB1NA8EH4 AB1NA8PH4 AB1NA8PS1H15 AB1NA8PSH4 AB1NAL7PH4 AB1NAZ3EH1 AB1NAZ3EH4 AB1NAZ3PH4 AB1NAZ7EH4 AB1NAZ7PH4 AB1NAZ8EH4 AB1NAZ8PH4 AB1NB3PH4 AB1NB7PH AB1NB7PH4 AB1NB7PJ AB1NB7WH4 AB1NB7WPH4 AB1NB8PH4 AB1NB8WH4 AB1NBAZ7PH4 AB1NBL7PH4 AB1NBZ3PH4 AB1NBZ7PH4 AB1ND7PH4 AB1NDZ7EH4 AB1NF3PH4 AB1NF7PH AB1NF7PH4 AB1NF7PH432 AB1NF7PH4SLS AB1NF7WH4 AB1NF8PH4 AB1NFL7PH4 AB1NFZ3PH4 AB1NFZ7PH AB1NFZ7PH4 AB1NFZ7PJ AB1NFZ8PH4 AB1NGZ017PH4 AB1NH7PH4 AB1NHH7PH4 AB1NI7EH4 AB1NI7EYH4 AB1NIZ3EH4 AB1NIZ7EH4 AB1NIZ8EH4 AB1NJ7PH4 AB1NJ8PH4 AB1NK7PH4 AB1NK7WH4 AB1NK8WH4 AB1NKKZ7PH4 AB1NL7PH4 AB1NLZ7PH4 AB1NNXZ7PH4 AB1NT3PH4 AB1NT7PH4 AB1NT7PH432 AB1NT8PH4 AB1NTL7PH4 AB1NTZ3PH4 AB1NTZ7PH4 AB1NX3PH4 AB1NX7PH4 AB1NX7PJ AB1NX7PS1H15 AB1NX7PS1H4 AB1NX7PSH4 AB1NX7PSJ AB1NX7PY1H4 AB2LV7PH4 AB2NA3EH4 AB2NA3PH4 AB2NA7EH4 AB2NA7EH4-GI AB2NA7PH4 AB2NA7PS1H4 AB2NA7PS1J AB2NA7PSH1 AB2NA8EH4 AB2NA8PH4 AB2NAL7PH4 AB2NAZ3EH4

7 AB2NAZ3PH4 AB2NAZ7EH4 AB2NAZ7PH1 AB2NAZ7PH4 AB2NB3WH4 AB2NB7PH4 AB2NB7WH4 AB2NB7WPH4 AB2NB8WH4 AB2NB8WPH4 AB2NBAZ7PH4 AB2NBL7PH4 AB2NBZ3EH4 AB2NBZ7PH4 AB2ND7PH4 AB2ND8PH4 AB2NF7PH AB2NF7PH4 AB2NF8PH4 AB2NFL7PH4 AB2NFZ3PH4 AB2NFZ7PH4 AB2NFZ7PJ AB2NFZ7WJ AB2NFZ8PH4 AB2NGZ7PH4 AB2NH7PH4 AB2NIZ3EH4 AB2NIZ7EH4 AB2NJ7PH4 AB2NK7PH4 AB2NK7WH4 AB2NK7WPH4 AB3NA3EH4 AB3NA3EYH4 AB3NA3PJ AB3NA7EH AB3NA7EH4 AB3NA7EH4-GI AB3NA7EYH4 AB3NA7PH AB3NA7PH4 AB3NA7PSJ AB3NA7PY1H4 AB3NA8PH4 AB3NAZ3WJ AB3NAZ7EH4 AB3NAZ7PH4 AB3NAZ8EH4 AB3NAZ8PH4 AB3NB7PH4 AB3NB7WH4 AB3NB8PH4 AB3NB8WH4 AB3NBAZ7PH4 B3NBL7PH4 AB3NBZ7PH4 AB3ND7PH4 AB3NF3PH4 AB3NF7PH AB3NF7PH4 AB3NF8PH4 AB3NFZ3PH4 AB3NFZ7PH AB3NFZ7PH4 AB3NFZ7PJ AB3NJ7PH4 AB3NK7PH4 AB3NK8WH4 AB3NL7PH4 AB3NLZ7PH4 AB3NLZ7PJ AB3NT7PH4 AB3NT8PH4 AB3NTL7PH4 AB3NTZ7PH4 AB3NX7PH4 AB3NX7PS1J AB3NX7PSJ AB3NX8PH4 AB3UNIZ7EH4 AB4NA7EH4 AB4NA7EH4-GI AB4NA7PH4 AB4NA8EJ AB4NAZ7PH4 AB4NB7PH4 AB4NBL7PH4 AB4NBL7PH4-GI AB4NF7PH4 AB4NFZ7PH4 AB4NL7PH4 AB4NLZ7PH4 AB4NR7PS1J AB4NT7PH4 ABD1UNI7EH1 ABY05NT2PH4- GE C3NTP1 DSLK 1NFP DSLK DSLK 2NFP-GI DSLK 2NFZP DSLK DSLK 2NTP-GI DSLK 2NTZP FLF6001NAEY KA1NAP2S KA1NDP1 KA1NDP2 KA1NFLP1 KA1NFLP2 KA2NAP1G KA2NAP1S KA2NAP2S KA2NAP6G KA2NAP6S KA2NDP1 KA2NDZE3 KA2NFP16G KA2NFP2G KA3NFLP1 KA3NFP1G KA3NLP1 KA3NLP6 KA3NTP1 KA4NFP16 KA4NFP6 MCY1001NAEH13 MCY1001NAPH13MCY1001NASH13 MCY1001NAZEH13 MCY1001NBPH13MCY1001NBWH13MCY1001NBWJ MCY1001NIZEH13MCY4463NAEYH13 MCY4463NIEYJ MCY4463NRPH13 MDY1002NAEH MDY1002NAEH13 MDY1002NAEJ DY1002NBWH MDY1002NBWH13MDY1003NAEH13MDY1003NAEYJ MDY1003NBWH13 NA31A00E1H4 SLK7002NNP SLK7002NNXZP SLK7002NRP-GI SLK7002NTP-GI SLK7002NXLP Contact Information Copyright Pall Corporation Visit us on the Web at This information is accurate as of the revision date indicated.