PureFlo PTFE Validation Guide. Hydrophobic PTFE Filter Cartridges and Capsules for Sterile Venting and Liquid Filtration. ZenPure. Rev

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1 PureFlo PTFE Validation Guide Hydrophobic PTFE Filter Cartridges and Capsules for Sterile Venting and Liquid Filtration

2 CONTENTS 1. Introduction 2. Product Description 3. Product Specifications 4. Quality Systems Certification 5. Certificate of Conformance 6. Testing Summary 7. Test Methods and Results 7.1. Integrity Testing by Diffusional Flow Rate, Bubble Point, and Water Intrusion 7.2. Bacterial Retention of Brevundimonas diminuta 7.3. Bacterial Endotoxins by LAL Test 7.4. ASTM Hemolysis 7.5. USP Biological Reactivity Tests for Class VI Plastics 7.6. ISO Cytotoxicity Test (MEM Elution) 7.7. Gravimetric Extraction in Isopropanol 7.8. Cartridge Integrity with Multiple Steam-In-Place Cycles 8. Technical Assistance 2

3 1. Introduction PureFlo PTFE Validation Guide The PureFlo PTFE Validation Guide is a reference to provide assistance in validating s Pharmaceutical Grade 0.2 µm PureFlo PTFE cartridge and capsule filters. These filters are manufactured by Corporation to meet the requirements of the pharmaceutical industry. 2. Product Description All 0.2 µm Pharmaceutical Grade PureFlo PTFE cartridge and capsule filters are manufactured with PTFE membrane capable of complete retention of B. Diminuta and designed to provide sterile fluids in biopharmaceutical applications. The PTFE membrane provides superior flow per surface area (flux) compared with many other available membrane types. The PureFlo PTFE cartridge and capsule filters are optimized to provide complete bacterial retention in liquids and gases while maintaining high flow rates (low pressure drops) in biopharmaceutical venting applications. The filters robust construction provides superior resistance to multiple sterilization cycles for applications that require long periods of continuous aseptic and contamination-free operation. All PureFlo PTFE cartridge and capsule filters are manufactured in the same production facility, on the same production lines, using the same raw materials of construction. Each filter is labeled with the filter type, catalogue number, lot number, pore size, and logo. 3

4 2.1 Catalog Numbers Each of s PureFlo PTFE Cartridge and Capsule designs are identified with a unique multi-digit catalogue number. A list of current catalogue numbers follow. PureFlo Junior PTFE Cartridge Filter PureFlo Junior PTFE Cartridge Filters Pore Size (Micron) Length MJF = Junior Size 020 = 0.2 µm H = 1.5" 0H = 1/16-3/32" Hose Barb Cartridge Filter S = 2.5" 1C = 1/8" Compression 1H = 1/8-3/16" Hose Barb 1N = 1/8" NPTM 1Q = 1/8" Male Quick Coupling 2H = 3/16-1/4" Hose Barb 2UF = 1/4-28 thread Female 3H = 1/4-3/8" Hose Barb LF = Luer Lock Female LM = Luer Lock Male LS = Male Luer Slip MT = 1/2" Tri Clamp PureFlo Mini Vent Cartridge Filter End Modification O-ring Blank = O-ring Silicone (Standard) -OE = O-ring EPDM -ON = O-ring Nitrile -OV = O-ring Viton Optional Sterilization -ETO = Ethylene Oxide Sterilization Example - MJ Cartridge with 0.2 µm Pharmaceutical-Grade PTFE Membrane and 1/4" Hose Barb Outlet is MJF020H2H Quick Couplings are molded, compatible with CPC (Colder), LinkTech and others. PureFlo PTFE Pore Size Cartridge Filters (Micron) End Modifications O-Ring Materials Standard Package Qty Inserts MVF = Mini Vent Size µm C = 015 O-Ring E = EPDM 3P = 3pc/pack Blank = Standard Cartridge Filter N = Buna N -5 = Stainless Steel Insert S = Silicone U = TES T = TEV V = Fluroelastomer Example - Mini Vent Filter with 0.2 µm Pharmaceutical-Grade PTFE Membrane, Code C Connection, Silicone O-ring, and a SS Insert is MVF020CS3P-5 Note: MVF Cartridges 400cm2 PureFlo Mini PTFE Cartridge Filter PureFlo PTFE Cartridge Filters MMF = Mini Size Cartridge Filter Pore Size (Micron) End Modifications Length µm 0 = 222 O-Ring Flat H = 1.5" E = EPDM 2P = 2 pc/pack (5") Blank = Standard 6 = 226 O-Ring Flat S = 2.5" N = Buna N 3P = 3 pc/pack -5 = Stainless Steel Insert A = 116 Inner O-Ring L = 5" S = Silicone (1.5" and 2.5") C = 015 O-Ring T = TEV D = 1/2" MNPT U = TES E = 118 O-Rings V = Fluroelastomer F = Flange* O = O-Ringless M = 123 O-Rings with hold down tabs** N = 116 Inner Housing Seal 4 O-Ring / Gasket Materials Package Qty Inserts S = 116 Inner O-Ring with locking groove T = 126 O-Rings with locking tabs*** Example - 5" PureFlo PTFE Mini Cartridge with 0.2 µm Pharmaceutical-Grade PTFE Membrane, Code A Connection, Silicone O-ring, and a SS Insert is MMF20ALS2P-5 * - F end modification is compatible to fit in a PALL SealKleen TM Housing, **- M end modification is compatible to fit in a Millipore OptiSeal TM Housing, ***-T end modification is compatible to fit a Parker Trueseal TM Housing

5 PureFlo PTFE Cartridge Filter PureFlo PTFE Cartridge Filters Pore Size (Micron) End Modifications Length O-Ring / Gasket Materials Package Qty Inserts MCF = Standard µm 0 = 222 O-Ring Flat 1-10" E = EPDM 1 = 1pc/ pack Blank = Standard Size Cartridge 3 = 222 O-Ring w/tabs Spear 2-20" N = Buna N -5 = Stainless Steel Insert Filter 5 = 222 O-Ring Spear 3-30" P = Peroxide Cured EPDM 6 = 226 O-Ring Flat 4-40" Q = Platinum Cured Silicon 7 = 226 O-Ring Spear 5 = 5" S = Silicone 8 = 223 O-Ring w/tabs Flat 9 = 9.75" T = TEV or FEP Gasket B = 1.5" Tri-Clamp Flat U = TES* Z = SOE Internal O-ring Flat ** V = Fluoroelastomer O = No O-ring Example - 10" PureFlo PTFE Cartridge with 0.2 µm Pharmaceutical-Grade PTFE Membrane, Code 7 Connection, Silicone O-rings, and a SS Insert is MCF2071S1-5 * - not available in Code Z, ** - only available in 5", 9.75", 10" and 20", retrofit for DOE housings PureFlo PTFE Cartridge Filter with High-Temp PP PureFlo PTFE Pore Size Cartridge Filters (Micron) End Modifications Length O-Ring / Gasket Materials Package Qty Inserts MBF = Standard µm 0 = 222 O-Ring Flat 1-10" E = EPDM 1 = 1pc/ pack Blank = Standard Size Cartridge 3 = 222 O-Ring w/tabs Spear 2-20" N = Buna N -5 = Stainless Steel Insert Filter 5 = 222 O-Ring Spear 3-30" P = Peroxide Cured EPDM with High Temp 6 = 226 O-Ring Flat 4-40" Q = Platinum Cured Silicon PP Construction 7 = 226 O-Ring Spear 5 = 5" S = Silicone 8 = 223 O-Ring w/tabs Flat 9 = 9.75" T = TEV or FEP Gasket B = 1.5" Tri-Clamp Flat Z = SOE Internal O-ring Flat ** U = TES* V = Fluoroelastomer O = No O-ring Example - 10" PureFlo PTFE Cartridge with 0.2 µm Pharmaceutical-Grade PTFE Membrane, Code 7 Connection, High-Temp PP Construction, Silicone O- rings, and a SS Insert is MBF2071S1-5 * - not available in Code Z ** - only available in 5", 9.75", 10" and 20", retrofit for DOE housings PureFlo PTFE Cartridge with SS Core PureFlo PTFE Cartridge Filters Pore Size (Micron) End Modifications Length O-Ring / Gasket Materials Package Qty MSF = Standard Size µm 0 = 222 O-Ring Flat 1-10" E = EPDM 1 = 1pc/ pack Cartridge Filter 3 = 222 O-Ring w/tabs Spear 2-20" N = Buna N with SS Core and 5 = 222 O-Ring Spear 3-30" P = Peroxide Cured EPDM SS Insert 6 = 226 O-Ring Flat 4-40" Q = Platinum Cured Silicon 7 = 226 O-Ring Spear 5 = 5" S = Silicone 8 = 223 O-Ring w/tabs Flat 9 = 9.75" T = TEV or FEP Gasket B = 1.5" Tri-Clamp Flat Z = SOE Internal O-ring Flat ** U = TES* V = Fluoroelastomer O = No O-ring Example - 10" PureFlo PTFE Cartridge with 0.2 µm Pharmaceutical-Grade PTFE Membrane, Code 7 Connection, SS Core, Silicone O-rings, and a SS Insert is MSF2071S1 * - not available in Code Z, ** - only available in 5", 9.75", 10" and 20", retrofit for DOE housings PureFlo PTFE Cartridge with PE Construction PureFlo PTFE Cartridge Filters Pore Size (Micron) End Modifications Length O-Ring / Gasket Materials Package Qty MEF = Standard Size µm 0 = 222 O-Ring Flat 1-10" E = EPDM 1 = 1pc/ pack Cartridge Filter 3 = 222 O-Ring w/tabs Spear 2-20" N = Buna N with PE 5 = 222 O-Ring Spear 3-30" P = Peroxide Cured EPDM C onstruction 6 = 226 O-Ring Flat 4-40" Q = Platinum Cured Silicon 7 = 226 O-Ring Spear 5 = 5" S = Silicone 8 = 223 O-Ring w/tabs Flat 9 = 9.75" T = TEV or FEP Gasket B = 1.5" Tri-Clamp Flat Z = SOE Internal O-ring Flat ** 5 U = TES* V = Fluoroelastomer O = No O-ring Example - 10" PureFlo PTFE Cartridge with 0.2 µm Pharmaceutical-Grade PTFE Membrane, Code 7 Connection, with PE Construction and Silicone O-rings is MEF2071S1 * - not available in Code Z ** - only available in 5", 9.75", 10" and 20", retrofit for DOE housings

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7 PureFlo PTFE Disc Filter PureFlo Encapsulated Disk Filters Filter Media Pore Size Inlet Fitting* Outlet Fitting* D4 = 4 mm Disk F = PTFE 020 = 0.2 µm 0H 0H = 1/16" or 1/16" to 3/32" Hose Barb D13R = 13 mm Disk 1C 1C = 1/8" Compression Options O-Ring for Quick Connect D25C = 25 mm Disk 1H 1H = 1/8" or 1/8" to 3/16" Hose Barb Blank = Silicone D40C = 40 mm Disk 1N 1N = 1/8" MNPT (Standard) G50C = 50 mm Disk 1NF 1NF = 1/8" FNPT -OE = EPDM D65R = 65 mm Disk 1Q 1Q = 1/8" Male Quick Coupling -ON = Nitrile RD65 = Rectanular Disk 1QE 1QE = 1/8" Male Quick Coupling Elbow -OV = Viton 1QF 1QF = 1/8" Female Quick Coupling Sterilization 1QFV 1QFV = 1/8" Female Valved Quick Coupling BLANK = Non- 1QV 1QV = 1/8" Male Valved Quick Coupling Sterile 1QVE 1QVE = 1/8" Male Valved Quick Coupling elbow -ETO = Ethylene AH AH = 3/32" Hose Barb Oxide 2D 2D = DN5 Lundecke fitting Sterilization 2H 2H = 1/4" to 3/8" or 1/4" to 5/16" or 3/16 to 1/4" Hose Barb Packaging 2HE 2HE = 1/4"Hose Barb Elbow Blank = Bulk 2K 2K = 1/4" Hose Barb -1 = Single Bagged 2N 2N = 1/4" MNPT 2NF 2NF = 1/4" FNPT 2Q 2Q = 1/4" Male Quick Coupling for Metal latch 2QE 2QE= 1/4" Male Quick Coupling for Metal latch elbow 2QF 2QF = 1/4" Female Quick Coupling for Metal latch 2QFV 2QFV = 1/4" Female Valved Quick Coupling for Metal latch 2QP 2QP = 1/4" Male Quick Coupling for Plastic latch 2QPL 2QPL = Long 1/4" Male Quick Coupling for Plastic latch 2QV 2QV = 1/4" Male Valved Quick Coupling for Metal latch 2UF 2UF = 1/4-28 Thread Female 3H 3H = 3/8" or 1/4" to 3/8" or 5/16 to 3/8" Hose Barb 3HE 3HE = 3/8" Hose Barb Elbow 3N 3N = 3/8" MNPT 3NF 3NF = 3/8" FNPT 4H 4H = 3/8" to 1/2" Hose Barb 4HL 4HL = 1/4" to 1/2" Hose Barb 4N 4N = 1/2" MNPT 4T 4T = 11.8mm Tube Seal FV FV = Female Ventilator LF LF = Luer Lock Female LM LM = Luer Lock Male LS LS = Luer Male Slip MT MT = 1/2" Tri-clamp MV MV = Male Ventilator OV OV = Male Medical Coupling Regular OVS OVS = Male Medical Coupling Short SM SM = Stainless Steel, 1/2" Triclamp TC TC = 1.5" Tri Clamp *ALL FITTINGS NOT AVAILABLE FOR ALL SIZES. REFER TO PRODUCT DATA SHEET FOR AVAILABLE CONFIGURATIONS. Example Pharma Grade 50 mm Encapsulated Disk Filter with 0.2 µm Pharmaceutical-Grade PTFE Membrane, and 1/4" Hose Barb Fittings is G50CF0202H2H PureFlo Junior PTFE Capsule Filter PureFlo Junior PTFE Capsule Filters JKPF = Capsule Filter Pharma grade Pore Size Effective Inlet (Micron) Filtration Area Fitting Outlet Fitting Options 020 = 0.2 µm Blank = 260 cm 2 1H 1H = 1/8" Hose Barb Vent & Drain B = 150cm2 1Q 1Q = 1/8" Male Quick Coupling -N= No vent or drain fittings 2H 2H = 1/4" Hose barbs -NI = No vent or drain inlet fitting 2H -FB= 1/4" Hose barbs with Filling Bell -NO = No vent or drain Outlet fitting 2H -FC= 1/4" Hose barbs with Filling Bell with Cap 2N 2N = 1/4" MNPT O-Rings 2Q 2Q = 1/4" Male Quick Coupling for Metal latch -OE = O-ring EPDM 3H 3H = 3/8" Hose Barb -ON = O-ring Nitrile 5MF 5MF = M5 Female thread -OV = O-ring Viton LF LF = Female Luer Lock Blank = O-ring Silicon (Standard) LM LM = Male Luer Lock MT MT = 1/2" Tri clamps Sterilization -ETO = Ethylene oxide sterilization Example - JKP Capsule with 0.2 µm Pharmaceutical-Grade PTFE Membrane, and 1/4" Hose Barb I/O is JKPF0202H2H 7

8 PureFlo Mini PTFE Capsule Filter PureFlo Mini PTFE Capsule Filters MKPF = Capsule Filter Pharma grade Pore size Effective Inlet Outlet Fitting Options (Micron) Filtration Area Fitting 020 = 0.2 µm A = 200 cm 2 1C 1C = 1/8" Compression Vent & Drain B = 300 cm 2 1H 1H = 1/8" Hose Barb -N= No vent or drain fittings C = 400 cm 2 1Q 1Q = 1/8" Male Quick Coupling -NI = No vent or drain inlet fitting D = 500 cm 2 1QF 1QF = 1/8" Female Quick Coupling -NO = No vent or drain Outlet fitting 1QE 1QE = 1/8" Male Quick Coupling Elbow 1QFV 1QFV = 1/8" Female Quick Connect w/valve O-Rings 1QV 1QV = 1/8" Male Quick Connect w/valve -OE = O-ring EPDM 2C 2C = 1/4" Compression -ON = O-ring Nitrile 2CE 2CE = 1/4" Compression Elbow -OV = O-ring Viton 2H 2H = 1/4" Hose barbs Blank = O-ring Silicon (Standard) 2H -FB = 2H with Filling Bell 2H -FC = 2H-FB with Cap Sterilization 2N 2N = 1/4" MNPT -ETO = Ethylene oxide sterilization 2NO 2NO = Short 1/4" MNPT+EP O-Ring 2NS 2NS = Short 1/4" MNPT 2Q 2Q = 1/4" Male Quick Coupling for Metal latch 2QE 2QE = 1/4" Male Quick Coupling for Metal latch Elbow 2QF 2QF = 1/4" Female Quick Coupling with Metal latch 2QFV 2QFV = 1/4" Female Quick Connect w/valve 2QV 2QV = 1/4" Male Quick Connect w/valve 3H 3H = 3/8" Hose Barb 3NF 3NF = 3/8" Female NPT 5H 5H = 5/8" Hose Barb LF LF = Female Luer Lock LFE LFE = Female Luer Lock Elbow MT MT = 1/2" Tri clamps Example - MKP Capsule with 0.2 µm Pharmaceutical-Grade PTFE Membrane, 500 cm 2 EFA, and 1/4" Hose Barb I/O is MKPF020D2H2H PureFlo SKL and SKP PTFE Capsule Filter PureFlo PTFE Capsule Pore size Inlet Length Filters (Micron) Fitting Outlet Fitting Options SKLF = Capsule filter 020 = 0.2 µm H = 1.5" 1C 1C = 1/8" Compression Vent & Drain Luer Lock Vent/Drain S = 2.5" 1H 1H = 1/8" Hose barbs -N= No vent or drain fittings L = 5" 1N 1N = 1/8" MNPT -NI = No vent or drain inlet fitting SKPF = Capsule filter E = 7.5" 1NF 1NF = 1/8" FNPT -NO = No vent or drain Outlet fitting M8 Plug vent/ Drain K = 10" 1Q 1Q = 1/8" Male Quick Coupling with Metal latch Limited Options 1QF 1QF = 1/8" Female Quick Coupling with Metal latch O-Rings 1QFV 1QFV = 1/8" Female Valved Quick Coupling with Metal latch -OE = O-ring EPDM 1QV 1QV = 1/8" Male Valved Quick Coupling with Metal latch -ON = O-ring Nitrile 2C 2C = 1/4" Compression -OV = O-ring Viton 2H 2H = 1/4" to 1/2" Hose barbs Blank = O-ring Silicon (Standard) 2HS 2HS = 1/4" to 3/8" Hose barbs 2LF 2LF = Large Female Luer Lock fitting Sterilization 2N 2N = 1/4" MNPT -ETO = Ethylene oxide sterilization 2NF 2NF = 1/4" FNPT 2P 2P = 1/4" Push to Connect 2PE 2PE = 1/4" Push to Connect Elbow 2Q 2Q = 1/4" Male Quick Coupling for Metal latch 2QF 2QF = 1/4" Female Quick Coupling with Metal latch 2QFP 2QFP = 1/4" Female Quick Coupling with Plastic latch 2QFV 2QFV = 1/4" Female Valved Quick Coupling with Metal latch 2QP 2QP = 1/4" Male Quick Coupling for Plastic latch 2QV 2QV = 1/4" Male Valved Quick Coupling with Metal latch 2V 2V = 1/4" Walther Quick Connect 3C 3C = 3/8" Compression 3H 3H = 3/8" Hose Barb 3HE 3HE = 3/8" Hose Barb Elbow 3H-FB = 3/8" Hose Barb with filling bell or -FC with C ap 3NF 3NF = 3/8" FNPT 4C 4C = 1/2" Compression 4H 4H = 1/2" Hose Barb 4N 4N = 1/2" MNPT 4Q 4Q = 1/2" Male Quick Coupling for Plastic latch 8C 8C = 5/16" Compression MT MT = 1/2" Tri clamps TC TC = 1-1/2" Tri clamp TS = Shower Head Example - 5" SKL Capsule with 0.2 µm Pharmaceutical-Grade PTFE Membrane and 1.5" Tri-Clamp I/O is SKLF020LTCTC Quick Couplings are molded, Female Quick Coupling with Plastic latch will be threaded on, compatible with CPC (Colder), LinkTech and others. 8

9 PureFlo SKV PTFE Capsule Filter PureFlo Capsule Filters Pore size (Micron) Length Input Fitting Output Fitting Options SKVF = Capsule filter 020 = 0.2 µm H = 1.5" 1H 1H = 1/8" Hose barbs Vent & Drain Bleed Valve S = 2.5" 1Q 1Q = 1/8" Male Quick Coupling with Metal latch -N= No vent or drain fittings Vent/Drain L = 5" 1QF 1QF = 1/8" Female Quick Coupling with Metal latch -NI = No vent or drain inlet fitting E = 7.5" 1QFV 1QFV = 1/8" Female Valved Quick Coupling with Metal latch -NO = No vent or drain Outlet fitting K = 10" 1QV 1QV = 1/8" Male Valved Quick Coupling with Metal latch 2H 2H = 1/4" Hose barb O-Rings 2HL 2HL = 1/4" to 1/2" Hose barbs -OE = O-ring EPDM 2H-FB = 1/4" Hose Barb with filling bell -FC with C ap -ON = O-ring Nitrile 2N 2N = 1/4" MNPT -OV = O-ring Viton 2P 2P = 1/4" Push to Connect Blank = O-ring Silicon (Standard) 2PE 2PE = 1/4" Push to Connect Elbow 2Q 2Q = 1/4" Male Quick Coupling for Metal latch Sterilization 2QF 2QF = 1/4" Female Quick Coupling with Metal latch -ETO = Ethylene oxide sterilization 2QFV 2QFV = 1/4" Female Valved Quick Coupling with Metal latch 2QP 2QP = 1/4" Male Quick Coupling for Plastic latch 2QV 2QV = 1/4" Male Valved Quick Coupling with Metal latch 2V 2V = 1/4" Walther Quick Connect 3H 3H = 3/8" Hose Barb 3H-FB = 3/8" Hose Barb with filling bell or -FC with C ap 4H 4H = 1/2" Hose Barb 4Q 4Q = 1/2" Male Quick Coupling for Plastic latch 5H 5H = 5/8" Hose Barb MT MT = 1/2" Tri clamps TC TC = 1-1/2" Tri clamp TS = Shower Head Example - 5" SKV Capsule with 0.2 µm Pharmaceutical-Grade PTFE Membrane and 1.5" Tri-Clamp I/O is SKVF020LTCTC Note: Quick Couplings are molded on. Female Quick Coupling with Plastic latch will be threaded on. Compatible with CPC (Colder), LinkTech and others. * - 2H PureFlo SKS PTFE Capsule Filter PureFlo Capsule Filters Filter Media Pore size (Micron) Length Inlet Fitting Outlet Fitting SKS = Capsule filter F = PTFE Phobic 020 = 0.2 µm H = 1.5" 2QP 2QP = 1/4" Male Vent & Drain "E" configuration S = 2.5" Quick Coupling -N= No vent fittings Quick Connect L = 5" for Plastic latch E = 7.5" O-Rings K = 10" -OE = O-ring EPDM -ON = O-ring Nitrile -OV = O-ring Viton Blank = O-ring Silicon (Standard) RFID - RI = RFID C hip Options Sterilization -ETO = Ethylene oxide sterilization Example - 2.5" SKS Capsule with 0.2 µm Pharmaceutical PTFE Membrane and 1/4" Male Quick Coupling for Plastic Lach I/O/V is Note: Quick Couplings are molded on. Compatible with CPC (Colder), LinkTech and others. ZenCap PTFE Full Size Capsule Filter ZenCap Capsule Filters Filter Media Pore size (Micron) Configuration Length Vents * Output Fitting Options L = Full Size I = In-Line 1-10" F = PTFE 020 = 0.2 µm A = No vents 1QFV 1QFV = 1/8" Female Quick connect Vent & Drain Capsule Filter T = T-Line 2-20" B = 1/2" Sanitary vent w/valve for Metal latch -N= No vent or drain fittings C = C-Line 3-30" C = 1/2" Sanitary vent, with upstream 1QV 1QV = 1/8" Male Quick connect -NI = No vent or drain inlet fitting S = S-Line 4-40" and down stream 1/4" Bleed Valve w/valve for Metal latch -NO = No vent or drain Outlet fitting L = L-Line D = 1/2" Sanitary vent, with upstream 2QFV 2QFV = 1/4" Female Quick connect 1/4" Bleed Valve w/valve for Metal latch O-Rings E = 1/2" Sanitary vent, with down stream 1/4" Bleed Valve 2QV 2QV = 1/4" Male Quick connect w/valve for Metal latch -OE = O-ring EPDM -ON = O-ring Nitrile F = Inlet and Outlet 1/4" Bleed Valve 3H 3H = 3/8" Hose Barb -OV = O-ring Viton G = Inlet 1/4" Bleed Valve 4H 4H = 1/2" Hose Barb Blank = O-ring Silicon (Standard) H = Outlet 1/4" Bleed Valve 4Q 4Q = 1/2" Male Quick connect N = No vents or drains 5H 5H = 9/16" Hose Barb Sterilization 6H 6H = 3/4" (19mm) Hose Barb -ETO = Ethylene oxide sterilization 8H 8H = 1" (25mm) Hose Barb Note: Option B,C, D &E not for In-Line TC TC = 1-1/2" Tri-Clamp 2T 2T = 2" Tri-Clamp Example - 10" ZenCap I-Line Capsule with 0.2 µm Pharmaceutical-Grade PTFE Membrane, 1.5" Tri-Clamp Inlet/Outlet and 1/4" Bleed Valve Vent/Drain is LI1F020FTCTC Notes: * 1/4" Drain bleed Valve standard on all T-Line filters Except for option A 9 Inlet Fitting

10 3. Product Specifications PureFlo PTFE Validation Guide Good Manufacturing Practices PureFlo PTFE filters are made in a manufacturing facility which adheres to Good Manufacturing Practices. Regulatory Compliance PureFlo PTFE filters are manufactured from materials that conform to the requirements of 21CFR Part 177 of the U.S. Code of Federal Regulations and USP Class VI Biological test for Plastics. Bacterial Retention 0.2 µm PureFlo PTFE filters are quantitatively retentive of Brevundimonas diminuta (ATCC #19146) at a minimum challenge level of 10 7 CFU per cm 2 of filtration area. USP Bacterial Endotoxin Aqueous extraction contains <0.25 EU/ml as determined by the Limulus Amebocyte Lysate (LAL) Test. Bubble Point Specification 18 psi (0.12 MPa) in a mixture of 60% Isopropanol and 40% water at 20 C 10

11 Nominal Dimensions, Effective Filtration Area, and Diffusional Specifications Dimensions Max Air Diffusion Max Water Intrusion Effective Filter Filter (Nominal, No Fittings) in 60% IPA Flow Rate Filtration Area Type Size Length Diameter at 1.0 bar (14.5 psi) at 2.6 bar (37.7 psi) inch mm inch mm in² ft² cm² ml/min ml/min 4 mm N/A N/A 13 mm N/A N/A Disk (D) 25 mm N/A N/A 40 mm N/A N/A 65 mm N/A N/A Disk (G) 50 mm N/A N/A Disk (RD) 65 mm x x N/A N/A JKP N/A A MKP B C D H SKV S SKL L SKP SKS E K ZenCap 10" H S Mini L Cartridge E K Standard Cartridge 10"

12 Operating Conditions Filter Type Disk (D/G) Disk (RD) Junior Capsules Mini Capsules SKL Capsules SKV Capsules SKS Capsules ZenCap Capsules Junior Cartridges Mini Vent Cartridges Max Operating Temperature 80 C (176 F) 60 C (140 F) 80 C (176 F) 80 C (176 F) 80 C (176 F) 80 C (176 F) 80 C (176 F) 80 C (176 F) Max Working Pressure Liq: 5.5 bar (80 psi) Gas: 4.1 bar (60 psi) Liq: 2 bar (29 psi) Gas: 2 bar (29 psi) Liq: 5.5 bar (80 psi) Gas: 4.1 bar (60 psi) Liq: 5.5 bar (80 psi) Gas: 4.1 bar (60 psi) Liq: 5.5 bar (80 psi) Gas: 4.1 bar (60 psi) Liq: 5.5 bar (80 psi) Gas: 4.1 bar (60 psi) Liq: 5.5 bar (80 psi) Gas: 4.1 bar (80 psi) Liq: 5.5 bar (80 psi) Gas: 4.1 bar (60 psi) 80 C (176 F) - 80 C (176 F) - Mini Cartridges 80 C (176 F) - Cartrdiges (MCF) High Temp PP Cartridges (MBF) High Temp SS Core Cartridges (MSF) PE Construction Cartridges (MEF) 80 C (176 F) - 80 C (176 F) - 80 C (176 F) - 60 C (140 F) - 12 Max Forward Differential Pressure Max Reverse Differential Pressure 4.1 bar (60 22 C 2.1 bar (30 22 C 1 bar ( C 1 bar ( C 5 bar (72 22 C 2.1 bar (30 22 C 5 bar (72 22 C 2 bar (29 80 C 5 bar (72 22 C 2 bar (29 80 C 5 bar (72 22 C 2 bar (29 80 C 5 bar (72 22 C 2 bar (29 80 C 5 bar (72 22 C 2 bar (29 80 C 4.1 bar (60 22 C 2 bar (29 80 C 4.1 bar (60 22 C 2 bar (29 80 C 4.1 bar (60 22 C 2 bar (29 80 C 5 bar (72 22 C 2 bar (29 80 C 6 bar (87 22 C 3 bar (58 80 C 6 bar (87 22 C 4 bar (43 80 C 5 bar (72 22 C 2 bar (29 60 C 2.1 bar (30 22 C 1 bar (14 80 C 2.1 bar (30 22 C 1 bar (14 80 C 3 bar (43 22 C 1 bar (14 80 C 2.1 bar (30 22 C 1 bar (14 80 C 3 bar (43 22 C 1 bar (14 80 C 4.1 bar (60 22 C 2 bar (29 80 C 2 bar (29 22 C 1 bar ( C 2 bar (29 22 C 1 bar ( C 3 bar (43 22 C 1 bar (14 80 C 3 bar (43 22 C 1 bar (14 80 C 3 bar (43 22 C 1 bar (14 80 C 3 bar (43 22 C 1 bar (14 60 C

13 Sterilization and Sanitization PureFlo PTFE MCF Cartridge can be sterilized by Steam in Place, up to 50x 30 minute cycles at 135 C (275 F) Autoclave, up to 50x 30 minute cycles at 125 C (257 F) Chemical Sanitization, by common sanitizing agent compatible with the filter s materials of construction PureFlo PTFE MSF Cartridge can be sterilized by Steam in Place, up to 150x 30 minute cycles at 142 C (287.6 F) Autoclave, up to 150x 30 minute cycles at 135 C (275 F) Chemical Sanitization, by common sanitizing agent compatible with the filter s materials of construction PureFlo PTFE MBF Cartridge can be sterilized by Steam in Place, up to 100x 30 minute cycles at 142 C (287.6 F) Autoclave, up to 100x 30 minute cycles at 135 C (275 F) Chemical Sanitization, by common sanitizing agent compatible with the filter s materials of construction PureFlo PTFE MEF Cartridge can be sterilized by Chemical Sanitization, by common sanitizing agent compatible with the filter s materials of construction PureFlo PTFE MJF, MMF, and MVF Cartridges can be sterilized by Steam in Place, up to 10x 30 minute cycles at 135 C (275 F) Autoclave, up to 25x 30 minute cycles at 125 C (257 F) Chemical Sanitization, by common sanitizing agent compatible with the filter s materials of construction PureFlo PTFE D4, D13R, D25C, D40C, G50C, D65R, and RD65 Disk Filters can be sterilized by Autoclave, up to 10x 30 minute cycles at 125 C (257 F) Chemical Sanitization, by common sanitizing agent compatible with the filter s materials of construction PureFlo PTFE JKP, MKP, SKL, SKP, SKV, SKS, and L Capsules can be sterilized by Autoclave, up to 25x 30 minute cycles at 125 C (257 F) Chemical Sanitization, by common sanitizing agent compatible with the filter s materials of construction 13

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15 Components Membrane: Membrane Supports: Cage: Core: Shell: End Caps: PTFE Polypropylene Polypropylene or High Temperature Polypropylene Polypropylene or High Temperature Polypropylene or Stainless Steel Polypropylene or High Temperature Polypropylene Polypropylene or High Temperature Polypropylene 4. Quality Systems Certification All PureFlo PTFE cartridges and capsules are manufactured under ISO 9001:2008 quality procedures for the Design, Development, and Manufacturing of Filtration Products for Pharmaceutical, Medical, Food and Beverage, and Microelectronics applications under the Environmental Management System of ISO 14001:2004, and under the Quality Management System of ISO 12485:2003 for the Design, Development, Production, and Distribution of Filtration Products for Medical Use. s PureFlo PTFE filters undergo testing and inspection according to internal Quality Control Procedures. These procedures define acceptance criteria for the filter cartridges with regard to standard controls, destructive tests, and traceability of materials. All components used for the filter cartridges are previously checked, tested, and accepted by s Quality Control Department. 5. Certificate of Conformance s PureFlo PTFE filters are supplied with a Certificate of Conformance that assures that each lot of cartridges is manufactured, tested, and released to the specifications designated in this guide. This certificate provides the quality characteristics and acceptance criteria for each cartridge. Each certificate lists the catalogue and lot number of the cartridge. Three sample Certificates of Conformity are shown here. 15

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17 6. Testing Summary PureFlo PTFE Validation Guide 6.1 Integrity Testing by Diffusional Flow Rate, Bubble Point, and Water Intrusion The Diffusional Flow Integrity Test and the Bubble Point Test are non-destructive tests that allow for the integrity and bubble point of the filter to be determined. The result of Integrity and Bubble Point tests are used in conjunction with bacterial retention tests (Sections 6.2 and 7.2) to determine the maximum allowable diffusional flow and minimum allowable bubble point required to achieve sterilizing-grade performance. Every PureFlo PTFE filter is integrity tested during the manufacturing process to ensure proper product performance. 6.2 Bacterial Retention Testing by B. diminuta Testing was performed to determine and verify the bacterial retention capabilities of the PureFlo PTFE filters. Each filter was integrity and bubble point tested prior to bacterial challenge, such that correlation could be made between the integrity and bubble point specifications and a filter s sterilizing-grade performance. 6.3 Bacterial Endotoxins LAL Test During the LAL test, an extract from the filter is mixed with Limulus Amebocyte Lysate (LAL). A reaction at different dilutions indicates the maximum level of endotoxin present. The test results determine the worst-case endotoxin level eluted from a PureFlo PTFE Capsule. The endotoxin limits for water defined by USP are as follows: 1) Water for Hemodialysis: 2 EU/ml 2) Sterile Water for Irrigation: 0.25 EU/ml 3) Sterile Water for Injection: 0.25 EU/ml 4) Sterile Water for Inhalation: 0.5 EU/ml s Pharma Grade PureFlo PE Capsules are held to a specification of <0.25 EU/ml and a sample of each lot is tested as part of s Lot Release Criteria to ensure each lot conforms to this specification. 17

18 6.4 ASTM Hemolysis This test determines the hemolytic properties of a test sample when brought into contact with rabbit blood. The procedure involves exposing the test material to a blood cell suspension and determining the amount of hemoglobin released as a result. The amount of hemoglobin released is measured by spectrophotometry at 540 nm, and the absorption is compared with the negative and positive controls to calculate the hemolytic index. Samples with a Hemolytic index between 0 and 2 are considered Non-Hemolytic. Figure 1 Hemolytic Index 6.5 USP Biological Reactivity Tests for Class VI Plastics Samples of the plastic components or raw materials used in the construction of s PureFlo PTFE Series cartridges and capsules were tested against the requirements of the USP Biological Reactivity Test for Class VI Plastics. 6.6 ISO Cytotoxicity Test (MEM Elution) Testing was performed, per ISO , to ensure that PureFlo PTFE cartridges and capsules are non-cytotoxic. This test evaluates the acute adverse biological effects of extractables from the filter. A negative result indicates that a material is free of harmful extractables or has an insufficient amount of extractables to cause acute effects under exaggerated conditions using isolated cells. 18

19 6.7 Gravimetric Extraction in Isopropanol The amount of non-volatile extractables from a PureFlo PTFE disk capsule was determined by way of gravimetric analysis. 6.8 Cartridge Integrity with Multiple Steam-In-Place Cycles Testing was performed to verify the resistance of PureFlo PTFE cartridge filters with 0.2 µm PTFE membrane to multiple in-line steam sterilization cycles. 19

20 7. Test Methods and Results 7.1 Integrity Testing by Diffusional Flow Rate, Bubble Point, and Water Intrusion The Diffusional Flow Integrity Test, the Bubble Point Test, and the Water Intrusion Test are non-destructive tests that allow for the integrity and bubble point of the filter to be determined. The bubble point and the diffusional flow at 1.0 bar were measured using 60% Isopropanol/40% Water as the wetting fluid. The Water Intrusion test was performed using water as the non-wetting fluid. Values are shown in Figure 2. Water 60% Isopropanol/40% Water Part Number Lot # - Serial # intrusion Diffusional Flow Bubble Point Flow Rate at 1.0 bar in 60% IPA (ml/min) (ml/min) (bar) Z8JD N/A 1.6 D50CF0202H2H Z8JD N/A 1.6 Z8JD N/A 1.6 Z2NCR1411A Z2NCR1411A MCF2071S1-5 Z2NCR1411A Z2NCR1412B Z2NCR1412B Z2NCR1412B Z2NKR1413C LTF020ATCTC Z2NKR1413C Z2NKR1413C Figure 2 Integrity and Bubble Point Test Values 20

21 7.2 Bacterial Retention Testing by B. diminuta Testing was performed to determine and verify the bacterial retention capabilities of the PureFlo PTFE filters. Each filter was integrity tested prior to bacterial challenge. All filters demonstrated complete retention for B. diminuta. Water 60% Isopropanol/40% Water Total Challenge Filtrate intrusion Diffusional Flow Bubble Point Part Number Lot # - Serial # Challenge per EFA Count Flow Rate at 1.0 bar in 60% IPA Retention (ml/min) (ml/min) (bar) (CFU) (CFU/cm 2 ) (CFU) (LRV) Z8JD N/A x x 10 7 <1 >8.48 D50CF0202H2H Z8JD N/A x x 10 7 <1 >8.48 Z8JD N/A x x 10 7 <1 >8.48 Z2NCR1411A x x 10 7 <1 >11.00 Z2NCR1411A x x 10 7 <1 >11.00 MCF2071S1-5 Z2NCR1411A x x 10 7 <1 >10.99 Z2NCR1412B x x 10 7 <1 >10.99 Z2NCR1412B x x 10 7 <1 >11.04 Z2NCR1412B x x 10 7 <1 >11.04 Z2NKR1413C x x 10 7 <1 >10.94 LTF020ATCTC Z2NKR1413C x x 10 7 <1 >10.94 Z2NKR1413C x x 10 7 <1 >10.92 Figure 3 Bacterial Retention Test Results 21

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28 7.3 Bacterial Endotoxins LAL Test Results from LAL testing of 27 lots of PureFlo PTFE Capsules are shown below. All lots sampled meet the specification of <0.25 EU/ml. LAL Lot Release Test Results Catalogue Number Lot No. Result MCF2071S1 Z3EC Pass SKVF020S2N2N Z3EK03454 Pass MCF2071S1 Z3EC Pass SKVF020H4H4H Z3EK03232 Pass SKVF020H4H4H-D Z3EK03233 Pass MMF020FLO2P Z3EC Pass MCF2075S1-5 Z3EC Pass SKVF020S2N2N Z3DK02941 Pass J50RF0201QM1QF Z3DD02537 Pass MVF020CS3P-5 Z3DC Pass MMF020PLS2P-F20 Z3DC02766 Pass SKLF020S2Q2Q-G005 Z3DK02382 Pass SKLF020S2Q2Q-G005 Z3DK02992 Pass G50CF0202H2H Z3DD03064 Pass MMF020ELS2P Z3DC Pass MBF2071S-5 Z3DC Pass MMF020ALS2P-F020-5 Z3DC Pass MBF2071S1-5 Z3DC02708 Pass MBF2071S1-5 Z3DC Pass D65RF020RMRM-NV-1 Z3DD02203 Pass JKPF0202H2H Z3DK02583 Pass MBF2071S1-5 Z3DC Pass MSF2072S1-5 Z3CC Pass D40CF0201H1H Z2CD01236 Pass MKLF020D2N2N-N Z1AK00176 Pass SKLF020HTCTC-PH P1AK00114 Pass SKLF020L3NF3NF Z0PK05204 Pass 28

29 7.4 ASTM Hemolysis This test determines the hemolytic properties of a test sample when brought into contact with blood. The PureFlo PTFE 50 mm disc filter gave a Corrected Hemolytic Index of 0.56% which is considered Non-Hemolytic. Conclusion: The difference between the hemolytic index of the test sample and the negative control is 0.56 percent. This places the test samples in the non-hemolytic range according to the grade outlined in the following table. 7.5 USP Biological Reactivity Tests for Class VI Plastics Samples of the plastic components or raw materials used in the construction of s PureFlo PTFE cartridges and capsules meet the requirements of the USP Biological Reactivity Test for Class VI Plastics. Tests were completed by third party labs. 29

30 7.6 ISO Cytotoxicity Test (MEM Elution) Testing was performed using a PureFlo PTFE 50 mm disc filter capsule, per ISO , to ensure that PureFlo PTFE filters are non-cytotoxic. The PureFlo PTFE filter was found to be non-cytotoxic showing no reactivity during the test. 7.7 Gravimetric Extraction in Isopropanol The amount of non-volatile extractables from a PureFlo PTFE 50 mm disc filter capsule was determined by way of a 24-hour dynamic recirculation at 22 C of 70% Isopropyl Alcohol and subsequent gravimetric quantification. The conditions of the 24-hour dynamic extraction were chosen as a worst-case scenario for filter extractable levels. The result of the gravimetric extractables test is shown in Figure 7. Figure 7 Gravimetric Extractables Test Results 7.8 Cartridge Integrity with Multiple Steam-In-Place Cycles Testing was performed to verify the resistance of PureFlo PTFE cartridge filters with 0.2 µm PTFE membrane to multiple in-line steam sterilization cycles. Standard (all Polypropylene) constructed mini and full-size filter cartridges were subjected to 20 minute steam cycles at 135 C. Figure 8 shows the filters maintained their integrity for over 50 total cycles. Hightemperature constructed filter cartridges were subjected to an extended number of test cycles at even high temperatures as seen in Figures 9 and

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32 Figure 8 Resistance to Steam In Place Standard Construction Cartridges 32

33 The PureFlo High Temp PTFE Cartridge with high temperature polypropylene construction was subjected to over 150 steam cycles at 142 C, using 60 minute cycles. The results in Figure 9 show that the cartridge has maintained its integrity throughout the 150 cycles. SIP Conditions 60% Isopropanol/40% Water SIP Conditions 60% Isopropanol/40% Water SIP Conditions 60% Isopropanol/40% Water Cycle T ime T emp Diffusional Flow at 1.0 bar Bubble Point Cycle T ime T emp Diffusional Flow at 1.0 bar Bubble Point Cycle T ime T emp Diffusional Flow at 1.0 bar Bubble Point (#) (min) ( ) (ml/min) (Bar) (#) (min) ( ) (ml/min) (Bar) (#) (min) ( ) (ml/min) (Bar) Figure 9 Resistance to Steam In Place High Temp PP Construction Cartridges (MBF) 33

34 The PureFlo High Temp PTFE Cartridge with stainless steel core and high temperature polypropylene construction was subjected to over 100 steam cycles at 142 C, using 60 minute cycles. The results in Figure 9 show that the cartridge has maintained its integrity throughout the 100 cycles. Cycle SIP Conditions T ime 60% Isopropanol/40% Water Diffusional Flow Tem Bubble Point at 1.0 bar p Cycle SIP Conditions T ime T emp 60% Isopropanol/40% Water Diffusional Flow at 1.0 bar Bubble Point SIP Conditions Cycle T ime T emp 60% Isopropanol/40% Water Diffusional Flow at 1.0 bar Bubble Point (#) (min) ( ) (ml/min) (Bar) (#) (min) ( ) (ml/min) (Bar) (#) (min) ( ) (ml/min) (Bar) Figure 9 Resistance to Steam In Place High Temp SS-Core Construction Cartridges (MSF) 34

35 , PureFlo, and ZenCap are registered trademarks of Corporation or an affiliated company 35