zenpure - pharmaseptic, inc

Rev. 2013.07.A

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

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PureFlo® PTFE Validation Guide

2 Rev. 2013.07.A

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 10993-5 Cytotoxicity Test (MEM Elution) 7.7. Gravimetric Extraction in Isopropanol 7.8. Cartridge Integrity with Multiple Steam-In-Place Cycles

8. Technical Assistance

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1. Introduction The PureFlo PTFE Validation Guide is a reference to provide assistance in validating ZenPure’s Pharmaceutical Grade 0.2 µm PureFlo PTFE cartridge and capsule filters. These filters are manufactured by ZenPure 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 ZenPure 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 ZenPure logo.

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2.1 Catalog Numbers Each of ZenPure’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 Mini Vent Cartridge Filter

PureFlo Mini PTFE Cartridge Filter

H = 1.5" 0H = 1/16-3/32" Hose BarbS = 2.5" 1C = 1/8" Compression

1H = 1/8-3/16" Hose Barb -OE = O-ring EPDM1N = 1/8" NPTM -ON = O-ring Nitrile1Q = 1/8" Male Quick Coupling -OV = O-ring Viton2H = 3/16-1/4" Hose Barb2UF = 1/4-28 thread Female3H = 1/4-3/8" Hose BarbLF = Luer Lock FemaleLM = Luer Lock MaleLS = Male Luer SlipMT = 1/2" Tri Clamp

-ETO = Ethylene Oxide

Sterilization

Optional Sterilization

Blank = O-ring Silicone (Standard)

PureFlo Junior PTFE Cartridge Filters

Pore Size(Micron)

Quick Couplings are molded, compatible with CPC (Colder), LinkTech and others.Example - MJ Cartridge with 0.2 µm Pharmaceutical-Grade PTFE Membrane and 1/4" Hose Barb Outlet is MJF020H2H

Length End Modification

MJF = Junior Size Cartridge Filter

020 = 0.2 µm

O-ring

020 - 0.2 µm C = 015 O-Ring E = EPDM 3P = 3pc/pack Blank = StandardN = Buna N -5 = Stainless Steel InsertS = SiliconeU = TEST = TEVV = Fluroelastomer

Standard Package Qty Inserts

Note: MVF Cartridges 400cm2

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

PureFlo PTFE Cartridge FiltersMVF = Mini Vent Size

Cartridge Filter

Pore Size(Micron) End Modifications O-Ring Materials

020 - 0.2 µm 0 = 222 O-Ring Flat H = 1.5" E = EPDM 2P = 2 pc/pack (5") Blank = Standard6 = 226 O-Ring Flat S = 2.5" N = Buna N 3P = 3 pc/pack -5 = Stainless Steel InsertA = 116 Inner O-Ring L = 5" S = Silicone (1.5" and 2.5")C = 015 O-Ring T = TEVD = 1/2" MNPT U = TESE = 118 O-Rings V = FluroelastomerF = Flange* O = O-Ringless

N = 116 Inner Housing Seal

End Modifications Length O-Ring / Gasket Materials Package Qty

MMF = Mini Size Cartridge Filter

* - F end modification is compatible to fit in a PALL SealKleenTM Housing, **- M end modification is compatible to fit in a Millipore OptiSealTM Housing, ***-T end modification is compatible to fit a Parker TruesealTMHousing

M = 123 O-Rings with hold down tabs**

S = 116 Inner O-Ring with locking grooveT = 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

PureFlo PTFE Cartridge Filters

Pore Size(Micron) Inserts

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PureFlo PTFE Cartridge Filter

PureFlo PTFE Cartridge Filter with High-Temp PP

PureFlo PTFE Cartridge with SS Core

PureFlo PTFE Cartridge with PE Construction

20 - 0.2 µm 0 = 222 O-Ring Flat 1 - 10" E = EPDM 1 = 1pc/ pack Blank = Standard3 = 222 O-Ring w/tabs Spear 2 - 20" N = Buna N -5 = Stainless Steel Insert5 = 222 O-Ring Spear 3 - 30" P = Peroxide Cured EPDM6 = 226 O-Ring Flat 4 - 40" Q = Platinum Cured Silicon7 = 226 O-Ring Spear 5 = 5" S = Silicone8 = 223 O-Ring w/tabs Flat 9 = 9.75" T = TEV or FEP GasketB = 1.5" Tri-Clamp Flat U = TES*Z = SOE Internal O-ring Flat ** V = Fluoroelastomer

O = No O-ringExample - 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

MCF = Standard Size Cartridge

Filter

* - not available in Code Z, ** - only available in 5", 9.75", 10" and 20", retrofit for DOE housings


Pore Size(Micron) End Modifications Length O-Ring / Gasket Materials Package Qty Inserts

20 - 0.2 µm 0 = 222 O-Ring Flat 1 - 10" E = EPDM 1 = 1pc/ pack Blank = Standard3 = 222 O-Ring w/tabs Spear 2 - 20" N = Buna N -5 = Stainless Steel Insert5 = 222 O-Ring Spear 3 - 30" P = Peroxide Cured EPDM6 = 226 O-Ring Flat 4 - 40" Q = Platinum Cured Silicon7 = 226 O-Ring Spear 5 = 5" S = Silicone8 = 223 O-Ring w/tabs Flat 9 = 9.75" T = TEV or FEP GasketB = 1.5" Tri-Clamp Flat U = TES*Z = SOE Internal O-ring Flat ** V = Fluoroelastomer

O = No O-ring

Inserts

MBF = Standard Size Cartridge

Filterwith High TempPP Construction

* - not available in Code Z ** - only available in 5", 9.75", 10" and 20", retrofit for DOE housings

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


Pore Size(Micron) End Modifications Length O-Ring / Gasket Materials Package Qty

20 - 0.2 µm 0 = 222 O-Ring Flat 1 - 10" E = EPDM 1 = 1pc/ pack3 = 222 O-Ring w/tabs Spear 2 - 20" N = Buna N5 = 222 O-Ring Spear 3 - 30" P = Peroxide Cured EPDM6 = 226 O-Ring Flat 4 - 40" Q = Platinum Cured Silicon7 = 226 O-Ring Spear 5 = 5" S = Silicone8 = 223 O-Ring w/tabs Flat 9 = 9.75" T = TEV or FEP GasketB = 1.5" Tri-Clamp Flat U = TES*Z = SOE Internal O-ring Flat ** V = Fluoroelastomer

O = No O-ring

MSF = Standard Size Cartridge Filter

with SS Core andSS Insert

* - not available in Code Z, ** - only available in 5", 9.75", 10" and 20", retrofit for DOE housings

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



20 - 0.2 µm 0 = 222 O-Ring Flat 1 - 10" E = EPDM 1 = 1pc/ pack3 = 222 O-Ring w/tabs Spear 2 - 20" N = Buna N5 = 222 O-Ring Spear 3 - 30" P = Peroxide Cured EPDM6 = 226 O-Ring Flat 4 - 40" Q = Platinum Cured Silicon7 = 226 O-Ring Spear 5 = 5" S = Silicone8 = 223 O-Ring w/tabs Flat 9 = 9.75" T = TEV or FEP GasketB = 1.5" Tri-Clamp Flat U = TES*Z = SOE Internal O-ring Flat ** V = Fluoroelastomer

O = No O-ring

MEF = Standard Size Cartridge Filter

with PEConstruction

* - not available in Code Z ** - only available in 5", 9.75", 10" and 20", retrofit for DOE housings

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



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PureFlo PTFE Disc Filter

PureFlo Junior PTFE Capsule Filter

D4 = 4 mm Disk F = PTFE 020 = 0.2 µm 0H 0H = 1/16" or 1/16" to 3/32" Hose BarbD13R = 13 mm Disk 1C 1C = 1/8" CompressionD25C = 25 mm Disk 1H 1H = 1/8" or 1/8" to 3/16" Hose Barb Blank = SiliconeD40C = 40 mm Disk 1N 1N = 1/8" MNPT (Standard)G50C = 50 mm Disk 1NF 1NF = 1/8" FNPT -OE = EPDMD65R = 65 mm Disk 1Q 1Q = 1/8" Male Quick Coupling -ON = NitrileRD65 = Rectanular Disk 1QE 1QE = 1/8" Male Quick Coupling Elbow -OV = Viton

1QF 1QF = 1/8" Female Quick Coupling Sterilization1QFV 1QFV = 1/8" Female Valved Quick Coupling1QV 1QV = 1/8" Male Valved Quick Coupling1QVE 1QVE = 1/8" Male Valved Quick Coupling elbowAH AH = 3/32" Hose Barb2D 2D = DN5 Lundecke fitting2H 2H = 1/4" to 3/8" or 1/4" to 5/16" or 3/16 to 1/4" Hose Barb Packaging2HE 2HE = 1/4"Hose Barb Elbow Blank = Bulk2K 2K = 1/4" Hose Barb -1 = Single Bagged2N 2N = 1/4" MNPT2NF 2NF = 1/4" FNPT2Q 2Q = 1/4" Male Quick Coupling for Metal latch2QE 2QE= 1/4" Male Quick Coupling for Metal latch elbow2QF 2QF = 1/4" Female Quick Coupling for Metal latch2QFV 2QFV = 1/4" Female Valved Quick Coupling for Metal latch2QP 2QP = 1/4" Male Quick Coupling for Plastic latch2QPL 2QPL = Long 1/4" Male Quick Coupling for Plastic latch2QV 2QV = 1/4" Male Valved Quick Coupling for Metal latch2UF 2UF = 1/4-28 Thread Female3H 3H = 3/8" or 1/4" to 3/8" or 5/16 to 3/8" Hose Barb3HE 3HE = 3/8" Hose Barb Elbow3N 3N = 3/8" MNPT3NF 3NF = 3/8" FNPT4H 4H = 3/8" to 1/2" Hose Barb4HL 4HL = 1/4" to 1/2" Hose Barb4N 4N = 1/2" MNPT4T 4T = 11.8mm Tube Seal FV FV = Female VentilatorLF LF = Luer Lock FemaleLM LM = Luer Lock MaleLS LS = Luer Male SlipMT MT = 1/2" Tri-clampMV MV = Male VentilatorOV OV = Male Medical Coupling RegularOVS OVS = Male Medical Coupling ShortSM SM = Stainless Steel, 1/2" TriclampTC TC = 1.5" Tri Clamp

-ETO = EthyleneOxide

Sterilization

*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

Options

BLANK = Non-Sterile

O-Ring forQuick Connect

PureFlo EncapsulatedDisk Filters

FilterMedia

PoreSize

InletFitting*

OutletFitting*

020 = 0.2 µm Blank = 260 cm2 1H 1H = 1/8" Hose Barb Vent & DrainB = 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 fitting2H -FB= 1/4" Hose barbs with Filling Bell -NO = No vent or drain Outlet fitting2H -FC= 1/4" Hose barbs with Filling Bell with Cap

2N 2N = 1/4" MNPT O-Rings2Q 2Q = 1/4" Male Quick Coupling for Metal latch -OE = O-ring EPDM3H 3H = 3/8" Hose Barb -ON = O-ring Nitrile5MF 5MF = M5 Female thread -OV = O-ring VitonLF LF = Female Luer Lock Blank = O-ring Silicon (Standard)LM LM = Male Luer LockMT 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

PureFlo Junior PTFE Capsule Filters

JKPF = Capsule Filter Pharma grade

OptionsOutlet FittingInlet Fitting

Effective Filtration Area

Pore Size (Micron)

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PureFlo Mini PTFE Capsule Filter

PureFlo SKL and SKP PTFE Capsule Filter

020 = 0.2 µm A = 200 cm2 1C 1C = 1/8" Compression Vent & DrainB = 300 cm2 1H 1H = 1/8" Hose Barb -N= No vent or drain fittingsC = 400 cm2 1Q 1Q = 1/8" Male Quick Coupling -NI = No vent or drain inlet fittingD = 500 cm2 1QF 1QF = 1/8" Female Quick Coupling -NO = No vent or drain Outlet fitting

1QE 1QE = 1/8" Male Quick Coupling Elbow1QFV 1QFV = 1/8" Female Quick Connect w/Valve O-Rings1QV 1QV = 1/8" Male Quick Connect w/Valve -OE = O-ring EPDM2C 2C = 1/4" Compression -ON = O-ring Nitrile2CE 2CE = 1/4" Compression Elbow -OV = O-ring Viton2H 2H = 1/4" Hose barbs Blank = O-ring Silicon (Standard)

2H -FB = 2H with Filling Bell2H -FC = 2H-FB with Cap Sterilization

2N 2N = 1/4" MNPT -ETO = Ethylene oxide sterilization 2NO 2NO = Short 1/4" MNPT+EP O-Ring2NS 2NS = Short 1/4" MNPT2Q 2Q = 1/4" Male Quick Coupling for Metal latch2QE 2QE = 1/4" Male Quick Coupling for Metal latch Elbow2QF 2QF = 1/4" Female Quick Coupling with Metal latch2QFV 2QFV = 1/4" Female Quick Connect w/Valve2QV 2QV = 1/4" Male Quick Connect w/Valve3H 3H = 3/8" Hose Barb3NF 3NF = 3/8" Female NPT5H 5H = 5/8" Hose BarbLF LF = Female Luer Lock LFE LFE = Female Luer Lock ElbowMT MT = 1/2" Tri clamps

Example - MKP Capsule with 0.2 µm Pharmaceutical-Grade PTFE Membrane, 500 cm2 EFA, and 1/4" Hose Barb I/O is MKPF020D2H2H

PureFlo Mini PTFE Capsule Filters

MKPF = Capsule Filter Pharma grade

OptionsOutlet FittingInlet Fitting

Effective Filtration Area

Pore size (Micron)

SKLF = Capsule filter 020 = 0.2 µm H = 1.5" 1C 1C = 1/8" Compression Vent & DrainLuer 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 fittingSKPF = Capsule filter E = 7.5" 1NF 1NF = 1/8" FNPT -NO = No vent or drain Outlet fittingM8 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-Rings1QFV 1QFV = 1/8" Female Valved Quick Coupling with Metal latch -OE = O-ring EPDM1QV 1QV = 1/8" Male Valved Quick Coupling with Metal latch -ON = O-ring Nitrile2C 2C = 1/4" Compression -OV = O-ring Viton2H 2H = 1/4" to 1/2" Hose barbs Blank = O-ring Silicon (Standard)2HS 2HS = 1/4" to 3/8" Hose barbs2LF 2LF = Large Female Luer Lock fitting Sterilization2N 2N = 1/4" MNPT -ETO = Ethylene oxide sterilization 2NF 2NF = 1/4" FNPT2P 2P = 1/4" Push to Connect2PE 2PE = 1/4" Push to Connect Elbow2Q 2Q = 1/4" Male Quick Coupling for Metal latch2QF 2QF = 1/4" Female Quick Coupling with Metal latch2QFP 2QFP = 1/4" Female Quick Coupling with Plastic latch2QFV 2QFV = 1/4" Female Valved Quick Coupling with Metal latch2QP 2QP = 1/4" Male Quick Coupling for Plastic latch2QV 2QV = 1/4" Male Valved Quick Coupling with Metal latch2V 2V = 1/4" Walther Quick Connect3C 3C = 3/8" Compression3H 3H = 3/8" Hose Barb 3HE 3HE = 3/8" Hose Barb Elbow

3H-FB = 3/8" Hose Barb with filling bell or -FC with Cap3NF 3NF = 3/8" FNPT4C 4C = 1/2" Compression4H 4H = 1/2" Hose Barb 4N 4N = 1/2" MNPT4Q 4Q = 1/2" Male Quick Coupling for Plastic latch8C 8C = 5/16" CompressionMT MT = 1/2" Tri clampsTC TC = 1-1/2" Tri clamp

TS = Shower Head

Quick Couplings are molded, Female Quick Coupling with Plastic latch will be threaded on, compatible with CPC (Colder), LinkTech and others.Example - 5" SKL Capsule with 0.2 µm Pharmaceutical-Grade PTFE Membrane and 1.5" Tri-Clamp I/O is SKLF020LTCTC

Pore size (Micron) Length Inlet

Fitting Outlet FittingPureFlo PTFE Capsule Filters Options

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PureFlo SKV PTFE Capsule Filter

PureFlo SKS PTFE Capsule Filter

ZenCap® PTFE Full Size Capsule Filter

SKVF = Capsule filter 020 = 0.2 µm H = 1.5" 1H 1H = 1/8" Hose barbs Vent & DrainBleed Valve S = 2.5" 1Q 1Q = 1/8" Male Quick Coupling with Metal latch -N= No vent or drain fittingsVent/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 fittingK = 10" 1QV 1QV = 1/8" Male Valved Quick Coupling with Metal latch

2H 2H = 1/4" Hose barb O-Rings2HL 2HL = 1/4" to 1/2" Hose barbs -OE = O-ring EPDM

2H-FB = 1/4" Hose Barb with filling bell -FC with Cap -ON = O-ring Nitrile2N 2N = 1/4" MNPT -OV = O-ring Viton2P 2P = 1/4" Push to Connect Blank = O-ring Silicon (Standard)2PE 2PE = 1/4" Push to Connect Elbow2Q 2Q = 1/4" Male Quick Coupling for Metal latch Sterilization2QF 2QF = 1/4" Female Quick Coupling with Metal latch -ETO = Ethylene oxide sterilization 2QFV 2QFV = 1/4" Female Valved Quick Coupling with Metal latch2QP 2QP = 1/4" Male Quick Coupling for Plastic latch2QV 2QV = 1/4" Male Valved Quick Coupling with Metal latch2V 2V = 1/4" Walther Quick Connect3H 3H = 3/8" Hose Barb

3H-FB = 3/8" Hose Barb with filling bell or -FC with Cap4H 4H = 1/2" Hose Barb 4Q 4Q = 1/2" Male Quick Coupling for Plastic latch5H 5H = 5/8" Hose Barb MT MT = 1/2" Tri clampsTC TC = 1-1/2" Tri clamp

TS = Shower Head

Note: Quick Couplings are molded on. Female Quick Coupling with Plastic latch will be threaded on. Compatible with CPC (Colder), LinkTech and others. * - 2H Example - 5" SKV Capsule with 0.2 µm Pharmaceutical-Grade PTFE Membrane and 1.5" Tri-Clamp I/O is SKVF020LTCTC

Output FittingInput FittingLengthPore size

(Micron)PureFlo Capsule

Filters Options

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 latchE = 7.5" O-RingsK = 10" -OE = O-ring EPDM

-ON = O-ring Nitrile-OV = O-ring VitonBlank = O-ring Silicon (Standard)

RFID- RI = RFID Chip

Sterilization-ETO = Ethylene oxide sterilization

PureFlo Capsule Filters

Note: Quick Couplings are molded on. Compatible with CPC (Colder), LinkTech and others.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

OptionsOutlet FittingInlet FittingLengthPore size (Micron)Filter Media

L = Full Size I = In-Line 1 - 10" F = PTFE 020 = 0.2 µm A = No vents 1QFV Vent & DrainCapsule Filter T = T-Line 2 - 20" B = 1/2" Sanitary vent -N= No vent or drain fittings

C = C-Line 3 - 30" 1QV -NI = No vent or drain inlet fittingS = S-Line 4 - 40" -NO = No vent or drain Outlet fittingL = L-Line 2QFV

O-Rings2QV -OE = O-ring EPDM

-ON = O-ring NitrileF = Inlet and Outlet 1/4" Bleed Valve 3H 3H = 3/8" Hose Barb -OV = O-ring VitonG = 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 connectN = 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-Clamp2T 2T = 2" Tri-Clamp

1QV = 1/8" Male Quick connect w/Valve for Metal latch

1QFV = 1/8" Female Quick connect w/Valve for Metal latch

Notes: * 1/4" Drain bleed Valve standard on all T-Line filters Except for option AExample - 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

2QV = 1/4" Male Quick connect w/Valve for Metal latch

2QFV = 1/4" Female Quick connect w/Valve for Metal latch

LengthConfigurationZenCap Capsule Filters

C = 1/2" Sanitary vent, with upstream and down stream 1/4" Bleed Valve

E = 1/2" Sanitary vent, with down stream 1/4" Bleed Valve

D = 1/2" Sanitary vent, with upstream 1/4" Bleed Valve

OptionsOutput FittingVents *Pore size (Micron)

Filter Media

Inlet Fitting

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3. Product Specifications Good Manufacturing Practices PureFlo PTFE filters are made in a ZenPure 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 ZenPure 0.2 µm PureFlo PTFE filters are quantitatively retentive of Brevundimonas diminuta (ATCC #19146) at a minimum challenge level of 107 CFU per cm2 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

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Nominal Dimensions, Effective Filtration Area, and Diffusional Specifications

inch mm inch mm in² ft² cm² ml/min ml/min4 mm 0.2 4 0.5 12 0.005 - 0.03 N/A N/A13 mm 0.15 3.7 0.6 16 0.124 - 0.8 N/A N/A25 mm 0.2 5.1 1.3 33 0.7 - 4.6 N/A N/A40 mm 0.3 8 1.8 45.5 1.6 - 10.5 N/A N/A65 mm 0.4 10.2 2.9 73.1 4 - 26 N/A N/A

Disk (G) 50 mm 0.3 8 2.1 54 2.5 - 15.9 N/A N/A

Disk (RD) 65 mm 0.2 42.7 x 1.7

69.5 x 42.5 3.4 - 22 N/A N/A

JKP N/A 1.6 41 1.6 41 - 0.22 200 0.6 0.011A 3.9 99 2.3 60 - 0.22 200 0.6 0.011B 3.9 99 2.3 60 - 0.33 300 0.9 0.016C 3.9 99 2.3 60 - 0.44 400 1.2 0.022D 3.9 99 2.3 60 - 0.56 500 1.5 0.027H 1.5 100 2.75 70 - 0.65 650 2.0 0.04S 2.5 125 2.75 70 - 1.3 1200 3.5 0.06L 5 220 2.75 70 - 2.7 2400 7.0 0.13E 7.5 345 2.75 70 - 4 3600 11.0 0.19K 10 440 2.75 70 - 5.4 4800 15.0 0.26

ZenCap 10" 10 440 3.54 90 - 7 6500 20 0.35H 1.5 38 2.2 56 - 0.65 650 2.0 0.04S 2.5 75 2.2 56 - 1.3 1200 3.7 0.06L 5 135 2.2 56 - 2.7 2400 7.5 0.13E 7.5 210 2.2 56 - 4 3600 11.0 0.19K 10 270 2.2 56 - 5.4 4800 15.0 0.26

StandardCartridge 10" 10 440 2.75 70 - 7 6500 20 0.35

Max Air Diffusionin 60% IPA

at 1.0 bar (14.5 psi)

Max Water IntrusionFlow Rate

at 2.6 bar (37.7 psi)

Disk (D)

MKP

SKVSKLSKPSKS

MiniCartridge

FilterType

FilterSize Length Diameter

Dimensions(Nominal, No Fittings) Effective

Filtration Area

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Operating Conditions

Filter Type Max Operating Temperature

Max Working Pressure

Max Forward Differential Pressure

Max Reverse Differential Pressure

Disk (D/G) 80 °C (176 °F) Liq: 5.5 bar (80 psi)Gas: 4.1 bar (60 psi)

4.1 bar (60 psi) @ 22 °C 2.1 bar (30 psi) @ 22 °C

Disk (RD) 60 °C (140 °F) Liq: 2 bar (29 psi)Gas: 2 bar (29 psi)

1 bar (14.5 psi) @ 22 °C 1 bar (14.5 psi) @ 22 °C

JuniorCapsules

80 °C (176 °F) Liq: 5.5 bar (80 psi)Gas: 4.1 bar (60 psi)

5 bar (72 psi) @ 22 °C 2.1 bar (30 psi) @ 22 °C

MiniCapsules


5 bar (72 psi) @ 22 °C2 bar (29 psi) @ 80 °C

2.1 bar (30 psi) @ 22 °C1 bar (14 psi) @ 80 °C

SKLCapsules


5 bar (72 psi) @ 22 °C2 bar (29 psi) @ 80 °C

2.1 bar (30 psi) @ 22 °C1 bar (14 psi) @ 80 °C

SKVCapsules


5 bar (72 psi) @ 22 °C2 bar (29 psi) @ 80 °C

3 bar (43 psi) @ 22 °C1 bar (14 psi) @ 80 °C

SKSCapsules


5 bar (72 psi) @ 22 °C2 bar (29 psi) @ 80 °C

2.1 bar (30 psi) @ 22 °C1 bar (14 psi) @ 80 °C

ZenCapCapsules


5 bar (72 psi) @ 22 °C2 bar (29 psi) @ 80 °C

3 bar (43 psi) @ 22 °C1 bar (14 psi) @ 80 °C

Junior Cartridges

80 °C (176 °F) - 4.1 bar (60 psi) @ 22 °C2 bar (29 psi) @ 80 °C

4.1 bar (60 psi) @ 22 °C2 bar (29 psi) @ 80 °C

Mini Vent Cartridges

80 °C (176 °F) - 4.1 bar (60 psi) @ 22 °C2 bar (29 psi) @ 80 °C

2 bar (29 psi) @ 22 °C1 bar (14.5 psi) @ 80 °C

Mini Cartridges 80 °C (176 °F) - 4.1 bar (60 psi) @ 22 °C2 bar (29 psi) @ 80 °C

2 bar (29 psi) @ 22 °C1 bar (14.5 psi) @ 80 °C

Cartrdiges (MCF)

80 °C (176 °F) - 5 bar (72 psi) @ 22 °C2 bar (29 psi) @ 80 °C

3 bar (43 psi) @ 22 °C1 bar (14 psi) @ 80 °C

High Temp PP Cartridges

(MBF)80 °C (176 °F) - 6 bar (87 psi) @ 22 °C

3 bar (58 psi) @ 80 °C3 bar (43 psi) @ 22 °C1 bar (14 psi) @ 80 °C

High Temp SS Core

Cartridges (MSF)

80 °C (176 °F) -6 bar (87 psi) @ 22 °C4 bar (43 psi) @ 80 °C

3 bar (43 psi) @ 22 °C1 bar (14 psi) @ 80 °C

PE Construction Cartridges

(MEF)

60 °C (140 °F) -5 bar (72 psi) @ 22 °C2 bar (29 psi) @ 60 °C

3 bar (43 psi) @ 22 °C1 bar (14 psi) @ 60 °C

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Sterilization and Sanitization

ZenPure 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 ZenPure 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 ZenPure 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 ZenPure PureFlo PTFE MEF Cartridge can be sterilized by • Chemical Sanitization, by common sanitizing agent compatible with the filter’s

materials of construction ZenPure 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 ZenPure 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

ZenPure 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

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Components Membrane: PTFE Membrane Supports: Polypropylene Cage: Polypropylene or High Temperature Polypropylene Core: Polypropylene or High Temperature Polypropylene or Stainless Steel Shell: Polypropylene or High Temperature Polypropylene End Caps: 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. ZenPure’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 ZenPure’s Quality Control Department.

5. Certificate of Conformance ZenPure’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.

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6. Testing Summary 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 ZenPure 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 ZenPure’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 ZenPure’s Lot Release Criteria to ensure each lot conforms to this specification.

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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 ZenPure’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 10993-5 Cytotoxicity Test (MEM Elution) Testing was performed, per ISO 10993-5, to ensure that ZenPure 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. Zen

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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.

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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.

Figure 2 Integrity and Bubble Point Test Values

(ml/min) (ml/min) (bar)Z8JD03361-1 0.0036 N/A 1.6Z8JD03361-2 0.0041 N/A 1.6Z8JD03361-3 0.0063 N/A 1.6Z2NCR1411A-1 0.082 1.5 1.8 Z2NCR1411A-2 0.094 3.5 1.8 Z2NCR1411A-3 0.094 3.5 1.8 Z2NCR1412B-1 0.13 2.0 1.7 Z2NCR1412B-2 0.11 2.5 1.7 Z2NCR1412B-3 0.11 3.0 1.7 Z2NKR1413C-1 0.213 1.5 1.8 Z2NKR1413C-2 0.113 2.5 1.8 Z2NKR1413C-3 0.150 3.5 1.8

LTF020ATCTC

Diffusional Flow at 1.0 bar

Bubble Pointin 60% IPA

D50CF0202H2H

MCF2071S1-5

Part Number Lot # - Serial #

Water intrusion

Flow Rate

60% Isopropanol/40% Water

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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.

Figure 3 Bacterial Retention Test Results

(ml/min) (ml/min) (bar) (CFU) (CFU/cm2) (CFU) (LRV)Z8JD03361-1 0.0036 N/A 1.6 3.0 x 108 1.9 x 107 <1 >8.48Z8JD03361-2 0.0041 N/A 1.6 3.0 x 108 1.9 x 107 <1 >8.48Z8JD03361-3 0.0063 N/A 1.6 3.0 x 108 1.9 x 107 <1 >8.48Z2NCR1411A-1 0.082 1.5 1.8 1.0 x 1011 1.5 x 107 <1 >11.00Z2NCR1411A-2 0.094 3.5 1.8 1.0 x 1011 1.5 x 107 <1 >11.00Z2NCR1411A-3 0.094 3.5 1.8 9.8 x 1010 1.5 x 107 <1 >10.99Z2NCR1412B-1 0.13 2.0 1.7 9.8 x 1010 1.5 x 107 <1 >10.99Z2NCR1412B-2 0.11 2.5 1.7 1.1 x 1011 1.7 x 107 <1 >11.04Z2NCR1412B-3 0.11 3.0 1.7 1.1 x 1011 1.7 x 107 <1 >11.04Z2NKR1413C-1 0.213 1.5 1.8 8.7 x 1010 1.3 x 107 <1 >10.94Z2NKR1413C-2 0.113 2.5 1.8 8.7 x 1010 1.3 x 107 <1 >10.94Z2NKR1413C-3 0.150 3.5 1.8 8.3 x 1010 1.3 x 107 <1 >10.92

LTF020ATCTC

Filtrate Count RetentionDiffusional Flow

at 1.0 barBubble Pointin 60% IPA

D50CF0202H2H

MCF2071S1-5

Part Number Lot # - Serial #

Water intrusion

Flow Rate

60% Isopropanol/40% Water Total Challenge

Challengeper EFA

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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.

Catalogue Number Lot No. ResultMCF2071S1 Z3EC03572-3 PassSKVF020S2N2N Z3EK03454 PassMCF2071S1 Z3EC03459-1 PassSKVF020H4H4H Z3EK03232 PassSKVF020H4H4H-D Z3EK03233 PassMMF020FLO2P Z3EC03117-24 PassMCF2075S1-5 Z3EC03168-8 PassSKVF020S2N2N Z3DK02941 PassJ50RF0201QM1QF Z3DD02537 PassMVF020CS3P-5 Z3DC02584-3 PassMMF020PLS2P-F20 Z3DC02766 PassSKLF020S2Q2Q-G005 Z3DK02382 PassSKLF020S2Q2Q-G005 Z3DK02992 PassG50CF0202H2H Z3DD03064 PassMMF020ELS2P Z3DC03013-1 PassMBF2071S-5 Z3DC02834-5 PassMMF020ALS2P-F020-5 Z3DC02832-2 PassMBF2071S1-5 Z3DC02708 PassMBF2071S1-5 Z3DC02795-1 PassD65RF020RMRM-NV-1 Z3DD02203 PassJKPF0202H2H Z3DK02583 PassMBF2071S1-5 Z3DC02534-1 PassMSF2072S1-5 Z3CC01683-21 PassD40CF0201H1H Z2CD01236 PassMKLF020D2N2N-N Z1AK00176 PassSKLF020HTCTC-PH P1AK00114 PassSKLF020L3NF3NF Z0PK05204 Pass

ZenPure LAL Lot Release Test Results

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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 ZenPure’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.

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7.6 ISO 10993-5 Cytotoxicity Test (MEM Elution)

Testing was performed using a PureFlo PTFE 50 mm disc filter capsule, per ISO 10993-5, to ensure that ZenPure 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. High-temperature constructed filter cartridges were subjected to an extended number of test cycles at even high temperatures as seen in Figures 9 and 10.

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Figure 8 Resistance to Steam In Place – Standard Construction Cartridges

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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.

Figure 9 Resistance to Steam In Place – High Temp PP Construction Cartridges (MBF)

Time TempDiffusional Flow

at 1.0 barBubble Point





(#) (min) (℃) (ml/min) (Bar) (#) (min) (℃) (ml/min) (Bar) (#) (min) (℃) (ml/min) (Bar)

1 60 142 8 - 54 60 142 7 - 107 60 142 9 -2 60 142 8 - 55 60 142 6 - 108 60 142 10 -3 60 142 7 - 56 60 142 6 - 109 60 142 9 -4 60 142 6 - 57 60 142 6 - 110 60 142 9 -5 60 142 2.5 - 58 60 142 7 - 111 60 142 9 -6 60 142 5 - 59 60 142 6 - 112 60 142 10 -7 60 142 14 - 60 60 142 6 - 113 60 142 10 -8 60 142 14 - 61 60 142 6 - 114 60 142 9 -9 60 142 13 - 62 60 142 7 - 115 60 142 9 -

10 60 142 10 - 63 60 142 6 - 116 60 142 10 -11 60 142 11 - 64 60 142 7 - 117 60 142 9 -12 60 142 12 - 65 60 142 7 - 118 60 142 9 -13 60 142 10 - 66 60 142 6 - 119 60 142 9 -14 60 142 12 - 67 60 142 7 - 120 60 142 9 -15 60 142 11 - 68 60 142 7 - 121 60 142 10 -16 60 142 9 - 69 60 142 6 - 122 60 142 9 -17 60 142 9 - 70 60 142 6 - 123 60 142 9 -18 60 142 9 - 71 60 142 6 - 124 60 142 9 -19 60 142 8 - 72 60 142 8 - 125 60 142 9 -20 60 142 8 - 73 60 142 7 - 126 60 142 10 -21 60 142 8 - 74 60 142 8 - 127 60 142 9 -22 60 142 8 - 75 60 142 8 - 128 60 142 9 -23 60 142 8 - 76 60 142 8 - 129 60 142 10 -24 60 142 6 - 77 60 142 7 - 130 60 142 8 -25 60 142 8 - 78 60 142 7 - 131 60 142 9 -26 60 142 6 - 79 60 142 8 - 132 60 142 9 -27 60 142 7 - 80 60 142 7 - 133 60 142 9 -28 60 142 6 - 81 60 142 7 - 134 60 142 10 -29 60 142 6 - 82 60 142 7 - 135 60 142 9 -30 60 142 6 - 83 60 142 8 1.4 136 60 142 9 -31 60 142 6 - 84 60 142 8 - 137 60 142 10 -32 60 142 5 - 85 60 142 8 - 138 60 142 9 -33 60 142 6 - 86 60 142 7 - 139 60 142 9 -34 60 142 5 - 87 60 142 8 - 140 60 142 9 -35 60 142 5 - 88 60 142 7 - 141 60 142 9 -36 60 142 6 - 89 60 142 8 - 142 60 142 10 1.437 60 142 6 - 90 60 142 8 - 143 60 142 9 -38 60 142 5 - 91 60 142 8 - 144 60 142 9 -39 60 142 6 - 92 60 142 8 - 145 60 142 - 1.4540 60 142 6 - 93 60 142 8 - 146 60 142 10 1.441 60 142 5 - 94 60 142 8 - 147 60 142 - -42 60 142 5 - 95 60 142 8 - 148 60 142 - -43 60 142 6 - 96 60 142 9 - 149 60 142 - -44 60 142 6 - 97 60 142 9 - 150 60 142 - -45 60 142 5 - 98 60 142 9 - 151 60 142 - -46 60 142 6 - 99 60 142 10 - 152 60 142 - -47 60 142 5 - 100 60 142 9 - 153 60 142 - -48 60 142 6 - 101 60 142 9 - 154 60 142 - -49 60 142 5 - 102 60 142 9 - 155 60 142 - -50 60 142 6 - 103 60 142 10 - 156 60 142 10 1.451 60 142 6 - 104 60 142 9 1.45 157 60 142 - -52 60 142 6 - 105 60 142 9 - 158 60 142 9 -53 60 142 6 - 106 60 142 9 -

60% Isopropanol/40% Water60% Isopropanol/40% Water

Cycle

SIP Conditions

Cycle

SIP Conditions60% Isopropanol/40% WaterSIP Conditions

Cycle

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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.

Figure 9 Resistance to Steam In Place – High Temp SS-Core Construction Cartridges (MSF)

TimeTem

p


Bubble PointTime Temp


Bubble PointTime Temp


Bubble Point

(#) (min) (℃) (ml/min) (Bar) (#) (min) (℃) (ml/min) (Bar) (#) (min) (℃) (ml/min) (Bar)

1 60 142 7 - 41 60 142 6 - 81 60 142 10 1.42 60 142 6 - 42 60 142 6 - 82 60 142 10 -3 60 142 7 - 43 60 142 7 - 83 60 142 10 -4 60 142 6 - 44 60 142 7 - 84 60 142 11 -5 60 142 5 - 45 60 142 7 - 85 60 142 10 -6 60 142 8 - 46 60 142 7 - 86 60 142 10 -7 60 142 9 - 47 60 142 6 - 87 60 142 11 -8 60 142 8 - 48 60 142 7 - 88 60 142 11 -9 60 142 3.5 - 49 60 142 7 - 89 60 142 10 -

10 60 142 5 - 50 60 142 8 - 90 60 142 11 -11 60 142 5 - 51 60 142 7 - 91 60 142 10 -12 60 142 5 - 52 60 142 8 - 92 60 142 11 -13 60 142 5 - 53 60 142 8 - 93 60 142 10 -14 60 142 5 - 54 60 142 7 - 94 60 142 11 -15 60 142 5 - 55 60 142 8 - 95 60 142 10 -16 60 142 5 - 56 60 142 8 - 96 60 142 11 -17 60 142 6 - 57 60 142 9 - 97 60 142 10 -18 60 142 5 - 58 60 142 8 - 98 60 142 11 -19 60 142 6 - 59 60 142 9 - 99 60 142 11 -20 60 142 6 - 60 60 142 8 - 100 60 142 10 -21 60 142 5 - 61 60 142 9 - 101 60 142 11 -22 60 142 6 - 62 60 142 9 - 102 60 142 12 -23 60 142 5 - 63 60 142 8 1.45 103 60 142 8 -24 60 142 6 - 64 60 142 9 - 104 60 142 9 -25 60 142 5 - 65 60 142 9 - 105 60 142 8 -26 60 142 6 - 66 60 142 8 - 106 60 142 9 -27 60 142 6 - 67 60 142 9 - 107 60 142 9 -28 60 142 6 - 68 60 142 9 - 108 60 142 9 -29 60 142 5 - 69 60 142 9 - 109 60 142 8 -30 60 142 6 - 70 60 142 10 - 110 60 142 9 -31 60 142 5 - 71 60 142 9 - 111 60 142 8 -32 60 142 5 - 72 60 142 9 - 112 60 142 9 -33 60 142 5 - 73 60 142 9 - 113 60 142 8 -34 60 142 6 - 74 60 142 9 - 114 60 142 9 -35 60 142 6 - 75 60 142 9 1.4 115 60 142 8 -36 60 142 7 - 76 60 142 10 - 116 60 142 9 -37 60 142 6 - 77 60 142 10 - 117 60 142 9 -38 60 142 7 - 78 60 142 9 - 118 60 142 9 1.439 60 142 7 - 79 60 142 10 - 119 60 142 9 -40 60 142 6 - 80 60 142 9 - 120 60 142 9 -

60% Isopropanol/40% Water

Cycle

SIP Conditions 60% Isopropanol/40% Water

Cycle

SIP Conditions 60% Isopropanol/40% Water

Cycle

SIP Conditions

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

zenpure - pharmaseptic, inc

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