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Millipak Final Fill Filtration Presentation
- 1. Millipak® Final FillFilter Maximize recovery and enhance protection of your high value product
- 2. 2 Intense Regulatory Focuson Final Sterile Filtration EU GMP Annex 1 draft for the manufacture of sterile medicinal products, March 2018 PDA® TR26 – 2008 Sterilizing filtration of liquids Where the claimed purpose of the filter is to sterilize, pre and post filtration integrity tests should be performed. Prefiltration integrity test may be performed prior to sterilization of the filter and, preferably, after sterilization. Steps should be taken to ensure that the downstream side of the system remains sterile when performing a post sterilization, pre-use integrity test. p 34
- 3. Benefits of Millipak®Final Fill Filters
- 4. 4 Title ofPresentation | DD.MM.YYYY Maximize product recovery and cost savings Reduced risk of contamination and process errors Comprehensive Support Benefits of Millipak® Final Fill
- 5. 5 Easy to stabilize Assemblysetup with handle Stacked Disk with Durapore® Membrane Flow direction Aseptic Multi Purpose Port GS1 2D barcode Product Features Transparent polysulfone housing Product Recovery Risk Reduction
- 6. 6 Stacked Disc Designminimizes hold-up volume Pleated Filter Stacked Disc Design Filter . • Upstream and downstream support • Particulates, oxidizables, extractables • Hold-up volume • Thermal bonding • Manufacturing concerns • “Wasted filtration” • Too much filter • Not enough process • Few materials of construction • Low particulates • Low oxidizables • Low extractables • Low hold-up means High product recovery • Less lost $$$ • Small filtration areas • Maximize process efficiency • Good for small batches
- 7. 7 Proven Durapore® Membrane oConsistentpore size and shape oLow protein binding oHigh flowrate oLow extractables oLow particle shedding oBroad chemical compatibility oExtreme robustness Proven Durapore® membrane is the membrane of choice for sterile filtration of high value products.
- 8. 8 Stacked Disc DesignMaximizes Product Recovery with Filter Blow- down 0 200 400 600 800 1000 1200 1400 1600 1800 2000 $0 $10,000 $20,000 $30,000 $40,000 $50,000 $60,000 Potential Revenue loss as a result of Holdup Volume Millipak Final Fill 200 (1000 cm^2) 0.22 Pleated Filter (900 cm^2) Drug cost per mL Potential Revenue Loss = Air Source; Integrity Tester Blow down
- 9. 9 Minimize contamination riskswith Aseptic Multi-Purpose Port (AMPP) Risk Reduction Prevent contamination during pre- use integrity testing Reducing contamination risk during sampling Validated to maintain aseptic flow- path during actuation Aseptic Actuations Integrity Testing Sampling Aseptic Multi Purpose Port
- 10. 10 AMPP- Simplify AssemblyDesign Simplified Design Fewer Connections; less dead volume Simplified operation
- 11. 11 Millipak® Final FillFilter streamlines integrity testing Integrity Tester AMPP Protects product flow-path Simplified design reduces product loss Easy operation reduces errors
- 12. 12 Confirming Filter Integrity MembraneSize 20 Size 40 Size 60 Size 100 Size 200 0.1 µm @56psi ≤ 1.5 ≤ 1.5 ≤ 1.5 ≤ 2.0 ≤ 2.0 0.22 µm @40psi ≤ 1.5 ≤ 1.5 ≤ 1.5 ≤ 2.0 ≤ 2.0 0.45 µm @21psi ≤ 1.5 ≤ 1.5 ≤ 1.5 ≤ 2.0 ≤ 2.0 Membrane Bubble Point 0.1 µm 70 psi 0.22 µm 50 psi 0.45 µm 26 psi 0.22 µm hydrophobic 18 psi (60/40 IPA) 17 psi (70/30 IPA) Bubble Point Diffusion *must be directly connected to inlet (no tubing)
- 13. 13 Materials of Construction Capsule:PSU (polysulfone) Disc: PSU (polysulfone) O-ring: Silicone AMPP: PES (polyethersulfone) Membrane: Durapore® PVDF
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- 15. 15 Product Offerings *All formatsavailable in both pre-sterilized (gamma irradiation) and non-sterile (gamma-compatible) MOC
- 16. 16 Emprove® Portfolio –available by Q1 2020 Information to start a material qualification • General information • Manufacturing flow chart • Product characterization and qualification • Specification, release criteria a • Materials of construction • Extractables summary • Residual solvents statement • Elem. Impurities statement • Regulatory statements Answers questions during risk assessment Quality Self Assessment • Supplier and CMO management • Shelf life testing and results • Packaging and Sterility Validation Supports process optimization Full Extractables profile • Elemental Impurity (ICH Q3D) • Analytical procedure
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- 18. 18 Title ofPresentation | DD.MM.YYYY Competitive Analysis Capsules for biopharma Full line, 100 cm2 and up Full line, 200 cm2 and up Full line, 150 cm2 and up Membrane PVDF(Durapore), PES(Express) PVDF, PES, PES+PDVF PES only Holdup volume Best in class Standard pleated Standard pleated Particulates, Bioburden Low (stacked disk) Standard pleated Standard pleated Validated aseptic vent Yes (multiple actuations) No No Integrity test through vent Yes No No Process monitoring Yes (transparent, labels) No No Easy setup Yes (stabilizer, hook, lock) Standard Standard Industry-standard testing USP 788, TOC TOC No
- 19. 19 Title ofPresentation | DD.MM.YYYY Millipak® Final Fill Filters Offer Lowest Hold-up Volume of Market Leading Filters 0 200 400 600 800 1000 1200 1400 0 5 10 15 20 25 30 35 40 Millipak Final Fill Linear (Millipak Final Fill) Filtration area (cm2) Hold Up Volume (mL)
- 20. 20 Comparison with otherMillipore® Sterilizing Filters Millipak Final Fill Millipak Opticap XL Filtration Area 100 - 1000 100 - 1000 220 -5400 Membrane Durapore PVDF Stacked disk Durapore PVDF Stacked disk PES, PVDF Pore Sizes .1μm, .22μm, .45μ m, 5μm .1μm, .22μm, .45μm .1μm, .22μm, .45μm Material of construction Polyethersulfone Polycarbonate Polypropylene Maximum Inlet Pressure 5.5 bar @ 60 psi 5.2 bar @ 75 psi 5.5 bar @ 80 psi Validated Aseptic Port Emprove Dossier Specialized Mobius Assemblies Diffusion Testing
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- 22. 22 Datasheet UserGuide Durapore Wetting Guide Product Web pages Product video + Wetting video Tech Brief holdup + blowdown Tech Brief AMPP performance Artista enablement Emprove MQD (0.22µm, 0.1µm) Emprove OED (0.22µm) Q2 2019 TBA App Note SU Design and AMPP recovery SURF assembly best practices and operation video App Note 5um particulate removal Emprove MQD (5.0µm, 0.45µm) Emprove OED (5.0µm) Product Resources
- 23. 23 Millipak® Final Fillis the Best-in-Class, Small Scale Filter for Critical Filtration Operations Benefit Feature Maximum product recovery and cost savings Stacked disc design minimizes product loss Reduced risk of contamination and processing errors AMPP validated to prevent contamination, and simplifies assembly design (integrity test, sample) Comprehensive support Emprove® suite (including E&L) Up-to-date industry standard testing BioReliance® Validation Services
- 24. 24 Title ofPresentation | DD.MM.YYYY Holdup Volume Cost per filter MF 20, 100cm2 1.1 140 MF 40, 200cm2 1.5 200 MF 60, 300cm2 3.2 260 MF 100, 500cm2 4.8 400 MF 200, 1000cm2 7.2 600 Sartopore2 size 4, 150cm2 3.0 69 Sartopore2 size 5, 300cm2 4.9 108 Sartopore Plat Midicap 7, 650cm2 21.2 259 SuporEKV PES Mini Kleenpak, 220cm2 6.7 67 Fluorodyne2 DFL PVDF Mini Kleenpak, 200cm2 9.7 76 Fluorodyne2 DFL PVDF Kleenpak3, 1500cm2 32.8 292 SHC Opticap XL150, 140cm2 5.3 64 SHC Opticap XL300, 290cm2 7.7 89 SHC Opticap XL600, 590cm2 12.9 132 KVGL Opticap XL2, 900cm2 25.3 102 KVGL Opticap XL4 21.5 144 Numbers from Saving Calculator
- 25. 25 Title ofPresentation | DD.MM.YYYY Aseptic Actuation Test parameter Objective Treatment Result Positive control Demonstrate simulated defects allow bacterial ingress O-rings removed from device B. diminuta detected Typical test article Demonstrate aseptic barrier maintained 25-40 kGy gamma irradiation, 1x autoclave at 121°C for 30 minutes No microorganisms detected Treated test article Demonstrate aseptic barrier maintained 25-40 kGy gamma irradiation, 3x autoclave at 126°C for 90 minutes, ≥18 actuations, and test preparation autoclave at 121°C for 30 No microorganisms detected Negative control Demonstrate method can be run aseptically ≥18 actuations No microorganisms detected
Editor's Notes
- #2 Fix Merck to M -fix
- #10 Fix image
- #11 Benefit of subassemblies Shrink of your assembly through main flowpath Reduce potential losses in or on tubing Fast to operate / Easier to handle Open and close amp Easier to ensure open and close
- #15 Remove two bottom tables and put in appendix
- #19 Add pleated to end
- #22 Change blue to black Change from launch to availability
- #23 First slide talk about benefit
- #25 appendix