Millipak Final Fill Filtration Presentation

Millipak Final Fill

1. Millipak® Final Fill Filter Maximize recovery and enhance protection of your high value product

2. 2 Intense Regulatory Focus on 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 of Presentation | 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 Assembly setup 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 Design minimizes hold-up volume Pleated Filter Stacked Disc Design Filter . Upstream and downstream support Particulates, oxid izables , extractables Hold-up volume Thermal bonding Manufacturing concerns “Wasted filtration” Too much filter Not enough process Few materials of construction Low particulates Low o xidizables Low extractables Low hold-up means High product recovery Less lost $$$ S mall filtration areas Maximize process efficiency Good for small batches

7. 7 Proven Durapore® Membrane Consistent pore size and shape Low protein binding High flowrate Low extractables Low particle shedding Broad chemical compatibility Extreme robustness Proven Durapore® membrane is the membrane of choice for sterile filtration of high value products.

8. Presentation title in footer | 00 Month 0000 8 Stacked Disc Design Maximizes Product Recovery with Filter Blow-down = Air Source; Integrity Tester Blow down

9. 9 Minimize contamination risks with 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 Multi Purpose Port

10. 10 AMPP- Simplify Assembly Design Simplified Design Fewer Connections; less dead volume Simplified operation

11. 11 Millipak® Final Fill Filter streamlines integrity testing Integrity Tester

12. 12 Confirming Filter Integrity Membrane Size 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

14. Product Offering

15. 15 Product Offerings * All formats available in both pre-sterilized (gamma irradiation) and non-sterile (gamma-compatible) MOC

16. 16 Emprove ® Portfolio – available by Q1 2020

17. Competitive Analysis

18. 18 Title of Presentation | DD.MM.YYYY Competitive Analysis Capsules for biopharma Full line, 100 cm 2 and up Full line, 200 cm 2 and up Full line, 150 cm 2 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 of Presentation | DD.MM.YYYY Millipak® Final Fill Filters Offer Lowest Hold-up Volume of Market Leading Filters

20. 20 Comparison with other Millipore® 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 . 1 μm, .22μm, . 45 μm, 5μm . 1 μm, .22μm, . 45 μm . 1 μm, .22μm, . 45 μm 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    Millipak Final Fill Millipak Opticap XL Filtration Area Membrane Durapore PVDF Stacked disk Durapore PVDF Stacked disk PES, PVDF Pore Sizes . 1 μm, .22μm, . 45 μm, 5μm . 1 μm, .22μm, . 45 μm . 1 μm, .22μm, . 45 μm 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   

21. Conclusion

22. Datasheet User Guide 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) 22 Product Resources

23. 23 Millipak® Final Fill is 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 of Presentation | 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 of Presentation | 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