ImaPore' FiltersSolutions for Pharma and Biopharma Applications www.amipolymer.com

| About Us Since 1998, APPL has been engaged in the business of polymer products, which ultimately provide solutions for fluid transfers, sealing, and contamination controls for the pharma, biopharma, medical, laboratory, food, beverage, and engineering sectors worldwide. APPL has ISO class 7 and 8 cleanroom facilities certified with ISO 9001:2015, IS014001:2015, ISO 45001:2018, ISO 27001:2013 and IS013485:2016. We also have a BPOG extractables program for our products for regulatory markets worldwide. APPL has world-class manufacturing technology with end-to-end process capabilities to fulfill...

Our portfolio includes a diverse range of filters suitable for Pharmaceutical, Biopharmaceutical, and API manufacturing processes, covering applications from sample preparation to final product filtration.

The ImaPore™ PES cartridges and capsules feature a unique single layer and Dual Layer hydrophilic polyether sulphone membrane. This membrane is characterized by excellent throughput and higher durability in many applications such as pharmaceutical and biological filtration and beverage filtration. Higher flow rates than any other sterilizing grade filter cartridge offers, ImaPore™ PES filter assures there by the most economical design of filtration systems with better output. • Pharmaceuticals and biologicals filtration •CellCulture Media • Media additives • Small volume parenteral & Large volume...

•All materials used in PES meet the requirements of FDA 21 CFR and EU No. 1935/2004 and EU10/2011 • Biological Safety: The component materials of PES pleated filter cartridges meet the criteria of the USP Biological Reactivity Tests USP<87> Biological Safety Test (In-Vitro), USP<88> Biological Safety Test (In-Vivo) •Bacterial Endotoxin: The aqueous extraction of PES pleated filter cartridges contains< 0.25EU/mL as determined by Limulus Amebocyte Lysate (LAL), meeting the requirements of Ch.P monographs for Water for Injection (WFI). • Non- fiber releasing: PES pleated filter cartridge meets the...

• Capsule Autoclaving is recommended at a maximum temperature of 126°C for 3 cycles of 60 • Note: Autoclaving beyond 3 cycles is subject to validation.

Media Pore Rating End cap Example for Catalogue Number: IMACG73S*SL = Single Layer *DL = Double Layer Ordering Information: Capsule Filter IMA Format Media Pore Rating Sterility Length K=Capsule Polyethersulfone

ImaPore™ PTFE filter cartridges, are constructed from a PTFE membrane and Polypropylene core, outer cage and big bore inner dia. which provide excellent flow rates, long service life and minimal extractable. The materials of construction give filter superior chemical compatibility and oxidation resistance suitable for sterile filtration of aggressive solutions such as acids, bases and oxidizable solvents. ImaPore™ filter are also compatible with high temperature and oxidizable gases for vent specific application etc. • All kinds of aggressive bases and solvents • High temperature applications...

• Biological Safety: The component materials of PTFE pleated filter cartridges meet the criteria of the USP Biological Reactivity Tests In • Bacterial Endotoxin: The aqueous extraction of PTFE pleated filter cartridges contains< 0.25EU/mL as determined by Limulus Amebocyte Lysate (LAL), meeting the requirements of Ch.P monographs for Water for Injection (WFI). • Non- fiber releasing: PTFE pleated filter cartridge meets the criteria for "non-fiber releasing" standard as defined in 21 CFR 210.3 (b) (6). • Bacterial Retention Quantitative retention of 107 CFU/cm2 Brevundimonas diminuta ATCC® 19146...

• Steam-in-Place (SIP): Cartridge can be SIP Up to a maximum temperature of 125°C for 30 minutes, validated for 20 cycles • Capsule Autoclaving is recommended at a maximum temperature of 126°C for 3 cycles of 60 minutes each. ‘Note: Autoclaving beyond 3 cycles is subject to validation.

Example for Catalogue number: IMACTK272E*SL = Single Layer *DL = Double LayerOrdering Information: Capsule Filter IMA Format Media Sterility Pore Rating Length End connection S=Pre sterile Example for Catalogue number: IMAKTAK325H1*SL = Single Layer *DL = Double Layer www.amipolymer.com

ImaPore™ PVDF Pleated Filters feature a high-performance PVDF membrane known for excellent resistance to organic and inorganic solvents. They offer absolute retention, low extractables, high throughput, and broad chemical compatibility to meet critical process needs. • LVP (Large Volume Parenteral) • SVP (Small Volume Parenteral) • Pharmaceutical Water Treatment • API (Active Pharmaceutical Ingredients) • Process Water • Raw Materials Intermediate Polishing • PVDF membrane retention rate, can ensure absolute precision filtration. • Has excellent resistance to conventional chemical reagents. minutes,...

• All materials used in PVDF meet the requirements of FDA 21 CFR and EU No. 1935/2004 and EU10/2011 • Biological Safety: The component materials of PVDF pleated filter cartridges meet the criteria of the USP Biological Reactivity Tests In • Bacterial Endotoxin: The aqueous extraction of PVDF pleated filter cartridges contains< 0.25EU/mL as determined by Limulus Amebocyte Lysate (LAL), meeting the requirements of Ch.P monographs for Water for Injection (WFI). • Non- fiber releasing: PVDF pleated filter cartridge meets the criteria for "non-fiber releasing" standard as defined in 21 CFR 210.3 (b)...

Ordering Information: Cartridge FilterIMA Format Media Pore Rating End cap Length O-Ring IMA C=Cartridge *SL = Single Layer *DL = Double Layer Example for Catalogue number: IMACV71SOrdering Information: Capsule FilterIMA Format Media Pore Rating Sterility Length End connection IMA K=Capsule S=Pre sterile *SL = Single Layer *DL = Double Layer