Prefiltration in Pharmaceutical formulation and filling

Prefiltration in Pharmaceutical formulation and filling About

High-Surface Area Pleated Prefilters | Bio-Burden Reduction for WFI & Buffers
Product Overview

Achieve sterile process security and maximize the life of your final membrane filters with our comprehensive range of Pharmaceutical Prefiltration Solutions. We offer both Pleated Filter Cartridges (for low-viscosity fluids) and Lenticular Filter Modules (for viscous liquids and high particulate loads).

Our systems are designed for critical formulation and filling applications, ensuring bio-burden reduction, particle removal, and clarification in a fully enclosed, GMP-compliant environment.

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1. Pleated Prefilter Cartridges (PP / Glass Fiber)

Best for: Buffers, Water for Injection (WFI), Solvents, and SVPs.

• Description: High-surface area pleated cartridges that protect expensive 0.2-micron final filters.

• Glass Fiber (GF): Exceptional for lipid removal and serum filtration due to high dirt-holding depth media.

• Polypropylene (PP): Ideal for general particle removal and clarifying aqueous solutions.¹

• Key Benefit: Extends sterile filter life by up to 50% by removing colloidal particles.

2. Lenticular Filter Modules (12" / 16")

Best for: Syrups, Linctus, Fermentation Broths, and Decolorization.

• Description: A "Closed System" upgrade to traditional filter presses. Stacked disc technology combines depth filtration sheets in a sealed, leak-free module.²

• Activated Carbon Options: Available with immobilized carbon for color removal (decolorization) without loose powder handling.

• Key Benefit: Handles high viscosity and heavy sludge loads without rapid clogging, ensuring zero drip loss in cleanrooms.

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Technical Specifications (Comparison)

Feature	Pleated Cartridges (PP/GF)	Lenticular Modules (Depth Stack)
Primary Use	Polishing / Low Viscosity Fluids	Clarification / High Viscosity / Haze
Media Type	Polypropylene or Borosilicate Glass	Cellulose + DE + Resin (or Carbon)
Micron Ratings	0.5, 1, 3, 5, 10, 20 Micron	0.2 m to 25 m (Nominal)
Filtration Area	0.6 m per 10" cartridge	1.8 m (12") / 3.6 m (16") module
Max Temp	80C	80C
Sterilization	Autoclavable / SIP (121C)	Autoclavable / SIP (121C)
Connection	Code 7 (Fin), Code 0 (Flat), DOE	Flat Gasket or Double O-Ring Bayonet

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Critical Pharma Applications

Formulation (Liquid Orals & Syrups)

• Lenticular: Used for clarifying sugar syrups and removal of undissolved solids in heavy viscous liquids (Linctus/Suspensions).

• Cartridges: Used downstream for final polishing before the filling tank.

Sterile Filling (Injectables)

• Cartridges (Glass Fiber): Prefiltration of blood plasma or serums to remove lipids.³

• Cartridges (PP): Reducing bio-burden in buffers and media before the final 0.2 m sterile filter.

API Manufacturing

• Lenticular (Carbon): Removal of color and organic impurities from API slurries.⁴

• Lenticular (Standard): Removal of activated carbon fines (Trap Filtration).

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Why Choose Our Prefiltration Systems?

• Zero-Leakage Design: Both our Cartridge and Lenticular housings are fully enclosed, ensuring a cleanroom-compliant, drip-free process (unlike old plate & frame presses).

• Cost Savings: Protecting your final sterile filters with the correct pre-filter can reduce your filter spend by 30-50%.

• Validation Support: We provide CoQ (Certificate of Quality), material compliance reports (USP Class VI), and extractable studies support.

Optimized Prefiltration for Pharmaceutical Clarity

Engineered for the critical prefiltration step in liquid formulation, this product ensures removal of a broad spectrum of particulates. Its depth filter media and customizable pore sizes provide robust protection before sterile filtration, reducing bioburden and contaminants. This makes downstream filtration smoother and greatly prolongs the final filter's operational life, saving time and resources in pharmaceutical production.


Assured Compliance and Low Endotoxin Risk

Complying with stringent USP Class VI standards, this filter minimizes risks associated with cytotoxicity and extractables. The low endotoxin release ensures it is safe for parenteral applications, addressing high purity and safety mandates in pharmaceutical processes. Its suitability is reinforced by gamma irradiation compatibility, further supporting cleanroom and aseptic workflows.