PureFlo D50C Series PES 0.2µm Single Layer Disc Filters Instruction Manual

: June 17, 2024
: PUREFLO

Table of Contents

PureFlo D50C Series PES 0.2µm Single Layer Disc Filters
Application
Technical Data Sheet
19146) at a minimum challenge level of 107 CFU per ??2 of filtration area,
Regulatory Information
Part Number Description
References
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PureFlo D50C Series PES 0.2µm Single Layer Disc Filters

PureFlo-D50C-Series-PES-0.2µm-Single-Layer-Disc-Filters-
product

PureFlo® D50C Series PES 0.2µm – Single Layer Disc Filters PureFlo® D50C Filter Discs (50mm diameter) have been designed for simple, quick, and efficient filtration of fluids and gases used in laboratory, pilot, and small- scale applications. These discs are designed for small pre-filtration, clarification, and final filtration, in pharmaceutical, and biotechnological applications. The small compact design of the filter capsule also reduces hold-up volume and exposure to hazardous chemicals. No adhesives or binders are used in the encapsulation process.

The unit is thermally sealed to ensure integrity. The filters are manufactured under GMP and comply with guidelines. The filters are flushed with pharmaceutical-grade purified pyrogens-free water, and 100% integrity tested before dispatch. Our filters and free from animal-derived components raw materials can be traced by Lot Number and are strictly regulated maintaining ISO 13485 & ISO 14001 quality standards.

PureFlo® D50C Disc Filters with various Inlet/Outlet Connections

$PureFlo-D50C-Series-PES-0 $1$$

LFLF Connections

Inlet: Luer Lock Female

Outlet

Luer Lock Female
LFLM Connections

LFLM Connections

Inlet: Luer Lock Female
Outlet: Luer Lock Male

2H2H Connections

Inlet: 1/4” Hose Barb
Outlet: 1/4” Hose Barb

Application

Aqueous Solution
Product Sterilization
Alcohols
Low Flow Filtration
Bio Bags Compatible
Pharmaceuticals
Vaccines
Biologics
Antibiotics
Scale up processing
Ultrapure Water
Serums

Technical Data Sheet

Micron Rating

Final Membrane: 0.2 μm PES [Sterilizing Grade Membrane]

Effective Filtration Area

D50C Series; 2.5 2 (15.9 2)

Materials of Construction

Membrane: Pharmaceutical Grade PES (Polyethersulfone) Sterilizing Grade
Membrane Feature: Hydrophilic, Low Protein Binding, High Flow Rate
Shell, Cage, Core, End Caps: Polypropylene
Sealing: Thermally Bonded

Operating Conditions

Maximum Forward Differential Pressure: Liquid: 5.5 bar (80psi) at 72°F/22°C
Gas: 4.1 bar (60psi) at 72°F/22°C
Minimum Burst Pressure: 8.3 bar (120psi) at 72°F/22°C
Maximum Forward Differential Pressure: 4.1 bar (60psi) at 72°F/22°C
Maximum Reverse Differential Pressure: 2.1 bar (30psi) at 72°F/22°C
Maximum Operating Temperature: 176°F/80°C

Nominal Dimension

$PureFlo-D50C-Series-PES-0 $2$$

LFLF Connections

typical Filtered Volume: 165mL – 700mL

[Aqueous and alcohol base solution]
Volume Filtering is an estimated range for Sterile Compounding, Pharmaceutical & Biological applications. The Filtration Volume is significantly influenced by your solution’s viscosity, active ingredients, etc., properties. The best way to determine the exact filtration volume per filter is to try it with your solution.

Filter Integrity
The finished product was sampled and shown to exhibit a minimum bubble point of ≥18 psi (1.2 bar) in 60%IPA / 40% water and ≥ 50 psi (3.5 bar) in DI Water (at 22℃ ).

Bacterial Retention ASTM F838-05
The filters are quantitatively retentive towards Brevundimonas diminuta (ATCC

19146) at a minimum challenge level of 107 CFU per ??2 of filtration area,

consistent with ASTM F838-05

Sterilization

International Filter Products Inc. mostly stocks ETO Sterilized (Factory Sterilized) Filter Discs.
Ethylene Oxide (ETO) Sterilization Process complies with ISO 10993-7:2008 Biological Evaluation.
Medical Devices – Part 7. Each filter is subjected to a validated ETO process.
Sterilization of the fluid path has been validated per ANSI/AAMI/ISO 11135 which provides a minimum sterility assurance level (SAL) of 10-6
Discs can be autoclaved 25 times at 125 °C (257°F) for 30 minutes or chemically sanitized in situ using common sanitizing agents or hot water at 90 °C (194°F) for a limited time (dependent on time and temperature).
Warning: The filters cannot be sterilized by steam-in-place (SIP)

Regulatory Information

Regulatory Compliance 21CFR Part 177 & USP <88>:
The filters are constructed with polypropylene resins and filtration media in compliance with 21CFR Part 177 of the US Code of Federal Regulations and
USP Class VI Biological USP <88>Test for Plastic. USP <85> Bacterial Endotoxins:
The filters were tested to confirm that an aqueous extraction of this product contains <0.25 EU/ml as determined by the Limulus Amebocyte Lysate (LAL) Test USP <645> Conductivity USP: Effluent is tested during the manufacturing process and shown to meet the requirements for USP Sterile Water for Injection for conductivity. USP <87> / ISO 10993-5
Cytotoxicity:
Extract from this product is non-Cytotoxic Hemolysis ASTM F756-17: Extract from this product is non-hemolytic Human and Veterinarian Use: The product is safe for Human and Veterinarian use. CGMP CFR parts 210 & 211, the additional requirements of 21 CFR part 600 and 21 CFR part 680 apply to the aseptic manufacturing process.

Animal-Derived Components & TSE/BSE

Risk:
No animal-derived material is intentionally added or used during the manufacture of this product.
Shelf Life:
The D50C Discs have a shelf life of 3 years from the date of sterilization. Ethylene Oxide (ETO) Sterilized product packaging provides adequate protection to maintain a sterile barrier throughout the product’s distribution, handling, and 3-year shelf life.

D50C – Series PES Disc Capsule (Pharmaceutical Grade)

Ordering Guide

$PureFlo-D50C-Series-PES-0 $3$$

Example
D50CS020LFLM-PH-ETO PureFlo® D50C Series Disc Capsule, Single Layer 0.2μm PES membrane (Sterilizing Grade), Filtration Area 15.9 cm2 Luer Loc Female Inlet and Luer Loc Male Outlet, Pharmaceutical Grade (PH), ETO Sterilized (Factory Sterilized)