3M NT-P User Manual

Betapure™

Plasma Fractionation Bacterial Fermentation

NT-P Series

The Next Generation in Pharmaceutical Depth Filter Technology

Enhanced flow. Lower pressure drop. Extended service life and lower total filtration costs…these are the benefits of Betapure™ NT-P Series filter cartridges & capsules, the latest advance in depth filtration technology. The all polypropylene filter is constructed using a process that utilizes flow enhancing filter media and an innovative flow pattern. The result is an absolute-rated filter with vastly superior life that provides more cost effective filtration than conventional polypropylene depth filters. Betapure NT-P Series filter cartridges - the new leader in filtration performance.

Betapure NT-P Series Filter Construction

Betapure NT-P Series cartridges and capsules are designed to provide significantly superior service life while maintaining a consistent filtration efficiency. They achieve this through an innovative design that allows uniform distribution of fluid flow and contaminant throughout the entire depth of the filter. Betapure NT-P Series filter construction combines a unique polypropylene media with fluid distribution netting to form multiple layers. Critically positioned media flow channels allow greater movement of fluid from layer to layer. Three distinct media sections, made from multiple media/netting layers, are combined to form the filter cartridge (see Figure 1).

Figure 1: Betapure NT-P Series Media Sections. Note that the actual ﬁ lter sections contain multiple layers of media.

Features & Beneﬁ ts

Superior Service Life.

■

As much as 4 times greater contaminant holding capacity than competitive ﬁ lters.

All polypropylene depth ﬁ lter cartridges.

■

Allow for broad chemical and temperature compatibility.

Ratings from 0.5 to 70 micron.

■

Suit a wide range of applications.

Absolute-Rated Performance.

■

Allows for consistent ﬁ ltration quality.

Provided with Certiﬁ cate of Quality documenting pharmaceutical testing & lot release criteria.

Pharmaceutical Grade Filters

Applications

Pharmaceutical Large and Small Volume Parenterals (LVP/SVP)

Diagnostic Reagents & Buffers Fine Chemical/Bulk Pharmaceutical

Chemical (BPC) Orals & Topicals Antibiotics Vial & Stopper Washers Ophthalmic Solvent streams

Biologicals & Bioprocessing

Vaccines Downstream Protein Puriﬁ cation Animal Sera & Media Feeds Pre-column clariﬁ cation (protection) Mammalian Cell Culture

TFF Protection

Facilities & Deionized Water Plant Services Water-for- Inj ect ion Sys tems ( WFI)

Air/Gas Pre-ﬁ ltration Solvent Streams

Plasma Fractionation Bacterial Fermentation

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3.1

1.33

The outer and middle sections contain multiple layers of interleaved filter media and fluid distribution netting. Within each media layer a portion of the fluid travels through the media while the balance of the fluid is delivered directly to the next distribution layer through the flow channels. The fluid distribution netting provides longitudinal and latitudinal flow paths to evenly distribute fluid flow across the surface of each successive media layer.

The Difference is Performance

Flow channels appear in the outer and middle sections of the filter matrix, as seen in the cartridge cut-away. The size, number, and location of the flow channels combined with the fluid distribution netting ensure that a uniform amount of contaminant is distributed to each layer within these two sections, while maintaining a consistent flow .

Cut-away of the Betapure NT-P Series ﬁ lter cartridge showing the three sections of media layers and core

Graph 1: Betapure NT-P Series ﬁlters deliver longer service life

Service Life Comparison of Betapure NT-P Series to Competitive 5 μm Filter Cartridges

100

Percent of Betapure NT-P Series L ife

Betapure

NT-P Series

Competitor A

5 Micron Nominal

Competitor B

5 Micron Absolute

The number of media flow channels decrease from the outer to middle sections to ensure even contaminant loading throughout the entire filter matrix. Extensive laboratory testing has demonstrated that 3M Purification Inc. has developed the optimal filter cartridge design.

The inner section, supported by a rigid polypropylene core and equal to approximately one third of the filter’s depth, contains no flow channels and is the final qualifying section ensuring absolute rated performance.

The even distribution of contaminated fluid throughout the depth of the cartridge is the key to the Betapure NT-P Series pharmaceutical grade filter’s exceptionally long service life, low pressure drops, and increased cost effectiveness.

The Result

Superior Filter Service L if e

Extensive testing has demonstrated that competitive filters of equivalent removal ratings subjected to the same contaminant load plug more quickly than Betapure NT-P Series filters. The result is significantly shorter service life, and unpredictable filtration efficiencies. In this case, Betapure NT -P Series 5 micron filters provide a service life improvement of up to 2 times greater than competitive products. (Graph 1)

Lower Pr essur e Drop

The unique design and construction of the Betapure NT -P Series cartridge allows for significantly lower pressure drops compared to equivalently rated polypropylene depth filters. Based on published data, a 5 micron Betapure NT-P Series filter system with a given flow would use up to 50% fewer cartridges than a 5 micron Pall® Profile. To underscore the Betapure NT-P Series filter cost benefit, use the example in Table 1 as a guideline.

Table 1: Comparison of 5 Micron* Filters in a 110 GPM Syste

etapure NT-P Series FiltersPall Profile II (AB Style

Flow (gpm) / 10” cartridge @ 1 psi

Number of filters for a 110 gpm flow rate 12 / 30” cartridges 28 / 30” cartridges

Based on the manufacturer’s published rating.

For the same initial cartridge differential pressure, a 110 gpm system using Betapure

()

(

)

()

P20020P

P50050P

NT-P Series 5 micron filters require significantly fewer, less than half, cartridges. This results in lower capital investment for the filter housing and fewer cartridges to purchase.

The Conﬁ dence of Consistency

Betapure NT-P Series filters utilize advanced design and construction to achieve a level of filtration consistency unattainable by competitive filters. Combined with an exceptionally long service life, the Betapure NT-P Series filter’s consistent performance, as illustrated by comparative Beta-Ratio vs. Differential Pressure (Graph 2), provides predictable results throughout the filter’s usable life. F ilters A, B, and C show a degradation in the Beta-Ratio as the differential pressure increases. These filters exhibit a pattern of either unloading previously held particles or a loss of filtration efficiency. The result of this inconsistent performance is a reduction in finished product quality, product yield, and an increase in total filtration cost.

Absolute Betapure NT-P Series

Consistent filtration performance, time after time, from start to finish - the goal of every filter user, the solution provided by Betapure NT-P Series filters. Absolute removal ratings for Betapure NT-P Series filters are determined using a filter performance test developed by 3M Purification Inc. to comply with the general procedures outlined in ASTM STP 97 5. 3M Purification Inc. defines absolute rating as the particle size (x) providing an initial Beta Ratio (Bx) = 1000. At this Beta Ratio, the removal efficiency is equal to 99.9%. Betapure NT -P Series filter ratings are specified in Table 2.

Your Beneﬁ t - Total Filtration Cost Reduction

The Betapure NT-P Series filter’ s performance and superior life advantage allows direct cost savings by reducing the number of filters used. In addition, the resulting reduction in filter change-out frequency decreases direct labor and filter disposal costs. Betapure NT-P Series filter cartridges - providing performance and value.

Betapure™ NT-P Series

Graph 2: Beta Ratios demonstrate the Betapure NT-P Series ﬁlter’s ability to perform consistently throughout its life

Beta Ratio Comparison of 20μm Filter Cartridges

1000

900

800

700

600

500

400

300

200

Beta Ratio

100

Betapure NT-P Series

Competitor B

Gradient Pore Structure Melt-Blown with Core

Pharmaceutical Grade Filters

0.5 1 10Initial

Differential Pressure (psid)

Competitor A

Gradient Pore Structure Melt-Blown with Core

Competitor C

Graded Density Structure Melt-Blown, Coreless

Pharmaceutical Testing and Optimization

Betapure NT-P Series filters undergo extensive quality testing prior to release, assuring safe and consistent performance in critical applications. Betapure NT-P Series filter cartridges and capsules are manufactured and tested in accordance with an ISO 9001 :2 008 Quality Management Systems Standard. Betapure NT-P Series filter cartridges and capsules are supplied with a Certificate of Quality for traceability and documentation control. Filter cartridges and capsules are marked with a unique lot number to provide full traceability through manufacturing records of raw material components. A Regulatory Support File (70-0201-8826- 7) is available f or ease of compliance to regulatory requirements. Specific biosafety and effluent quality tests include the following:

• Meets USP Biological Reactivity,

• Non-pyrogenic per USP Bacterial Endotoxins Test (<0.25 EU/ml) .

• Meets oxidizable substances and pH test per USP Purified Water.

• Cleanliness - Meets USP Particulates in Injectables limits, microscopic examination of effluent particle counts serve to conform with requirements for non-fiber releasing filter per CFR 21.

• Conductivity & Total Organic Carbon (TOC) - Meets requirements of USP Purified Water after flushing.

In Vi vo

, for Class VI 121°C Plastics.

Tab le 2: Betapu re NT-P Series Filter Ratings

rade Designation

005 0.5

010

020

030

050

100

300

400

700 7

* extrapolated

Absolute Ratin

Micron

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