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
m
B
)
d
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
90
85
70
60
50
40
30
20
10
Percent of Betapure NT-P Series L ife
0
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.
2
For the same initial cartridge differential pressure, a 110 gpm system using Betapure
G
g
()
(
)
()
P
*
P
1
P
2
P
3
P
5
P
10
P20020P
30
P
40
P50050P
0
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
0
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
3
Betapure NT-P Series Filter Applications
Increasing emphasis on pharmaceutical process economies and end product purity are driving today’s pharmaceutical and biotechnology industries to high technology filtration products that offer tangible performance benefits. Betapure NT-P Series filters provide high throughput, enabling reduced filter change-outs, longer on-stream service life, and significant improvements in overall process economies.
Pharmaceutical
Betapure NT-P Series filters are ideally suited for general clarifying and prefiltration ap­plications such as solvent streams, prefiltration of fermentation additives, and parenteral prefiltration. Specific pharmaceutical process applications for Betapure NT-P Series fil t ers in clud e:
Large and Small Volume Parenterals (LVP/SVP )
Fine Chemical/Bulk Pharmaceutical Chemical (BPC)
• Antibiotics
• Ophthalmic
Diagnostic Reagents & Buffers
Orals & T opi cals
Vial & Stopper Washers
• Solvent Streams
Biologicals & Bioprocessing
In biological and bioprocess production, Betapure NT-P Series filters provide high capac­ity clarification of turbid biological solutions, including animal sera, vaccine broths, and plasma fractions. Effective prefiltration with Betapure NT -P Series cartridges can avoid costly oversized final filter systems. Specific biological and bioprocess applications for Betapure NT-P Series filters include:
• Plasma Fractionation
• Vaccines
Animal Sera & Media Feeds
Mammalian Cell Culture
• Bacterial Fermentation
Downstream Protein Purification
Pre-Column Clarification (Protection)
• TFF Protection
Facilities & Plant Services
The Betapure NT-P Series filter’s unique construction provides longer service life in general water filtration service, and in other continuous use applications. Polypropylene depth media offers high contaminant capacity and low extractables in demanding solvent fil t r a t ion a ppli c atio n s:
• Deionized Water
Water-f or-Injection Systems (WFI)
• Air/Gas Prefiltration
• Solvent Streams
4
Betapure™
s
g
g
s
e
s
)
5
g
e
)
I
n-situ
steam sterilization**
s
7
C)
ffere
essure
)
e
)
Ste
on
in-situ
S
M
A
5
Inside Diamete
1
3
/32” nominal
Outside
1/2
” nominal
Available Length
s
*
W
)
A
BCD
E
)
01
5
1/2
1/4
02
1/2
8
1/271/2
3
/
4
)
01302
)
01
2
3
/
4
0
g
e
NT-P Series
Table 3: Betapure NT-P Series Filter Specification
Materials of Construction, Cartridge & Capsules*
Filter Media, Netting, Core, End Connector & Capsule Body Polypropylene
Optional Support Rin
Gaskets & O-rin
Option
Operating Conditions, Cartridge
Maximum Operating Tempe ratur e 180 °F (82°C
Maximum Differential Pressure
Recommended Chan
e-Out Differential Pressur
Operating Conditions, Capsule
Maximum Operating Pressure
Maximum Forward Di
ntial Pr
Recommended Change-out Differential Pressur
rilizati
utoclave
Cartridge Dimensions
r
Diameter2
s 2.5, 5, 10, 20, 30, and 40 inches
Stainless Steel or Polysulfone
See ordering guid
0 psid at 86°F (3.4 bar at 30°C) 30 psid at 131°F (2.0 bar at 55°C) 15 psid at 180°F (1.0 bar at 82°C)
35 psid at 86°F (2.4 bar at 30°C
Maximum ten (10) 1 hour cycles at 259°F (126°C)
5 psig (5.2 bar) at 104°F (40°
35 psid at 104°F (2.4 bar at 40°C
35 psid at 86°F (2.4 bar at 40°C
DO NOT
TEA
cycles maximum for 30 minutes at 129°F (126°C)
Pharmaceutical Grade Filters
Nominal Capsule Dimension
ith End Connections*** (inches
5
555
7
Length (L
Nominal Length**
7
Diameter (D
Width to Vent (W
*** see Orderin
* All materials are FDA compliant per CFR 21 ** For cartridges with support ring options (1 or 2) only. Capsules cannot be steam sterilized.
Guid
2
FLOW
7
Flow
D
L
W
5
Cartridge Flow Rates
s
Grade
Absol
)
S
s
s
P005
0.5
4.5
81.9
P01012.5
45.5
P02020.8715.9
P03030.44
8.0
P05050.32
5.9
P100100.14
2.5P20020
0.065
1
P300300.05
0.91
P40040
0.0420.76
P500500.029
0.52
P700700.025
0.45
g
End Fitting
Maxi
)
H
id)
1
1/2
6.00
1.003/
8
T
6.00
1.001/
b
3.00
1.501/
4
” MNPT
1.50
2.40
T
b
0.50
2.20
Flow vs. differential pressure in water is calculated for each Betapure NT-P Series filter grade using the formula below. Detailed information for calculating flows for fluids with other viscosities is located in the following table. use the formula in conjunction with the values from columns 3 or 4 in the table. The specific pressure drop values may be effectively used when three of the four variables (viscosity , flow, differential pressure, and cartridge grade) are set.
The specific aqueous pressure drop at ambient temperature is for a single length equiva­lent (10”) cartridge. For cartridge lengths OTHER than 10” , divide the total flow by the number of equivalent lengths. For liquids other than water, multiply the specific pressure drop value provided in the table by the viscosity in centipoise.
Table 4: Betapure NT-P Series Cartridge Flow Rate
ute Rating (μm
pecific Pressure Drop per 10” Cartridge
psid/gpm/cp
mbar/lpm/cp
.2
Table 5: Betapure NT-P Series Capsules - Maximum Recommended Flow by End Fittin
Sanitary Flange
FNP
” Hose Bar
mum Recommended Flow Rate (gpm
ousing Pressure Loss (ps
apered Hose Bar
Clean
Δ p
psi (mbar)
6
Total System gpm [lpm]
(
Viscosity in Cp
) (
) (
=
Number of Equivalent Single Length Cartridges in Housing
(
Value From Table
)
)
Capsule Flow Rates
Model
D
n
of
f
C
ge
Maximu
Flow Rate*
Maxi
P
Temp
e
Literature
Reference
ZWB
T
h
bol
SO
O
s
0”
m
(
)
@
2
F
LITZRH106
S
ith clamp
closure
SO
O
gs
1
0”
26
m
(
)
200°FLITZRH10
S
Mini-
H
g
T-typ
cl
O
gs
1
2.5” or 5”
26
m
(
)
200°FL
S2
S
In-li
ith cl
cl
SO
O
gs
1
26
m
(
)
@
2
F
LITZRH
g
The following are typical water flow rates for Betapure NT-P Series capsules with 1 1/2” sanitary flange connections. Other end connections will affect maximum flow rates, see the following table. Consult factory representative for flow rates for other end connections.
3M Purifi cation Inc. Filter Housings
3M Purification Inc. provides a wide array of filter housings designed to meet the sanitary requirements of the pharmaceutical and biological manufacturing industries. Surface finishes of all sanitary housings are mirror polished 316L stainless steel, pro­viding a high quality, lo w adhesion surface for full cleanability.
Table 6: Betapure NT-P Series Housing Specifications
escriptio
Cartridge
Style
Number Cartridges
Length o
artrid
m
mum
ressure @
eratur
Betapure™ NT-P Series
Graph 3: Flow Rates for 2 1/2” capsules with 1 1/2” Sanitary Flanges @ 20°C
Pharmaceutical Grade Filters
-type wit t closure
T-type
ZM
w
ZM
with clamp
ousin
osure
ne
ZV
amp
w
osure
* Flow rates are for housings only. Do not use to size an application. Actual process flow rates are determined by the recommended flow rates of the installed cartrid
E - 226
-ring
E - 226
-rin
e
SOE - 226
-rin
E - 226
-rin
e and other process conditions.
3, 5, 7, 12 10” to 4
10” to 4
10” to 40
360 gp
1,3 60 lpm
gp
98 lpm
gp
98 lpm
gp
98 lpm
150 psi
00°
150 psi @
150 psi @
150 psi
00°
ITZRHZM
104
2.5
2.0
1.5
4
1.0
0.5
Differential Pressure (psid)
0.0
P030
P005
P010
P050
P020
1.0
P100
2.0
Fluid Flow (gpm)
Graph 4: Flow Rates for 5” capsules with 1 1/2” Sanitary Flanges @ 20°C
2.5
P005
P020
P010
2.0
1.5
1.0
0.5
Differential Pressure (psid)
0.0
2.0
1.0
Fluid Flow (gpm)
3.0
P030
P050
3.0
4.0
4.0
P200
P300 P400
P500 P700
5.0
P100
P200
P300 P400
P500 P700
5.0
6.0
6.0
7
Betapure™ NT-P Series Cartridge Ordering Guide
Cartridge Type Length
Code Rating (μm)
Grade
NT - Betapure NT-P Series
03 - 2.5” * 06 - 5” * 10 - 10” 20 - 20” 30 - 30” 40 - 40”
* 2.5” and 5” length cartridges available with “J” end modification only. ** Optional polysulfone support ring is available for applications requiring complete cartridge disposal or incineration. *** Available for 2.5” and 5” cartridge lengths only.
P005 0.5 P010 1 P020 2 P030 3 P050 5 P100 10 P200 20 P300 30 P400 40 P500 50 P700 70
Packaging Option
Z - Standard
Support Ring Option
0 - None 1 - Polysulfone ** 2 - Stainless Steel
Betapure NT-P Series Capsule Ordering Guide
Cartridge Type
Grade Code Rating (μm)
Confi guration
Nominal Length
End Connection
End Modifi cation Gasket/O-ring Material
B - 226 O-Ring with Spear C - 222 O-Ring with Spear F - 222 O-Ring with Flat Cap J - 226 O-Ring with Flat Cap***
Vent O-Ring Option
A - Silicone B - Fluorocarbon C - EPR D - Nitrile K - PTFE Encapsulated
Fluorocarbon
Packaging Option
NT - Betapure NT-P Series
Important Notice: The information described in this literature is accurate to the best of our knowledge. A variet y of factors, however, can affect the performance of the Product(s) in a particular application, some of which are uniquely within your knowledge and control. INFORMATION IS SUPPLIED UPON THE CONDITION THAT THE PERSONS RECEIVING THE SAME
WILL MAKE THEIR OWN DETERMINATION AS TO ITS SUITABILITY FOR THEIR USE. IN NO EVENT WILL 3M PURIFICATION INC. BE RESPONSIBLE FOR DAMAGES OF ANY NATURE WHATSOEVER RESULTING FROM THE USE OF OR RELIANCE UPON INFORMATION.
It is your responsibility to determine if additional testing or information is required and if this product is fit for a particular purpose and suitable in your specific application.
3M PURIFICATION INC. MAKES NO REPRESENTATIONS OR WARRANTIES, EITHER EXPRESS OR IMPLIED INCLUDING WITHOUT LIMITATION ANY WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR OF ANY OTHER NATURE HEREUNDER WITH RESPECT TO INFORMATION OR THE PRODUCT TO WHICH INFORMATION REFERS.
Limitation of Liability: 3M Purification Inc. will not be liable for any loss or damage arising from the use of the Product(s), whether direct, indirect, special, incidental, or consequential,
regardless of the legal theory asserted, including warranty, contract, negligence or strict liability. Some states do not allow the exclusion or limitation of incidental or consequential damages, so the above limitation may not apply to you.
P005 0.5 P010 1 P020 2 P030 3 P050 5 P100 10 P200 20 P300 30 P400 40 P500 50 P700 70
C - Capsule
01 - 2 1/2” 02 - 5”
A - 1 1/2” Sanitary Flange B - 1/2” (14 mm) Hose Barb C - 1/4” MNPT D - 3/8” FNPT E - 1/4” - 5/16” - 3/8”
Tampered Hose Barb
A - Silicone B - Fluorocarbon C - EPR
01 - Single Pack 03 - 3 Pack 20 - 20 Pack
Your Local 3M Purifi cation Inc. Distributor:
3M Purifi cation Inc.
400 Research Parkway Meriden, CT 06450 U.S.A. (800) 243-6894 (203) 237-5541 Fax (203) 630-4530 www.3Mpurifi cation.com
3M is a trademark of 3M Company. Betapure is a trademark of 3M Company used under license. All other trademarks are the property of their respective owners. © 2011 3M Company. All rights reserved.
70-0201-8721-0 REV 0411vb
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