Millipak® Final Fill Filters

Benefits
• Maximizes product recovery in final and high
value filtration
• Simplifies operation and reduces risk of microbial
and particulate contamination
• Contains Durapore®
membrane for high flow
rates, low binding and extractables, and broad
chemical compatibility
• Improves integration into single-use assemblies
Membrane Pore Sizes
Available with particulate removal, bioburden
reduction and sterilizing-grade Durapore®
polyvinylidene fluoride (PVDF) membranes
for both liquid and gas applications.
• Hydrophilic Durapore®
membrane: 0.1 µm,
0.22 µm, 0.45 µm, 5.0 µm
• Hydrophobic Durapore®
membrane: 0.22 µm
The life science business of Merck KGaA,
Darmstadt, Germany operates as
MilliporeSigma in the U.S. and Canada
Millipak®
Final Fill Filters
Maximize recovery and enhance protection of your high value product
Millipak®
Final Fill capsules are designed for reliable
sterile filtration of small volume, high value solutions.
In final filling it is critical to maximize product
recovery and maintain sterility.
The capsule's stacked disc design minimizes hold up
volume over standard pleated devices, increasing
product recovery.
These user-friendly filters contain a multi-purpose
port that simplifies venting, integrity testing and
sampling and is validated to maintain an aseptic
flowpath even after multiple actuations.
Millipak®
Final Fill capsules contain the proven and
trusted Durapore®
membrane in multiple pore sizes
offering flexibility for your specific process needs.

2
Maximize Product Recovery
In applications like final filtration where
maximizing product recovery is critical, the
low hold up volume of Millipak®
Final Fill filters
translates to more vials filled, as compared to
traditional pleated filters. Millipak®
Final Fill
filters incorporate Durapore®
membrane
bonded to solid discs instead of the support
material in pleated filters, resulting in lower
holdup volume and reduced risk of particulates,
Figure 1. Consistent high product recoveries
are achieved across filtration areas from
100-1000 cm2
. Millipak®
Final Fill filters
maximize your product recovery, increasing
the efficiency of this critical process step,
Figure 2.
Figure 2
Hold up volume of Millipak®
Final Fill filters as compared to pleated polyethersulfone (PES) or polyvinylidene fluoride
(PVDF) filters of different areas. Values represent the mean and standard deviation from replicate tests.
HoldUpVolume(mL)
Filtration area (cm2
)
00
1010
2020
3030
4040
200200 400400 600600 800800 10001000 12001200 1400140000
Hold Up Volumes of Market Leading Filters
Millipak®
Final Fill filters PES pleated filters PVDF pleated filters
Figure 1
Membrane is bonded to solid discs instead of support
material used in pleated filters, resulting in lower holdup
volume and reduced risk of particulates
Monitor wetting and filtration operations
through the transparent housing
Proven performance with time-tested
Durapore®
membrane
Vent, sample, and integrity test while
preventing contamination with the
Aseptic Multi-Purpose Port (AMPP)
Single-use assembly integration is
simplified with a hook that protects
the AMPP
Enhanced digital integration with the
2-D barcode
Minimize hold-up volume with the
stacked disc design
Millipak®
Final Fill Design Features

3
Robust Protection Combined with
Ease of Use
The Aseptic Multi-Purpose Port (AMPP) has
been designed for ergonomic use with gloves,
and visible ‘open’ and ‘closed’ locking positions.
It contains three O-rings – the lower O-ring
seals the flowpath when the AMPP is closed,
and two upper O-rings maintain an aseptic area
that prevents cross-contamination between the
environment and flowpath. This sterile
boundary is maintained after heavy microbial
challenge and multiple actuations keeping your
process safe from contaminant exposure. This
is critical in final fill, and also for sterility
assurance in redundant filtration trains where
the flowpath upstream of the primary filter
must not be compromised.
Filter venting, integrity testing and sampling can
all be performed through the single AMPP, lowering
the risks associated with multiple filter connection
points and streamlining process design.
Scalable
Multiple filter sizes enable easy scale up and
sizing. All Millipak®
Final Fill filter capsules are
available as non-sterilized (gamma irradiation
and autoclave compatible) or sterilized by
gamma irradiation.
Size Format
Durapore®
Membrane
20
(100 cm2
)
40
(200 cm2
)
60
(300 cm2
)
100
(500 cm2
)
200
(1000 cm2
)
0.1 μm √ √ √ √ √
0.22 μm √ √ √ √ √
0.45 μm √ √ √ √ √
5.0 μm √ √
0.22 μm phobic √ √ √
Mobius®
Single-use Solutions
Millipak®
Final Fill filters are part of the
Mobius®
library. This provides you with
the flexibility to design single-use
assemblies that meet your specific
processing requirements.
The Emprove®
Program – Your Fast
Track through Regulatory Challenges
The Emprove®
Program, complements our
product portfolio, and provides three types
of dossiers to support different stages of
development and manufacturing operations
such as qualification, risk assessment,
and process optimization. This program
consolidates comprehensive product-specific
testing, quality and regulatory information,
making it readily available to our customers
to simplify their compliance needs.
Compliance and Traceability
Millipak®
Final Fill filters are designed,
developed and manufactured in accordance
with a Quality Management System
approved by an accredited registering
body to an ISO®
9001 Quality Systems
Standard. Each unit is 100% integrity
tested during manufacturing and includes
a certificate of quality.
Figure 3
Aseptic Multi-Purpose Port (AMPP).

4
Specifications
Millipak®
Final Fill 20 Millipak®
Final Fill 200
Nominal Dimensions
Maximum length 8.1 cm (3.2 in.) 8.6 cm (3.4 in.) 10.9 cm (4.3 in.) 11.9 cm (4.7 in.) 14.5 cm (5.7 in.)
Body diameter 7.6 cm (3.0 in.) 7.6 cm (3.0 in.) 7.6 cm (3.0 in.) 7.6 cm (3.0 in.) 7.6 cm (3.0 in.)
Body diameter w/
anti-roll edges
/ / / 8.1 cm (3.2 in.) 8.1 cm (3.2 in.)
Filtration Area 100 cm2
(0.11 ft2
) 200 cm2
(0.22 ft2
) 300 cm2
(0.32 ft2
) 500 cm2
(0.54 ft2
) 1000 cm2
(1.08 ft2
)
Aseptic Multi-Purpose
Port
3.2 mm (1/8 in.) hose barb
Materials of
Construction
Filter membrane Durapore®
PVDF (polyvinylidene fluoride) membrane
Support discs Polysulfone
Filter capsule Polysulfone
Port (AMPP)
Polyethersulfone
Port (AMPP) O-rings
Silicone
Hold Up Volume (mL)
at 70 psi for 1 minute
1.1 1.5 3.2 4.8 7.2
Maximum Inlet Pressure 60 psi (4.1 bar) at 25°C 80 psi (5.5 bar) at 25°C
Maximum
Differential Pressure
Forward: 60 psi (4.1 bar) at 25°C
50 psi (3.5 bar) at 25°C (5 µm)
25 psi (1.7 bar) at 80°C
80 psi (5.5 bar) at 25°C (0.1 µm, 0.22 µm, 0.45 µm, hydrophobic 0.22 µm)
Reverse: 10 psi (0.7 bar) at 25°C
Bubble Point at 23 °C
0.1 μm: ≥ 70 psi (4830 mbar) air with water
Hydrophobic
0.22 μm:
≥ 29 psi (2000 mbar) air with water
≥ 18 psi (1240 mbar) in 60/40% IPA/water
≥ 17 psi (1170 mbar) in 70/30% IPA/water
Bacterial Retention for
0.1 μm and 0.22 μm
Quantitative retention of 107
CFU/cm2
Brevundimonas diminuta ATCC®
19146 per ASTM®
F838 methodology.
Bacterial Endotoxin Aqueous extraction contains < 0.25 EU/mL per device as determined using the Limulus Amebocyte Lysate (LAL) test, meeting
requirements of USP <85>, EP 2.6.14 and JP 4.01.
Total Organic Carbon
(TOC)/Conductivity
Samples exhibited < 500 ppb TOC per USP <643> and < 1.3 µS/cm conductivity per USP <645> at 25°C after sterilization and a
water flush of:
1.0 L 2.0 L 2.0 L 3.0 L 5.0 L
Sterilization Device integrity and retention was maintained after 3 autoclave cycles of 90 minutes at 126 °C. Devices can withstand a dose ≤ 40
kGy gamma exposure.
Toxicity Component materials meet the criteria for Class VI testing based on USP <88> Biological Reactivity, in vivo, USP <87> Biological
Reactivity, in vitro, and ISO 10993-5 Tests for in vitro Cytotoxicity. This product also meets physicochemical specifications, as
described in USP <661> Containers-Plastics.
Particle Shedding Effluent meets the acceptance criteria set forth in USP <788> for large volume parenterals.
Non-Fiber Releasing This product was manufactured with a Durapore®
membrane which meets the criteria for a “non-fiber releasing” filter as defined in
21 CFR 210.3 (b)(6), validated based on large volume parenteral specifications as detailed in USP <788> Particulate Matter in
Injections.
Indirect Food Additive All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177–182, based on information provided
by raw material suppliers.
Quality Management
System
These products are manufactured in a facility which is certified to ISO®
9001:2015 Quality Management Systems.

5
Typical Clean Water Flow Rates
0
10
20
30
40
50
2
Millipak®
Final Fill 20/40/60 Capsule Filters with 0.1 µm
Hydrophilic Durapore®
Membrane
DifferentialPressure(psid)
Flow Rate (L/min)
0 0.5 1 1.5
20 H, Typical 40 H, Typical 60 H/T, Typical
0
10
20
30
40
50
Flow Rate (L/min)
Millipak®
Membrane
20 All Types, Typical 40 All Types, Typical 60 All Types, Typical
0 0.5 1 1.5 2.52 3
0
10
20
30
40
50
Millipak®
Membrane
Flow Rate (L/min)
20 H, Typical 40 H, Typical 60 H, Typical 60 T, Typical
0 2 4 6 8 10
Millipak®
Final Fill 60/200 Capsule Filters with 5.0 µm
Membrane
Flow Rate (L/min)
60 H, Typical 60 T, Typical 200 B, Typical 200 T, Typical
0
1
2
3
4
5
0 2 4 6 8 10
0
10
20
30
40
50
Millipak®
Membrane
Flow Rate (L/min)
100 B/T, Typical 200 B/T, Typical
2 4 6 120 108
0
10
20
30
40
50
Millipak®
Membrane
Flow Rate (L/min)
100 B, Typical 100 K/L, Typical
200 B, Typical 200 K/L, Typical
100 F/T, Typical
200 F/T, Typical
2 4 6 12 14 16 18 200 108
0
10
20
30
40
50
Millipak®
Membrane
Flow Rate (L/min)
100 B, Typical 100 T, Typical 200 B, Typical 200 T, Typical
15100 20 255 30
Legend
B = 13 mm (½ in.) stepped hose barb inlet and outlet
C = 19 mm (¾ in.) sanitary flange inlet and
6 mm (¼ in.) hose barb outlet
F = 19 mm (¾ in.) sanitary flange inlet and outlet
H = 6 mm (¼ in.) stepped hose barb inlet and outlet
K = 19mm (¾ in.) sanitary flange inlett and
13 mm (½ in.) hose barb outlet
L = 38 mm (1 ½ in.) sanitary flange inlet and
13 mm (½ in.) stepped hose barb outlet
T = 38 mm (1 ½ in.) sanitary flange inlet and outlet

6
Ordering Information
Millipak®
Final Fill Filters with Hydrophilic Durapore®
0.1 μm/0.45 μm Membrane
* Millipak®
Final Fill 20 filters will be available for order in the near future
Millipak®
Final Fill Filter
M F 3
Membrane Type
VL = Durapore®
0.1 μm
HL = Durapore®
0.45 μm
Size/Sterilization
*02G = 20, non-sterilized
*02S = 20, sterilized by
gamma irradiation
04G = 40, non-sterilized
04S = 40, sterilized by
gamma irradiation
gamma irradiation
gamma irradiation
gamma irradiation
Connection Type
Millipak®
Final Fill 20, 40, 60
Millipak®
Final Fill 100, 200
Millipak®
Final Fill 60, 100, 200
T = 38 mm (1½ in.) sanitary flange inlet and outlet
Quantity per Pkg
3 = 3 per package
Size/Sterilization
gamma irradiation
gamma irradiation
gamma irradiation
gamma irradiation
gamma irradiation
Connection Type
Millipak®
Final Fill 20, 40, 60
C = 19 mm (¾ in.) sanitary flange inlet and
6 mm (¼ in.) hose barb outlet
Millipak®
Final Fill 60, 100, 200
L = 38 mm (1½ in.) sanitary flange inlet and
13 mm (½ in.) stepped hose barb outlet
Millipak®
Final Fill 100, 200
K = 19 mm (¾ in.) sanitary flange inlet and 13 mm
(½ in.) hose barb outlet
Millipak®
Final Fill 20, 40, 60, 100, 200
F = 19 mm (¾ in.) sanitary flange inlet and outlet
Millipak®
Final Fill Filter
Membrane Type
GL = Durapore®
0.22 μm
M F G L 3
Millipak®
0.22 μm Membrane
Quantity per Pkg
3 = 3 per package

7
Size/Sterilization
gamma irradiation
gamma irradiation
Connection Type
Millipak®
Final Fill 60
H = 6mm (¼ in.) stepped hose barb inlet and outlet
Millipak®
Final Fill 200
Millipak®
Final Fill 60, 200
Millipak®
Final Fill Filter
Membrane Type
SL = Durapore®
5.0 μm
Ordering Information
Millipak®
5.0 μm Membrane
M F S L 3
Millipak®
Final Fill Filters with Hydrophobic Durapore®
0.22 μm Membrane
Size/Sterilization
gamma irradiation
gamma irradiation
gamma irradiation
Connection Type
Millipak®
Final Fill 20, 60
H = 6 mm (¼ in.) stepped hose barb inlet
and outlet
Millipak®
Final Fill 200
B = 13 mm (½ in.) stepped hose barb inlet
and outlet
Millipak®
Final Fill 60, 200
T = 38 mm (1½ in.) sanitary flange inlet
and outlet
Millipak®
Final Fill Filter
Membrane Type
GB = Hydrophobic
Durapore®
0.22 μm
M F G B 3
Quantity per Pkg
3 = 3 per package
Quantity per Pkg
3 = 3 per package
* Millipak®
Final Fill 20 filters will be available for order in the near future

8
© 2019 Merck KGaA, Darmstadt, Germany and/or its affiliates. All Rights Reserved. MilliporeSigma, the vibrant M, Millipore,
Millipak, Durapore, Emprove and Mobius are trademarks of Merck KGaA, Darmstadt, Germany or its affiliates. All other
trademarks are the property of their respective owners. Detailed information on trademarks is available via publicly
accessible resources.
For additional information, please visit
www.emdmillipore.com
To place an order or receive technical assistance, please visit
www.emdmillipore.com/contactPS
Lit. No. MS_DS1635EN Ver. 1.0
06/2019

Millipak® Final Fill Filters

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