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Improved Product Recovery using Blow-down and Millipak®Final Fill Filters
sterilizing-grade pleated membrane filters with those
of Millipak® Final Fill stacked disc filters following filter
drain by gravity and air blow-down.
Implementation of a filter blow-down was shown to
reduce
Redesigned Filter Capsule Improves Final Filtration Assembly Design & Operation
Connector
Millipak®
Final Fill Filter
Millipak®
Final Fill Filter
Millipak®
Final Fill Filter
Millipak®
Final Fill Filter
Millipak®
Final Fill Filter
Millipak®
Final Fill Filter
Millipak®
Barrier
Mobius®Single-Use Final Fill Solutions
container types and
volumes ranging from 5mL to 1L.
3 Millipak® Final Fill Filter or Opticap® Product Filter
4 Millipak® Barrier filters have both a hydrophobic and hydrophillic membrane, allowing
flushing
User Guide - MFGB06GH3
use by date of the filter. Integrity
test all Millipak® Final Fill Filters before
use to ensure no damage occurred during
shipping or storage.
Millipak® Final Fill Filters User Guide 3
Adoption Of Single-Use For Final Filtration
redundant sterilizing filters should be considered in many cases’. In Europe, the
guidelines for final filtration state that 'a second sterilizing-grade filter immediately prior to filling may be
advisable
Reduce Contamination Risks and Simplify Filtration System Design and Operation
sterilizing filters -
A: connection through the filter inlet, B: connection through the AMPP on Millipak® Final Fill filters.
A B
Clamp
Clamp
Automated
Integrity Tester
Gas Filter
Sterilizing
Durapore® Family Guide
Information
Filters Containing Hydrophobic 0.22 μm Durapore® Membrane
Millipak® Final Fill Capsule Filter Specifications
Description Millipak® Final Fill 20 Millipak® Final Fill 60 Millipak® Final Fill
Comprehensive Solutions for Your Vaccine Platforms
Durapore®
0.22 µm filters
• Millipore
Express® SHC
filters
• Millipak® Final
Fill filters
• Single-use and
filter validation
services
• Analytical
testing of
final fill drug
product
Optimization of Final Filtration Operations using Single-Use Systems
Pre-sterilized single-use assemblies offer particular
benefits to final filtration.
On Millipak® Final Fill filters the traditional filter vent has been
replaced with a specialized aseptic multi-purpose
PARENTERAL PROCESS GUIDE
30
35
40
1400120010008006004002000
20
15
10
5
0
Millipak® Final Fill filters Pleated filters
Portfolio
Design options
Filtration FillingFormulation
Advantages
Plasma Processing Capabilities
Sterile Filtration
Series 3000 housings
Durapore® filters
Final Fill
Excipients
BioReliance® final product
release testing
Final pasteurization
heat treatment
EMPROVE® Raw materials
Data Sheet - Helium Integrity Test
bags
Filter* Millipak® filters (Except for Millipak® Final Fill filters and Millipak® Barrier filters)
Sensors PendoTech pressure sensors
Others BetaBags, Filling needles, Luers
*Filter vent design
EX-CELL ANTIFOAM Frequently Asked Questions
used in autoclaving. Antifoam
is too thick to filter through a sterile filter. The PE media
bags used during manufacture are not sterile prior to fill
and the product is terminally sterilized so
Vent Filter Sizing for Mobius®Single-use Mixing Solution
accumulation when
filling a Mobius® Single-use Mixing Solution, tests have
been performed with different vent filters at different
filling flow rates. The study identified a suitable vent
filter could limit
User Guide -RDYSTRM01
case the remaining filter capacity is insufficient to fill the media bag,
a message is displayed to notify the user accordingly and to request a
filter change.
Priming of the filter set
For optimal performance
User Guide -RDYSTRM20
case the remaining filter capacity is insufficient to fill the media bag,
a message is displayed to notify the user accordingly and to request a
filter change.
Priming of the filter set
For optimal performance
User Guide -RDYSTRM10
case the remaining filter capacity is insufficient to fill the media bag,
a message is displayed to notify the user accordingly and to request a
filter change.
Priming of the filter set
For optimal performance
1X PBS (Phosphate Buffered Saline) Buffer Mixing Optimization
area) were used during Vmax™
testing. Table 2 outlines the filters that were evaluated
in this study.
Table 2. Filter Evaluation
Filter Chemistry Pore Size
Millipore Express® SHC Hydrophilic PES
User Guide - ReadyStream® System
of the
media bag stock.
Before filling the bag, please check if the
remaining volume of the filter is enough to fill
it.
The user is asked to confirm filling to begin by pressing
[+]. The stopcock
High sensitivity integrity test for manufacturing release of Mobius®single-use fill finish assemblies
for manufacturing release of Mobius® single-use fill finish assemblies
Introduction
The filling operation for bulk drug substances
is a critical final step that requires sterile
processing to assure
Leveraging the advantages of single-use in plasma processing
or redundant filtration?
2 Do you require the filter in or out of the isolator?
The adoption of single-use technologies for final filling process is steadily increasing, as it provides the
flexibility
Tailoring flushing procedure to modern Pods systems
alternative procedure for
flushing the filters at a lower flowrate.
Definition of wetting targets
Process scale Pod filters are composed of different
surface areas (each filter being made of several media
Protocol-933090
capacity)
SLFH025
Syringe filters 0.45µm (for filtering non-aqueous solutions like
polymer/drug solutions)
SLHAR33SS
Syringe filters 0.45µm (for filtering aqueous solutions like stabilizer
Brochure: Milli-Q® SQ 2Series
R
IE
S
5
Final filters to
match specific
application needs
SQPAK™
Final Filter
Removes particulates
and bacteria
SQPAK™
Bio Final Filter
Removes pyrogens,
nucleases
Risk Free Connection of Pre-Sterilized Single Use Fluid Path Assemblies to Stainless Steel SIP Systems with Lynx ST (Steam-To) Connectors
control plate to a
filling machine. The fluid path has
been split into two components: a
flexible 200 L container complete
with sterilizing grade filters, and a
pre-sterilized filling feed complete
with
Protocol-933082
capacity)
SLFH025
Syringe filters 0.45µm (for filtering non-aqueous solutions like
polymer/drug solutions)
SLHAR33SS
Syringe filters 0.45µm (for filtering aqueous solutions like stabilizer
Mobius®2D and 3D Assemblies and Storage Systems
sampling capabilities
• Tubing and filling needles in
a range of sizes and styles
to fit a variety of filling
machine models
• Millipak® Final Fill Filter
for maximum product
recovery and
Wetting Instructions for Filter Units with Durapore Membrane
test
hydrophilic filters and to troubleshoot post use integrity test failures of hydrophilic filters.
NOTE The polysulfone component of Millidisk® and Millipak® Final Fill filters is not
compatible
Buffer Preparation for Plasma Processes
sterilizing-grade filters
might be preferred for processing formulation buffers as these
are closer to the end of the process and the final filling operation.
Bioburden reduction filters Sterilizing-grade
Implementing a Single-Use Solution for Fill-Finish Manufacturing Operations
mobius single-use fill–finish assembly
Secure Sterile
Connection
Lynx S2S
Test Preuse
and Line
Drainage
Closed
Venting in
2-L Bag
In-Line
Filtration
Closed Filter
Integrity Test
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