USD 2715(1)
Pall Validation Services for
AllegroTM Single-use Systems
Providing Comprehensive Validation Services
for the Allegro Single-use Platform
The Allegro system platform offers a
comprehensive single-use product line to serve all
applications from upstream through downstream as
well as formulation and filling. Pall can therefore
provide the Biopharmaceutical industry with
process solutions, technical support and validation
for single-use systems.
Pall Validation and Technical services play a key
role in providing validated single-use solutions for
fluid handling and assisting in the implementation
of Allegro single-use processing solutions from
drug development to manufacturing operations.
Our Allegro single-use system validation program
includes thorough documentation of test protocols
and issuance of final reports that are ready to
support regulatory submissions.
Pall maintains close working relationships with
government and industry organizations around the
world to ensure that we are up-to-date with the latest
GMP1 requirements and industry best practices.
Validation Services
u Extractables and leachables
u Compatibility testing
u Sterilizing filter capsule validation
1
Good Manufacturing Practices
™
AllegroSystems
The Single- Use Solution
A general overview of available validation services focusing
on single-use system implementation is listed below:
Allegro Single-use
Extractables/Leachables Determination
Extractables/leachables determination are performed
following BioProcess Systems Alliance (BPSA)
recommendations: (reference: Recommendations for
Extractables and Leachables Testing Part 1: Introduction,
Regulatory Issues, and Risk Management).
our global Pall Advanced Separation Systems (PASS)
engineering staff. These teams are located around the
globe to offer fast local services, as required.
Compatibility Testing
Functional testing to evaluate compatibility of
the components or materials after autoclave
or gamma irradiation.
Compatibility testing can be based on either
chemical and/or mechanical studies.
Complete data reference library of single-use
components evaluated in water and ethanol.
Validation studies including:
Validation studies including:
• Leak testing for all connections in the system
• Study design and execution of extraction
• Pre-treatment and analysis of extracts
• Drop performance studies for biocontainers
(ASTM D4169-05)
• Characterization of extracts, including:
• Integrity testing for filter capsules
– Non-volatile residue (NVR) gravimetric measurement
• Study design and execution
• Burst testing for connectors
– Fourier Transform Infrared (FTIR) spectroscopy
• Leak testing of connectors (ASTM D4991-94)
– TOC, pH and conductivity measurements
All testing can include product/process specific
conditions and Pall scientific services recommendations.
– Headspace and derivatization GC/MS
– ICP/MS
How to Initiate Allegro Validation Services
– LC/UV and LC/UV/MS
To find out how Pall can assist you with implementation of
single-use solutions within your processes, please contact
your local Pall representative or email Allegro@pall.com.
All testing can include product/process specific
conditions and Pall scientific services recommendations.
Sterilizing Filter Capsule Validation
Filter capsule study design as part of the single-use
system. Validation test examples include:
Figure 1
Pall Global Services
Pall Scientific and
Laboratory Services
• Viability
• Bacterial challenge
• Product specific integrity test value
For all services, Pall assigns a project manager to facilitate
the communication and study design procedure. Further, a
comprehensive and detailed report is provided upon completion
of the study that can be directly incorporated into the process
validation documentation for regulatory submissions.
Laboratory Services
Field Technical
Support Group (TSG)
Instrument Service
Group (ISG)
Pall Advanced
Separation Systems (PASS)
Integrated System
Services (ISS)
Global Expertise...
Delivered
Expertise in Single-use Systems
The validation services offered by Pall are provided by
our global Scientific and Laboratory Services (SLS),
our Technical Support Group (TSG) specialists, and
™
AllegroSystems
The Single- Use Solution
Visit us on the Web at www.pall.com/allegro
E-mail us at allegro@pall.com
United States
1.800.717.7255 toll free (USA)
1.516.484.5400 phone
1.516.801.9548 fax
biopharm@pall.com E-mail
Europe
+41 (0)26 350 53 00 phone
+41 (0)26 350 53 53 fax
LifeSciences.EU@pall.com E-mail
International Offices
Pall Corporation has offices and plants throughout the world in locations such as: Argentina, Australia, Austria,
Belgium, Brazil, Canada, China, France, Germany, India, Indonesia, Ireland, Italy, Japan, Korea, Malaysia, Mexico,
the Netherlands, New Zealand, Norway, Poland, Puerto Rico, Russia, Singapore, South Africa, Spain, Sweden,
Switzerland, Taiwan, Thailand, the United Kingdom, the United States, and Venezuela. Distributors in all major
industrial areas of the world.
The information provided in this literature was reviewed for accuracy at the time of publication. Product data may be
subject to change without notice. For current information consult your local Pall distributor or contact Pall directly.
© 2010, Pall Corporation. Pall,
, Allegro and the Allegro design are trademarks of Pall Corporation.
® indicates a trademark registered in the USA and TM indicates a common law trademark.
Filtration. Separation. Solution. is a service mark of Pall Corporation.
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USD2715(1)