Integrity™ 3-D Bioprocess Vessel Overview Cleanliness, Integrity and Simplicity Product

Product Data
Integrity™ 3-D Bioprocess Vessel
Cleanliness, Integrity and Simplicity
Overview
Efficient movement and storage of liquids is critical
to modern biotechnology processes. The deployment
of single-use containers for this task has become
ubiquitous in recent years because they reduce risk
while also driving down costs in comparison with
traditional stainless steel equipment.
Pall Life Sciences Integrity 3-D Bioprocess Vessel (BPV)
products have been developed to meet the demand
for cost-effective, scalable single-use liquid storage
containers that are compatible with Pall Life Sciences
market-leading range of single-use mixing and bioreactor
technologies.
At the heart of Pall Life Sciences Integrity systems
and products is Integrity TK8 film, a state-of-the-art
multi-layer gas-barrier polymer laminate. The productcontacting layer of TK8 film is blow extruded in-house
by Pall Life Sciences under cleanroom conditions using
medical-grade ultralow-density polyethylene resin, then
laminated to create a gas barrier film of exceptional
cleanliness, strength and clarity that is animal derived
component free (ADCF) and complies fully with USP
Class VI requirements.
Integrity 3-D Bioprocess Vessels (BPVs)
TK8 film is standard across the Pall Life Science Integrity
product lines, providing users with easy scalability and
simplified cross-platform validation.
Highlights
• State-of-the-art designs and materials
• Standard and custom configurations available
• Manufactured on automated equipment under
ISO Class 5 (class 100) cleanroom conditions
• Integrity tested using Pall Life Sciences advanced
whole-bag testing technology
• Suitable for virtually any storage application
• “Universal” TK8 bioprocess film
Scalable and Configurable
Standard 3-D BPV sizes range from 100L to 1,000L,
and are consistent with industrydimensional norms.
By incorporating TK8 film, users can easily step down
to Pall Life Sciences 2-D BPVs as process scale or
application dictates. Tubing connections are made
via a molded fitment sealed into the 3-D BPV. Broad
connectivity options exist, with tubing sizes from 1/8” to
1” as standard. Specialty components such as sterile
connectors and filters are available upon request.
To discuss your specific needs, contact your Pall Life
Sciences representative.
Specifications
Metric
Specifications
Standard Nominal Capacity
Capacity Overage
Port Locations
100L, 200L, 500L, 1,000L
5%
Face ported. Top mounted single- or multiple-port fitments for fill lines. Bottom mounted single-port fitment for drain. Dip
tubes or Easy Drain available upon request.
C-Flex TPE standard. Platinum cured silicone optional.
Luer connectors and CPC MPX connectors as standard, others available upon request.
Most brands available upon request.
TK8 – Specification available upon request.
All materials and final assemblies meet USP Class VI requirements (USP<87>, USP<88>, USP<661>), USP<788>
(particulates), EP 2.9.19 (particulates), ISO 11737 (bioburden). Full extractables/leachables data package available upon
request. All contact materials certified Animal Derived Component Free (ADCF).
Certificate of Conformity delivered with every order. Certificate of Analysis available upon request.
Gamma irradiation, 25-50KGy.
24 months after gamma.
Under cGMP protocols in ISO Class 5 cleanroom conditions. Full traceability of all components.
Individual bags, clean double-bagged. Labels on packaging with gamma indicator, article code, description, expiration date
and batch code.
Tubing
Connectors
Filters
Film
Compliances
Supplied Documentation
Sterilization Method
Shelf Life
Manufacturing
Packaging
Capacity
100 L
200 L
500 L
1000 L
100 L
200 L
Bag Body
Dimensions
Top-Mounted
Fill Tubing
Bottom-Mounted
Drain Tubing
Connectors
Container
720 mm (W) x 307 mm (H)
x 520 mm (D)
720 mm (W) x 614 mm (H)
x 520 mm (D)
1107 mm (W) x 725 mm (H)
x 720 mm (D)
1095 mm (W) x 1098 mm (H)
x 910 mm (D)
392 mm (W) x 726 mm (H)
x 332 mm (D)
462 mm (W) x 924 mm (H)
x 402 mm (D)
500 mm x 1/2” ID
C-Flex TPE
500 mm x 1/2” ID
C-Flex TPE
500 mm x 1/2” ID
C-Flex TPE
1,000 mm x 1/2” ID
C-Flex TPE
500 mm x 1/2” ID
C-Flex TPE
500 mm x 1/2” ID
C-Flex TPE
500 mm x 1/2” ID C-Flex TPE
CPC MPX M
200L Cubical “Q-Mix”
500 mm x 1/2” ID C-Flex TPE
CPC MPX M
200L Cubical “Q-Mix”
500 mm x 1/2” ID C-Flex TPE
CPC MPX M
500L Cubical “Q-Mix”
1,000 mm x 1/2” ID C-Flex TPE
CPC MPX M
1,000L Cubical “Q-Mix”
500 mm x 1/2” ID C-Flex TPE
CPC MPX M
100L Cylindrical “W-Mix”
500 mm x 1/2” ID C-Flex TPE
CPC MPX M
200L Cylindrical “W-Mix”
Visit us on the Web at www.pall.com/biopharm
E-mail us at biopharm@pall.com
Corporate Headquarters
Port Washington, NY, USA
+1.800.717.7255 toll free (USA)
+1.516.484.5400 phone
biopharm@pall.com e-mail
European Headquarters
Fribourg, Switzerland
+41 (0)26 350 53 00 phone
LifeSciences.EU@pall.com e-mail
Asia-Pacific Headquarters
Singapore
+65 6389 6500 phone
sgcustomerservice@pall.com e-mail
International Offices
Pall Corporation has offices and plants throughout the world in: Argentina, Australia,
Austria, Belgium, Brazil, Canada, China, France, Germany, India, Indonesia, Ireland, Italy,
Japan, Korea, Malaysia, New Zealand, Norway, Philippines, Poland, Russia, Singapore,
South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom, and
Vietnam. Distributors in all major industrial areas of the world. To locate the Pall office
or distributor nearest you, visit www.pall.com/contact.
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.
© 2014, Pall Corporation. Pall,
, and Integrity 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.
2/14, PDF, GN14.9222
USD2945