Integrity™ TK8 Film Overview Process Control, Traceability, Cleanliness Product

Product Data
Integrity™ TK8 Film
Process Control, Traceability, Cleanliness
Overview
Outer Layer
PA
Pall Life Sciences is a technology leader in the manufacture
of single-use vessels and consumables for the life science
industry. Integrity TK8 film represents the culmination of
over a decade of experience in ultra-clean polymer film
extrusion and bioprocess vessel manufacture, and delivers
performance to meet or exceed the expectations of the
most demanding users. Integrity TK8 film embodies Pall
Life Sciences “one film” philosophy, giving users access
to a single film capable of serving in the single-use
applications, from storage to mixing and even bioreactor
processes. This approach can yield significant savings in
validation effort, time and cost.
15 µm
Tie Layer
ULDPE
50 µm
Tie Layer
EVOH
10 µm
ULDPE
100 µm
ULDPE
50 µm
TK8 Film Structure
The TK8 film is constructed from laminated layers of PA
(polyamide), EVOH (ethylene vinyl alcohol polymer) and
ULDPE (ultralow density polyethylene). The outer PA
layer provides robust puncture resistance, strength, and
excellent thermal stability. The EVOH layer minimizes gas
diffusion across the film while maintaining a very good
flex crack resistance. The ULDPE layers provide flexibility,
integrity and an ultra-clean, ultra-pure, low-extractables
product contacting layer. The combination of these layers
results in a film that has outstanding optical clarity, is
easy to handle, and performs well in a broad range of
bioprocess applications. The inner ULDPE layer used
in TK8 is blow-extruded in-house by Pall Life Science
under cleanroom conditions (0.2 µm filtered air), ensuring
the cleanest possible product-contacting surface.
Lamination is also performed under controlled, ultraclean conditions. Lastly, TK8 film is converted into Pall
Life Sciences bag products in our ISO Class 5 cleanroom.
Traceability and Compliance
All of the layers in TK8 are made from “medical grade”
materials, meaning that they comply with industry
standards and are subject to strict change controls.
The entire structure of TK8 is totally free of any animal
derived components (ADCF). Pall Life Science has also
created TK8 with dual sourcing and contingency
planning in mind, to ensure security of supply.
• TK8 complies with USP <87>, USP Class VI
(USP <88>) and USP <661>
• TK8 film complies with EP3.2.2.1
• Shelf life is supported by aging validation studies
• Certified ADCF
• Bioburden evaluation available (ISO 11737)
• Particle count data available (USP<788>)
• By performing blow extrusion in-house, Pall Life
Sciences maintains full control and traceability of
the contact film composition, from resin through
to finished bag product
Leachables/Extractables and Chemical Compatibility Data
An extensive dossier of leachables/extractables data is
available upon request. Extractable testing was performed
in CH2Cl2 (8 hours reflux). Leachable tests were performed
at 40 °C over durations up to six months. Leachable
solvents include:
• WFI
• Ethanol (20%)
• Tween (0.1%)
• HCl (pH < 3)
• DMSO (10%)
• NaOH (pH > 11)
(tested at -20 °C)
• Saline (1M NaCl)
Additional studies have demonstrated chemical
compatibility with the following common bioprocess
materials under various, process-typical conditions:
•
•
•
•
•
•
•
MgSO4.7H2O
Ethanol (55%)
Kanamycine sulfate
Tromethanine
Guanidine HCl
KH2PO4
Acetic acid
•
•
•
•
•
•
•
MnSO4.7H2O
Riboflavin
Casein hydrolysate
Diethanolamine
Yeast extract
NaOH (0.5 M-50%)
NaClO (15° ) ÷ NaOH (0.5 M)
The film is fed directly into Pall Life Sciences ISO Class 5
cleanroom to ensure the highest levels of cleanliness and
bioburden control.
Biocompatibility Data (Tested on 50kGy gamma irradiated film)
Test
Biological Reactivity Test In Vitro
Biological Reactivity Test In Vivo
Protocol
USP <87>
ISO10993 part 5
Result
PASS
USP <88>
ISO10993, part 11
ISO10993, part 10
I ISO10993, part 6
PASS- Class VI - 70°C
Pysiochemical Data (Tested on 50kGy gamma irradiated film)
Test
Non-Volatile
Residue
Heavy
Metals
Buffering
Capacity
Appearance
of Solution
Acidity or
Alkalinity
Reducing
Substances
Transparency
Absorbance
Protocol
Result
USP <661>
PASS
USP <661>
PASS
USP <661>
PASS
EP3.2.2.1
PASS
EP3.2.2.1
PASS
EP3.2.2.1
PASS
EP3.2.2.1
PASS
EP3.2.2.1
PASS
Biocompatibility Data (Tested on 50kGy gamma irradiated film)
Property
Test Method
Typical Value
Thickness
Barrier properties
O2 transmission rate
Pall Life Science
250 μm
ASTM D3895, 23 °C, 50% RH outside,
90% RH inside
ASTM F1249
23 °C, 0% RH outside, 100% RH inside
ASTM F-2476 - 23°C, 0% RH
0.37 cc/m²/day
Water vapor transmission rate
CO2 transmission rate
Tested on 50kGy gamma irradiated film:
Strength and Elongation
Strength (machine direction)
MD
(transverse direction)
TD
Elongation
MD
TD
Young Modulus
MD
TD
Puncture resistance
Max load
Deflection at max load
Dart drop (method B)
Tear resistance
Avg. force
MD
TD
Initial Max Force
MD
TD
Shelf life
0.41 g/m²/day
< 1 cc/m²/day (below detection limit)
ASTM D882-91
25 MPa
25 MPa
125%
100%
590 MPa
500 MPa
ASTM D882-91
FTMS 101B
130N
9 mm
1100 g
ASTM D1709-01B
ISO 6383/1
17 N
32 N
18 N
32 N
3 years
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.
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