USD2955(5)

Newform™ Medical Grade LDPE Bags

Ultra-Pure, Clean Gamma-Sterilizable Packaging

Features Benefits
In-house extrusion of LDPE film using certified Low visible and subvisible contaminant level
and virgin resin without any additives
Low bioburden and endotoxin level
 lown-film extrusion of LDPE film, conversion and
B
Low leachables and extractables level
packaging in certified ISO Class 5 cleanrooms
Certified cleanliness level
 lexibility in customizing sizes, thicknesses and
F
shapes (bags, tubing, sheets, film,..) Improved process efficiency
Dye-penetration test (methylene blue) to show Gamma sterilizable up to 50 kGy
packaging integrity
Pre-sterilized bags available upon request
cGMP focused manufacturing (gamma irradiated at 25 kGy, certified)
Material Drug Master File on resin is registered
with FDA
In the biopharmaceutical and medical industries, visible and
subvisible contaminants from packaging materials not only
reduce process efficiency by generating unacceptable waste
percentages, but they can also constitute real chemical and
biological hazards when delivering parenteral drugs to patients.
Low particle levels should be guaranteed by the product supplier,
and product integrity must be 100% guaranteed by the
packaging itself.
Newform Bags are medical-grade, low-density-polyethylene
(LDPE) bags, ideal for packaging and gamma irradiation of
powders, products and components.
Applications
Packaging and/or gamma sterilization of:
Stoppers, caps and closures
Vials and containers
API, medical powders, buffers, media
Filters
Medical devices
Cleanroom garments
Syringe components
Ordering Information
Part Number Inner Bag Size
UP1F10-0000-0001 150 mm W x 200 mm L (7.9 in. L x 5.9 in. W)
UP1F10-0000-0002 200 mm W x 300 mm L (11.8 in. L x 7.9 in. W)
UP1F10-0000-0003 300 mm W x 450 mm L (17.7 in. L x 11.8 in. W)
UP1F10-0000-0004 450 mm W x 600 mm L (23.6 in. L x 17.7 in. W)
UP1F10-0000-0005 600 mm W x 800 mm L (31.5 in. L x 23.6 in. W)
Width (W) equals opening of the bag
Thickness: 100 μm
All bags are double packed per 100 piece
A COC (Certificate of Conformity) is included with each delivery
Customization is available on request and can include:
• Other sizes
• Other thicknesses (from 75 μm up to 200 μm)
• Gamma irradiation (25-50 kGy)
• Other shapes (sheets, sleeves, tubing, film,…)

Quality
Cleanliness level 100 according to IEST-STD-CC1246D standard
LDPE film is Animal-Derived-Component-Free (ADCF)
Compliant to:
FDA Title 21 CFR 177.1520 ‘Olefin Polymers’
EU Commission Directive 10/2011 (food contact approval)
USP<87> Biological Reactivity test in vitro
USP <88> Biological Reactivity test in vivo, class VI
USP <661> Physicochemical test – plastics
EP monograph 3.1.3 ‘Polyolefins’
 P monograph 3.1.4 ‘Polyethylene without additives for
E
containers for parenteral and ophthalmic preparation’
 P monograph 3.2.2 ‘Plastic containers and closures for
E
pharmaceutical use’

Visit us on the Web at www.pall.com/biotech

Contact us at www.pall.com/contact
Corporate Headquarters International Offices
Port Washington, NY, USA Pall Corporation has offices and plants throughout the world in: Argentina, Australia, Austria, Belgium, Brazil,
+1 800 717 7255 toll free (USA) Canada, China, France, Germany, India, Indonesia, Ireland, Italy, Japan, Korea, Malaysia, New Zealand, Norway,
+1 516 484 5400 phone 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
European Headquarters
Fribourg, Switzerland 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
+41 (0)26 350 53 00 phone Pall directly.

Asia-Pacific Headquarters © 2020, Pall Corporation. Pall, and Newform are trademarks of Pall Corporation. ® indicates a trademark
Singapore registered in the USA. TM indicates a common law trademark. Filtration.Separation.Solution. is a service mark
+65 6389 6500 phone of Pall Corporation.

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