USD 2955(3)
Newform™ Medical Grade LDPE Bags
Ultra-Pure, Clean Gamma-Sterilizable Packaging
Features
Benefits
In-house extrusion of LDPE film using certified and
virgin resin without any additives
Low visible and subvisible contaminant level
Blown-film extrusion of LDPE film, conversion and
packaging in certified ISO Class 5 cleanrooms
Low leachables and extractables level
Flexibility in customizing sizes, thicknesses and
shapes (bags, tubing, sheets, film,..)
Improved process efficiency
Dye-penetration test (methylene blue) to show
packaging integrity
cGMP focused manufacturing
Material Drug Master File on resin is registered
with FDA
Low bioburden and endotoxin level
Certified cleanliness level
Gamma sterilizable up to 50 kGy
Pre-sterilized bags available upon request
(gamma irradiated at 25 kGy, certified)
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
Ordering Information
Part Number
Outer Bag Size
UP1F10-0000-0001
UP1F10-0000-0002
UP1F10-0000-0003
UP1F10-0000-0004
UP1F10-0000-0005
7.9 in. L x 5.9 in. W (150 mm W x 200 mm L)
11.8 in. L x 7.9 in. W (200 mm W x 300 mm L)
17.7 in. L x 11.8 in. W (300 mm W x 450 mm L)
23.6 in. L x 17.7 in. W (450 mm W x 600 mm L)
31.5 in. L x 23.6 in. W (600 mm W x 800 mm L)
Customized sizes available upon request
All bags labeled and double packed per 100 pieces and delivered with
a Certificate of Conformity
Standard thickness: 100 micron. Other thicknesses available upon request
Can be delivered gamma-irradiated upon request and delivered with a
Certificate of Sterilization
Width equals opening of bag
Certificate of Analysis available upon request
Filters
Additional Services
Medical devices
Part Number
Description
Cleanroom garments
LABIRSCOA
LABMECHCOA
Infra-Red Test Report
CoA for cleanliness, seal strength, dimensions,
surface resistivity (if applicable)
CoA for bacterial endotoxins; 1 x LAL test
CoA for bioburden TVC
Syringe components
LABMICROLAL
LABMICROTVC
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’
EP monograph 3.1.4 ‘Polyethylene without additives for
containers for parenteral and ophthalmic preparation’
EP monograph 3.2.2 ‘Plastic containers and closures for
pharmaceutical use’
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
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. To locate the Pall office or distributor nearest you, visit www.pall.com/contact.
European Headquarters
Fribourg, Switzerland
+41 (0)26 350 53 00 phone
LifeSciences.EU@pall.com e-mail
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.
Asia-Pacific Headquarters
Singapore
+65 6389 6500 phone
sgcustomerservice@pall.com e-mail
© 2015, Pall Corporation. Pall,
, and Newform 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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USD 2955(3)