Newform™ Medical Grade LDPE Bags

Ultra-Pure, Clean Gamma-Sterilizable PackagingFeatures In-house extrusion of LDPE film using certified and virgin resin without any additives

Blown-film extrusion of LDPE film, conversion and packaging in certified ISO Class 5 cleanrooms

Flexibility in customizing sizes, thicknesses and shapes (bags, tubing, sheets, film,..)

Dye-penetration test (methylene blue) to show packaging integrity

cGMP focused manufacturing

Material Drug Master File on resin is registered with FDA

Benefits Low visible and subvisible contaminant level

Low bioburden and endotoxin level

Low leachables and extractables level

Certified cleanliness level

Improved process efficiency

Gamma sterilizable up to 50 kGy

Pre-sterilized bags available upon request (gamma irradiated at 25 kGy, certified)

USD2955(5)

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.

ApplicationsPackaging and/or gamma sterilization of:

Stoppers, caps and closures

Vials and containers

API, medical powders, buffers, media

Filters

Medical devices

Cleanroom garments

Syringe components

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’

Ordering InformationPart 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,…)

Visit us on the Web at www.pall.com/biotechContact us at www.pall.com/contact

© 2020, Pall Corporation. Pall, and Newform are trademarks of Pall Corporation. ® indicates a trademark registered in the USA. TM indicates a common law trademark. Filtration.Separation.Solution. is a service mark of Pall Corporation.

6/20, PDF, GN20.10348 USD2955(5)

Corporate HeadquartersPort Washington, NY, USA+1 800 717 7255 toll free (USA)+1 516 484 5400 phone

European HeadquartersFribourg, Switzerland+41 (0)26 350 53 00 phone

Asia-Pacific HeadquartersSingapore+65 6389 6500 phone

International OfficesPall 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.