Single Use Film and Packaging

New England Sales is a supplier of USP VI films, Mixing Bags, and Contained Powder Transfer Bags.

The single-use powder transfer bag is the optimal solution to protect the operator from the Active Pharmaceutical Ingredients (API) and/or the API from operator-borne contamination.
The specific design of this flexible single-use transfer system allows for easy, safe and clean transfer of API powders and drug substances between different process steps.
The bottle shaped bag has a handle for easy transfer of powders and a PE tri-clamp connector for safe and easy connection.

Typical applications
• Transfer of API powders.
• Bulk Pharmaceutical Chemicals (BPC).
• Potent drug substances destined for clinical trials.
• Transfer of hazardous powders.
• Transfer to tablet or capsule machines.

Benefits
• Eliminates cleaning and validation steps.
• All contact materials are FDA approved.
• Liner materials comply with EC directive EEC 90/128, SI 1376, and FDA   21CFR.
• Low particle and bio-burden levels.
• 100% visual inspection.

Features
• Cleanliness level 200 for interior and exterior of bags (according to
  IEST-STD-CC1246D).
• In-house PE film extrusion in a controlled environment.
• Bag is produced in an ISO Class 5 environment.
• Sterilizable by gamma-irradiation (25 kGray).
• Antistatic, pinhole-free LDPE film
• Tri-clamp connectors available in 2.5, 4 and 6 inches.
• Rigid handle for easy handling.

 Medical Grade Polyethylene (PE)

Description
Any step of the manufacturing process can introduce contamination, which can affect the purity of the product. The Newform Medical Grade Bag provides an ultraclean way to package medical devices, pharmaceutical ingredients and other devices for sterilization. These bags are composed of a pure, pinhole-free, medical grade polyethylene film produced by ATMI LifeSciences.

Product Design
• Standard thickness : 100 um
• Other thicknesses available upon request
• Available in various shapes: tubing, centerfold, sheets, bags and other specialties   upon request
• Standard cleanliness level 50

  
Application
• Intravenous solutions
• Filters
• Active pharmaceutical ingredients
• Sensitive medical devices
• Medical components

Specifications
• Cleanliness levels available from level 50 to visible clean (according to   IEST-STD-CC1246D) for bag interiors and exteriors
• Sterilizable by gamma irradiation (25 kGray).
• Pinhole-free medical grade PE film extruded in a controlled environment.   Bag is produced in a Cleanroom ISO Class 5 environment
• Multi-layered, puncture resistant PE

Benefits
• DMF-file registered with FDA
• Conforms to European and U.S. Pharmacopoeia
• Free of ionic and organic contaminates
• PE film is free of black points and gel
• No outgassing
• Certificate of sterilization delivered with every shipment
• Higher performance over paper and nonclean Tyvek® which can lead to   particle and molecular contamination
• Gamma sterilizable  

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