NEWSAFE™ Disposable Containment Systems

Source: ATMI LifeSciences

As today's health and safety requirements are getting more stringent and demanding, the single-use contained 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

Details

Click Here To Download:
•Datasheet: Newsafe™ Contained Powder Transfer Bag
•Datasheet: Films For Newsafe™ Contained Powder Transfer Bags
•Datasheet: Newsafe™ cPTBag Filling Funnel
•Datasheet: Vertical Integration
•Application Note: Newsafe cPTB - Transfer of Diatomaceous Earth
•Application Note: Newsafe cPTB - Transfer of Lactose
•Application Note: Newsafe cPTB - Transfer Of SAFC Cell Culture Media Powder
•Application Note: Newsafe cPTB - Transfer Of Sodium Chloride
•Application Note: Newsafe cPTB - Transfer Of Sucrose

Safe and Easy Contained Transfer of Powder Between Process Steps

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. High containment levels (OEB 4: 1- 10µg/m3) can be met in combination with a split butterfly valve.

The bottle shaped bag has a rigid handle for easy transfer of powders and and HDPE Tri-Clamp connector for safe and easy connection.

Applications

High contained transfer of (H) API powders and hazardous powders in combination with split butterfly valve
Contained transfer of media and other powders

Benefits

Eliminates cross-contamination
Reduces production cost and time for cleaning and validation
99.99% product recovery
See through liner for visibility
Quick change over
USP Class VI approved liner materials
Low particle and bio-burden levels
Easy-tear opening of secondary packaging, no scissors needed
Small storage needed
All bags resist 100 mbar pressure (1.45 PSI)
Intergrity of each bag is tested with pressure decay test

Features

In-house PE film extrusion in a controlled environment
Static dissipative, pinhole-free LDPE film
Bag is produced under ISO Class 5 conditions at rest
Cleanliness level 200 (according to standard IEST-STD-CC1246D)
Sterilizable by gamma-irradiation (25 kGy)
Rigid handle for easy handling
Accessories available for specific applications

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