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GMP Aseptic Filling of Oligonucleotide
GMP Aseptic Filling of Oligonucleotide
 
 

GMP Aseptic Filling of Oligonucleotides


Our capabilities for Aseptic Filling Oligonucleotides will support your pharmaceutical drug development process as it advances through clinical trials and on to commercial production. Our pharmaceutical cGMP Manufacturing Facility handles both aseptic liquid and aseptic powder fills into vials.

 

The aseptic fill suite maintains a local Grade A (ISO Class 5) environment for the filling operations. All areas of our cGMP aseptic processing facility are routinely monitored for viable airborne contamination, viable contamination on surfaces and non-viable airborne contamination by our Microbiology Laboratory.

 

We are flexible and committed to the success of your oligonucleotide program and pharmaceutical drug development program. We welcome small scale aseptic fills that may not meet the minimum number of vials required by other sterile fill companies.

Dalton offers fully integrated Aseptic Filling and capping of liquid in-vial injectable drugs, and aseptic powder filling and capping for preclinical and early stage clinical trials.
  • Sterile Liquid Injectables: Aseptic fill on a state-of-the-art fill / finish crimp-cap line, capable of aseptic filling 1 – 125 ml vials. We have validated processes in place for sterile filling 2, 3, 5, and 20 ml vials up to 15,000 units per run.

Supporting our process equipment are validated services including a WFI system, pure steam generator, autoclave and depyrogenation oven. Validation capabilities include, but are not limited to, aseptic fill simulation studies, terminal sterilization loads, autoclave loads, depyrogenation oven loads, container closure integrity and process validation. Dalton also has the ability to develop or transfer technology related to aseptic processing. In addition, Dalton’s analytical service laboratory offers method development, validation and ICH stability programs to its clients. QC/QA, Microbiology support all analytical data.
 

We are currently manufacturing sterile clinical trial products under cGMP at Dalton.


 

 

 

 

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