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cGMP Sterile Filling

cGMP Sterile Filling Services

 
 

cGMP Sterile Filling Services

Dalton has specialized in the development and manufacture of cGMP sterile pharmaceutical and biotechnology products for nearly 15 years.  With the ability to offer aseptic filling and terminally sterilized products in a variety of finished dosage forms Dalton can support your sterile needs at virtually any scale, starting the smallest clinical sizes through to small scale commercial batches.
 

Our focus is what is the most important to you. We develop and manufacture cGMP sterile products fast meeting your stringent quality standards.  Our flexible approach and integrated offering means we make complex steriles simple. With our Steriles made Simple℠ programs we can make your sterile liquid in a vial Phase I/II clinical supplies in about 4 months.*
 

Click on the links below to learn more about our aseptic filling and sterile manufacturing of capabilities.

Dalton can utilize your API, or we can make API for you, even if you require sterile API.  Our formulation experts then work with you to create the right aseptic or sterile vial dosage form, by creating a new formulation or optimizing your own.

We manufacture your products in our newly expanded and upgraded sterile suites which now include upgraded HEPA systems, RABS aseptic filling line enclosures, vial washing and depyrogenation as well as  a new in-house WFI system which meets global standards.  Our cGMP approved aseptic filing suites offer a static and operational Grade A (ISO Class 5) environment. All areas of our aseptic processing facility, including ancillary support areas, are routinely monitored for viable airborne contamination, viable contamination on surfaces and non-viable airborne contamination by our on-site QC Microbiology Laboratory. The area is fully supported by our in-house Analytical Chemistry Laboratory and Quality Assurance Departments.

* subject to terms and conditions

 
 

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