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FDA Accepts Updated DMFs from Celsis

Celsis International has recently updated its Drug Master Files with the FDA to include information on testing both non-sterile and sterile raw materials, in-process solutions, and finished goods on the Celsis system.

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Celsis International has recently updated its Drug Master Files with the FDA to include information on testing both non-sterile and sterile raw materials, in-process solutions, and finished goods on the Celsis system. “A growing number of our Rapid Detection customers are using their Celsis systems to confirm sterility,” said Judy Madden, vice president of Celsis. “By updating and expanding the information available in our DMFs regarding micro limits and sterility testing, we are helping to s...

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