Sterile products

19
Apr
Continuous Manufacturing and its Regulatory Challenge Image

Particles, Particles, Particles – Some Have a Game Plan

During day 2 of the PDA conference, there was a very enlightening session called “Game Plan: Progress to the Next Stage of Contamination Control.”  Anne Marie Dixon-Heathman, President of Cleanroom Management Associates, Inc., gave a presentation called “Contamination Control: A new approach to the Reduction of 5-micron particles.”  She discussed product loss resulting from five-micron […]

Read More
05
Apr
Close-up medical syringe with a vaccine.

Compounders of Sterile Products Remain on FDA’s Radar

In the past six (6) months, FDA has issued two (2) Alerts (here and here), for patients and caregivers to not use sterile products manufactured by the two companies cited in the alerts. One company compounds product for human patients, and the other for veterinarians and animals (pet owners, beware). In that same 6-month period, […]

Read More