Overcoming Aseptic Manufacturing Challenges To Prevent Contamination

The pharmaceutical industry has steadily moved to increased production and handling of sterile highly potent active ingredients (HPAPIs). Sterile drug product manufacturing requires dedicated and specialized multi-purpose plants, which comply with FDA & EMA aseptic guidance and regulatory requirements.  

Dec’s containment technologies comply with pharmaceutical quality manufacturing standards and are available for aseptic operations. To prevent risk of contamination from pathogens, it is recommended to run a fully closed or contained operation under strictly controlled conditions.

The key challenge in GMP sterile manufacturing is to prevent product contamination at all stages of the process by maintaining a fully controlled, sterile environment.

Dec proposes a range of aseptic solutions including sterile transfer, micronizing, blending, sampling and aseptic process isolators with no further need for cost-intensive cleanrooms.