2 batches per day in sterile

Production
1

Hello

I want to know about the sterile DPI manufacturing process, can we filled 2 batches of same product per day in Dry powder injection facility. Please guidance on same, i am thankful to your valuable efforts and guidance.

2

You can fill two batches of the same sterile powder product in one day provided following aspects are complied with,

  • Cleaning of the area and equipment at the time of batch changeover is done satisfactorily as per validated / standard cleaning procedures
  • QA Line clearance is certified before batch changeover
  • Environmental monitoring is continuously followed, meeting the requirements