This presentation is based on a study on recent advancements in the aseptic operations enriched through the principles of Pharma 4.0 which include the opportunity of digitalization. The current trend of regulatory audit observations during aseptic operations indicate a variety of novel issues which remained low-lying during the past decades. The issues of data integrity violations, inadequacy during media fill validations and environment monitoring remained common concern across the pharmaceutical industry engaged in aseptic operations. There is a need to adopt the modern approach of handling the aseptic operations through digital tools and data forecasting duly enabled with artificial intelligence.
This study covers the (i) Trend of current inspectional findings from global auditors in sterile manufacturing facilities (ii) The efficient use of conventional activities like media fill validations (iii) Inadequate media fill validations Vs data integrity violations (iv) Common challenges during aseptic operations (v) The forecasting of causes of failures through digital means enabled through artificial intelligence and statistical process control (vi) The way forward Good Aseptic Practices Vs. Better Aseptic Practices.
The study outlines the way to implement Pharma 4.0 in industry either holistically or in bits and pieces.