Contamination risk levels differ in aseptic, non-sterile and terminally sterilized products. In terminally sterilized products, contamination for a terminally sterilized medical device may differ from a terminally sterilized drug product.
Contamination risk in a non-sterile drug product may be different for a healthy patient as compared to an immunocompromised patient or children.
Contamination risk assessment initially begins with understanding the nature of a product, release specifications and which organisms are objectionable. In some medical device manufacturing, particulate contamination could also be objectionable because of the electronics involved.
The manufacturing facility is designed to mitigate and reduce contamination risks. Facility controls vary depending upon final product requirements. Contamination may also result due to inadequate cleanroom/RABs/Isolator/design and maintenance.
Similarly, if a risk-based approach is not adopted right from the beginning, contamination risks can occur due to utilities, raw materials, excipients, process and also inadequate testing.
With ICH Q9, Q10, ISO and EU all aligned on a risk-based approach; it is time to explore performing a real risk assessment to control contamination in your product.
- Cleanroom Requirements for Aseptic Facilities
- Risk Based Monitoring of Aseptic Facilities-A Paradigm Shift
- Cleanroom Requirements for Manufacture of Terminally Sterilized Drugs and Devices
- Risk Based Monitoring for Terminally Sterilized Products
- Facility Controls for Non-Sterile Products
- Risk Based Monitoring for Non-Sterile Products
- Water Quality Risk Assessment
- Assessing Risk of Added Gases
- Gowning requirements for Aseptic, Non-Sterile and Terminally Sterilized Products
- Process Risk Assessment
- Assessing Risk during testing