Following the last blog, which discussed the overview of chapter <1116>, we move on to discuss the most notable changes.
The most obvious change concerns the title of the chapter. The previous title was “Microbial Control and Monitoring Environments Used for the Manufacture of Healthcare Products” while the revised title is “Microbial Control and Monitoring of Aseptic Processing Environments”.
Below are the other noteworthy change:
- Aseptically Filled Product – The emphasis on the word “aseptic” in the introduction implies that the chapter is not applicable to all “sterile” products. This means that terminally sterilized products are outside the scope of the chapter.
- Room Classes – In the revised, all old notations (e.g., M3.5) and old FDA 209E classes (e.g., Class 100) were eliminated and replaced by ISO 14644-1 classes in the operational state.
- Risk Assessment – The chapter emphasizes that even with a good total particulate monitoring program in place, “It is not possible to clearly distinguish between background particulate contamination generated…by mechanical operations and the total particulates contributed by personnel”. Therefore, it is standard routine to implement both total particulate and microbiological monitoring programs.
- Air Changes – As specifications for air changes per hour and air velocities were not included in ISO 16444 (5), nor in Federal Standard 209E, chapter provides the following guidance: ISO class 8 (minimum 20 air changes per hour [ac/hr]), ISO class 7 (>50 ac/hr), and ISO class 5 (>100 ac/hr). I
- The Case for CRR – Chapter emphasizes that if human operators are present, microbial contamination at some level is inevitable.
Learn more about USP <1116> by downloading the entire paper.