August 26, 2021: Pharmaceutical Interview Questions and Answers
#AsepticAreaEnvironmentalMonitoring #EnvironmentalMonitoringLocation #EnvironmentalMonitoringTrend
1. During aseptic area environmental monitoring program, what should be covered?
The environmental monitoring program should cover all production shifts and include air, floors, walls, and equipment surfaces, including the critical surfaces that come in contact with the product, container, and closures.
2. Which location should be covered during environmental monitoring for aseptic area?
It is important that locations posing the most microbiological risk to the product be a key part of the program.
It is especially important to monitor the microbiological quality of the critical area to determine whether or not aseptic conditions are maintained during filling and closing activities. Air and surface samples should be taken at the locations where significant activity or product exposure occurs during production. Critical surfaces that come in contact with the sterile product should remain sterile throughout an operation. When identifying critical sites to be sampled, consideration should be given to the points of contamination risk in a process, including factors such as difficulty of setup, length of processing time, and impact of interventions. Critical surface sampling should be performed at the conclusion of the aseptic processing operation to avoid direct contact with sterile surfaces during processing.
3. How to ensure that environmental monitoring locations are reproducibly monitored?
All environmental monitoring locations should be described in SOPs with sufficient detail to allow for reproducible sampling of a given location surveyed. Written SOPs should also address elements such as (1) frequency of sampling, (2) when the samples are taken (i.e., during or at the conclusion of operations), (3) duration of sampling, (4) sample size (e.g., surface area, air volume), (5) specific sampling equipment and techniques, (6) alert and action levels, and (7) appropriate response to deviations from alert or action levels.
4. Why environmental monitoring results should not be averaged?
Averaging of results can mask unacceptable localized conditions.
5. What should be covered while performing trend analysis of the environmental monitoring data for aseptic area?
Trend reports should include data generated by location, shift, room, operator, or other parameters. Significant changes in microbial flora should be considered in the review of the ongoing environmental monitoring data.
Reference: FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice – September 2004