Case Study: Un-optimized Procedures and Practices Leading to Recurring Microbial Contamination in Grade A (ISO 5)

Case Study: Un-optimized Procedures and Practices Leading to Recurring Microbial Contamination in Grade A (ISO 5)

04/03/2019, 2:15 PM - 3:15 PM

Javits Conventions Center - Stage 2, Booth 1577, Exhibit Hall
Language:
English
The case study describes a compliance event with recurrent microbial contamination observed in a grade A filling RABS from January 2017 to June 2017. The microbial contamination incidences were mainly due to gram-positive bacteria. This presentation details the steps taken (e.g., reviewing historical EM data and smoke studies, audit of the practices, etc.) to perform the investigation by the cross-functional team and how the different possible root causes were identified. Furthermore, the presentation shares lessons learned on how to develop a robust and optimized procedure to control contamination program. Also, the presentation shares the parameters to be taken into account to develop robust procedures and processes while being globally compliant. Finally, the presentation concludes with the short and long-term CAPAs implemented to address the recurring microbial contamination.

Contributors

  • Walid El Azab

    Speaker

    Technical Service Manager

    STERIS Life Science

    Walid El Azab is an Industrial pharmacist and a Qualified Person (QP). He is a Technical Services Manager for the Life Sciences Division of STERIS...

Type of Session

  1. Type of Session
    Session

Categories

  1. Track
    Optimizing Facilities through Innovation & Technologies

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