Overview
In this warning letter breakdown, we are going to examine how you can avoid microbial contamination citations and also the importance of adhering to best practices when using RABS and laminar air flow.
Reference From Actual Warning Letter
“1. Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR 211.113(b)).
Poor Aseptic Behavior
On May 23, 2017, our investigator observed multiple poor aseptic practices during the set-up and filling of (b)(4) batch (b)(4).
For example, during the aseptic filling of vials, an operator used restricted access barrier system (RABS) (b)(4) to remove a jammed stopper by reaching over exposed sterile stoppers in the stopper bowl. The RABS (b)(4) disrupted the unidirectional airflow over the stopper bowl, creating a risk for microbial contamination. After the operator removed the jammed stopper, the filling line was restarted, but the affected stoppers were not cleared.
In your response, you included revised aseptic technique procedures for set-up and filling. However, your response was inadequate because you did not perform a retrospective investigation and thorough risk assessment of the effect on your product. In addition, your revised procedure FF21024 permits contamination of product-contact surfaces during set-up, followed by wiping with a disinfectant, instead of preventing sterile equipment contamination by improved design and procedures.”
Want to Avoid This Situation For Your Company?
Sign up today for a free 30 minute demo and we’ll show you how our accredited online training programs will keep your workforce compliant.
