Aseptic Isolators play a pivotal role in pharmaceutical manufacturing, providing a controlled environment to ensure the sterility of aseptic medicines. These isolators are designed to minimize contamination risks for parenteral drugs. However, maintaining their cleanliness, particularly concerning nonviable particulate contamination, relies heavily on the tools and materials introduced through the airlock. In one facility, unexpected particulate contamination inside the isolator raised concerns. To get to the bottom of this issue, an investigation was conducted using Foamtec’s cutting-edge PolyCHECK® particle identification system. The results were eye-opening, shedding light on the source of the problem and highlighting the importance of using Foamtec’s MiraWIPE® for a thorough cleaning process.
The Challenge of Contamination in Aseptic Isolators
Aseptic Isolators are designed to create an environment that prevents contamination, ensuring the safety and efficacy of aseptic medicines. Achieving this requires meticulous attention to detail, especially regarding the materials and tools introduced into the isolator through the airlock. Proper cleaning of these items before they enter the controlled environment is paramount.
However, at one facility, a surprising discovery was made. Particulate contamination was found both inside the isolator and in the airlock area. This raised concerns about the effectiveness of the cleaning process and prompted an investigation to identify the source of the contamination.
Foamtec’s PolyCHECK®: The Forensic Investigator
To unravel the mystery of the contamination, the facility turned to Foamtec’s PolyCHECK® particle identification system. This advanced technology is like a forensic investigator for particulate contamination. It can identify and analyze particles to determine their composition and origin.
The investigation revealed that the contamination was primarily composed of polypropylene fibers. This finding was significant because the facility used pre-saturated polypropylene non-woven wipers to clean the materials transferred through the airlock. The forensic analysis confirmed that the polypropylene contamination inside the isolator matched the polypropylene fibers on the materials and the wipers.
MiraWIPE®: The Solution for Thorough Cleaning
In addition to the polypropylene fibers, smaller polyester fibers were found inside the isolator. These polyester fibers were traced back to the wipers used to sanitize the inside of the isolator before the Vapor Hydrogen Peroxide (VHP) sterilization step. This discovery highlighted the need for a more effective cleaning process.
This is where Foamtec’s MiraWIPE® comes into play. MiraWIPE®, with its woven microfiber structure, offers superior cleaning capabilities. It ensures that residues, including particulate contaminants, are entirely removed from critical surfaces. By using MiraWIPE® to clean and decontaminate both materials transferred through the airlock and the isolator interior, the facility can significantly reduce the risk of particulate contamination and maintain the required sterility levels.
Maintaining the cleanliness and sterility of aseptic isolators is essential for pharmaceutical manufacturers producing aseptic medicines. Contamination risks must be minimized, especially when introducing materials and tools through the airlock. The recent discovery of particulate contamination in an isolator is a cautionary tale, emphasizing the importance of a thorough cleaning process.
Foamtec’s PolyCHECK® particle identification system played a crucial role in identifying the source of contamination, highlighting the connection between the polypropylene fibers and the wipers used for cleaning. To address this issue, Foamtec’s MiraWIPE® offers an effective solution for comprehensive cleaning, ensuring that no residues or contaminants are left behind.
By combining Foamtec’s PolyCHECK® and MiraWIPE®, pharmaceutical facilities can enhance the cleanliness and sterility of their aseptic isolators, ultimately safeguarding the quality and safety of aseptic medicines. These cutting-edge solutions are indispensable in the ongoing battle against particulate contamination in pharmaceutical manufacturing.