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Identifying the Root Causes of Fiber Contamination in Parenteral Drug Manufacturing with Foamtec’s PolyCHECK® System

by | Jan 22, 2024

Maintaining the highest standards of product quality and purity is paramount in parenteral drug manufacturing. However, fiber-shaped non-viable particles, often originating from non-woven and knitted fabrics used in lint-free mops, wipers, face masks, and bouffants, pose a significant challenge. These particles, along with glass, are the main sources of visible particle contamination in the manufacturing process. Due to their high static attraction, fibers can easily accumulate on equipment, packaging, garments, gloves, vials, and syringe components, and subsequently be transported into aseptic isolators and processing areas. In this blog post, we will explore how Foamtec’s PolyCHECK® System has proven successful in definitively identifying the sources of fiber contamination. By leveraging the high static attraction of fibers, the PolyCHECK® System enables quality staff to correlate visible contamination with specific process or supplier sources, facilitating targeted interventions and enhancing product quality.

1. Understanding the Origin of Fiber Contamination:
The use of non-woven and knitted fabrics in lint-free mops, wipers, face masks, and bouffants is a common practice in parenteral drug manufacturing. However, these fabrics can shed fibers, which become a major source of visible particle contamination. In combination with glass particles, fiber-shaped non-viable particles pose a significant challenge to maintaining product purity and quality.

2. The Role of Static Attraction in Fiber Contamination:
Fibers, due to their high static attraction, have the ability to adhere to various surfaces, including equipment, packaging, garments, gloves, vials, syringe components, and even aseptic isolators and processing areas. This makes them readily transportable and susceptible to contamination. Identifying and understanding the sources of fiber contamination is crucial in implementing effective preventive measures.

3. Introducing Foamtec’s PolyCHECK® System:
Foamtec’s PolyCHECK® System offers a comprehensive solution for definitively identifying the sources of fiber contamination in parenteral drug manufacturing. Leveraging the high static attraction of fibers, the PolyCHECK® System effectively collects particles from various surfaces, enabling quality staff to correlate the contamination observed during visible inspections with specific process or supplier sources.

4. Collecting Fiber Contamination with the PolyCHECK® System:
The PolyCHECK® System utilizes the high static attraction of fibers to collect particles from equipment surfaces, garments, isolator gloves, plastic film, syringe components, and packaging components. By capturing these particles, the PolyCHECK® System provides crucial evidence to determine the sources of fiber contamination.

5. Correlating Visible Contamination with Process or Supplier Sources:
With the data collected by the PolyCHECK® System, quality staff can correlate the visible contamination identified during inspections with specific process or supplier sources. This correlation enables manufacturers to pinpoint the root causes of fiber contamination and implement targeted interventions to mitigate the issue effectively.

6. Enhancing Product Quality and Purity:
By definitively identifying the sources of fiber contamination, manufacturers can take proactive measures to improve product quality and purity. The insights provided by the PolyCHECK® System empower quality staff to work closely with process and supplier teams to address the root causes of contamination, reducing reject rates and ensuring the highest standards of product quality.

Conclusion:
Fiber-shaped non-viable particles originating from non-woven and knitted fabrics used in lint-free mops, wipers, face masks, and bouffants pose a significant challenge in parenteral drug manufacturing. Foamtec’s PolyCHECK® System offers a reliable solution for definitively identifying the sources of fiber contamination. By leveraging the high static attraction of fibers, the PolyCHECK® System enables quality staff to correlate visible contamination with specific process or supplier sources. This correlation facilitates targeted interventions, leading to enhanced product quality and purity. Foamtec’s PolyCHECK® System is a valuable asset for parenteral drug manufacturers seeking to maintain the highest standards of quality and ensure patient safety.

Learn more about the PolyCHECK® System:

https://www.foamtecintlwcc.com/products/foreign-material-identification-service