When it comes to pharmaceutical production, maintaining stringent cleanliness standards is necessary to comply with the industry’s strict regulatory requirements. As a result, it is paramount for pharmaceutical companies to establish comprehensive contamination control strategies aimed at minimizing the potential introduction of particulate into critical areas. This strategy should also address the risks associated with floor-level contamination and employ effective risk management measures.
A leading European pharmaceutical company has a mission focused on patient well-being and is committed to providing exceptional, high-quality products. In pursuit of this mission and commitment, they sought a solution to maintain the impeccable condition of their cleanrooms, ensuring the highest standards of product purity. Their choice of an effective floor-level contamination control solution led them to Dycem.
CHALLENGE
The company found itself facing ongoing challenges in maintaining the pristine condition of its cleanrooms. Despite not having encountered contamination-related issues at the time, they remained aware of the potential risks associated with such incidents. Contamination can pose numerous risks including threats to health and safety, quarantined batches, product recalls, and in severe cases, factory shutdowns.
Initially, the company attempted to address this challenge by intensifying its cleaning efforts, which proved only somewhat effective. However, this strategy came at a considerable cost, consuming substantial resources in terms of time and financial investments.
SOLUTION
The company was familiar with Dycem mats from previous experiences, and their past usage had proven highly effective. Dycem CleanZone and WorkZone mats have been deployed throughout the site, spanning changing areas and locations preceding production rooms with significant traffic flow. CleanZone is primarily suited for pedestrian and foot traffic, and WorkZone is designed to withstand heavy-wheeled traffic, e.g. forklifts.
This success prompted their decision to expand the implementation of Dycem Contamination Control solutions to new areas within the facility. In particular, they chose to introduce Dycem’s CleanZone mats at the entrances to their cleanrooms. Dycem mats reduce particulate contamination by as much as 99.9%, effectively preventing the ingress of contaminants from both shoes and wheels.
RESULTS
Following the incorporation of Dycem mats, the need for frequent cleaning in these areas significantly diminished. While in use, Dycem mats may appear dirty; however, this company discovered firsthand that the apparent dirt is a positive sign. The particles captured on the mat serve as a visible indicator of its effectiveness, leading to less contaminants entering clean spaces and a reduced need for specialized and costly cleaning.
This pharmaceutical company has expressed its satisfaction with the impressive performance of the Dycem mats, further highlighted by our long-lasting relationship with them. These mats have proven to be both effective and efficient, offering a user-friendly solution that minimizes user downtime. Personnel can effortlessly decontaminate their shoes and wheels by simply walking over the Dycem mats.
ABOUT THE INDUSTRY
The pharmaceutical industry is a dynamic sector focused on the discovery, development, and manufacture of drugs and medications. Playing a crucial role in global health, pharmaceutical companies are overseen by regulatory bodies, ensuring the safety and efficacy of the products produced. This results in the industry facing significant challenges to maintain the high standards required for manufacturing.