Medical Device Contamination

Medical Device Manufacturing Partner

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Executive Summary

In 2018, CCS began a partnership with a medical device manufacturing client in the Bay Area. Although the client's previous janitorial service provider performed daily cleaning of their cleanrooms, the areas failed to meet the client's standards and regulatory guidelines. CCS quickly identified that the janitorial staff was not trained in, lacked industry knowledge for cleanroom cleaning and disinfection, and lacked GMP experience. After our Contamination Control Expert performed a gap assessment and audit of the current janitorial service, our auditor further discovered that the client's cleaning supplies were not used or stored properly which failed to meet expectations. Due to the contamination and particulate levels, the client lost hundreds of dollars and had to shut down their cleanroom to dispose of their product and allow us to perform a thorough 3X cleaning.

CCS engaged with the manufacturer in providing appropriate recommendations to update their current cleaning and disinfection supplies based on their cleanroom classifications and the bioburden and particulates that had been identified on their floor surfaces. As part of the improvements for the cleanroom environment, CCS developed and implemented a cleaning program in the space with the CCS micro-cleaning team performing the cleaning which reduced particulate levels, increased product yield, and visually improved the areas of concern from the client’s perspective. Due to the longstanding and trusted partnership between the client and CCS, we have been able to provide additional support services and were the first company the client called when the COVID-19 outbreak began.

Executive Summary

In 2018, CCS began a partnership with a medical device manufacturing client in the Bay Area. Although the client's previous janitorial service provider performed daily cleaning of their cleanrooms, the areas failed to meet the client's standards and regulatory guidelines. CCS quickly identified that the janitorial staff was not trained in, lacked industry knowledge for cleanroom cleaning and disinfection, and lacked GMP experience. After our Contamination Control Expert performed a gap assessment and audit of the current janitorial service, our auditor further discovered that the client's cleaning supplies were not used or stored properly which failed to meet expectations. Due to the contamination and particulate levels, the client lost hundreds of dollars and had to shut down their cleanroom to dispose of their product and allow us to perform a thorough 3X cleaning.

CCS engaged with the manufacturer in providing appropriate recommendations to update their current cleaning and disinfection supplies based on their cleanroom classifications and the bioburden and particulates that had been identified on their floor surfaces. As part of the improvements for the cleanroom environment, CCS developed and implemented a cleaning program in the space with the CCS micro-cleaning team performing the cleaning which reduced particulate levels, increased product yield, and visually improved the areas of concern from the client’s perspective. Due to the longstanding and trusted partnership between the client and CCS, we have been able to provide additional support services and were the first company the client called when the COVID-19 outbreak began.

Medical Device Contamination

Executive Summary

Executive Summary

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