Background

A medical device manufacturer was encountering recurring instances of unacceptable endotoxin levels on finished, cleaned surgical needles. The issue led to an FDA 483 observation citing non conformances with established procedures related to needle cleaning and endotoxin control. Regulatory Compliance Associates® Inc. (RCA) was engaged to conduct a comprehensive analysis of the needle cleaning process, develop a protocol to evaluate cleaning efficacy, and recommend improvements to both the process and the associated specifications.

RCA Approach

RCA designed and executed controlled testing using a “worst-case” product scenario, inoculating surgical needles with approximately 300 EU/device. The objective was to achieve post-cleaning endotoxin levels below 2.15 EU/device. Testing revealed a gradual accumulation of bio-burden in the cleaning water across sequential batches, highlighting the need for process improvements. RCA supported the client in designing and building a new, automated cleaning system, which included clean compressed air and vacuum drying capabilities. The new equipment and cleaning process were fully validated. To further strengthen contamination control, RCA developed a clean-room behavior SOP and conducted comprehensive staff training. Additionally, a robust sampling plan was implemented, incorporating defined action and alert levels for endotoxin monitoring on finished product.

Result

As a result of the improvements, product endotoxin levels were substantially reduced, and the risk of nonconforming product reaching customers was effectively mitigated. These outcomes were supported and documented through rigorous process validation and enhanced process controls, ensuring compliance with regulatory expectations and strengthening overall product quality.