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Product Cleaning Endotoxin Control
Challenge
RCA’s medical device consultants were requested to analyze the process used to clean the needles, develop a protocol for evaluating cleaning efficacy, and recommend improvements to the Endotoxin control process and specifications.
Background
A medical device manufacturer was experiencing occurrences of unacceptable endotoxin levels on finished, cleaned surgical needles, and an FDA 483 observation was received for non-conformances.
Additionally, specific non-conformances included procedures related to the needle cleaning process.
RCA also assisted in the design and build of new cleaning equipment.
Result
Product endotoxin levels were substantially reduced, and the risk of nonconforming product reaching customers was effectively addressed and documented through process validation and improved process control.
Approach
Regulatory Compliance Associates® Inc. developed and coordinated controlled testing using a “worst case” product example inoculated at a target level of approximately 300 EU/device, with the final goal being endotoxin levels at below 2.15EU/device after cleaning.
Test results showed a gradual buildup of bioburden in the cleaning water from one batch of needles to the next. RCA also assisted the client in the design and build of new cleaning equipment. The final cleaning system was replaced with the automated system, a clean compressed air system was installed, vacuum driers were installed, the equipment and process was validated, a clean room behavior SOP was developed, and training was performed.
Additionally, a sampling plan with action and alert levels for product endotoxin levels was established.
About RCA
Regulatory Compliance Associates® (RCA) provides worldwide services to the following industries for resolution of compliance and regulatory challenges:
We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA-and globally-regulated companies. As your partners, we can negotiate the potential minefield of regulatory compliance and private equity due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.
- Founded in 2000
- Headquartered in Wisconsin (USA)
- Regional offices in Florida, Colorado and Europe
- Expertise backed by over 500 industry subject matter experts
- Acquired by Sotera Health in 2021
To begin the RCA® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage.
References
- U.S. Pharmacopoeia, Chapter 161, Transfusion and Infusion Assemblies and Similar Medical Devices.
- U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, “Guideline on Validation of the Limulus Amebocyte Lysate Test as an End-Product Endotoxin Test for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices,” December 1987.
