Addressing the Presence of Residuals in Manufacturing—A Medtech Makers Q&A

By Sean Fenske, Editor-in-Chief
 
Industrial manufacturing is often viewed as a “dirty” process as chemicals, grease, oil, and other things are used at various stages and for different purposes. Even in the much cleaner manufacturing environment of medical devices, outside contaniments can exist in areas it shouldn’t be, creating residuals. When these are in medical devices, they can lead to serious complications for patients.
 
Due to the seriousness of having residuals in a medical device, it is critical manufacturers understand as much about the potential for these to exist as possible. They need to realize the sources of such contaniments, how to determine their presence, and how to address them. Part of the solution could involve leveraging an expert testing partner to help determine if residuals exist and where in the device.
 
To help address the questions around residuals, detection of them, and the problems they present is Jesse Giunta, group leader, chemistry, at Eurofins Medical Device Testing. He took time to respond to many of the aforementioned questions and shares insight on why residuals can be such a problem for medical device manufacturers.
 
Sean Fenske: What is meant by residuals in the manufacturing process?
 
Jesse Giunta: Residuals in manufacturing are materials (residuals or degradation products) from the manufacturing process that are not intended to be part of the final product. These residuals would include any contaminate on or in a final product that is not included in the characterization of the material.
 
Fenske: What are the sources of residuals in the manufacturing process?
 
Giunta: Residuals can come from processing, packaging, and sterilizing a product and could include contaminates in the raw material, oil, grease, and plastic or metal particulates from machinery. Other sources could be unprocessed or overreacted materials and unreacted chemicals from the manufacture or sterilization that were not sufficiently removed, washed, reacted, evaporated, or outgassed. Residuals and contaminates can also come from equipment, rooms, packaging, and materials that were not properly cleaned before or after a processing run.
 
Fenske: Why is it important to understand residuals in the manufacturing process?
 
Giunta: Understanding residuals is essential on multiple levels. Not only is it a requirement as part of characterization, but a manufacturer has an obligation to know and understand the possible sources of contamination on their medical device. Many regulations require full characterization of any possible residual or contaminate. These contaminates could potentially harm the device, causing a failure with a patient. More importantly, it could be the source of an adverse event with a patient that could ultimately cause serious harm or death.
 
Fenske: Can you speak to the regulations involving residuals in manufacturing?
 
Giunta: There are a multitude of regulations and standards that provide guidance for the medical device industry. ISO 10993-18 requires that all materials and residuals are fully characterized. Additional relevant documents include the ISO documents that cover contaminates (ISO 13485 and 22442), sterilization residuals (ISO 10993-7), and cleanliness of implants (ISO 19227), as well as the more general medical device evaluation guidelines (ISO 10993 and 17664). Also, ASTM provides many documents that outline procedures for a variety of test methods. These include ASTM F2847, F2459, and F3127, which address residue and cleaning, as well as other documents associated with these standards. ICH also has a specific document to address residual solvents (ICH Q3C). Finally, AAMI has written standards and guidances for residuals, sterilization of products, and cleaning of reusable devices.
 
Fenske: How do you control residuals in the manufacturing of medical devices?
 
Giunta: The ideal way to control the introduction of residuals on a medical device is to have a “clean” manufacturing environment and process. Vigilant requirements for raw materials and testing of such materials, as well as thorough testing on the final product, is necessary to maintain clean and safe processes that will help to prevent contamination. Validated cleaning of process equipment and testing areas also helps to maintain a contaminate-free work area and minimize points in the production process where residuals and contaminates can impact the medical device. Testing on the final device may be necessary if a process cannot be validated to consistently produce low levels of questionable materials. Testing would also be necessary if there is a major change in a validated process to ensure the change does not adversely affect the presence of residuals on the device.
 
Fenske: What should a manufacturer be seeking when identifying the right outside laboratory for assistance in testing?
 
Giunta: When looking to outsource testing, a manufacturer must identify a laboratory that has the capabilities and experience to meet all of their testing needs. Identifying a laboratory familiar with the medical device industry, regulatory processes, and guidance documents is essential to ensure the product avoids pitfalls and delays. There is also an added value to working with a company that can perform all testing needs for a device, whether it be residuals, biocompatibility, packaging, or human factors. A manufacturer should look to partner with a laboratory that values their own reputation as much as the client values their reputation.
 
Fenske: Do you have additional advice to offer a company seeking laboratory testing?
 
Giunta: Sourcing a testing laboratory with the resources and experience to support specific and unique testing required for a medical device can be a daunting task. This can be further complicated by novel materials and innovative products. This can complicate testing, so one must identify a partner laboratory capable and willing to apply new parameters to test designs. Be sure to work with the right people for the job, such as those who are industry leaders with a global presence and a multitude of years of experience.
 
Fenske: Do you have any additional comments you’d like to share based on any of the topics we discussed or something you’d like to tell medical device manufacturers?
 
Giunta: When dealing with contract testing for residuals, it is best to align the services with a laboratory able to support you through all stages of device development and production, as well as all the various aspects of testing that may be needed. Partner with a laboratory that performs as a“one-stop-shop” and has the resources to be leaders in the field for all testing types required in the medical device industry.
 
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