Medical Manufacturing Advice for Non-Medical Manufacturers

Author: Krissy Dempsey, Medical Marketing Manager

For the benefit of human kind, all walks of life and business are stepping up and working feverishly to help one another to increase the availability of components and devices for personal protective equipment (PPE) such as respirators, diagnostic testing kits, treatment devices such as ventilators and oxygenators, and supporting research and manufacturing for potential drug treatments and vaccines.

Many businesses that don’t typically manufacture medical devices are joining the fight against COVID-19 and are looking to use their existing manufacturing footprint to help manufacture medical devices and PPE.  If you’re part of this group, thank you for turning your attention to our market in a time of global need.  Also, we wanted to share some quick advice on things to keep in mind as you (quickly) search for suppliers to help you in your quest.

• Raw Material Considerations
  • USP <88> Class VI approved raw materials:  If you can find a raw material that is Class VI certified, you will at least have the confidence that prior to converting into a component, it was considered “medical grade.” 

With relaxed FDA requirements, food and beverage grade materials may be acceptable. With relaxed FDA requirements, food grade materials may be also acceptable. In this case, for polymers, our Food and Beverage team follows the requirements of FDA Food Additive Regulation (21 CFR 177)   

• Manufacturing Environments
  • Certified cleanroom manufacturing may be preferred, but in time of crisis, this may not be a requirement.  Cleanrooms are classified by the maximum acceptable numbers of particles (by size) in the air per cubic meter.  When using the ISO standards for cleanroom classifications, the higher the number, the more and larger allowable particulate matter. For example, an ISO Class 8 cleanroom allows more particulate than an ISO Class 7 certified cleanroom.
  •  The next option would be a controlled environment, sometimes referred to as a “white room.”  These spaces will have some controls/monitoring over key environmental parameters such as pressure, temperature, a certain amount of air filtration, etc. but are not certified to meeting any specific standard.
  • Additional ideas for keeping your parts and/or devices clean for medical use:
    • Point-of-manufacture packaging - This could be immediately from an injection molding press for a molded part, right off of an extruder, or as soon as a minimum quantity of an assembled product is completed.  This will minimize the opportunity for particulate matter to find its way onto the product.
    • Antistatic add-ons for your manufacturing process that utilize ionized air to help reduce static and remove surface particulates.  Some might recommend using air to blow particulate away. However, this just introduces more particulates into the air to float around and find its way onto something, potentially your product so we try to steer clear of this option if possible.
    • Using appropriate cleaning methods, if needed.  Depending on the materials you’re working with, your cleaning methods may vary. In the silicone and polymer world, we use a lot of isopropyl alcohol, for example.
• Quality Systems
  • Look for a manufacturer that has a Quality management system (QMS) that is ISO 13485 certified. This is specific for medical device manufacturing. It will give you peace of mind that their system is set up for this market and its expectations. 
  • If not ISO 13485, they should have a QMS certified to ISO19001 at a minimum which is not specific to medical device manufacturing but aims to ensure a manufacturer has the ability to consistently provide products and services that meet customer and regulatory requirements.
• Validations
  • In the midst of the COVID-19 global pandemic, full validations may not be required (see Blog).  However, having a supplier that has an understanding of this can ensure that proper steps are taken and an “express” validation can be completed. This would ensure that the product that the supplier is providing can repeatedly meet any print specification at an agreed upon quality level.

Thank you again, for joining the fight. We hope we can all work together to keep our healthcare workers as protected as possible, slow the spread, and eventually eradicate this virus. We’re all in this together!

Contact us if you have any questions.