Anoosha,
The main difference or thought process between stainless steel components and plastic components of a medical device (such as in a delivery system) is there would be no leaching or degrading of the stainless steel component. There are some ASTM standards concerning stainless steel which can be referenced. However, plastics or stainless steel in a Dry Powder Inhaler (DPI) device would still follow the requirements of ISO 10993-1 for any component which comes in direct contact with the drug as it is being delivered to the patient. If there is no contact with the drug or indirect contact, then a rationale could be written. The risk level of biocompatibility testing may be less for stainless steel as compared to a plastic as noted above.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 29-Aug-2023 00:55
From: Anoosha Bhat
Subject: Regulatory requirements for Stainless steel to be used in the medical device - Dry powder Inhaler
Hello,
Can anybody tell what are all the regulatory requirements (for US and EU) that are to be met by the Stainless steel part of the Dry powder inhaler medical device, if
- It comes in contact with the drug
- it doesn't come in contact with the drug
Many regulations are there for plastic, but for Stainless steel I couldn't find many.
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Anoosha Bhat
Bengaluru
India
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