Hello Sapna,
It depends on what type of Nasal Spray device you are inquiring about. There are some which are non-sterile, but there are others were the "container" for the oral suspension or solution are self-contained, sterilised, and then put into the finished device. As Raje pointed out the United States has requirement for sterile oral inhalation suspensions or solutions, but if you look at other areas like Australia or European Union, there are not specific requirements. I would say most of the requirements around sterility of the solution, medicinal product, or heameopathic product are driven by the customer needs. So it depends on what type of Nasal Spray solution/device you are speaking about as well as the regulatory jurisdiction and customer base.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 09-Feb-2023 13:23
From: Rajeswari Devanathan
Subject: Nasal spray sterilization query
Hi,
Nasal spray products can be non-sterile, when it comes to oral inhalation sprays there is a requirement for FDA. Aqueous-based oral inhalation solutions and suspension
must be sterile (21 CFR 200.51)
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Raje Devanathan
Amerisource Bergen
TPIreg, Innomar Strategies
Senior Manager - Regulatory Affairs, Medical Devices
rdevanathan@tpireg.com
3470 Superior Court
Oakville ON L6L0C4
Canada
Original Message:
Sent: 09-Feb-2023 13:00
From: sapna rathi
Subject: Nasal spray sterilization query
Hello all,
Does Nasal spray required to be sterile?
Is there any specific guidances or examples?
Regards,
Sapna
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sapna rathi
Regulatory specialist
AHME
India
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