3 replies to this topic

[matthewcc]

Hello all,

 

We have never done a nitrogen flush, so this area is completely new for us. Does a supplier of high-purity nitrogen that we use for flushing ingredient bags need to go through supplier qualification to be an approved supplier? We had an NSF GMP audit (NSF/ANSI 455-2 2021 GMP for Dietary Supplements), and the auditor suggested that the supplier does need to be approved, but this was not an official nonconformance, and we are uncertain as to how to proceed. We had originally categorized the supplier as a contract service provider, which in hindsight might not have been the best fit.

 

Also, if a component, because it comes into contact with a dietary ingredient, do we need to test it to verify the identity of the component, and do we need to perform any other testing to confirm the supplier certificate of analysis results? We received the component and QC evaluated the COA and released the nitrogen, but we have not tested it ourselves.

 

I can't search the forums for prior posts because of the driver error ("There appears to be an error with the database"), so hopefully this isn't redundant. We are certified with NSF GMP and SQF for food safety in the United States and manufacture dietary supplements under 21 CFR Part 111 regulations.

 

Thank you,

Matthew

[imeandmyself]

Hello Matthew, our company is BRC certified and I am going to answer as per BRC standards, however I am sure it would be very similar with SQF too. Under this, suppliers of raw materials, including nitrogen, should be approved and meet certain safety and quality requirements. The BRC Global Standards emphasize that any supplier of materials, ingredients, or services involved in the production process should be regularly assessed to ensure they meet the required quality, safety, and compliance standards. Even though nitrogen itself might seem like a simple inert gas, if it’s used in a critical part of your process (like flushing ingredient bags for preservation), it is treated similarly to any other ingredient that can impact the final product's safety, quality, or efficacy. 

 

 

Specifically regarding nitrogen, the supplier should be approved and provide documentation (such as Certificates of Analysis or CoA) that confirms the nitrogen meets the necessary quality standards. However, it's not always a requirement that you test the nitrogen yourself if the supplier provides adequate documentation showing that the nitrogen is of the required quality and complies with regulations.

That said, you may still conduct your own testing to verify the quality of the nitrogen if you feel it is necessary, especially since the nitrogen is critical to product safety or quality. 

[matthewcc]

Thanks, and as a follow-up, in terms of US FDA regulations, doesn't this need at least identity testing, or as a processing aid would it be exempted?

 

Hello Matthew, our company is BRC certified and I am going to answer as per BRC standards, however I am sure it would be very similar with SQF too. Under this, suppliers of raw materials, including nitrogen, should be approved and meet certain safety and quality requirements. The BRC Global Standards emphasize that any supplier of materials, ingredients, or services involved in the production process should be regularly assessed to ensure they meet the required quality, safety, and compliance standards. Even though nitrogen itself might seem like a simple inert gas, if it’s used in a critical part of your process (like flushing ingredient bags for preservation), it is treated similarly to any other ingredient that can impact the final product's safety, quality, or efficacy. 

 

 

Specifically regarding nitrogen, the supplier should be approved and provide documentation (such as Certificates of Analysis or CoA) that confirms the nitrogen meets the necessary quality standards. However, it's not always a requirement that you test the nitrogen yourself if the supplier provides adequate documentation showing that the nitrogen is of the required quality and complies with regulations.

That said, you may still conduct your own testing to verify the quality of the nitrogen if you feel it is necessary, especially since the nitrogen is critical to product safety or quality. 

[G M]

If your compressed gasses are touching the product or the product contact surfaces, yes, there should be verification testing and validation.

 

 

9.5.5 Air and Other Gases

9.5.5.1 Compressed air or other gases (e.g., nitrogen or carbon dioxide) that contact food or food contact surfaces shall be clean and present no risk to food safety.

9.5.5.2 Compressed air systems and systems used to store or dispense other gases that come into contact with food or food contact surfaces shall be maintained and regularly monitored for quality and applicable food safety hazards. The frequency of analysis shall be risk-based and at a minimum annually.