Dried surrogate bacteria could help with process validation, FSMA compliance

By Hank Schultz

- Last updated on GMT

Novolyze photo.
Novolyze photo.

Related tags Verification

A new validation technique using dried surrogate bacteria that could help companies come into compliance with new FSMA requirements has been developed by French company Novolyze.

The new dried surrogates can be added to test lots of material to validate kill steps.  The surrogates mimic the properties of harmful bacteria such as salmonella and can verify that the processes that a given lot of material undergoes, such as steam sterilization for botanical raw materials, is really getting the job done.

Benefits of surrogates

Actually putting salmonella or another harmful bacterium into process machinery to make sure those bacteria are actually getting destroyed during production runs is something to be avoided, of course. In the past, there have been validated methods of assuring, via bench-level mockups or analogues, that the full-scale process is having the intended effect.  (And, of course, lots can be tested for contamination after the kill step and prior to release.) But the gold standard, said Jena Roberts, Novolyze’s US-based vice president of business development, is to validate the process on the actual equipment itself.

An in-plant validation is the gold standard. You have validated the process with your people on your equipment. You have to be able to put a really good story together if you are not doing an in-plant validation,​ Roberts told NutraIngredients-USA.

Novolyze, which has its headquarters in Dijon, France and a US office in Cambridge, MA, has been working on the dried surrogates for about five years, said CEO Karim-Franck Khinouche.

The need for a dried surrogate has been there for quite a while,​ Khinouche said.  Surrogates have been in use for a while, but have been restricted for the most part to moist applications. 

Dried form opens up applications

novolyze pouch

The new product can be used in dried applications, such as dried herbs and food ingredients, which would be more difficult with cultures that need a moist environment.

You have to be able to introduce enough bacteria to make sure you validate the process,” ​Khinouche said. You have to be able to show a 5-log ​(or 100,000 fold) reduction in the amount of microorganisms.

In addition to providing greater assurance, Roberts said an in-plant validation can also be simpler to accomplish.

The validation procedure itself can get complicated and our surrogate is a tool to take some of the complexity out.  Our work has been primarily focused on low water activity foods and we have done a lot of work on spices in particular,” ​she said.

Roberts said the simplicity and robustness of the process could be a boon when it comes to qualifying foreign suppliers, something that has become of increasingly important as the foreign supplier verification aspects of the Food Safety Modernization Act (FSMA) take hold.

You need to validate your process for preventive controls and you need to do that for your suppliers as well.  This is a tool to do that more easily in-plant.  There are other options to validate a process;  you might have mimicked the process in the lab, for example.  You might have done challenge tests. There might be safe harbor data out there that can justify your procedure. That approach is becoming more limited, though, because FDA is wanting to see results on the exact ingredient,​she said.

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