Quinolizidine Alkaloids in Lupins
ContaminantsQuinolizidine alkaloids are secondary metabolic products that serve plants as defense and protection against herbivores....
How do we ensure the safety of the product when implementing or modifying pasteurization or sterilization steps?
Conducting thorough process validation beforehand can provide valuable assistance in this regard.
What is proper Process Validation?
Process validation is an essential step always conducted before implementing a new production process. This validation is a dual process, involving both theoretical and practical aspects.
Theoretical Validation
During theoretical validation, the various product properties are meticulously examined. Factors such as Aw, pH, and salinity play a crucial role in pathogen reduction and growth. The assessment includes identifying the types and quantities of pathogens to eliminate, essentially evaluating the efficacy of pasteurization or sterilization.
Compliance with legislation and meeting specific customer requirements is paramount. Technical details and installation settings are analyzed to determine whether the necessary reduction is achieved, potentially supported by historical data from the same installation.
Practical Validation
While a theoretical validation, accounting for worst-case scenarios, may suffice to address the risk of food safety hazards, practical validation for pathogen-reducing processes (like pasteurization and sterilization) is equally vital. Testing the installation with the product and checking the desired outcome can prevent unexpected or misjudged risks. The absence of practical validation in real-world scenarios has, at times, led to excessive contamination levels or recalls due to installations not performing as anticipated in theory.
As mentioned, two practical validations are essential:
- for the process equipment
- for the product
Process equipment undergoes validation in various aspects, including temperature range, temperature distribution, time, etc. Typically, the equipment supplier carries out this validation.
In product validation, deliberate contamination with a pathogen (the target organism) takes place, which the process must eliminate. Subsequently, the process is executed. By quantifying the target organism before and after the process step, we can assess whether the process meets expectations.
Two Product Validation Methods
Method 1: Simulate the Process in a Laboratory
In the laboratory validation, we intentionally introduce a known amount of pathogens into the product. Subsequently, we heat the product using data provided by the company, initiating a reduction in pathogens. A new count allows us to quantify the extent of pathogen reduction. We then compare these results with theoretical validation. If the outcomes align with the set requirements and expectations, we can confidently assert that hazards are under control, ensuring safe production. Yet, a challenge remains: how can we effectively replicate the real-world process conditions in the laboratory?
Method 2: Conducting Validation at the Company
Achieving greater precision in validation occurs when replicating the same pathogen contamination process within the company, using the intended installation. Validating within the company brings the advantage of automatically incorporating specific measurement uncertainties and process fluctuations, such as changes in flow and discharge. These elements, sometimes overlooked in theoretical validations, undeniably impact the pathogen reduction capacity. Additionally, fully simulating the process conditions in a laboratory is often impossible.
However, employing a pathogen in a process is not without its risks. A well-defined protocol must be established to identify all risks and eliminate any unintended product contamination. To mitigate these risks, we often use a surrogate organism. Prior to this, laboratory testing must demonstrate that the reduction of this surrogate organism is comparable or less than that of the target organism. In such studies, a particular strain of Enterococcus faecium is commonly employed, known for being slightly more heat-resistant than Salmonella.
Properly conducting a process validation in advance allows for a comprehensive mapping of all potential risks in the process, ensuring the guarantee of food safety. This proactive approach prevents the need for recalls, thereby avoiding subsequent financial and reputational damage. Additionally, it serves to minimize unnecessary repair costs. Identifying errors early in the process often results in significantly lower repair expenses.