Validation Studies

Our comprehensive validation studies provide an in-depth analysis of your manufacturing process, guaranteeing that it can achieve the desired level of safety at every stage. We meticulously evaluate each step to ensure it meets and exceeds all regulatory requirements, giving you peace of mind and confidence in the reliability of your process. With our expert guidance, you can rest assured that your manufacturing operations are optimized for maximum safety and compliance, ensuring the highest product quality and customer satisfaction.

We design our bench-top and in-plant validation studies to provide actionable data to verify the effectiveness of your process and the safety of your finished product. Services include:

  • Thermal and non-thermal process validations

  • Equipment validation studies

  • In-plant validation studies, both domestic and international

  • Novel processing technique evaluations

  • Development of non-pathogenic surrogate culture for plant validations

Three Approaches, From Simple to Complex, To Fit Your Needs

Log Reduction

By employing the innovative method of inoculating products and subjecting them to the application of heat, a meticulously carried out comparison study is undertaken to analyze and comprehend the efficacy of the process and the remarkable reduction in bacterial load. This study contrasts the initial and final counts, shedding light on the significant difference achieved before and after the implementation of this groundbreaking technique. Through this comprehensive evaluation, valuable insights are gained into the effectiveness of the process and the logarithmic reduction achieved, further enhancing our understanding of its immense benefits.

Degree of Inactivation

Determining the D-value is crucial in assessing the effectiveness of your process temperature in reducing microbial counts. The D-value, representing the decimal (log) reduction, provides valuable insights into the degree of inactivation achieved over any given period. By understanding the D-value, you can confidently gauge the efficiency of your process temperature in eliminating harmful microorganisms. Knowing the D-value empowers you to make informed decisions about the optimal length of time required to ensure complete inactivation, whether it's a short burst of high heat or prolonged exposure. With this knowledge, you can maintain the highest safety and quality standards in your processes, giving you peace of mind and assurance in your operations.

Predictability of Lethality

Determining D-values at various temperatures is crucial in deriving a Z-value, which plays a pivotal role in comprehending the predictability of lethality for any given heating profile. By analyzing the D-values across a range of temperatures, we can gain valuable insights into the thermal resistance of microorganisms, enabling us to make informed decisions about the effectiveness of heat treatments. The Z-value acts as a unifying factor that allows us to confidently assess the impact of temperature changes on the lethality of the heating process. With this knowledge, we can optimize heating profiles, ensuring the highest safety and efficiency in various industries, from food processing to pharmaceutical manufacturing.

Contact Us to Learn More About Our Validation Study Services

Discover the hidden secrets behind the long-lasting success of your products! Connect with our team of experts today to delve into validation studies and unlock invaluable insights for your products.