Automated PAT
Media-Fill inspection
Recent developments in regulatory standards, particularly the revisions introduced in Annex 1 of the EU Good Manufacturing Practice (GMP), have significantly impacted aseptic filling practices. The revised annex contains new requirements to ensure the quality and safety of sterile medicinal products. These changes necessitate a more rigorous approach, leading to additional and more extensive tests. Learn how Aseptic Process Simulation (APS) / Media Fill test can be automated with our solutions.
Media Fill Inspection for pharmaceutical products
Recent developments in regulatory standards, particularly the revisions introduced in Annex 1 of the EU Good Manufacturing Practice (GMP), have significantly impacted aseptic filling practices. The revised annex contains new requirements to ensure the quality and safety of sterile medicinal products. These changes necessitate a more rigorous approach, leading to additional and more extensive tests.
Learn how Aseptic Process Simulation (APS) / Media Fill test can be automated with our solutions.
Media Fill Testing Evolved
In the pharmaceutical industry, ensuring the sterility of manufacturing processes is paramount. Media Fill testing, a critical simulation of the aseptic filling process, traditionally relies on manual visual inspections, which is prone to human fatigue and possibly error. With recent regulatory changes, notably the updates in Annex 1 of the EU Good Manufacturing Practice (GMP), there’s an increased need for optimizing processes.
What is Turbitity Testing?
Media Fill tests are designed to simulate the aseptic filling process in pharmaceutical manufacturing, replacing the actual drug product with a growth medium to test whether the environment and process maintain sterility. Goal is to ensure that the aseptic manufacturing process – especially for parenterals – can produce reliably products. Traditionally, this involves manual checks for microbial contamination by manual visual turbidity inspection in the medium.
Today's manual media fill process involves the following:
- Replacing the actual product with a nutrient-rich broth
- Simulating a manufacturing process with all relevant resources
- The Media Fill Test samples are incubated during a defined period to promote microbial growth
- The test samples are analyzed manually for signs of contamination
This process is repeated regularly in at a large time interval. Therefore, the manual inspectors need to be trained regularly per case.
Innovative Approach with HSA
At WILCO, we are establishing a shift from the traditional to the automated approach with our innovative Headspace Analysis (HSA). This method utilizes Tunable Diode Laser Absorption Spectroscopy (TDLAS) to monitor changes in O2 and CO2 levels within container headspaces, providing a precise, non-invasive way to detect microbial growth. This technique not only enhances accuracy but also circumvents the challenges posed by manual inspections.
Manual vs. Automated Aseptic Process Simulation
Manual Challenges:
Traditional manual Media Fill inspection methods, such as turbidity checks and visual inspections, are labor-intensive and subject to variability due to human interpretation. Manual turbidity inspection struggles especially with containers where direct visual inspection is not possible. The medium must be decanted into a transparent container, with the risk of contamination.
Automated Advantages:
Microorganisms have aerobe or anaerobic metabolisms and therefore influence CO2 and in the aerobe case O2 concentration of the headspace. After an incubation phase, when microorganisms start to grow, oxygen consumption inside the sealed container increases, accompanied by a corresponding rise in carbon dioxide production. Our automated media fill testing leverages Headspace Analysis to monitor changes in these CO2 and O2 levels, using Tunable Diode Laser Absorption Spectroscopy (TDLAS).
The automated process with TDLAS not only detects contaminated samples but also, when paired with automated visual inspection techniques, identifies agglomerates. Combining Headspace Analysis and Visual Inspection allows you to improve and streamline your aseptic filling operations.
Key Benefits of Automated Headspace Analysis for Media Fill Inspection
- Efficiency:
Automated systems significantly speed up the testing process, handling large volumes effortlessly and in a non-destructive way, which is critical under the stringent demands of updated GMP guidelines. - Versatility:
Capable of testing in difficult to inspect containers that traditional methods cannot assess without risking contamination, such as those made from amber glass or container made of optically diffuse material.
- Cost Reduction:
Reduces labor costs and minimizes the risk of contamination, potentially decreasing the frequency of costly batch failures. This is especially interesting for filling lines with frequent product / packaging changes. - Accuracy:
Eliminates human error and subjective judgment from turbidity checks, providing consistent and reliable results.
Manual to Automated: Transitioning with Ease
Transitioning from manual to automated Media Fill testing doesn't just mean adopting new technology—it’s about embracing a more reliable, scalable system that meets rigorous regulatory standards while improving operational efficiency. Our automated Headspace Analyzers are designed to integrate seamlessly, ensuring that pharmaceutical manufacturers can stay ahead of compliance issues and lead in innovation.
Embrace the Future with us
Our innovative approach in automated analysis of media fill positions your operations at the forefront of technological advancements in pharmaceutical manufacturing. By integrating WILCO's automated Headspace Analyzer, you can enhance your operational efficiency, comply with international standards, and ultimately deliver safer products.
Explore how our solutions can transform your media fill testing or contact us for a personalized consultation.
