Automated PAT
Driven by continuous innovation, WILCO has continuously developed the HSA and NIR technology since 2003 when the first inline HSA system was installed. Both can be used as a Process Analytical Technology (PAT) for testing various quality criteria of parenterals.
SPECTRA HSX
The verification of quality relevant attributes of the headspace conditions e.g. in lyophilized and liquid filled vials, requires non-destructive and robust inspection technologies. The SPECTRA HSX platform impresses with its highly sensitive laser system and the flexibility to be configured for individual requirements for automated Headspace Analysis. Headspace Analysis may be used for nitrogen purging efficiency, vacuum verification or container closure integrity testing (CCIT) for small volume parenterals (SVP).
The SPECTRA HSX is an inspection platform developed for non-destructive Headspace Analysis for pharmaceutical packages with modified headspace conditions. Headspace Analysis may be used for nitrogen purging efficiency, vacuum verification or container closure integrity testing (CCIT).
Due to the continuous developments of the laser system it can be used for the highest requirements and provides the option to add further inspection technologies. Depending on the given conditions and requirements, up to ten test heads can be integrated. By increasing the number of test heads both the throughput and the sensitivity can be improved.
Inspection of multiple gases
With our newest laser generation we reach industry leading sensitivity. Optionally, two different laser heads can be integrated to check for both the partial pressure of oxygen or carbon dioxide and the total pressure inside the test sample.
Integration of additional inspection methods for vials
The integration of NIR spectroscopy modules for moisture detection in lyophilizates or barcode readers for container identification is optional. The combination with other inspection platforms such as the automated visual inspection platform is also possible.
Latest generation of HSA lasers
With our latest Head Space Analysis generation, we are setting new milestones in terms of sensitivity and inspection speed.
Integrated online calibration system
To verify the correct calibration of the HSA system during multiple-hour production runs, an online calibration tool was integrated to ensure maximum process reliability.
Integration of multiple test heads
The SPECTRA HSX 500 platform can accommodate up to 10 test heads providing the highest sensititity.
Different solutions for different customer requirements
We offer 3 different automated Headspace Analyzer platforms for different production speeds.
SPECTRA HSX 100
is a mobile and very compact inspection platform for pharmaceutical packages such as vials or ampoules. Glass or plastic containers from 2 ml up to 100 ml can be inspected at a speed of up to 100 test samples per minute.
SPECTRA HSX 300
is a compact inspection platform. The system is capable of testing 2ml vials to LVP bottles or other packaging types at a speed of up to 300 test samples per minute. Depending on the given conditions and requirements, up to two test heads can be integrated.
SPECTRA HSX 500
the SPECTRA HSX 500 qualifies for the highest requirements and provides the option to add further inspection technologies. Depending on the given conditions, up to ten test heads can be integrated. By increasing the number of test heads both the sensitivity and throughput (up to 500 samples per minute) are improved.
Features SPECTRA HSX
- Up to 500/min
- 2ml up to 100 ml containers
- Non-destructive head space analysis of vials, syringes, ampoules
- Deterministic test method preferred acc. USP1207
- Applicable for glass and plastic containers
- Applicable for liquid, lyophilized and solid products
- Designed according to GMP guidelines
- Data Handling in compliance with 21 CFR part 11
- Reliable product handling
- Toolless format changeover
- Optional integration of visual inspection systems
- Optional integration of 2D DataMatrix Code reader
- Optional integration of NIR Module for residual moisture and lyo defects
SPECTRA NIV
NIR spectroscopy provides multiple advantages over wet chemical analysis methods such as Karl Fischer titration. NIR spectroscopy is a non-destructive process analytical technology that allows real time testing at production speeds.
Our SPECTRA NIV is an inspection platform for lyophilized products. It uses a high speed near infrared spectrometer that allows 100% inspection of lyophilized products at production speeds of up to 600/min.
High-speed
The NIR module can generate and analyze up to 600 spectra per minute and allows the integration into high-speed production lines.
Verification system
Automated positioning of reference standards onto the NIR station allows the operation of the system without user intervention.
Adjustable for various vial sizes
Fast and easy change
The SPECTRA NIV 300 is a high speed inspection platform for the non-destructive acquisition and analysis of NIR spectra of lyophilized products. NIR spectroscopy allows the determination of multiple parameters simultaneously such as moisture concentration, defects of the lyophilizate and the identification of the product.
Once the method is developed and validated the system does not require human intervention as the analysis, as well as the system verification, is done fully automatically and is easy to use. The NIR data gives the same reliability which is comparable to the reference analytic methods (e.g. Karl Fischer Titration, HPLC).
System suitability tests are performed with the correct reference materials, such as wavelength standards and diffuse reflection standards, that are traceable to National Institute of Standards and Technology (NIST). Along with the inspection platform, we offer the full method development and validation.
Features
- Testing speed up to 600 vials per minute
- Applicable for lyophilized vials from 2ml – 100ml
- 100% spectrometric analysis of lyo defects
- Non-destructive testing allows 100% control
- No preparation of samples required
- Fully integrated in PLC and HMI system
- Automated system verification test
- Reference standards according to NIST
- Reliable product handling
- Design according GMP guidelines
- Data Handling in compliance with 21 CFR part 11
- Easy format changeover
- Optional integration with other inspection technologies
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.
