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
Aseptic Process Simualtion (APS) / Media Fill
The widely used method by visually inspecting the media filled samples for turbidity is very time consuming. Some package configurations may not even allow visible control due to the package properties. A new approach using non-destructive Headspace Analysis (HSA) for the determination of gas concentration changes is an alternative method for aseptic process simulation (APS).
More information you can find in our Media-Fill application below or contact us for your individual project.
Learn more about our manual or automated Media Fill inspection solutions.
