VisioNIR. High Speed NIR Spectrometer for 100% Process Inspection

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1 VisioNIR High Speed NIR Spectrometer for 100% Process Inspection

2 Table of Content Introduction... 2 visiotec VisioNIR High Speed NIR Spectrometer: Your Way to PAT... 2 The benefits of the VisioNIR system... 2 VisioNIR LS Applications - Examples... 3 VisioNIR LS for insulin content inspection on filling machines... 3 VisioNIR LS for Content Uniformity inspection on tablet presses... 3 VisioNIR for the inspection of freeze dried products in product inspection machines... 4 VisioNIR LS for identity of unlabelled bulk in secondary packaging... 4 VisioNIR LS for Blend Uniformity on a continuous mixer... 5 VisioNIR LS for Blend Uniformity and Water content on a fluid bed granulator... 5 VisioNIR LS for membrane coating identification on tablet printers... 6 VisioNIR LS for bulk tablet inspection... 6 VisioNIR AS Applications - Examples... 7 VisioNIR AS for optical inspection and identification of products by its chemical fingerprint... 7 Technical Specification... 8 Functional Principle... 8 Accessories... 9 Accessories Measuring heads... 9 NIR measuring head for tablets... 9 Inspection glass for powder stream monitoring... 9 Transmission measuring head for vials Multi-purpose reflection measuring head Accessories Illumination & fiber optics Collimation Light fiber Illumination Light Fiber Illumination Source Accessories Standards Reflection Standard Accessories Software and visualization Software packages Release Nov 2014 visiotec GmbH 1

3 Introduction visiotec VisioNIR High Speed NIR Spectrometer: Your Way to PAT VisioNIR LS is the result of continuous development from customer requirements, process understanding and experience in the pharmaceutical production. As a result of the flexible hardware and intuitive operating software, VisioNIR is easy to retrofit into any production machine and it meets the pharmaceutical requirements. Our focus is to provide a 100% inspection tool, thus the occurrence of any deviation can be detected on-line without any delays in order to make your process safe. Additionally to the VisioNIR LS device, we have a team of experts to support you with installation and startup, training, modeling and facilitation. The benefits of the VisioNIR system High Speed VisioNIR is a high speed NIR spectrometer. The diode arrays with transmission grid enable a rapid and precise data acquisition. As a result that in the diode array technology no moving parts are in use we reach scanning rates up to 100 spectra per second to inspect each individual product of the process. Flexibility The VisioNIR basic unit is either delivered in a stainless steel cabinet or can be implemented directly into the host machine. Six different NIR measuring heads are available for reflection and transmission mode data acquisition to provide a high selection of process inspection. All NIR measuring heads can be easily removed from the machine. Low Maintenance VisioNIR is easy to maintain: No adjustments of the spectrometer are required in diode array technology. Easy illuminant exchange and USP tests are supported in the software to ensure the linearity, photometric noise, wavelength correctness and wavelength repeatability in periodic cycles. Knowledge and Competence Center visiotec has an excellent team of NIR experts to support you with your application. Our long term experience in method calibration helps to find the best correlation between your process data and your critical quality attributes (CQA). We provide consultancy for the design of experiments (DOE), design space calculation and process calibration & validation. Sophisticated Software Package VisioNIR software is designed to operate for CFR 21 Part 11 compliance. For model development and prediction/classification the Unscrambler software with the Hierarchical Model Builder, the Hierarchical Model Prediction Engine and OLUP / OLUC are available. Release Nov 2014 visiotec GmbH 2

4 VisioNIR LS Applications - Examples The VisioNIR LS system was developed to be integrated in different host machines for numerous applications. Each setup is dedicated to the required application. VisioNIR LS for insulin content inspection on filling machines The non-destructive 100% inspection of the insulin content in cartridges directly after the filling process is an important tool to find process issues. At the end of the batch the insulin content is often dramatically decreased and the used HPLC (High Performance Liquid Chromatography) destructive method allows only sampling whereby the VisioNIR measures the insulin content of each cartridge. The accurate endpoint of OOS products can be inspected and no expensive in specification products must be rejected. VisioNIR LS for Content Uniformity inspection on tablet presses The content uniformity and the compaction force are the most important tablet properties in the tableting process and the subsequent drug release. Upstream process steps can lead to segregation of API and excipients and inaccurate adjustments at the tablet press results in OOS compression forces. The inline NIR system is integrated into tablet presses and the NIR spectrum of each single tablet is taken directly after the compaction process. The complex designed tablet measuring head focuses the NIR radiation onto the tablet and collimates the reflected radiation. The light fibers forward the NIR light to the spectrometer. Non conforming tablets can be rejected. Release Nov 2014 visiotec GmbH 3

5 VisioNIR for the inspection of freeze dried products in product inspection machines The drug shelf life depends on the residual moisture content and the quality of the lyophilization cake. Cake defects such as melt backs, shrunken cakes and collapsed cakes are important quality aspects and must be controlled. Furthermore the identity of the right product must be confirmed if more than one product is inspected on the host machine. The inline VisioNIR LS determines these defects after the lyophilization process as a final quality concept to avoid that any nonconforming products will reach the marketplace. With just one scan the residual water content, different cake defects and the identity is determined in one step in full machine speed. VisioNIR LS for identity of unlabelled bulk in secondary packaging The customization after the primary packaging is often done at different production plants or after storage periods of the unlabeled bulk. The used colored ring marking method provides no information of the real content of the container and enables the risk of dangerous mix-ups. The VisioNIR LS scans each individual container on the labeler before labeling and ensures that the correct drug with the right dosage is present in full machine speed. Non conforming products will be rejected. Release Nov 2014 visiotec GmbH 4

6 VisioNIR LS for Blend Uniformity on a continuous mixer The Blend Uniformity plays an important role in the continuous blending process. The homogeneity of API and excipients must be ensured to pass the downstream tableting process. The VisioNIR LS can be installed on the exit chute of the continuous blender and the powder stream can be measured with 50 spectra per second to ensure to inspect as much product as possible. VisioNIR LS for Blend Uniformity and Water content on a fluid bed granulator In fluid bed processing, information regarding moisture content in the material could only be determined indirectly by means of other physical parameters such as the exhaust air humidity. The VisioNIR LS can be installed on fluid bed granulators to determine the Blend Uniformity and the water content inline during the spraying and drying phase of the granulation. Release Nov 2014 visiotec GmbH 5

7 VisioNIR LS for membrane coating identification on tablet printers The presence of the membrane coating is important for the drug time resolved drug release in OROS tablets. The VisioNIR LS can be installed on tablet printers to identify the presence of the membrane coating and the right active ingredient content core inline with production speeds up to tablets per hour. VisioNIR LS for bulk tablet inspection After production the bulk tablets are often inspected by camera systems to detect cosmetic defects. The additional use of the inline NIR technology assures the Content Uniformity. The so called batch safer machines are often used if the batch release failed and 100% of the product inspection is required. The VisioNIR LS can be installed on a tablet handling machines to determine the Content Uniformity of each individual tablet. The process speed is up tablets per hour. Release Nov 2014 visiotec GmbH 6

8 VisioNIR AS Applications - Examples The VisioNIR AS system was developed to be integrated in different host packaging machines for numerous applications. The system can be used in two configurations: NIR only inspection or in combination of traditional optical inspection paired with high-speed NIR technology. Especially the combined system is very attractive for use in clinical trial or multi-dose packaging operations or when used as a re-inspection system of already packaged batches which are potentially subject to product mix-ups. VisioNIR AS for optical inspection and identification of products by its chemical fingerprint Actives and placebos are packaged together during a clinical trial study. The intention of such study is that products are not to be distinguishable by their looks. VisioNIR AS scans the entire fill area and checks each individual product for its chemical fingerprint to assure the correct locations are filled with the correct products. The same applies for the packaging of multi-dose products. VisioNIR AS also finds its use in blister and bottle packaging operations which have a potential high risk of product mix-up situations. As a batch saver, already produced blister packs can be re-inspected using VisioNIR AS. Release Nov 2014 visiotec GmbH 7

9 Technical Specification VisioNIR is a combination of a high speed NIR spectrometer, an industrial evaluation PC, special electronic cards, a powerful illumination source and a NIR measuring head. The heart of the VisioNIR LS is a diode array NIR spectrometer with 256 pixels. The transmission grid has a 30% increased radiation efficiency compared to the reflection grid and has extreme less scatter >1: The VisioNIR LS is equipped with a shutter to shade the optical entrance to the spectrometer for dark reference data acquisition. The dark reference and white reference spectra acquisition can be operated by the software. The optical entrance is provided with a SMA connector to implement 400 µm collimation fibers. The following wavelength ranges with InGaAs detector are available: 850 nm 1650 nm with a resolution of nm 1100 nm 2100 nm with a resolution of nm 1200 nm 2200 nm with a resolution of nm 1300 nm 2500 nm with a resolution of nm The special Front End Electronics Card (FEE) and Input/Output (IO) card allows rapid spectra acquisition up to 50 spectra per second. Functional Principle The VisioNIR can be operated in reflection or transmission mode: In the reflection mode the illumination source emits radiation between 500 and 2500 nm. The NIR radiation is coupled into the illumination fiber and directed to the NIR measuring head. The measuring head focuses the NIR radiation onto the sample and the reflected spectral information is captured and coupled into the collimation fiber. The collimation fiber is connected to the spectrometer and transports the NIR radiation to the transmission grid of the spectrometer. The polychromatic radiation is divided into its single wavelengths and enumerated in the 256 diodes. The FEE card calculates the NIR spectrum and the evaluation IPC signalizes the good/bad product signal to the host machine. In transmission mode the sample will be directly illuminated by the illumination source and the radiation is penetrating the sample. A collection head direct the transmitted NIR radiation via the collimation fiber to the spectrometer. Release Nov 2014 visiotec GmbH 8

10 Accessories Accessories Measuring heads NIR measuring head for tablets The NIR measuring head is dedicated to fit into tablet presses to inspect each tablet in reflection mode during production. Two illumination fibers supply the NIR measuring head with light and the deflection prism focuses a spot of 1.8 mm diameter with a focus of 2 mm onto the tablet. The measuring head is equipped with air hosts and with the air supply from the tablet press the upcoming dust during production is kept away from the measuring head. The aluminum and suprasil surfaces are easy to clean and the measuring head can be simple removed from the press. Inspection glass for powder stream monitoring The continuous inspection of wet and dry granulation and mixing processes requires a robust and multipurpose measuring head to handle flow capacities from 1-15 kg per hour. The inner surface is designed to ensure that no products layer will be established and the special setup of the optical pathway enables the measurement of small powder amounts. An automatically performed white balance can be operated via the software. Release Nov 2014 visiotec GmbH 9

11 Transmission measuring head for vials Our easy constructed transmission measuring head for vials enables a rapid inspection of moved objects such as vial, cartridges, ampoules and carpoules. The integrated light barrier starts the spectra acquisition and assures that each object is measured with equal positioning. Illumination is performed by light fiber; no heat is transferred to your product even during machine stops Multi-purpose reflection measuring head The multi-purpose reflection measuring head is the most favored part at our customers. It is easy to integrate and remove from the host machine, robust and easy to clean. The wide field of applications such as lyo-cake inspection, powder stream monitoring and fluidbed spectra acquisition makes this multipurpose tool indispensable for your process. Illumination is performed by light fiber; no heat is transferred to your product even during machine stops. Release Nov 2014 visiotec GmbH 10

12 Accessories Illumination & fiber optics Collimation Light fiber A 400 µm silica fiber with copper cladding forwards the NIR radiation to the spectrometer. One side is equipped with an stainless steel SMA connector (spectrometer side) and the other side has a customized stainless steel ferule to connect the fiber with your measuring head. The fiber is additional protected by a silicone coated stainless steel tube. The numeric aperture is Illumination Light Fiber 55 single silica fibers with a 400 µm core diameter are hexagonal arranged to provide powerful NIR radiation for your process analysis. The bundle is protected by a copper coating and is dedicated for rough conditions. Customized stainless steel ferules at the fiber ends can be connected to the measuring heads and the NIR source. The fiber is additional protected by a silicone coated stainless steel tube. The numeric aperture is Illumination Source The stainless steel illumination source provides NIR radiation in the range of nm. The heart of the source is the illumination cube with the special 40 W illuminant with a life period of more than 1500 hours. Two powerful fans purge the heat via the exhauster out of the housing and avoid overheating. The illumination source is integrated in the cabinet of the VisioNIR. Blower filter and illuminant can be easy replaced. Release Nov 2014 visiotec GmbH 11

13 Accessories Standards Wavelength Standard In order to achieve correct results in spectral analysis the calibration of the wavelength axis is enormous important. For the wavelength verification special reflection standards with mixtures of rare oxides as Holmium, Erbium and Dysprosium are used. These materials are embedded in PTFE under glass and do not age. The verification of the wavelength can be done with the characteristic absorption bands between 800 nm 2500 nm. Reflection Standard Visiotec offers a selection of diffuse reflectance standards in different sizes of Zenith Polymer. The standards show an ideal behaviar and constant reflectance within the the wavelength range of nm. The set of four standards is available in two sizes: 30 mm and 50 mm diameter and with seven reflectance values between 2.5% - 99%: 99%, 60%, 50%, 25%, 10%, 5%, 2.5%. Release Nov 2014 visiotec GmbH 12

14 Accessories Software and visualization Software packages The VisioNIR software connects the useroptimized features spectra acquisition, USP tests, NIR method administration, access- and user administration, audit trail and result- and trend monitoring. The access- and user administration is CFR21 Part 11 compliant and enables the assignment of miscellaneous rights to the users. All methods and recipes with the corresponding NIR model can be stored and administrated in the clear structured method administration. For quantitative evaluation warning- and reject limits are configurable. For qualitative evaluation the classification parameters and significance levels are selectable. A trend monitoring supervises each operation in the software. For calibration and validation NIR spectra can be recorded via Trigger button, auto-trigger or external trigger from a machine. The spectra are visualized by selectable colors and will be stored on the evaluation IPC. Dark current and white balance spectra can be acquired by easy clicks. For spectrometer performance characteristic USP test can be performed with wavelength correctness, wavelength repeatability, linearity and photometric noise. All results can be stored in the batch protocol for an audit. The result of each predicted or classified sample is visualized in the trend monitoring. Any process deviation will be detected immediately and out of spec products can be rejected. In case of using hierarchical modeling with several models each classification can be assigned to its related defect. All classification colors can be selected individual and all information is synchronal stored for each measurement. Release Nov 2014 visiotec GmbH 13