RapID is the next generation in raw materials verification, extending high-throughput spectroscopic identification through clear packaging to non-transparent and coloured containers – even multi-layer paper and plastic sacks
Raw Materials Verification Through Unopened Containers
Save Costs - Improve Quality
- ID through opaque and coloured sacks, tubs and bottles
- Cost-effective 100% materials ID testing
- Avoid contamination and sampling
- Compatible with most APIs and excipients
- Typical measurement time 5-20 seconds
- Easy learning of new materials: Train > Validate > Release
10x Increase in Testing Throughput
High volumes of materials in opaque containers can create a bottleneck in pharmaceutical manufacturing as a dedicated sampling area is needed to open, sample, test and re-seal each container to verify the content identity.
RapID allows the operator to verify the contents of each container in the warehouse in seconds without opening, sampling or re-sealing, enabling release immediately into production. This saving on handling and lab testing reduces the overhead from hours or days to only minutes per batch.
Avoid Sampling, Maintain Sterility and Prevent Cross-Contamination
Sterile manufacturing of parenteral and biological products benefits from RapID’s non-invasive approach, ensuring no bacterial or cross-contamination by other raw materials. Shelf life storage issues are avoided by not opening the containers in protective environments. Hazardous and toxic APIs, often transported in plastic containers, can be measured safely, without exposing the operators to potential danger.
Compatible with a Wide Range of Containers
Unlike conventional handheld Raman devices, RapID has few restrictions on container types and is compatible with multi-layer paper and plastic sacks, opaque plastic drums and thick amber glass bottles. RapID is also available with a range of optional accessories for working with different shaped containers.
Unique SORS Technology
RapID uses Cobalt’s Spatially Offset Raman Spectroscopy (SORS) technology, which is a new Raman tecnhique for non-invasive ID verification of raw materials. Raman spectroscopy gives chemically rich information that makes it ideal for identifying most pharmaceutical materials and is accepted for ID testing by the EU & US Pharmacopoeia. For ID testing, Raman minimises false positives and discriminates between chemically-similar compounds.
Production - In routine operation RapID is extremely simple to use and highly suitable for a warehouse / material storage environment.
The user selects the appropriate library item for the material to be tested, either through a barcode scan or by a simple three button manual selection, then adds brief information about the material batch, pushes the probe against the container and pulls the trigger. After a short measurement RapID then registers Pass / Fail against the item or batch and produces a full report for audit purposes.
Adding Materials - Library items are added for each material to be tested through a very simple process of training, validation and release to production. The total time to create a library entry and add a new material can be minutes. Cobalt Light Systems and their authorised distributors can provide training and consultation on this process.
RapID QC Workflow
- Train – Through a simple process a series of scans/measurements are taken and a ‘model’ spectrum for the material within its container is built. RapID can be trained on a new material in under 30 minutes.
- Validate – Library items are validated through a series of further measurements (guided by software), and are cross-checked against all other RapID production libraries to ensure similar materials do not provide a false ID of the new material. A detailed report containing the new library information is produced for QC sign-off, including spectral training data for each measurement and statistical results.
- Release to Production – The QC manager or responsible person then reviews and releases the new material library to production, all in the RapID software. All data, including the Training and Validation reports are stored electronically to provide evidence of regulatory compliance.
RapID is designed to be used in a production environment at a place close to ‘goods-in / goods receivable’, and as such is a robust system designed for safe and simple use.
RapID is operated by “gloved-hand” touchscreen with user-friendly 21 CFR Part 11 compliant software. Through its simple interface, touchscreen operation and barcode reader, users can quickly add, use and transfer ID verification models.
Dimensions: 394 mm wide / 693 mm high / 630 mm deep
The RapID system consists of a standalone LiteThruTM Engine and the RapID probe head, which are coupled by an integrated ruggedized cable. The probe head comprises a barcode reader and the spectroscopic measurement optics.
|Safety||Redundant interlock pathway to internal and external interlocks
Dual-activation (probe tip and trigger)
|Power Requirements||90-132 / 180-264 VAC, 47-63Hz|
|Software||21 CFR Part 11 compliant
Fully integrated touchscreen PC
Windows 7 integrated
|Hardware||RapID SORS probe
Integrated barcode scanner
Built to GAMP 5 guidelines
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