Rap-ID – Non Invasive, Sub Surface Portable Raman Analyser
Raw Material ID Verification THROUGH Containers – Save Costs, Improve Quality
- Do your bulk raw materials arrive in paper sacks, cardboard or other heavy duty non see through packaging?
- Need to distinguish different grades of polysorbates? (Tween 20, 40, 60, 80)?
- Do you need to verify starting materials in biological production without compromising sterility?
RapID Spectrometer enables fast and accurate raw material verification in seconds, through unopened non see through packaging such as Sacks * Plastic Tubs * Winchester Glass * Plastic Bottles etc…
It can also quickly ID a range of biopharmaceutical staring materials through unopened containers e.g.: growth media * environmentally sensitive materials * buffering agents * carbohydrates * tweens
RapID is the next generation in materials verification, extending high throughput spectroscopic identification capability from clear containers to non-transparent and coloured containers and even layered paper or plastic sacks.
RapID allows pharmaceutical manufacturers to achieve fast, accurate material identity verification in seconds without the need for laborious sampling regimes. Incoming goods are often supplied in opaque packaging such as sacks, plastic tubs, Winchester glass and plastic bottles, which makes identification difficult and expensive. RapID removes the cost and resource of opening and sampling each container, avoiding the need for expensive sampling booths. Additionally, RapID was designed to meet the stringent requirements of current good manufacturing practices (cGMP) and 21 CFR Part 11-compliant environments.
- ID through opaque and coloured sacks, tubs and bottles
- Compatible with most APIs and excipients
- No powder sampling or handling booths required – avoid contamination
- Identifies contents and containers in typically 5-20 seconds
- LIMS-compatible output files
- Cost Effective 100% materials ID testing
- 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
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.
RapID uses Cobalt’s Spatially Offset Raman Spectroscopy (SORSTM) 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 SystemsTM and their authorised distributors can provide training and consultation on this process.
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.
Click here to view RapID brochure
Click here to view Technical Note: ‘Verifying Raw Materials by SORS’
Click here to view Application Note: ‘Through-Container ID of Polysorbates’
Click here to view Application Note: ‘Raw MaterialsID in Sterile Mfg’
Click here to view Application Note: ‘Raw Material Verification in BioPharma Production’
Click here to view Case Study: ‘RapID for In-Container Testing of Raw Materials for PICS GMP’