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Q. What does the instrument measure? A: The VTT-1000 may perform up to three separate tests on the same sample: (1) chemical composition by Raman Spectroscopy, (2) object size by machine vision, and (3) color by RGB measurement
Q: Why does the sample rotate? A: This allows more complete sampling of the contents of the sample vial. When working with granular materials or solids such as tablets made from granular materials, a very small spot size can be a disadvantage due to the tendency to over represent a particular particle or granule that is not representative of the whole sample.
Q: What type of samples can the VTT measure? A: Solids including powders and solid dosage forms and liquids. Gases are not measured by the VTT because of the special sample cells normally required for gases.
Q: What types of sample containers may be used? A: Low-fluorescent glass, quartz, polymeric (bottles or bags), etc. The background of the material will be subtracted from the sample to examine Raman signal from the material of interest. For images a clear (transparent) material must be used. |
Mustard Tree Verifier® Tri-Test-1000
“Lab 2 Line” accelerating the QC Process
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Q: What size sample containers can be used? A: Any size up to 50 mm (2 inch) diameter and 155 mm (6 inch) height works. So long as the container fits into the sample stage and can be gripped by the device it can be used. Spectroscopic measurements are made through the optical window at the bottom of the sample stage, which has a 30mm diameter.
Q: Is Raman an “accepted” technology in Pharma ? A: Yes, please see USP <1120> Raman Spectroscopy; Raman shifts offer selectivity and peak intensity offers sensitivity.
Q: Where is the VTT currently being used ? How have the units performed? A: Approximately 25 units are currently in use in non-GMP drug identification applications, and have performed well over a three year period. In addition, exhaustive testing has shown the VTT to be very reliable. The stress testing at Mustard Tree labs has resulted in over 100,000 sample runs on multiple units over many hundreds of hours. The system is quite robust.
Q: What about quantitative analysis (determine how much of a material is present)? A: Currently, we support qualitative analysis (identification); if the reference material is a blend of a known composition, then a semi-quantitative comparison is supported. Future enhancements to the software will support quantitative analysis.
Q: How long does it take to build a method? To run a sample? A: It takes only minutes to enter a reference sample into the library and to construct a method for ID testing. Dialing in the sensitivity and selectivity of the method by adjustment of specific evaluation rules can be done quickly, typically less than one hour. Once the method has been developed, running samples takes 30-90 seconds each.
Q: How do I create a library of my materials? A: Place a small amount of material in a sample container of your choosing, select “Add Library Entry”, follow the on screen prompts, place the sample on the sample tray and press the orange button and then do the same for the sample container. The process takes approximately five (5) minutes.
Q: Can you qualify the VTT ? A: Yes, we will provide qualification documents (DQ, IQ, OQ, and PQ) as per USP #1058 on Analytical Instrument Qualification (AIQ), and can help execute these if needed.
Q: Can the unit be operated in a warehouse or process line, and outside the laboratory? A: Yes, the unit was developed to be used in different locations and requires a small 19 x 10 in footprint.
Q: What room utilities are needed? A: Just power from a standard 110 VAC 15-amp outlet; no additional utilities are needed.
Q: Does the unit require a separate computer? A: No, the VTT uses an embedded computer and can function as a “stand alone” system.
Q: What quick checks of the system are performed? A: Three quick Checks are provided: (1) Raman using an internal ASTM standard, which can be performed manually or programmed to be automatically performed at a desired frequency, or in conjunction with a login or testing event. (2) Color and (3) Size measurement quick checks are performed using customer inserted NIST traceable standards (provided by MTI) and can be executed at a desired frequency as specified by SOP.
Q: Can I connect the system to a LIMS or another computer? A: Yes, the unit has a LAN port which allows it to be connected to a network. The VTT can be set up to push reports up to the network or LIMS system or allow the LIMS to pull data from it on a periodic basis.
Q: What is the laser source for the Raman measurement? A: Class IIIb (3b) diode laser operating at 785nm
Q: How is size measured? A: Unit takes a series of IR reflectance images and determines the length, width, and area of the object based upon the pixels detected (part of algorithm developed by MTI).
Q: Is all data retained, and can it be viewed? A: All data is retained until an user defined event occurs whereby the user has specified a deletion as may be the case after an automatic transfer to a LIMS system.
Q: How is the Raman signal collected? A: The VTT utilizes a patented coded-aperture and two dimensional CCD to collect as much light scattered back from the sample as possible and give a Raman spectrum. This differs from traditional slit based spectrometers in that the light collection efficiency is improved by 10 fold.
Q: Is the color measurement the same as our L*a*b system? A: No, the VTT uses the sRGB color system to compare color of the sample vs. a reference. The sRGB standard was developed by Microsoft and HP and has the advantage of being widely adopted and NIST traceable. The VTT gives the user the option of converting the sRGB values to L*a*b values automatically for comparison with traditional modes of testing.
Q: Is the unit calibrated? A: Yes: Raman shift by ASTM E1840, Raman intensity using NIST SRM #2241; Color using certified NIST traceable targets; Size using NIST traceable disks of known dimensions
Q: How is the unit configured as a Class I laser safe device? A: The sample stage rotates to position the sample in laser path; the user cannot be exposed to laser light.
Q: What other peripherals are supported? A: An external USB keyboard can be attached, as well as a VGA monitor; the unit comes with a bar code reader which connects via USB.
Q: What is the resolution of the VTT?
A: For Raman, the spectral resolution as measured per ASTM Standard E-2529 is 8 cm-1.
Q: What is the chemical detection limit for the unit? A: Our ICH testing across multiple units according to Guidance Q2 “VALIDATION OF ANALYTICAL PROCEDURES: TEXT AND METHODOLOGY” using IPA in water indicated that the average DL < 0.5% and QL is < 1.3%
Q: Is the instrument 21CFR Part 11 compliant? A: Yes, the system software was designed to meet 21 CFR Part 11 as a closed system.
Q: What is the laser power? A: Between 300 and 400 mwatts
Q: What is the laser spot size? A: Approximately 10 mm long located at about ½ of the radius of the sample window. This is an exceptionally large spot size permitting large cross sectional sampling of bulk materials and finished products.
Q: How long until we fill up the unit’s hard drive? A: Using all sensors in every method and not deleting any data would fill up the hard drive after 15,000 runs. However, just using one sensor, i.e. the Raman sensor, storage capacity increases to go over 100,000 runs. The system has user selectable options for automatic deletion of data based on how long it was stored, the number of runs made or after an event such as a transfer to a secure LIMS system.
Q: Can you help us validate methods on the VTT ? A: Yes, we can support method development, as well as writing the validation protocol, its execution, and the final report for QA approval.
Q: Can I compare more than one library reference material in a given Method? A: Yes, more than one reference material can be used by a single method.
Q: Can you qualify the VTT? A: Yes, we will provide qualification documents (DQ, IQ, OQ, and PQ) as per USP # 1058 on Analytical Instrument Qualification (AIQ). MTI can help execute these if needed. |
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