Test Method Development and Validation as Pertaining to Microtrac Particle Size Measuring Instruments

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1 Test Method Development and Validation as Pertaining to Microtrac Particle Size Measuring Instruments Philip E. Plantz, PhD Application Note SL AN 17 Rev B Provided By: Microtrac, Inc. Particle Size Measuring Instrumentation

2 Scope This information is intended to provide some guidance on developing a test method for Microtrac particle size measurement of powders and slurries. It is intended as a starting point for those involved in development of validated methods and the user should refer to applicable documents and personnel within the user s company who have responsibility and knowledge of the specific requirements for the company. The items listed are taken from the FDA Guidance. The definitions have been paraphrased with commentary that relates to Microtrac experience with assisting customers to validate methods. The procedure involves Microtrac instruments which are used to measure volume percent as a function of particle size. The resulting data provides a fingerprint of the particle size distribution of a substance which can be used as a means to control product quality and provide evidence of in specification product. Part 1: Purpose The purpose should include a description as to why the Microtrac instrument is useful in determining particle size and particle size distribution. It may include the range of the instrument, compatibility with various chemicals, ease of use, etc. It also may include information on the general scheme of obtaining a representative sample, sample preparation, sample disposal or other primary feature of the measurement. Details on these issues are presented below. Part 2: Method Development Method development for Microtrac customers often begins with evaluation of the instrument by the customer prior to purchase. The information obtained by the Microtrac Particle Laboratory is available to customers for their specific samples. Laboratory personnel are available for customers to gain information and suggestions on any aspect of instrument operation. Issues that should be determined during this part of the test method development and validation include: Determination of particle shape irregular or optically spherical Determining refractive index of a substance or circulating/dispersing fluid Selection of stirrer type magnetic, manual, impeller. Determining stirrer speed for best representative sampling (see above) Determining Recirculator flow rate and circulation time prior to staring a measurement Sonic energy treatment time with either external or internal (ASVR or SDC) circulator ultrasonic device. Both treatment duration and intensity (power) should be determined. Part 3: System Suitability The object of these tests is to establish that components of the test system are suitable for routine testing and that the test system is under control and provides valid data. It answers the question as to whether the instrument can reproduce data of a given lot of material (after proper splitting, sampling, preparation, etc) so that the data can be compared effectively with new batches. Often this is determined as part of method development for purposes of efficiency. For particle size measurements, microscopy can be used to provide some measure of confidence. Quantitative microscopy measurements are not necessary, but indication of maximum and minimum sizes should be evaluated. Quantitative microscopy can require counting of at least 10,000 particles and 2

3 conversion to a volume distribution for comparison which may result in distortions to the distribution because of weighting concerns and small counting errors. Part 4: Accuracy Traceability of standards should be established. Traceability of Microtrac Reference Materials is described an application available from the Microtrac Website. Note that while the materials are traceable to a standards organization, the data may show some variation since the method used to obtain data may be different. Generally acceptable are values that do not vary more than 10%. For accurate measurement, a decision as to whether to measure agglomerates or primary particles is important. Method development should include this decision. Microtrac instruments provide particle size data measured and calculated as volume percent. The total percent will sum to 100%. Number and area distributions are calculated from the volume percent data assuming that the particles are spherical. It is best to use volume distributions for all testing since the instrument is designed around those units of measurement Part 5: Intermediate Precision (IP) This precision indicates variability for various locations, days, analysts, preparation, standards, etc. They incorporate external factors that can affect repeatability and reproducibility. It is desirable to do these tests simultaneously using an experimental design that allows simultaneous collection of needed data. IP allows getting the most information for the least investment of time. General information: Standard deviation (SD) must not exceed systems suitability error Often repeated for many days, typically 15. Requires only one product batch. Since there are potentially so many variables, ANOVA analysis is often used for statistical analysis. Coefficient of variation (CV%) is often used and should be presented as percent o CV%= (SD/ mean) X 100 Part 6: Repeatability Precision Describes in statistical terms how well the measurement repeats itself when more than one sample concentration is measured. Usually 3 different sample loading are used which are repeated 3 times. In addition, 6 measurements are made at the correct concentration. It requires that the same operator, sample, instrument is used and should be completed in one day. Microtrac suggests the following concepts for this precision determination: Conduct tests where the instrument is set up to make three measurements (and automatically calculate and save an average). This is done for three samples at a loading residing in the lower portion of the loading screen. A second test is conducted at a loading where the middle of the loading screen is achieved. Then a third loading is tested at a concentration that is higher than the previous two, but still within the expected loading shown by the screen. This will require some weighing tests to know the concentration or amount being transferred to the instrument. Often, a known amount of sample is dispersed into a fluid that does not dissolve the material. A known volume the resulting slurry is transferred to the instrument while conforming to good sampling practices as described during Microtrac courses. By back 3

4 calculation, the mass of the material transferred can be determined. As with this type of precision determination, the same operator, instrument and sample should conduct the test during a single day. Part 7: Robustness Robustness is a measure of the ability of a test to remain unaffected by small, but deliberate variations in method parameters and provides indication of its reliability during normal usage. It requires systematic changes to test conditions to document any effects on test data. A lack of sensitivity or changes is desirable. For Microtrac particle size measurements the following may be included: Ultrasonic treatment time and intensity should be varied. If using an external ultrasonic probe, maximum time normally is 2 minutes at full intensity or power. For the SDC Recirculator internal probe, 10 minutes is usually the maximum. Should the fluid become very warm or too hot to touch, the time required to reach such a temperature is the maximum that should be used. Eductor settings (dry powder measurement only) may be varied over the range 0 (high dispersion) to 5 (least dispersion). As well, pressure settings on the front of the cabinet would be varied. Sampling methods should be varied to see the effect of being able to obtain a representative sample of the material. These tests include sampling powders from a container or vial at various locations in the container. The tests also include sampling slurries from the top of the container to the bottom with various means of agitation (hand swirling, magnetic stir bar, impeller/shaft stirring). Types of pipettes or spatulas to be used for transfer of sample should also be evaluated. Variation of wetting agent and dispersant concentrations are important to address the possibility of bubble development and dispersion stability. A sample may be measured 7 times with the same sample aliquot in the circulation system as a means of test. Observation would be for trends in data where particle size parameters continually increase of decrease continually. Flow rate should be varied by 5% increments starting with 40% flow. For high foaming samples, a lower starting flow may be necessary to avoid bubble generation. Part 8: Quantitation Limit For many instrumental or other methods, it is desirable to achieve a signal to noise ratio of 10:1. When the ratio is achieved, adequate signal is believed to be present to overcome background noise and thus provide a quantitative measurement. This is not a concern to Microtrac particle instruments since proper loading using the loading screen assures adequate signal for measurements. The actual signals are dependent upon the size of the particles, instrument model and optical properties of the sample being measured as well as particle amount. Part 9: Limit of Detection This limit describes the lowest amount of analyte in a sample which can be detected. It does not include quantification of the amount, just how much material is necessary in a test to show a response. The 4

5 response may have unacceptable errors for use in quantitative studies. Microtrac instruments use a loading screen which if used properly will guide the user to the correct amount of particulate needed for measurement. This item is not applicable to particle size measurement by Microtrac since the loading screen demands an acceptable amount of signal due to the presence of sample material. This has been shown in some test method development studies, but is not commonly done for Microtrac instruments since the SOP will include instructions on using the loading screen to achieve proper sample amount for measurement. Part 10: Range For many instruments this refers to how an instrument responds to changes in concentration. Thus if the analyte increases by a factor of 2 the amount of analyte measured should increase proportionally. Range is not generally used for particle size since size is not a function of analyte concentration. Another view of range can include sizes that can be measured by the instrument. Review of the specifications of the Microtrac instrument provides an indication as to an appropriate instrument set up to satisfy a capability to measure particles over a wide particle size range. In this context, range is established prior to validation of the method and most likely before instrument purchase. All potential particles sizes being measured should fit within the measuring range of the instrument. One may use extremes of size of a product to test the Range. However, Range is usually used in the context of concentration. Microtrac instruments use a Loading Screen which assists the user in transferring an appropriate amount of sample particles to the instrument for measurement. This is often defined before validation of the test method begins. Part 11: Calibration Calibration of some instruments should be conducted every 6 months according to some documents. Microtrac instruments operate on first order principles and do not require calibration in the field. However, verification of performance should be conducted on a regular interval depending upon instrument use schedule. For instance, if the instrument is used every day, weekly tests may be conducted. If the instrument is used once per month, the test interval time may be once per month. Company policy should be adhered to as well as FDA or ICH or other governing organizational requirements. Some customers elect for a complete review of instrument performance often conducted at 6 month or 1 year intervals by a Microtrac Inc, certified service person trained by Microtrac, Inc to perform validation IQ/OQ procedures. Part 12: Linearity Within the stated range, Linearity is the ability to measure amounts that are directly proportional to the concentration. Thus if the product is to contain 20 to 40% active drug, the test must be linear over that range. This is often applied to HPLC and GC analysis. For particle size measurements, absence of a linear response is desirable, since particle size measurement should not be concentration dependent. However, when using Nanotrac at high concentrations, some dependence may occur since dynamic light scattering instruments can show changes at lower concentrations where particle particle interactions are eliminated. 5

6 Part 13: Specificity These are tests to determine whether materials and compounds in the mixture interfere with the measurement. Any effects should be well documented as to magnitude. It is desirable to able to measure only the compound of interest without any interferences. The only aspect of particle size measurement pertaining to specificity is whether particle agglomerates or primary particles (well dispersed system) are to be measured. This decision should be made prior to or part of test method development. Part 14: Recovery Recovery pertains to ability to measure the entire compound in a formulation. Recovery is not an issue with performing Microtrac particle size measurements since the instrument will measure 100% of the particles present within the measuring range. Part 15: Reproducibility Precision Reproducibility Precision is conducted when more than one location or laboratory will conduct same tests. This portion of testing is most important for method transfer to another lab facility is contemplated or completed. 6

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