| 00:00:00 | The principles of setting up robust particle characterization methods using a Quality by Design approach |
| 00:01:26 | Intro |
| 00:01:26 | The principles of setting up robust particle characterization methods using a Quality by Design approach |
| 00:03:03 | Intro |
| 00:03:03 | What is Quality by Design? |
| 00:03:49 | Applying QbD involves developing a full understanding of a product and its performance |
| 00:05:30 | Applying QbD for analytical methodologies involves developing a full understanding of a method and its performance |
| 00:05:41 | Stage 1: Analytical Target ProfileDetermining the goals of an analytical method |
| 00:05:48 | The first stage in developing a method is to understand why the measurement is being made |
| 00:07:24 | Untitled |
| 00:08:04 | Once we know why we are making a measurement, we can define the Analytical Target Profile |
| 00:08:19 | Stage 2: Identify Critical Method AttributesDeveloping a target method for product analysis |
| 00:08:25 | For particle size measurements, sampling and dispersion must be controlled |
| 00:10:11 | Sampling control ensures that the analyzed sample is representative of the bulk material |
| 00:11:17 | Dispersion control ensures we measure the sample in a relevant, reproducible way |
| 00:12:52 | Dispersing particles in liquids requires these steps to be followed: |
| 00:14:12 | Dispersing particles in liquids requires these steps to be followed: |
| 00:15:33 | Dispersing particles in liquids requires these steps to be followed: |
| 00:16:17 | Dispersing particles as dry powders requires these steps to be followed: |
| 00:17:41 | Stage 3: Risk AssessmentDefining the Method Operable Design Region |
| 00:17:49 | Guidance is available to help determine if a particle sizing method is fit for purpose |
| 00:19:13 | Risk Assessment for liquid dispersion methods |
| 00:21:06 | Liquid dispersion: sonication power and time |
| 00:21:30 | Liquid dispersion: sample concentration |
| 00:22:46 | Liquid dispersion: stir speed |
| 00:23:28 | Liquid dispersion: stir speed |
| 00:23:56 | Liquid dispersion: measurement time |
| 00:24:32 | Risk Assessment for dry dispersion methods |
| 00:26:45 | Dry dispersion: crystalline powder measured using a high energy disperser |
| 00:27:06 | Dry dispersion: crystalline powder measured using a lower energy disperser |
| 00:28:15 | Dry dispersion: feed rate / concentration |
| 00:28:55 | Dry dispersion: sample quality and measurement duration |
| 00:29:24 | Risk assessment: worked example for a wet laser diffraction method using external sonication |
| 00:30:17 | Not just for laser diffraction!Applies to any technique or any problem |
| 00:33:46 | Step 4: ControlMethod validation for particle size measurements |
| 00:33:52 | How should a particle sizing method be validated? |
| 00:34:16 | Instrument SOPs provide a means of controlling all critical quality attributes for methods |
| 00:34:29 | Assess the measurement precision using one operator |
| 00:35:01 | Change operator to assess the intermediate precision |
| 00:35:24 | Calculate the intermediate precision by pooling all of the results |
| 00:35:55 | What are the benefits of applying QbD for analytical method development? |
| 00:37:31 | References |
| 00:37:47 | Question & Answer SessionListening on demand?email your questions to:events@malvernpanalytical.comThank you for attending |
The Quality by Design (QbD) principles outlined by Jurong have found a natural home in the arena of pharmaceutical method development. This presentation will outline what QbD is, how it works within pharmaceutical development, and will provide some examples of the 'fishbone' diagrams which show the factors that should be considered when developing methods for laser diffraction and dynamic light scattering.