CAPA using Monte Carlo Simulation
Corrective Action and Preventive Action (CAPA) is a key focus for the FDA and other regulatory bodies for the certification of medical device. We have developed a tool and a method to predict dose distributions in real product by Monte Carlo simulations. Our tool allows 3D CAD imports and provides its own visual 3D graphic editor. In this way, a variation of any geometry could be set up within minutes.
- Effective for Variance Analysis
- Support Defect Resolution
- Indentify and predict Corrective Actions
- set limits for Preventive Actions
- Minor differences am movement inside the pachaging
- Shadow effects by variations
- Packaging optimization
- Material change effects on dose
- Qualitative and Quantitative Analysis
- Reduce Risk
Product Design using Monte Carlo Simulation
We integrated our method into the R&D and design phase of several medical products. Using the 3D CAD import and modification features of our new tool, we could interactively evaluate product variations with the design team, and produce sterilization dose maps within hours. Providing sterilization dose mapping results at this speed allows the design team to better focus on the design process and avoids tedious waiting times.
Medical Product Design
- include sterilization early in the design
- Combination Products
- Electronic Components (10-500Gy)
- Complex Shadow effects
- Define energy range
- Design for radiation sensitive aeras within the product
- Save development time
- Gain Predictability
- Reduce Risk
Simulate vs. Experiment
- Many more dose maps than one would perform experimentally
- Much less resource use (people, beam time, preparation time, travel, analysis)
- Reduce development time and cost
3D interface to Monte Carlo
- Quick Interations: Maintain focus of development team
- Allow to quickly increase complexity
Have you ever wondered if there is an easier and more informative way to do operational or product qualification? The number of dosimeters to read for a phantom dose map can be several thousands. You can save money and valuable irradiation time by knowing in advance of your final dosimetric validation:
- dose distribution at all realistic and extreme densities
- partial load effects
- fringe effects, scatter plates and filters
- behaviour during process interrupts and restarts
- with phantom material or real products.
Risk Reduction in X-ray or E-Beam Irradiator Design
Knowing what comes out before you build it – a key factor to reduce your risk and plan for success. With an executive summary of the technical results the management can make decisions based on sound input.
Especially with new X-ray facilities, where very little experimental data is available, simulation becomes a necessary tool for the design of a new irradiator. Ideas on efficiency improvemens can be tested immediately without building any hardware. Dose uniformity and production capacity can be estimated before capital investments have to be made.
While simulations try to model the reality as close as feasible, a mathematical model will, by definition, remain an approximation. Simplifications in order to make the simulation affordable as well as to reduce calculation time provide sources of uncertainty. Hence it is important to benchmark the employed codes and geometries against measurements or other proven models.
Meissner Consulting has significant experience in benchmarking Monte Carlo codes. We adhere to the standard ASTM E2232. We maintain our operating standards in line with other experts of mathematical modelling for radiation processing.