Feb 4 2013
Particle contamination causes product deterioration and challenges quality control in every industry and everywhere in the product life cycle. With over three decades of expertise in particle characterization and client collaboration, RJ Lee Group provides solutions for this problem. The company’s experts have developed an integrated modular approach called PC2 - Particle Contamination Control to detect and prevent particle contamination in production process.
PC2 - Particle Contamination Control
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PC2’s modular approach provides suitable solution based on the type of industry and situation using its component modules.
PC2 Program Modules
PC2 program modules include:
Mitigation Planning
Root Cause: identifies the how and where the contaminant got into a process
Strategy: Source material databases, phased product evaluations, qualification procedures
Analytical Arrangement
Preparation: Benefit from our results-oriented and novel techniques
Technique: Cost-efficient solutions for conclusive results
Phased Characterization: Customized plans to reduce costs
Information Delivery
Data: Organize and control data and documentation
Workflow: Ensure adherence to procedures
Integration: Launch of new systems and/or addition of legacy systems
Continuous Improvement
Frequency: One-time program qualifications or active, on-going maintenance
Compliance: More proactive regulatory compliance
Program Support
Process: Implementation support for all tailored modules
Management: Learn to manage and advance customized PC2 solution
Customers can ensure resolution and meet compliance as RJ Lee Group provides full program support and its experts are available for assistance.
Case Studies
Case study 1: Analysis Automation and Customized Reporting Provide the PC2 Solution
The issue was the catastrophic failure experienced in finished product and the root cause was particulate contamination found in a specific raw material. A screening process for particulate size and composition was required to prevent the use of contaminated powder.
RJ Lee Group recommended an automated SEM/EDS particulate characterization technique to solve the issue as it can provide the statistically significant data to meet the required criteria. The company created novel sample preparation methods to enable this automated technique. The huge amount of data generated by this analysis demanded a software solution capable of rapidly reducing the information. The company developed a package to set customized rules to instantly flag contaminant data and to create a mechanism capable of providing fail/pass summary reporting. This tailor-made information management system also facilitated assessment of overall pass/fail history per particular vendor or time of year.
Case study 2: Full Use of PC2 Program Mitigates Risk and Creates a Proactive Program
The issue was the presence of particle contamination in liquid product due to the shedding of process material into the product. What required was a program to monitor and classify contaminates found in the product.
For this issue, RJ Lee Group created a three tier strategy to detect root cause, create a monitoring program and make a library of reference materials to provide proactive investigation resolution. The company used various analytical techniques to determine the root cause, followed by physical characteristic evaluation utilizing simple, efficient analyses and then full characterization. Risk assessment identified and characterized likely contaminates to help any future root cause determinations. The monitoring program involved full characterization of particle types every year to ensure that there is no change in contaminates. The company created a completely customized solution that allowed contamination monitoring by material composition or physical property, trending contamination during specific production times, and identifying the origination of contaminates.
Conclusion
These case studies emphasize the modular approach of PC2 solution, which not only provides cost-efficient formula to identify root causes of contamination but also proposes measures to be taken for prevention of future contamination.
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This information has been sourced, reviewed and adapted from materials provided by RJ Lee Group.
For more information on this source, please visit RJ Lee Group.