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Topics Covered
Introduction
Validation of Surface Cleanliness
Materials and Process Validation
Advantage of Direct Surface Analysis
Materials Suitable for Ceram Validation Process
Validation and Certification of Surface Cleanliness
Interpretation of Surface Chemistry with VALIDATA Index
Molecular Fingerprinting of Contamination
Applications for VALIDATA
Introduction
Ceram is a global expert in materials analysis, research and quality testing, providing customised solutions and consultancy that help clients to measurably improve performance and profitability through safer, regulatory-compliant and better-engineered products. Setting new standards in materials testing, Ceram works as an extension of customers' teams, applying its expertise and capabilities to a wide range of sectors
Ceram has been working in partnership with R&D and production personnel in companies around the world for over 25 years. Using our expertise, experience and a comprehensive suite of advanced instrumentation we have been able to solve problems and create competitive advantage for our clients in a wide range of industries.
Validation of Surface Cleanliness
Ceram’s VALIDATA™ system offers a complete package for the validation of surface cleanliness (and surface modification). If necessary product/process can be validated from start to finish.
Materials and Process Validation
Ceram can validate a process from start to finish:
- Raw materials testing
- Process validation
- QC Acceptance criteria
- Effect of manual/automated handling systems
- Validation of contact media, gloves, bags, conveyor media
- Suitability of packaging (residue transfer)
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Advantage of Direct Surface Analysis
Direct surface analysis reveals exactly what is on the sample. With indirect methods involving leaching and swabbing of the sample it can never be certain what is being left behind.
Materials Suitable for Ceram Validation Process
Ceram can provide high quality test coupons for use in process validation work. To avoid up front expense from clients these can be leased from Ceram.
Standard materials available:
- Stainless steel
- Aluminium
- Ceramic
- Glass
- Basic alloys
In addition, bespoke alloys and doped materials can be reproduced to customer requirements. Test coupons are also available to companies who validate via the “ion leach” method.
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Validation and Certification of Surface Cleanliness
Ceram can provide certification for surface cleanliness and surface modification. Regular sampling (daily, weekly, monthly) can be monitored and checked against pre-determined acceptance criteria. Alternatively annual audits of a complete process can be performed and accredited.
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Interpretation of Surface Chemistry with VALIDATA Index
In addition to valuable interpretation of the surface chemistry most clients appreciate a single measure of the surface cleanliness. To satisfy this demand Ceram have developed the industry accepted VALIDATA cleanliness index. This is computed from a combinatorial algorithm and offers a simple comparison between samples and processes and enables the monitoring of trends.
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Molecular Fingerprinting of Contamination
In the event of a contamination outbreak Ceram's other resources can be used to provide detailed molecular information on the culprit even if low levels are involved. Molecular fingerprinting can then be used to trace the origin of the contamination.
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Applications for VALIDATA
Ceram's VALIDATA offers applications for the following:
- Cleanliness validation
- Each step in a multi step process can be evaluated
- Surface modification quantification
- Surface oxide build up
- Plasma deposition monitoring
- Corona/flame treatment oxidation
- Passivation monitoring
Source: Ceram
For more information on this source please visit Ceram