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Best Practices for Conducting Extractable and Reachable Studies March 20th, 2018 PARC Scientific de Barcelona Ed. Cluster Sale Felix Saratoga C/Balding Radar, 41215 08028 BarcelonaSpeakers: Simone
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How to fill out extractable and leachable studies
How to fill out extractable and leachable studies
01
Start by identifying the purpose and scope of the extractable and leachable studies.
02
Develop a protocol that outlines the specific procedures and methods for conducting the studies.
03
Collect samples of the material or product that will be tested.
04
Perform extractions using appropriate solvents and conditions to simulate the product's intended use.
05
Analyze the extracted samples using various analytical techniques, such as chromatography or spectroscopy.
06
Interpret the results to determine the types and levels of extractables and leachables present.
07
Document and report the findings in a comprehensive report or study summary.
Who needs extractable and leachable studies?
01
Extractable and leachable studies are typically needed by industries that produce materials or products that come into contact with biological systems, such as pharmaceutical, medical device, and food industries.
02
These studies are important for ensuring the safety and quality of the materials or products, as they help identify and quantify any potential compounds that could leach out and potentially have adverse effects on human health.
03
Regulatory agencies often require extractable and leachable studies to be conducted as part of the approval process for new materials or products.
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What is extractable and leachable studies?
Extractable and leachable studies are studies conducted to identify and quantify potential leachables from a material or product.
Who is required to file extractable and leachable studies?
Manufacturers and companies who produce materials or products that come into contact with pharmaceuticals, food, or other sensitive materials are required to file extractable and leachable studies.
How to fill out extractable and leachable studies?
Extractable and leachable studies are typically filled out by conducting laboratory tests, analyzing the results, and reporting the findings in a comprehensive report.
What is the purpose of extractable and leachable studies?
The purpose of extractable and leachable studies is to ensure the safety and quality of materials and products that come into contact with pharmaceuticals, food, or other sensitive materials.
What information must be reported on extractable and leachable studies?
Extractable and leachable studies must report details of the materials or products tested, testing methods used, results of the analysis, and conclusions drawn from the findings.
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