5. ART example

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The fifth lecture on modelling exposure for a course held in Norway 2011. Note, the input screens in ART refer to an older implementation of the model than is currently available.

Health & Medicine

Example calculations using ART Powder exposure in pharmaceutical industry John Cherrie

Data collection – BOHS survey ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Results for BOHS – ART data collection ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Case 1: Scenario description … ,[object Object],[object Object],[object Object],[object Object]

Exposure Data … Data set 1 (only site A) and 2 (Site A and B) Data set 3

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intertnational council for harmonization The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is a project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects Details of the ICH guidelines for pharmaceutical quality from Q1 to Q12 including stability analysis, evaluation of impurities and quality risk management. ICH (Full form = International Conference on Harmonisation) is a committee that provides the pharmaceutical guidelines for industries.

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How to organize Extractables Assessments? FDA continues to issue Warning Letters to companies that fail to properly complete Design Verification, Design Validation, and Process Validation, and recently to include failures of manufacturers in Risk Management. The evaluation of extractables and leachables has become an increasingly important aspect in the Quality by Design (QbD) initiative of the FDA in the area of drug product design, including materials used in the drug product production process and container and closure systems used for product packaging. This presentation provides general approaches and practical aspects in E&L testing.

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5. ART example

1. Example calculations using ART Powder exposure in pharmaceutical industry John Cherrie

5. Operator checks powder flow

6. Filling kegs from blender…

7. Check weighing…

8. Application of ART

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27. Exposure Data … Data set 1 (only site A) and 2 (Site A and B) Data set 3

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Editor's Notes

operator checking powder flow at end of drop from mixer into IBC; inflatable seal released momentarily (up to 30 secs.) to allow visual check - no visible dust emissions.
filling kegs from blender; visible dust emission when plastic liner released.
operator checking weights of product in kegs and adjusting to correct wieght by hand-scooping powder from one keg to another.

5. ART example

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Editor's Notes