Download Cleanliness Validation White Paper Medical Device PDF Free - Full Version
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About Cleanliness Validation White Paper Medical Device
This document discusses cleanliness validation procedures for medical devices. It states that residues on medical devices can cause failures and issues. The FDA requires manufacturers to identify possible residues, set acceptable limits, and validate cleaning procedures to reduce residues below these limits. However, some devices still fail to meet FDA requirements for cleanliness. There are challenges in validation as residue limits are not officially defined and device surfaces are becoming more complex, with combination devices adding further difficulties. The document aims to provide guidance on regulatory requirements, identifying residues and limits, and analytical methods for validating cleanliness.
Detailed Information
| Author: | ['shah241'] |
|---|---|
| Publication Year: | 2014 |
| Pages: | 17 |
| Language: | English |
| Format: | |
| Price: | FREE |
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