$162
Points to Consider for Sensitivity to Oxidation by Peroxide
2020
- Format:
- Language(s) :
- Published :
- English
- 2020
PDA's Points to Consider for Sensitivity to Oxidation by Peroxide addresses aspects to consider in the design, development, processing, instrumentation, materials, and equipment specific to issues with products sensitive to oxidation when exposed to H2O2. This document primarily applies to isolator systems, where vapor phase hydrogen peroxide (VPHP) or vaporized hydrogen peroxide (VHP) is used to decontaminate the system. Current issues and approaches to consider for an oxidation-sensitive product are summarized, and industry experts outline best practices for developing a manufacturing process for drug product.
General topics related to sterility assurance and development of the VHP decontamination process are not included, nor is cycle development from a sterility standpoint. General isolator considerations are addressed in PDA Points to Consider on Aseptic Processing of Sterile Pharmaceutical Products in Isolators.
| Points to Consider for Sensitivity to Oxidation by Peroxide | |
|---|---|
| STANDARD INFO: | |
| Standard Name | Points to Consider for Sensitivity to Oxidation by Peroxide |
| Scope | |
| Publisher | PDA - Parenteral Drug Association |
| Languages | English |
| State | |
| Publication Year | 2020 |
| Most recent Version | MOST RECENT |
| Whether to be replaced | |
| Addendum | |
| FILE INFO: | |
| File Size | 1 file , 1.7 MB |
| ISBN(s) | 9781945584169 |
| Number of Pages | 24 |
| Product Code(s) | 43544, 43544, 43544 |
| Published | 2020 |
| Points to Consider for Sensitivity to Oxidation by Peroxide | ||
|---|---|---|
| History | Publisher Year | |
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