- Why are there no microbial requirements included in the monographs for Purified Water and Water for Injection?
- What is the purpose of microbial Alert and Action Levels for Purified Water and Water for Injection?
- For off-line testing of water samples for Water Conductivity <645> and Total Organic Carbon <643>, how long can I store samples before testing?
- For off-line testing of water samples for General Chapters Water Conductivity <645> and Total Organic Carbon <643>, how should I store the samples?
- Can I do Water Conductivity <645> and Total Organic Carbon <643> testing on-line?
- What is the total organic carbon (TOC) limit for Purified Water and Water for Injection?
- How often do I perform the system suitability test in Total Organic Carbon General Chapter <643>?
- How long can I store and reuse reference standard solutions prepared for the Total Organic Carbon <643> system suitability test?
- What is the main reason for KCl addition in the Water Conductivity <645> test for pH measurement?
- Can I start at Stage 2 for Water Conductivity <645>, or do I need to start at Stage 1?
- Is the requirement for conductivity cell constant of ±2% of the nominal value?
- What is a “suitable container” for off-line determination of conductivity?
- There are no tests for pH, nitrates, or heavy metals? Is this correct?
- May I release water for use by performing microbial testing on water from a sample port?
- Is the outlet on the water distribution system, sometimes called a point of use outlet, considered to be the point of use?
- If I do not have a water microbial specification but only an Alert and Action Level, is there a microbial level considered to be unfit for use?
- What are the most common issues encountered in the WFI production systems produced under GMP. What should we look for?
- Do you get nuclease generation from biofilm and is more released during sanitization?
- In the new USP 1231 the recommended temperature in hot sanitizing has changed. The previous recommendation of at least 80°C has been lowered to 65-80°C. Now temperatures far in excess of 80°C are explicitly deemed inadvisable. Is this correct?
- When sampling water ports should we hook up process hoses? Is this a requirement or a recommendation?
- What is your risk in increasing endotoxin levels due to the different sanitization methods?
SOURCE :https://www.usp.org