In Desiccator type leak test apparatus what is required vacuum and hold time of leak test for dry powder filled vials.any reference?
Please go through,USP31<381>.
ISO 8362 annexure C (modified ISO)
In usp time at vacuum is 10minute.and time at ambient is 30 minute.
What is time at ambient?
Time at vacuum hold is 30 min with -37KPa.and time at ambient is 30 minutes are we are using.as ISO.
Even though USP is given 10 minutes hold with vacuum -27kpa.and 30minutes hold at ambient,we are going to higher one.
Can we reduce the hold time by increasing the vacuum level?suppose -54kpa for 3 minute.