- Vacuum leak test is also called chamber integrity test.
- Vacuum leak test verify the any leakage in autoclave.
- Performed in daily once (first cycle). As per guideline HTM -2010 Vacuum leak test should be performed on weekly once.
- Vacuum leak test is a critical test because verify the chamber leakage.
- Vacuum leak test applied the vacuum inside the chamber and wait for reach the vacuum as per set point (NLT -600 bar).
- After reach vacuum as per the set point hold the vacuum ten minutes.
- After ten minutes release the vacuum .
- Calculate leakage as per formula.
- After that check the results whether autoclave chamber leakage is within the limit or not.
- If there is any leakage in the autoclave chamber or leakage is exceeding the limits it means there might be chance of entering non-sterile air inside the chamber.
- When vacuum break happens, air enter inside the chamber through the 0.22 micron filter which is located on the unloading side of the autoclave.
- There is no chance of contamination because sterile air enters inside the chamber after filtering through 0.22 micron filter.
- As per HTM 2010 Vacuum leak test should be not more than 1.3 mbar per minute. But in autoclave printouts (machin fabric) acceptance criteria mentioned is 0.013 bar and not showing whether this vacuum leakage limit is per minute or per 10 minute.
- Acceptable leakage = -0.0013 bar/1 mins (1.3 mbar) (1bar =1000 mbar)
- Acceptable leakage = -0.013 bar/10 mins (13 mbar)
P3 = Before hold the vacuum
P2 = After ten minutes hold
Example:
- Pre vacuum =-0.750 bar
- Delay Before Hold = 5 min
- Hold Time =10min
- After ten minutes Hold =-0.745 bar
=0.750-0.745 / 10
= 0.005bar per 10 minutes.
