Clinical Large Porous Load Steam Steriliser: Air Leakage Test

Testing Clinical Large Porous Load Steam Sterilisers

Air Leakage Test

The test is performed to ensure that during vacuum stages, the rate of air leakage back into the chamber is at the required tolerance. Air that is drawn into the chamber as a result of the vacuum will hamper sterilisation. Any air that leaks into the chamber from the outside also poses a risk of load contamination. 

This should only be undertaken by a competent and trained person.

The test is carried out by deducing the increase in pressure during vacuum by either the indicated rise from an automatic test cycle or taking measured readings from an installed pressure gauge when the steriliser does not have an automatic method.

Document Specific Test Schedule

Factory
Testing
Installation
& Commissioning
Periodic
Testing
Document Specific Title Reference TT WT IQ OQ PQ D W Q Y
CFPP
01-01
Part C
Air Leakage Test 2.69    
NI/CFPP/02 Air Leakage Test 2.69
CFPP 01-01
Part C
     
HTM 2010
Part 3:
Validation & Verification
Vacuum Leak Test 11.2    
SHTM 2010
Part 3:
Validation & Verification
Vacuum Leak Test 11.2    
WHTM
01-01
Part C
Air Leakage Test 2.69      
BS EN 285
TT/WT/IQ
BS EN ISO 17665
OQ/PQ/DWQY
Air Leakage Flow Rate Clause 18
BS EN 285
A.6
BS EN ISO
17665