Applicability Comparison Experiments of Hollow Process Challenge Device

Objective To study the applicability of hollow process challenge device(PCD) under different testing conditions in the steam sterilizer.

Method The successful and unsuccessful experiments of hollow PCD were tested under B1 low atmospheric pressure impulse, B2 tranatmospheric pressure impulse, B3 high atmospheric pressure impulse in sterlization of health care products-chemical indicators-Part 4 (GB 18282.4-2009) and the low atmospheric pressure impulse in appendix D in EN867-5 to contrast the experimental result of hollow PCD under different testing cycles, different coiling ways and placing direction in the steam sterilizer.

Results There was no effects on the experimental result of PCD under the different coiling ways and placing directions to the successfully tests of B1 and B3 cycle. However, the hollow PCD under the framing coil and horizontal placement were more sensitive to the poor vacuum condition in B1 and B3 cycle than other placement of the PCD. The hollow PCD were not sensitive to air injection in B1 and B3.It showed unsuccessful result for the air leakage to 3500mL in B1 cycle. The hollow PCD was not sensitive to the leak test of the sterilizer in appendix D in EN867-5. The successful test of the B2 cycle failed, so no other failed experiments were carried out.

Conclusions All of the test cycles(B1, B3 and the low atmospheric pressure cycle in appendix D in EN867-5) could be used to sterilize the hollow devices. The hollow PCD can represent the complexed devices to monitored the sterilization except for the tranatmospheric pressure cycle. The hollow PCD under the framing coil and horizontal placement is more sensitive to detecting poor vacuum condition of B1 and B3 than other coiling ways and placing directions. Hollow PCD are not sensitive to the air injection in B1 and B3, but can detect the leakage when it is enough in the steam sterilizer.