About temp. parameter of vial sterilizing tunnel

GOOD VALIDATION PRACTICE (cGVP)
1

Hi,
Everybody
Can anyone tell me about temperature acceptance criteria for valiidation of vial sterilizing tunnel, is it 300 degree celsius for 3 minutes ? in which guide line it is defined?
and what is the interrelation between temperature of drying zone and sterilization zone ? is there temperature of drying zone defined anywhere if sterilization zone is having above 350 degree.

regards,
pritesh.

2

For dry heat sterilization temperature and time is not a major acceptance criterias but this technology control points must be constant. You should research temperature profiles for sterilization zone for each individual belt speeds with and without vials different volumes. Usually temperature in vials less then 10 degrees in comparision with chamber temperature.
You need research endotoxins Log reduction by laltest. It must be not less then 3 stages.

http://www.pharmacopeia.cn/v29240/usp29nf24s0_c1211.html

Also you can use Fd criteria. This value the same like F0 for steam sterilization, but z-value equal 46,4. Fd must be not less then 30 minutes

3

Thanx, generationp
can you please explain about Fd criteria

4

See attaching pdf-file. Fd discribing on 8 page

Валидация тунн&#10.pdf (366.0 KB)

5

Thanks for this valuable information.
Can you please clear my one more doubt -
If your thermocouple or probe which you inserts in tunnel for temperature mapping touches the inner wall of vial during heat penetration test then What will be the effect on Temperature achieved by the probe will it achieves temperature slowly & cools down fastly as compaired to probe which does not touches to vial wall

Thanx & regards,
pritesh

6

“Curve 1” it is temperature profile of tunnel without vials. In fact it is hot air temperature in each point of belt distance
“Curve 2” it is temperature profile of inner wall of vials. In attaching pdf you can see that Max temperature of inner glass less then Max temperature of hot air in tunnel.
In result
peak zone 2 less then peak zone 1
Cooling time 2 more then 1
Heating time 2 more then 1
Also you can see displacement of Max temperatures between both curves

T curves.pdf (181.2 KB)

7

Thank you so much, for this valuable information .
i will follow your suggestions.

8

Thanks for the info!!!