Tubing heat penetration validation

GOOD DOCUMENTATION PRACTICE (GDocP) PQ (PERFORMANCE QUALIFICATION)
1

hi, does anyone know how to perform small tubing sterilization validation? I found the C-flex tubing is very thin, the thermocouple is hard put inside, even if pushed inside, the wire itself block the tubing completely, never mention to put BI with the TC together to insert into the tubing. how do you solve the problem?

thanks

2

When you are restricted by tube diameter, you will need to rely on your thermal data exclusively. As far as getting a thermocouple inside, use a thinner wire.

3

Hi Hanks,
The simplest way is to cut the tubing and insert a larger diameter tubing into the section you wish to monitor. you can easily integrity test the the tubing to give you assurance that the sterilisation medium is coming from the ends of the tubing and not from the joins. I would suggest using triclover fittings with smart gaskets to allow passing thermocouples into the tubing and giving an integral seal between the small and large diameter tubing.

4

As Slatea said, you can use triclover, there are lot solution on web. But you can cut the tube and put thin TC inside and seal with silicone (1 strand TC). For Bi you can put wires with BIs.

5

thanks a lot!