PQ Vial washer and de-pyrogenation tunnel

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

Hello!

I’ve been involved in validation for 4 years now, but I never had to perform a PQ on a Vial washer.
We can’t decide whether to split the two systems up to qualify the washer and the de-pyrogenation tunnel separately.

From what I’ve heard it’s not normal practice to use endotoxins in the vial washer as it’s likely to contaminate the washer and other general parts within the washer, possibly leading to contaminants in subsequent wash cycles.

If I split up the system by using two separate tests, one to check if residuals have been removed from the vials using the washer and one to confirm the removal of all endotoxin traces using the de-pyrogenation tunnel, the problem I face is gaining access to the vials after the wash cycle has been completed.

This is also a problem for adding contaminated vials to the de-pyrogenation tunnel.

There is an access panel between the two machines, but it’s not ideal.

Can anybody please tell me what the common practice is for performing this kind of PQ?

2

you can perform the PQ for tunnel separately by keeping the endotoxin challenged vials in washed vials. Minimum of three log reduction in pyroburden should achived.

3

Dear Jayo
There are seprate procedure for Validation of Vial Washing Machine and Tunnel.
for Washing Machine you can use Saturated Solution Of Nacl , Charcol and Vials of Endotoxin.
for tunnel validation , All HEPA Related Test and Different run like Heat Distribution , heat penetration with Endotoxin , conveyor Speed Chellange Test ,

If You Need Any Help Call Me / Mail me on Below

4

sir can you give me a validation protocol for vial washing…

thanks.
nida