De-Pyro tunnel re validation measures?

Hi

I’m new to this site and i was wondering if anyone could help me answer.

We wish to lower the temperature of the de pyro-tunnel, what would be the minimum required re validation to return the oven into service?

I know Iam replying to this question which was posted a long time back. Iam replying just to let you know :

-You are decreasing the temperature of Heating banks with out touching the probes and with manipulation on your soft ware takes lesser time.
-You must first reduce temperature in a stage wise format rather than reducing it suddenly.
-The reduction of temperature will have direct impact on your material being sterilized.So the residence time has to increase. This increases by decreasing the speeds of your tunnel.
-After doing the above parameters you have to do the temerature mapping studies for all formats of Vials/ampoules you sterilise , spike the materials with bacterial strips and also Endotoxins. After this carry out a thorough check on all materials to prove the sterility assurance of the Primary packing material is not compromised.
-When you decrease the speed of the Conveyer , it has direct impact on your filling machine in your Class 100 (Class A) area. Then it takes more time to fill the batch with less quantity or number of incomming vials from your tunnel.
-You have to carry a process validation again with your product as the product time changes from X hours to Y hours.
-You must ensure that your Class 100 area, Staff, Operators, Air, Temperature of operation is not compromised and your sterility assurance in that praticular filling area is intact. The reason is the time of people spending in your class 100 area and Class 10000 area where your filling and WASHING-DEPYROGENATING TUNNEL increases drastically than the initial fixed regimes.

You have to perform an overall validation study for your Class10000 and Class 100 areas including equipments and Sterility assurance studies.

This process looks simple when we discuss here. In reality the process optimization to Proving sterility assurance will take 30 to 45 days.

Regards

sir prasad,
we are increasing our depyrogenating tunnel speed from 110mm/minute to 130 mm/minute conveyor speed for our 8ml tubular vials. do we need to increase the temperature setting on the machine sir? do we need to run again for 3 heat distribution studies, 3 heat penetration studies and 1 endotoxin challenge test as per vial size that we want to run? can you provide me sir with refference study or documents with regards to depyrogenating tunnel validation?
thanks a lot and best regards! my e mail address is orca_slim@yahoo.com

orca_slim

Increasing the conveyer speed from 110 mm/min to 130mm/min decreases the residence time of vials in the heating chamber. Typically the chamber is about 0.5 meter in length.

When we see most of the runs in a tunnel the residence time is about 2.3 to 3.5 minits in the chamber depending up on size of vial based on volume or diameter.

Most of the process folks forget physics and start talking about increasing the temperature. If you look your 8 ml vial they are smaller in size and they almost have similar dimater like your 5ml vials.The rate of convection and conduction of heat is more thru a material than thru air.You will have less voids inbetween your vials and less air volumes with in your 8ml vials.So the heat penetration is almost nearer to the value that is require.

My Few suggestions are here:

Increase your heat bank temperature by 5 to 7 degrees only.
Carry out 3 distribution studies and Penetration studies.
Now comes the issue what the regulatory guidance says about number of probes?
Its says to use minimum 16 probes.
I would reccomend every one to use 20 probes.You will be extremly satisfied by the performance of your Depyrogenating tunnel after you map with 20 probes.Insist your boss or your higher authorities to perform with 20 probes.

Carry one spore kill test and one Bacterial endotoxin kill test.
Your operating confidence later will increase.
Before that I would suggest few things:
Decontaminate your cool zone with any decontaminating procedure.
Secondly wipe your conveyer with 70% IPA . Wipe that clean by running the empty conveyer with out running the heat banks. Run only the HEPA’s in the Tunnel.

Before you test for above revalidation or reverification runs I would suggest your Engineer to check the limit switch near the exhaust of your tunnel. Many times people observed if limit switch fails, after reaching 300C the tunnel shuts down automatically even if your Ack the system it will never run again.It will be so painful when the system fails in the middle of Revalidation procedure.
I wish you all the best and have a good Revalidation.
Regards

sir,
tnx a lot for your reply, hoping to continue communicating with you often. our plant here in the philippines is a pioneer in sterile injectable filling. im the one in charge of validating the depyrogenating tunnel, bung processor, DHS, and the HPHV sir. tnx again for helping me improve my work sir.
bobby de asis (orca_slim)

[quote=DURGA PRASAD]Increasing the conveyer speed from 110 mm/min to 130mm/min decreases the residence time of vials in the heating chamber. Typically the chamber is about 0.5 meter in length.

When we see most of the runs in a tunnel the residence time is about 2.3 to 3.5 minits in the chamber depending up on size of vial based on volume or diameter.

Most of the process folks forget physics and start talking about increasing the temperature. If you look your 8 ml vial they are smaller in size and they almost have similar dimater like your 5ml vials.The rate of convection and conduction of heat is more thru a material than thru air.You will have less voids inbetween your vials and less air volumes with in your 8ml vials.So the heat penetration is almost nearer to the value that is require.

My Few suggestions are here:

Increase your heat bank temperature by 5 to 7 degrees only.
Carry out 3 distribution studies and Penetration studies.
Now comes the issue what the regulatory guidance says about number of probes?
Its says to use minimum 16 probes.
I would reccomend every one to use 20 probes.You will be extremly satisfied by the performance of your Depyrogenating tunnel after you map with 20 probes.Insist your boss or your higher authorities to perform with 20 probes.

Carry one spore kill test and one Bacterial endotoxin kill test.
Your operating confidence later will increase.
Before that I would suggest few things:
Decontaminate your cool zone with any decontaminating procedure.
Secondly wipe your conveyer with 70% IPA . Wipe that clean by running the empty conveyer with out running the heat banks. Run only the HEPA’s in the Tunnel.

Before you test for above revalidation or reverification runs I would suggest your Engineer to check the limit switch near the exhaust of your tunnel. Many times people observed if limit switch fails, after reaching 300C the tunnel shuts down automatically even if your Ack the system it will never run again.It will be so painful when the system fails in the middle of Revalidation procedure.
I wish you all the best and have a good Revalidation.
Regards[/quote]