How to bond PVC (Tygon) Tubing and Validate the Process

somashekar

Leader
Admin
Re: How to bond PVC (Tygon) tubing and validate the process.

How is the solvent dispensed now to ascertain that within reasonable variations the same quantity of solvent is applied for all bonding ?
What is the control available now that assures the above happens every time ?
Is it a completely operator qualification aspect and that qualified operator determines the volume dispensed ?
Validation leads to assurance, and so I am keen to find out "How dispensed" to be able to juistify OQ.
 
S

Stevieray

Re: How to bond PVC (Tygon) tubing and validate the process.

How is the solvent dispensed now to ascertain that within reasonable variations the same quantity of solvent is applied for all bonding ?
What is the control available now that assures the above happens every time ?
Is it a completely operator qualification aspect and that qualified operator determines the volume dispensed ?
Validation leads to assurance, and so I am keen to find out "How dispensed" to be able to juistify OQ.

We use several types of solvent dispensers (Ventrex and Technomed) that provide the solvent at an adapter or bushing that you insert tubing to wet with solvent.

Procedure requirements and standard work.

The operator is responsible that there is not too little or too much solvent. Although they do not adjust equipment. If amount of solvent is in question it is escillated to a lead and or engineer.
 

somashekar

Leader
Admin
Re: How to bond PVC (Tygon) tubing and validate the process.

Although they do not adjust equipment
I was looking for something like this and you came up exactly with it.
So there is an adjustment provision and if this is set and locked (The range and not a precise point) to provide the optimum volume for your requirement in the OQ runs, add to this the required dispenser maintenance, add to this the operator qualification in the PQ. Respect the storage conditions and shelflife of the solvents, and perform necessary re-validations (OQ / PQ) when solvents brand is changed. The escalation to the lead or engineer can still be very much a part of your procedure.
Ensure that the dispenser has been installed per recommendation (IQ)
You are pretty much complete and assured of consistant dispensing (Not bonding). You have validated solvent dispensing.
Please note that you have only validated the dispensing. If there is a post cure requirement recommended either in ambient or in a curing oven, such requirements can also be performed in similar fashion and together the solvent bonding validation gets complete.
Please determine the measure and the method how you ascertain good bonding strength based on technical requirements and material properties.
 

Ronen E

Problem Solver
Moderator
Re: How to bond PVC (Tygon) tubing and validate the process.

I cannot calibrate or set the solvent dispensers to a specific flow, which makes performing an OQ on the solvent dispenser difficult if not impossible.

If you can't adequately control the amount of solvent on each and every unit, it becomes a noise. If you can establish that the end requirements are consistently met within the working window of your controllable parameters, taking account of worst case noises (e.g. too much or too little solvent), then you should be fine. A thorough risk analysis of the validated process may help get a better understanding of controllable parameters vs. noises.

Good luck,
Ronen.
 
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