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

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rick76

We are a small start up manufacturing company that would like to start bonding PVC tubing , the tygon tubing will attach to a simple vacuum filter and canister that vacuums to 700mmHg. Provided that we are ISO13845, I’m searching for IQ/OQ/PQ report that would helps us with this process, we would like to perform this process manually by adding clue to the tubing and attaching to cansisters and filters, however not sure what type of testing is required and what process makes more sense to ensure we perform this process efficient, the tubing will be sold non-sterile and ETO sterile. Please provide me with any advice or links. :confused:
 
Last edited by a moderator:

Stijloor

Leader
Super Moderator
Re: PVC (Tygon Tubing) Bonding Qualification Assistance

We are a small start up manufacturing company that would like to start bonding PVC tubing , the tygon tubing will attach to a simple vacuum filter and canister that vacuums to 700mmHg. Provided that we are ISO13845, I’m searching for IQ/OQ/PQ report that would helps us with this process, we would like to perform this process manually by adding clue to the tubing and attaching to cansisters and filters, however not sure what type of testing is required and what process makes more sense to ensure we perform this process efficient, the tubing will be sold non-sterile and ETO sterile. Please provide me with any advice or links. :confused:

Can someone with this expertise help?

Thanks!!

Stijloor.
 
S

sudwel

Re: PVC (Tygon Tubing) Bonding Qualification Assistance

I can *try* to help!

At my former company, we constructed pressure panels out of 1/2" Schedule 80 PVC plastic (ASTM 1785) - and had to have a bonding qualification procedure for our staff (to meet the ASME Codes B31.1 or B31.3 (can't remember which one specifically we needed to do). I'm not sure if it can be related to your question - but I'll provide a synopsis of what I did at that time (as the Quality Assurance Officer). I actually discovered that I have a copy of the Quality Manual I developed, so have included the Bonding control excerpt. I don't have the associated procedures, but will try to "fill in the gaps" below...

We had all staff who were to be "certified bonders" assemble a fitting (usually an elbow, two straight pieces and a cap - with a male-threaded end for attaching the hydrostatic pressure testing device), using the correct PVC glue ("bonding") procedure (recommended by the PVC pipe manufacturer). And after the appropriate cure time - we would pressure test the fitting to at least twice normal design pressure (generally 120psi); though we would occasionally pressure test to 10x design pressure, as the Authorized Inspector made us pressure test all the fittings that we would use to that pressure in order to give us a CRN number for our fittings (Canadian Registration Number - I believe that's what it stands for!) and allow us to construct our panels with the fittings.

The Shop Foreman would witness the pressure test. Each certified bonder would be given a unique number, and he would sign next to each successful "test". The renewal requirements etc. are provided in the attached excerpt.

Hope this helps and you can modify to suit your needs!

Darlene
 

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R

rick76

Re: PVC (Tygon Tubing) Bonding Qualification Assistance

The attached manual is very helpful, thanks for providing me with your assistance. However, not sure if I referenced the proper tubing, the type of tubing we are using is the Tygon® Formulation S-50-HL Tubing for Medical use. Do you or anyone can help me with any documentation or links how to solvent bond or bond without any expensive equipment?? any help, is appreciated.

Thanks!
 

somashekar

Leader
Admin
Re: PVC (Tygon Tubing) Bonding Qualification Assistance

We are a small start up manufacturing company that would like to start bonding PVC tubing , the tygon tubing will attach to a simple vacuum filter and canister that vacuums to 700mmHg. Provided that we are ISO13845, I’m searching for IQ/OQ/PQ report that would helps us with this process, we would like to perform this process manually by adding clue to the tubing and attaching to cansisters and filters, however not sure what type of testing is required and what process makes more sense to ensure we perform this process efficient, the tubing will be sold non-sterile and ETO sterile. Please provide me with any advice or links. :confused:
Reading THIS slowly and with attention will enlighten you on your requirement
 
R

rick76

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

Thanks for your response and link, I reviewed the report carefully and doesn't mention any bonding process or tubing qualification, sorry but I don't know too much about bonding tubing therefore I need an example to help me out how to qualify this process in-house. My thoughts was to bond the tygon tubing into a male luer using cyclohexane, but I'm not sure what testing or requirements that i need follow.

Thanks!
 
Last edited by a moderator:

somashekar

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

Thanks for your response and link, I reviewed the report carefully and doesn't mention any bonding process or tubing qualification, sorry but I don't know too much about bonding tubing therefore I need an example to help me out how to qualify this process in-house. My thoughts was to bond the tygon tubing into a male luer using cyclohexane, but I'm not sure what testing or requirements that i need follow.

Thanks!
The document in the link is about the qualificaton method for any process. However I now realize that apart from this, you also need the "How to bond" tygon tubing ... I am sure some experts about this will catch up to answer, while I will edit the subject to get more focused response.
 
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Stevieray

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

I am in a similiar position as Rick76 and any help on validating solvent bonding PVC "TYGON" tubing to medical grade components would be greatly appreciated.
 

Ronen E

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

I am in a similiar position as Rick76 and any help on validating solvent bonding PVC "TYGON" tubing to medical grade components would be greatly appreciated.

Hello and welcome to the Cove :bigwave:

First, Tygon is not PVC. It's a brand consisting of several product lines / formulations, but none of them is generic PVC. Are you using a Tygon grade, or just some medical grade PVC tubing?

Second, I recommend separating the 2 aspects -- the "how-to" of solvent-bonding disposable medical tubing; and process validation (specifically, tubing bonding processes). Which one are you interested in?

Cheers,
Ronen.
 
S

Stevieray

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

Hello and welcome to the Cove :bigwave:

First, Tygon is not PVC. It's a brand consisting of several product lines / formulations, but none of them is generic PVC. Are you using a Tygon grade, or just some medical grade PVC tubing?

Second, I recommend separating the 2 aspects -- the "how-to" of solvent-bonding disposable medical tubing; and process validation (specifically, tubing bonding processes). Which one are you interested in?

Cheers,
Ronen.

I understand TYGON is not PVC, someone else started the thread. I am using PVC UNICHEM 7077-GTX-015, 70 durometer.

I know "how to" solvent bond PVC tubing.

I was asking for some help in validating solvent bonding. 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.

Thanks for the response and any help you can provide.
 
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