Silicone Pipe used in pharma industry

GOOD ENGINEERING PRACTICE (cGEP)
1

Dear All,

Want to know, Is it necessary to used product dedicated silicone pipe in any spraying process (Like coating, top spray , bottom spray in FBP) by using peristaltic pump.

Also want to know, what is expiry period of such pipe?

Regards

Prashant Mhetre

2

It is essential to use dedicated tubings. Tubings are very difficult to clean inside and it always best practice to use dedicated tubing to prevent cross contamination.Silicon tubings are flexible and non reactive to most of pharmaceutical substances,but they have their own ware and tare.It is very difficult to asses the expiry period of such tubes and it all depends up on usage.The silicon rubber tube at times has shredding properties. They shred small pieces of silicon rubber especially from the end points on the both sides. For the purposes you have mentioned it is easy to use a flexible SS316 pipe with good surface finish inside. Such ubings are available from market or can be fabricated if you have specifications.

3

Use silicon tubings according to the following application

  1. If we are using for the filtration of diinfectant solution, u can use according to No of sterilization cycle recommended by the manufacturer. If he recommended 30 sterilization cycle use for 25 cycle only.
    Use dedicated tubings for the disinfectant/ santization solution.

  2. If we are using for the filtration for the product solution, then discard it after every use.

  3. SS 316 pipes are available in the market or u can customised acording to ur need.

4

I agree
with Durga , It is essential to use dedicated tubings. Tubings are very difficult to clean inside and it always best practice to use dedicated tubing to prevent cross contamination & shall be certified USP.If non dedicated shall be able to demonstrate all internal surface cleaning till appears to be like original (no stains /no discoloration/No media migration)

5

Hi All

can any one provide me the address where we can get SS 316 flexible pipes

6

The best is here :

http://www.swagelok.com/products/hoses-flexible-tubing/convoluted-316l-ss-core-hose-stainless-braid.aspx

Vortex Impex Pvt. Ltd.
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Raj Nagar, Ghaziabad - 201002, U.P. (India)
Tele : +91 - 120 - 2823577
Telefax : +91 - 120 - 2821077
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Email : vortex@vorteximpex.com | vorteximpex@vsnl.net





7

Thanq so much for the information