Change to equipment

Good morning
In my plant we are implementing a change to equipment. This change is the modifying of pipelines which communicate two tanks (tank A, tank B, dedicated to decanoic acid) to fermenter. Now the two tanks communicate between them before to communicate with fermenter.
(TankA+Tank B) → fermenter
The production department would modify these pipelines in this new way to check the traceability of lots of acid:
Tank A → tank B → fermenter

What is risk?
What are activities to execute for this change? (example IQ, OQ etc.)
What are the parameters to consider for the change?
May I have your opinion about good practise of this change?

Thank you in advance

What is risk?
-Leaks : make sure you always use seamless pipes as far as possible.
-Non return valves: Makes sure your flow is in one direction and not reverse.
-Make sure that all contact materials have suitability for the intended use.
-Make sure that the pumps operate at a prescribed delivery rate intended.
-Bends: Make sure that the bends are proper.In the bends the thickness of material is same as the thickness of the pipe.
-Make sure that they are properly insulated.
-Make sure that the operators know the direction of flow. Mark the flow directions.
-Make sure that you have Inspection ,Cleaning and Maintenance schedules in-place.
-Make sure that the joints are poperly sealed to prevent any leaks so that the sterility of the media etc etc are not compromised.

What are the parameters to consider for the change?

  • First reason if the pipes were existing before or not?
    -If new pipes have to be changed-- Indicate the reson for change.
    -The pipes must be fitted as per size, strength and flow capabilities.
    -If you have a flow meter in these pipes make sure that they have right capabilities and calibration procedures.
    -Is a special training required for this operation? If so who operates and look his training records.

What are activities to execute for this change? (example IQ, OQ etc.)
-Shutting down operations.

  • Difference between existing design and new design.
    -P & ID
  • Boroscopy of pipes.
    -Certificates of construction
    -Fitting the pipes.
    -Testing the sterility.
    -Testing that there is no backward flow.

Dear Durga
I appreciate your very fast answer
I have another question for you. Do you think that activities listed in “point” three must be executed making re-qulification? … so, do I need issue new IQ/ OQ protocol?.. and if it is necessary, how can I perform PQ?
Can you explain these my doubtful please?

Its true that you need to issue a new IQ/OQ protocol.
These protociol based on the changes mentioned.

The PQ protocol must Depict following tests:

  1. First ensure that there are no leaks. For this you always run a mock test with Purified Water or Water for injection.
  2. Run 3 batches of media hold test. So that it shows there are no leaks after new pipes between Fermentor and Pipes have been installed.
  3. Run flow tests on these pipes:
    a) The flow must be unidirectional.
    b) The flow rate will be constant from Fermentor to Tank A and then to Tank B— You need to find out the delivery rate between point 1 to point 2 and from Point 2 to Point 3.
    c) Passivation or even pretreatment of pipes is important. In this case I would suggest you to passivate with Citric acid (1.5 to 3%) in Purified water.
  4. The cleaning validation of these pipes must be done and verified too.
  5. Maintenance procedures must be in place.
  6. Always keep in mind that there are no dead sapces and bends in that pipes.
  7. Maintain proper slope of these pipe lines and make it as per documentation.
  8. Make a manadtory test where the backward flow is stopped or restricted. Non return values must be functional as intended.

I think almost all aspects are covered.