PQ of vial washing machine

hello,Good day for all,

How to Qualify vial washing machine.what kinds of tests are to be carried out to qualify the vial washing machine.Is there is any guideline about tempelate of PQ protocol.

In my workplace the following areas are addressed: microbial and endotoxin testing of the WFI and recirculated water used to wash the vials, particulate matter testing using rinses from a representative number of washed and unwashed vials and a test using a dried on salt solution and testing the washed vials afterwards for traces of the salt solution after they have been processed through the vial washer.

regarding a PQ (and revalidation), parameter changes are employed also where the pressure of the washing media are reduced and the time taken to wash is reduced also.

regards,

Michelle

HI,
it’s nice suggestion, when you preparing protocol for the vial washing machine youe must add speed of your machine.At what maximum speed you want to run it with accuracy by meeting the all acceptance criteria.

[quote=mgood]In my workplace the following areas are addressed: microbial and endotoxin testing of the WFI and recirculated water used to wash the vials, particulate matter testing using rinses from a representative number of washed and unwashed vials and a test using a dried on salt solution and testing the washed vials afterwards for traces of the salt solution after they have been processed through the vial washer.

regarding a PQ (and revalidation), parameter changes are employed also where the pressure of the washing media are reduced and the time taken to wash is reduced also.

regards,

Michelle[/quote]

[quote=tahir]hello,Good day for all,

How to Qualify vial washing machine.what kinds of tests are to be carried out to qualify the vial washing machine.Is there is any guideline about tempelate of PQ protocol.[/quote]

Dear tahit,
In PQ, there are following tests must be perform

  1. endotoxin removal test
  2. particulate matter test ( any sticking material)
  3. WAshing machine speed test
  4. chemical test ( AgCl)

Thanks

Dear Shahnawaz,

For the Particule and Chemical tests, what acceptance criteria would you recommend. If we perform such a test, we need to spike a % of vials out of a real production lots (lets say 500 vials out of 40 000). If we spike so many vials, the risk of failures caused by human error is risky. Would you accept fails in your protocol?

Nicolas

[quote=Shahnawaz]Dear tahit,
In PQ, there are following tests must be perform

  1. endotoxin removal test
  2. particulate matter test ( any sticking material)
  3. WAshing machine speed test
  4. chemical test ( AgCl)

Thanks[/quote]

dear Shahnawaz
we have done endotoxin removal test ,first we take the 3-logs as acceptabal ,but the best who can did was 2-logs ,can you tell us the acceptabal that you did
thanks

[quote=ster.yogesh]HI,
it’s nice suggestion, when you preparing protocol for the vial washing machine youe must add speed of your machine.At what maximum speed you want to run it with accuracy by meeting the all acceptance criteria.[/quote]

Pls. let me know how to validate the speed of vial washing machine