Media Fill Validation protocol for Sterile Dry powder Line

Almost ready to use format.
You can make necessary changes as per your plant or Machine or Regulatory requirement by addition of other contents and SOP numbers where ever required.

Note: Here Sterile Mannitol was used. You can substitute this by Sterile Carboximethyl Cellulose (Placebo) media or any Sterile media of your own choice or as per regulatory requirement in your country.


MEDIA FILL PROTOCOL.doc (164.0 KB)

Nice post. Keep it up dear.

On which guideline we are using Sterile mannitol during media fill of Dry powder injections

US FDA guidelines

Thank you!. Very valuable information. Do you by any chance have the attachments mentioned in the protocol?

Thank you very much for the validation protocol

Thank you for the validation reference you provided… It will help a lot to me…

This report will be soon updated.
All the updates are applicable for media fill tests other forms of small volume Parenteral products too.
You can see updated parts in this in red colour.
We will also justify why this has been updated.(Regulatory reasons)
Regards

Nice and useful post Dear,

In the protocol you mentioned the media fill with quantities of lactose and SCDM as 0.5g and 5ml respectively, please provide the rational behind it, for different size vials what proportion of lactose and SCDM we should prefer ?
l guess its based on the the lactose suitability test and established concentration of lactose. Is it necessary to carry out the lactose suitability test before each media fill run ?

Regards,

Is the media fill volume per vial required to be representative of the routine product fill volume and what in case of dry powder injection ?

In case of Sterile Dry powder injection it should be a representative of the weight of the actual product to be filled based on the Bulkdensity of the API filled and volume of the vial. Selection is an important criterion during product development of a product and same principle is followed during media fill.

I currently have the task to optimise the media fill we are doing on an aseptic powder filling machine (powder fill in syringes). We fill the syringes with liquid nutrient medium, so now powder fill step at all. For this a dosing unit is attached to the filling part of the filler. Since we do not really use the powder reservoir in this set-up, we ar seeking to optimise this.
My question (after having read the above protocol) is about technical feasability. If you fill a powder and then a liquid, do you have to modify the machine set-up, add parts? Are the (in your case ) vials filled first with powder (Mannitol) and the transferred to another line?
And I imagine some kind of cleaning risk assessment is necessary to demonstrate that no cross-contamination risk comes from the powder (Mannitol or other) you introduce in your powder filler?
Thank you very much for your input and best regards,

  1. You need to asses each risk of each intervention you make on equipment before you fill.
    2.Such document must be approved before you fill a media.
  2. Yes, you can ask your filling equipment provider to provide a filling sytem. If it not provide, you need to ask them to provide and should correct your URS with proper controls.
  3. The liquid filling attachment should be qualified and installed before such media fill.
    5.If you do not have one such attachment, it takes a great deal of work both in installation and documentation.

Transferring into other line is a bad practice and does not fulfill primary requirement of a media fill.
After such transfer on to another line your media fill is actually questioned.

You need to do the required interventions on the same line at same place with in prescribed area keeping controls as per your risks assessed.

If you remove your vials, your process will not provide sufficient data and evidence for such a filling operation is highly questionable and might bring a serious regulatory observation. All the interventions you make must be written, controlled and assessed.
You cannot technically move vials to another place before protocol completes and vials are perfectly and integrally sealed.
Moving out is only for incubation.
You need to look PDA Technical report : 22 (published 2011) for further details, clarity and scientific justification and understanding.

Regards

Thank you very much for the input, it is very helpful information. We are currently looking to how we can modifiy the machine so that it is able to fill powder and liquid into syringes for media fill purpose (and how to qualify that…).
Regards,

Thanks a lot for this sharing.

Thanks for sharing