Author Topic: Media fills  (Read 1842 times)

rockybell_77

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Media fills
« on: October 30, 2012, 07:10:52 AM »
We have established media fill policy on glass vials we are using for product filling. We have done media fill validation for 5 ml glass vials.

Now wehave a proposal to use other material 5 ml vials (plastic polymer) for a new product. Vials size and dimension is same as that of existing vial.

Is it required to perform media fills on the new MOC vials? Apart from change in MOC (Material of construction) , no other change in process. Tunnel validation for the new vials will be done independetly to ensure >3log reduction endotoxin levels.

Rocky
rockybell_77@yahoo.co.in
« Last Edit: November 01, 2012, 01:35:51 PM by PharmWeb »

Durga Prasad

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  • Organisation: Kneat Solutions Ltd
Re: Media fills
« Reply #1 on: December 18, 2012, 09:11:03 PM »
This is a good question.
Technically the process is same with out changing any process controls.
But at the same time you have changed the Material of Construction of a Primary packing material where sterile material is held for a long time stable with out hindering the quality properties of the filled product.
You have a major change control in terms of the Primary packing material and may be your supplier.
This change control function certainly attracts a media fill to show up the robustness of your process sequence and gives you over all Sterility Assurance.
You need to perform a Media fill with out any doubt.
Any regulator will question this when he review your Batch Manufacturing records and also your Primary packing material storage records.
Regards

 


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