Media fill simulation

GOOD VALIDATION PRACTICE (cGVP)
1

Can please anyone let me know how to carry themedia fill on the hydrophobic products.

Anil

2

Can you send me further details at kamal.consultants@hotmail.com or contact at +91 9909985314.

Jasbindersingh

3

Good afternoon!
I have to design a media fill simulation for a very very little batch size, in the world of vaccine manufacturing. So, I suppose there has to be different specs for this kind of production compared with pharma industry.

here the min batch size can be 1 unit and the max 100 hundred. there’s no sense to dosify 3000 units!!!

Could anyone clarify me this point?

Many thanks!

L.

4

Thanks L,
Can you please clarify furthur which will help me.

Anil

5

Hellow every body

Can anybody guide me regarding aseptic process simulation study? Can we take consiquetive three batches of media fill & conclude at the end of entire study & completion of incubation period?
In that case if 1st batch fails, can we consider the 2nd batch as 1st & fill another batch to complete the sequence?

I am waiting for reply.

6

Hi,

You can not consider 2nd batch as 1st (refer - USFDA guideline on sterile dosage forms) you have to investigate the cause of failure first.
regards ,
Abhi

7

[quote=abhikhapke]Hi,

You can not consider 2nd batch as 1st (refer - USFDA guideline on sterile dosage forms) you have to investigate the cause of failure first.
regards ,
Abhi[/quote]

For the media fill validation for sterile API,Have you some guidelines for us?Generally,how many days is the one campaign?

8

[quote=sterile]Good afternoon!
I have to design a media fill simulation for a very very little batch size, in the world of vaccine manufacturing. So, I suppose there has to be different specs for this kind of production compared with pharma industry.

here the min batch size can be 1 unit and the max 100 hundred. there’s no sense to dosify 3000 units!!!

Could anyone clarify me this point?

Many thanks!

L.[/quote]

Dear Laura

The size of media fills for small batch size products should at least equal the number of containers filled for the commercial product.

9

[quote=Anil Chaudhari]Can please anyone let me know how to carry themedia fill on the hydrophobic products.

Anil[/quote]

Dear Anil
Hydrophobic products are normally oily liquid products, these can be powders, here in case of oily liquids are normally viscous so you need to thickened the media to the appropriate viscosity, used as in the routine production procedure. Suitable thickening agents are agar and carboxymethyl cellulose. Other agents would need to be validated with regard to lack of their bacteriostatic and fungistatic properties.

It is important to remember that, as described in ISO 13408-1, the process simulation test is only a snapshot of the process design and cannot ensure that product fills using the same process will share the same microbiological quality.

You better give more detail about product so one can suggest u exactly.

10

Thanks for replying, everyone. It appears we have a decent cross-section of people here and a lot of well thought-out discussion:cool:
simulation credit
http://simulationcredit1.com