Author Topic: problem of manufacturing an injection  (Read 5478 times)

yungjang

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  • City: bkk
  • Organisation: gpo
problem of manufacturing an injection
« on: September 05, 2012, 01:10:27 PM »
Hi,
I have some problem occured when scaling up ciprofloxacin injection (from 40 L to 300 L).I found that some vials of ciprofloxacin injection is more yellow than the others. Moreover, there is different color of ciprofloxacin solution ex. pale light yellow to dark yellow.I have tried to solve this problem since 2009.
I try to solve by doing the following:
- avoid heat by using an aseptic technique
- clean up the filling needle and equipment by sonicate
- change the source of API
- Adjust pH of solution (pH 3.6, 3.9 and 4.3)
- Change Membrane filter
- Avoid API from light
- Protect from light during mixing process, except filling process (because it may be adjust the filling machine)
But, It is not work. The result is the same (differrent color of product in same production lot.)
Please help and suggest me to solve this problem.
I should reduce my batch size, shouldn't I?
I hope to hearing soon.
Thank you so much.

Best wish,
Yowwares J.

Contact: yungjang@hotmail.com

crysogenum

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  • City: Ahmedabad, Gujarat
  • Organisation: Claris Lifesciences Limited
Re: problem of manufacturing an injection
« Reply #1 on: October 31, 2012, 04:02:15 PM »
Dear Yowwares,

Description of Ciprofloxacin injection is light yellow. If concentration of the product is higher, i.e. 1%, this color is more apparent.
The problem here is container to container variation of color. Root cause of which can not be assigned to material, machine or man as per your investigation.

You may try to reduce dissolve oxygen / head space oxygen content. I think there is oxygen content variation amoungst vials in same batch. The Oxygen may be reacting with one of the ingredient of the formulation and changing colour.
   
« Last Edit: November 01, 2012, 01:35:08 PM by PharmWeb »

yungjang

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Re: problem of manufacturing an injection
« Reply #2 on: November 24, 2012, 09:50:22 AM »
Thank you for your suggestion.

 


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