Media Fill Requirement for ophthalmic cream/cream?

GOOD VALIDATION PRACTICE (cGVP)
1

Dear All,

Is the manufacturing of sterile ophthalmic cream/ointments fall under sterile process?
Let say, it is using aseptic process, does it require Media Fill & How should we do it?

Thanks in advance.

2

Ophthalmic products, eye drops in single-dose and multi-dose presentations, and eye ointments in multi-dose presentations are aseptically manufactured.

You can use TSB viscous solution by adding carboxymethyl cellulose and then fill in your tubes and Incubate for results at a concentration of 65grams/liter.

If your tubes are transperent you are lucky to see these bacteria growing .Some will buy transperent tubes only for validation purpose orelse you can squeeze and look when you use non-transperent tubes.

In the above formulation for media fills the bacteria will grow as colonies and you may not find that. In this case you need to add an metabolic indicator which changes the colour from Red to Purple when bacteria grow and respire. This indicator is 2,3triphenylterazolium chloride is added at a concentration around 0.0025%.

Regards

3

Thanks a lot Mr. Prasad,

4

Hi Mr./Mrs. Prasad,

Could you please share what needs to be included in process validation of Ophthalmic ointment manufacturing? If possible, can you share a template?