Fitration process - sterile eye drops

Yes garment should be sterilized.sterilzed garment can be used for 72 hours (as per validation).Garment should be stored in garment cubicle equipped with LAF.

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sterilization temp n pressure r same as for terminal sterilization of sterile products or different?

Set parameter of terminally sterilized product may be different for different product. Main factor for terminal sterilization are set temperature and sterilization time.

You can set desired temperature and sterilization time in PLC of terminal sterilizer.

Pressure in chamber of terminal sterilizer will be automatically adjusted…

Exposure time for ampule drying at 310-340degre?

Not less than 3 minute.

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In B area change room-If garment cubicle have exhaust system—also Validity data available for 48 hours,
Upto how extent it is acceptable? or LAF is mandatory
Thanks…

Is there any gudeline or …practice/validation required to check the traces of detergents after cleaning of the garments.
and how to perform the study?please provide procedure and method

Thanks.

@manojsingh
If i can have airlock and crossover to direct C class change room (Surgical change room) from unclassified then followed by B class change room (Overall garments) or D class change room is mandatory…
Is there a mandatory requirement to have complete Entry and exit way to sterile area, or if they can meet at one or two point is acceptable?

Thanks

How you can check the area is free from fogging agent (validation?)and which instrument you will use.Usually industry uses which agent for fogging- besides hydrogen peroxide…

Thanks

LAF is mandatory for garment cubicle

We can use 0.5%minncare,20%virosil or silvicide as fogging agent.after 4 hour of fogging .Clean the floor with scheduled disinfectant .Clean the equipment with 70%IPA.

No need to check the area is free from fogging agent.all fogging drops will settle down in 4 hours.it is required in fumigation by formaldehyde and KMnO4 which is not in practice now due to its carcinogenic effect.

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D class is mandatory between unclassified area and c class area for better control of contamination.exit change room is must.

Thank you so much Mr. Manoj.

Dear All,

As we know that 0.22 micron cartilage filter are not able to remove virus and mycoplasm, also virus need some vector or medium to travel and reproduce.
however, how we can assure the filtered product (eye drops) is free from virus or what is the mode?

Thanks

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Dear All,
How we can eliminate potential mycoplasma contamination that might occur during filtration process,
And use of heat or radiation is it appropriate!! Considering the liability of product!!!
Thanks

Please see the following detailed paragraph in EU (PIC/S,WHO) Annex 1 Draft 2017:

8.87 Where serial filtration (one filtration is followed by a subsequent filtration) is a process requirement the filter train is considered to be a sterilizing unit and all sterilizing-grade filters within it should satisfactorily pass integrity testing both before use, in case of damage during processing, and after use.

8.88 Where a redundant sterilizing filter is used, the additional filter does not require post integrity testing unless the primary sterilizing filter fails, in which case the redundant filter must then satisfactorily pass post-use integrity testing.

https://ec.europa.eu/health/sites/health/files/files/gmp/2017_12_pc_annex1_consultation_document.pdf

We should follow EMA Decision tree for selection of sterilization method

Please see the full EMA guideline for sterilisation which was published in March 2019 in the following link