Dear All,
Could you please mimic the following, as what you exactly do while executing media fill for the following intervention:
1.Clean up of spillage on star wheel or conveyour under LAF in filling machine.-----
2. Change of pump of the filling machine of ointment/eyedrops.----
3. Electrical intervention----
4.Planned power interruption----
5.Sensor adjustment----
6.Asceptic connections-----
Thanks
1.stop the machine ,clean the star wheel and conveyor with dry and sterilized lint free mop.mop with 70%Ipa solution. Hold for 15 minute.check the online particle counter if particles count is under limit start filling activity.
Planned power interruption-perform this intervention near to end of media fill. Power cut may be 2-4 minute.restart the filling after recovery time of LAF and AHU.
In case of pump change,aseptic connection perform these intervention carefully with minimum movement under LAF.after completion of activity ,disinfect the area with 70%IPA and after hold time (15minute) start the filling activity.
Thanks Mr. Manoj,
Could you please justify why need to wait for 15min- is it mandatory, as you have mentioned in all intervention, If my intervention will be of 10min!!
Ok, for drops or vials its easy to carry out pump change, what about ointment and Cream media fill!! how do you will execute it!!
Is there need to discard the initial quantities after pump change intervention and how much the qty. of filled bottles or vials should be discarded ideally?
Dear Mr. Manoj, Thank you for your responses, its really appreciated…
i have more query…Why power shut down shall be executed at the end? as Power shut down can happen at any moment of normal regular batch filling?
Power shut down is critical intervention for media fill.If power shut down is done at initial or middle and if they cause contamination to the area then all vials filled between middle to end of filling will get contaminated and if u perform other intervention at the end , it will be difficult to find out the root cause of contamination for that particular intervention.
You did not mentioned that filling line is in O-RABS or C-RABS. Your all activity is directly depend upon what type of filling machine you are using. Assessment of risk also varies. Its good to included all major and critical interventions during media fill, but for every intervention proper justification and historical evidence is required. For example: Planned power shut down intervention, now-a-days almost all companies use LAF supported by UPS so justifying this intervention is very tough to regulator as impact will be very high, and it should be supported by various studies. Just keep in mind, any critical intervention which require some major adjustment or major cleaning inside the area, all exposed vials (unstopped) has to be removed (Always). Risk assessment should always be available to justify your interventions.
Thanks.
Dear All,
Is it required to categorize the intervention as critical, major or minor and should be mentioned in intervention list?
Thanks
Dear All,
What are the challenges should be carried out during media fill run, also provide the guideline support?
Thanks