can anybody give a sop to see the procedure of non viable particle count in pharmaceutical facility or else please give a reference apart from iso14644 3
Th best guidance for “procedure” of non viable particle count is avialable in ISO-14644-3. Rest of th all guidlines will give the detailed regulatory requirments of clean rooms with respect to non viable count. e.g. US guidance on sterile drug products- september-2004, under the section: building and facilities. SOP can be prepared using the particle counter manual instructions.
Mr. Rathesh,
There are no Best or Worst guidelines.
Do you know that these ISO guidelines I4644-(1 to 5) are being revamped or changes taking place?
The reason for this is these are not in line with 2 importnt points of Regulatory requirements
- As per pharmaceutical GMP requirements – They are not 100% fit
- As per Risks involved-- No mention was done in these guidances.
Now they are calssifying all guidelines and revamping them based on Pharmceutical GMPs , Risks involved with Men, Materials, Process, Equipments and Environment.
One must use any regulatory guideline based on their understanding capacity, facility- process and procedure constraints.
And more importantly what guidances are being followed in country of manufacture.
At times places like India, if the manufacturer talks a higher regulatory system or guidance or technology with the regulatory inspectors-- Regulatory inspectors either do not understand or say its not applicable etc.
thanks buddy
can any one tell me about recovery test during HVAC validation?? is it necessary to every time recovery test to be perform???
Dear Sweety,
This test is performed to determine the performance of HVAC to eliminate air borne particles, so that subsequent sampling/ dispensing operation can be performed without contaminating the lot/product.
This test will be performed at as built condition by a calibrated Discrete particle counter. In general particles are generated to 100 times to the target level before recovery test. Then recovery time is determined with recovery rate to the target level.
T.Nageshwar
[quote=nageshwar]Dear Sweety,
This test is performed to determine the performance of HVAC to eliminate air borne particles, so that subsequent sampling/ dispensing operation can be performed without contaminating the lot/product.
This test will be performed at as built condition by a calibrated Discrete particle counter. In general particles are generated to 100 times to the target level before recovery test. Then recovery time is determined with recovery rate to the target level.
T.Nageshwar[/quote]
dear nageshwar,
integrity test (by using DOP) and above said recovery test are same???
if not could u explain clearly…
reagrds
svr
[quote=svrr]dear nageshwar,
integrity test (by using DOP) and above said recovery test are same???
if not could u explain clearly…
reagrds
svr[/quote]
Dear SVR
Integrity test and recovery tests are not same in the above case. Recovery time is established to restart the operation whenever the pharma block is stopped/shutdown due to power failure.
Where as integrity (DOP test) is performed to check the efficiency of HEPA filters being used in the AHU systems.
Hope your doubt may be clarified.
Regards
T.Nageshwar
Agreed with Mr. Durga