Dear all,
I am going to calculate the MACO with the addition of Recovery Factor.
We had completed Recovery Studies on four types of different surfaces for one product (i.e. SS, Teflon, Silicon & Glass)
Can i cosider the lower value for recovery calculation or average value?
Please clarify me.
[quote=vamsemicro]Dear all,
I am going to calculate the MACO with the addition of Recovery Factor.
We had completed Recovery Studies on four types of different surfaces for one product (i.e. SS, Teflon, Silicon & Glass)
Can i cosider the lower value for recovery calculation or average value?
Please clarify me.[/quote]
Dear Vamsemicro,
Most of the manufacturing equipments’ contact surface area made up of SS 316L , so due to this reason you must take %recovery factor of SS 316 L. The %recovery is influence by the type and the size of surface and not by the level of the drug spiked.
Thanks
Dear Vamshi,
You have to apply recovery factors as per Material Of Construction (MOC) of Equipments used.
I.e., if you calculate the recovery factor of one product in Stainless Steel Surface, apply the same to equipment having same MOC (stainless steel surface) used for manufacture of the product.
You can use these recovery factors in your Standard Test Procedure (Analysis of equipment cleaning samples of product) as correction factors for results obtained instead of applying at MACO stage.
Hope it clarifies your query. Anything further kindly let us know.
[quote=ssnmd]Dear Vamshi,
You have to apply recovery factors as per Material Of Construction (MOC) of Equipments used.
I.e., if you calculate the recovery factor of one product in Stainless Steel Surface, apply the same to equipment having same MOC (stainless steel surface) used for manufacture of the product.
You can use these recovery factors in your Standard Test Procedure (Analysis of equipment cleaning samples of product) as correction factors for results obtained instead of applying at MACO stage.
Hope it clarifies your query. Anything further kindly let us know.[/quote]
Dear Vamsee,
I agree with Mr.Noor & I would like to add something to this…
Recovery studies can be done in the following ways:
a) Spike the sample on the specified coupon (say 10cm x 10cm) and by applying swab techniques (Immediately) as per the protocol / VMP, and findout the recovery% and calculate the recovery factor.
b) Spike the sample on the specified coupon and air dry the sample for a particular period, to simulate the manufacturing practices (sometimes, swab may be taken after longtime of cleaning, so, it should be simulated) and apply the swab techniques as per the protocol/VMP and findout the recovery% and calculate the recovery factor.
c) Spike the sample on lesser quality like SS316 (even if your equipment MOC is SS316L), and follow any of the above mentioned (a / b).
If you get the recovery on SS316, you may get more recovery on SS316L, since the surface of SS316L is good rather than SS316.
Note: Some of the product contact surfaces may be SS316 & SS316L. In this case, point (c) will be useful for us, in reducing the validation activity.
With Best Regards,
Sudarshan Reddy
ys.sudarsan@gmail.com