Learnaboutgmp Community

Recovery time test

Dear all,
Is there any practical experience with respect to recovery time test on which classification areas this test should be performed?
I would consider areas with class B and C as mandatory. What about class A, D and LAF? If I understand well standard ISO 14644-3:2005 LAF and class D should be excluded regarding recovery test.

Thank you a lot

[quote=tedpliangos]Dear all,
Is there any practical experience with respect to recovery time test on which classification areas this test should be performed?
I would consider areas with class B and C as mandatory. What about class A, D and LAF? If I understand well standard ISO 14644-3:2005 LAF and class D should be excluded regarding recovery test.

Thank you a lot[/quote]

Dear tedpliangos,
as far as I am concerned class A I would challenge with respect to Recovery test and the adjacent air locks.

I am not quite sure (personally I do not think) whether there is any guidance referring to recovery test for class D areas.

Best regards,

[quote=Gigastorm]Dear tedpliangos,
as far as I am concerned class A I would challenge with respect to Recovery test and the adjacent air locks.

I am not quite sure (personally I do not think) whether there is any guidance referring to recovery test for class D areas.

Best regards,[/quote]

I would agree. I checked the data on my company and what I see is checking of recovery time at sterile areas Class A.

Cooly

[quote=tedpliangos]Dear all,
Is there any practical experience with respect to recovery time test on which classification areas this test should be performed?
I would consider areas with class B and C as mandatory. What about class A, D and LAF? If I understand well standard ISO 14644-3:2005 LAF and class D should be excluded regarding recovery test.

Thank you a lot[/quote]

Dear Tegpliangos,
In LAFH there is no rigid physical barrier present, just curtain is placed thats why there is no need to challange recovery test same case is apply on Class A.
thanks

[quote=Shahnawaz]Dear Tegpliangos,
In LAFH there is no rigid physical barrier present, just curtain is placed thats why there is no need to challange recovery test same case is apply on Class A.
thanks[/quote]

Dear Shahnawaz
Thank you for the answer. That is to say, we challange recovery test only in cleanrooms class B and C. if we have a cleanroom class A (lyofilizator), with 12 HEPA filters , will we need to challange recovery test?

Thanks alot

[quote=tedpliangos]Dear Shahnawaz
Thank you for the answer. That is to say, we challange recovery test only in cleanrooms class B and C. if we have a cleanroom class A (lyofilizator), with 12 HEPA filters , will we need to challange recovery test?

Thanks alot[/quote]

Dear Tedpliangos,

Yes, you can design (DOE) Design of experiment, in which you may challenge the class A from adjasent area and evaluate the recovery time. But this study is non- mandotory.

Thanks