As per ISO 14644-4, the air changes per hour is 70-160 for ISO-6 (grade-B).
Dear Kottipallisuresh
I am having first three parts of ISO 14644.
Could you send the softcopy of ISO 14644-4 on my mail ID upareravindra@rediffmail.com.
Thanking you in advance
Warm Regards
Ravindra Upare
I have sent you both.
regards,
cubica:D
Dear Cubica,
In ISO-4 (Design,Construction and Startup) they have mentioned that the Air changes should be between 70 to 160 for Class - B (ISO-6).
Suresh
[quote=sowmya]Hi,
I am not having more experience in sterile plant since i am working in non-sterile plant.If possible i will try to collect details regarding ur query from my friends[/quote]
Dear Sowmya,
Pl.clear one doubt, i.e which guideline describes that api should manufactued in the clean room only (Federal standard-100000 or ISO14644).
One more doubt is provide the clear picture how to check the validation report (process and clean room qualifications) and how to justify the this report is sufficient with reference any guideline.
regards,
rajuchs,
QA
Is it a liquid injection ampoule or vial filling you require
Good machine as per my experience is
IMA as they manufacture the machine as per your URS as far as Bosch is concerened they have a standard model hence you need to look for your requirement,
Macofar and Romaco too are good vendors
Even Groninger Germany too is good.
Coming to air changes, preffered air changes in grade B is 20 airchanges per hour, in actual you get the best envirnomental results if its from 60 to 200 air changes per hour as regenertion of air is faster and removal of contaminated air is faster.
Deepak KAbbur
[quote=cubica]Dear friend,
I am a little in doubt about the next…
We have an new built plant which is planned to fill parenteral sterile vials. I was in inspection of the same and I have found too much mistakes there.
The first one (and serious…by my opinion) is the number of air changes inside of class B. This room will be used for filling of vials.
Machines are under laminar flow cabinets in ISO 5 class A and that is OK, but in background of the filling process (mentioned class B), I have measured only 20 to 25 AC/Hr:eek:
What I will do??? To say ‘’ this is not good’’ or try to do recovery test and wait for results??? What will happen if recovery test approach successfully?? Shall I give permission to continue media fill test???
What say the law in this case, how is your expiriences???
thanks in advance, kindly regards:)
Milan:([/quote]
To All
Can any one tell us, which is Right Air Velocity Meter (Vane Type /Hot Wire or Analog) to check Air Velocity of Horizontal and Vertical Laminar Air Flow?
True Regards
A.Aziz Shaikh
Al- Pharao Air Data