Hvac System Audit

GOOD MANUFACTURING PRACTICE (cGMP)
1

Hello!
In a few month i’m going to have an auditory to our instalation, but I d’ont really have experience in the Hvac system field.
So I would like some help, to Know frequent questions that can be asked in an auditory about the Hvac system of a prodution unit.

Thanks for your help.

2

Dear

After the installation you have to check the ------

GA drawing of AHU ----- it should be installed as per GA drawing
Duct drawing -------------
Insulation is proper or not
Clean down process completed or not see the report
All the calibration certificate of instrument and test report of motor
MOC certificate of Insulated material

Calculate the desired CFM per area and it shall be meet your tendor document … See the report
DOP, Air velocity Pressure differential, Temp. RH ------- see the report it shall be in limit which is define in Tendor document.

Non viable particle count report it shall be meet as per ISO 146444 or EU CGMP which is followed by you.

See all the drawing like pressure zoning drawing, GA drawing, Ducting layout etc.

3

Dear Mahak, can you help me about a “dimensional problem”? We have a cleanroom with terminal HEPA filtering and a laminar flow plenum into this área. For the calculation of the volume for the Air Changes value, I have to put the total volume (cleanroom + plenum) or only the room whitout the plenum ? Theres not a phisical division between area and plenum.
Best regards
Javier

4

Dear Mr. Javier, Regarding the dimension of the room to consider, you have to consider the air flow pattern of HVAC System. What I means is that if the air supplied by the HVAC system passes inside the plenum then you should consider that volume also. But if the air does not passes inside the plenum and the air inside the plenum is independent of the air supplied by the HVAC system then you should not consider the volume of air plenum.

The Total volume is always the volume of the room where the air moves. In shortcut, if air passes inside plenum consider that volume otherwise not.

5

Dear cpalminha. Are you still in doubt as to what is required or has your question been answered to your satisfaction? If not, then please lets chat about this some more.

I enjoy helping others, do you?

6

Can some one provide the check list of HVAC Audit please.?

7

My problem is the designing of the Differential & positive pressure of a facility, can some one help me with this.
The pattern of sterile facility is;
corridor>airlock>gowning>degowning>buffer>cool down>sterile filling room

Can anyone help me what should be the limits/values for positive pressure and Differential pressure in each of the room, according to ISO or any other authority.

8

[quote=MImran]My problem is the designing of the Differential & positive pressure of a facility, can some one help me with this.
The pattern of sterile facility is;
corridor>airlock>gowning>degowning>buffer>cool down>sterile filling room

Can anyone help me what should be the limits/values for positive pressure and Differential pressure in each of the room, according to ISO or any other authority.[/quote]

please help regarding above matter.

9

Hi,

You may design like this patten:

External Corridor :1.0 mm of water (Un classified)

Change Room-1 : 2.5 mm of water (Class D)

change Room-2 : 4.0 mm of water (Class C)

Change Room-3 : 4.5 mm of water (Class C)

Sterile Corridor : 5.0 mm of water (Class C)

Filling Room : 6.5 mm of water (Class B)

With Regards,
Sitarama Raju