Powder handling in cleanroom

[jokke]

Dear colleagues,


I need some help about handling antibiotics in a C cleanroom.

We have to add manually some antibiotics from a bag (in bucket) into a vessel.

Can somebody help me with information about design of the local fumehoods wich I have to place on top of the handling points.
Information about capacity, regulations, filtersystem, duct system, control and suppliers of such a unit?

Thanx in advance

Jos Janssen

 

[quark]

The golden rule is to confine the powder by attaching hoods. I will not go for manual addition in such a case. There are systems available for automatic transfer of powder by pneumatic means. You can take care of containment and contamination by a double sliding valve mechanism. Load cells further enhance the quality of automation.

 

[sohini]

Sir,

Our drug authority have advised to put 5 micron filter in supply line of AHU of process rooms. Now they are asking for integrity test of 5 micron filters & particle count of the rooms.
What standard or process should I follow?
Please clarify & oblige

 

[abcmex]

Jokke,

check this link

http://www.felcon.co.uk/downflow.htm,

there are other suppliers which can deliver suitable systems. Use a supplier with Qualification/Validation experience in your contry and save yourself a lot of headaches

rgs

 

[Compositepro]

ILC Dover has some innovative systems where all the handling is done in sealed bags.

http://www.ilcdover.com/products/pharm_biopharm/pharmbiopharm.htm