Hi all,
Can somebody give me info on continious PVC mats used for flooring ( with heat welded joints) in Pharma Production areas ?
I would like to know the following:
1) General Specifications and an idea on cost
2) Some general comparison with other flooring materials ,
say, epoxy.
3)...
We are designing a small Bulk Drug(API) Manufacturing Facilty where solvents will be used.The Design basically centres around One main Reactor, one Supporting Vessel for Work Up,Filtration,Drying and Milling Facilities.There is a Corridor all around this facility and our Client has asked us...
The CGMP requirements for API are well described in Q7a guidelines. Can anybody give me some idea what further information are available in ISPE baseline guide- Volume one ? Based on this we have to make a "Buying Decision" of this volume.
Regards.
When you start a FBD with ,say some initial water content, there is always a tendency of ball formation ( of various size)initially.These balls contain much higher moisture than the rest of the mass and are rather difficult to dry.
In normal operation the operator runs the unit initially for...
I find in number of Multinational Pharma house a Design of Class 100,000 and even 10,000 Clean Rooms in normal Oral Solid Dosage preparation areas.It is not clear to me how the system with HEPA can operate in Dusty environment of OSD.Is there any international guideline which specifies any...
GMP prescribes positive pressure in Sterile manufacturing area.GMP also specifies negative pressure ( with respect to corridor etc) for Betalactum production.What should be the Design Philosophy for a Sterile Beta Lactum Production area ?
