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Dera mvor, Let us address the issue from other way.SS 316L Sanitary fittings are very costly. There is absolutely no point if someone uses these fittings and then do not use proper welding techniques. The very purpose of using these fittings is lost if rough uneven surface is generated through...

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)...

Dear greg87, Thanks. Could you please tell me more about these Relief panels ? Regards, bsg

Thanks. 1)The Closed vessels handling solvents are ,of course, designed properly. 2)The safety/Relief line will be routed to roof ( corridor only on sides) 3)The Flame Arrestors are also properly designed. 4)Rupture Discs will take care of any vigorous unpredicted run way reaction type...

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...

Dear Mr, PaulRiberio, You are very right.Following your suggestion we had advised one of our clients to have an initial run with little or no air temperature and then to increase the air temperature in steps. It has worked and there is lot of improvement. Your suggestion was simple; but...

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.

Dear zhanqbad, Thanks for the response.The formation of these balls is a Process phenomenon.At the start of drying the moisture gets evaporated near the heating surface( in this case at hot air inlet)and gets condensed immediately in the cold mass thereafter.This way a moisture rich layer is...

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...

Dear Mr. Quark, I had received your mail on time and got the concept in general. Subsequently I came across a few established design where the same principle had been applied. Thank you very very much. I am extremely pleased to inform you that right now one Beta Lactum sterile unit is being...

Dear G1DESIGN, Thanks for the reply.My question was whether any written guideline exists for cleanliness Class/level for non sterile Production ( say OSD) If GMP requirement in any guidelines ( WHO/FDA/TGA/EU etc) does not exist why should one go for 10,000 or for arguments sake 100,000 areas...

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...

Dear Quark, In my bulk Drug Plant I used this technique to shine the S.S. exterior parts of the vessels,containers. With a rubber gloves we used Muratic Acid ( Dilute Hcl for use in toilet cleaning)and a little quantity of sand and rubbed the surface. After a little rubbing we used to clean...

Dear Mr.Quark, Thanks for your quick response. My ID is nsenguptain@hotmail.com. Regards bsg Sengupta, Jayneil Technologies Pvt.Ltd.

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 ?