4 replies to this topic

[sateeshkumar830]

Dear Sir,

 I'm a Chemical Engineer working for pharmaceutical industry. My query is " As a Chemical engineer what are the observations and responsibilities  to be done while transferring a process  from R&D (Research and development) to Pilot plant to commercial plant. As "Reaction" part plays important role in the process of manufacturing a product, What are the observations to be done while performing experiments trails in R&D, Before transferring a process to plant. And as a Chemical engineer What are the observations to be done in ''layer separations, Isolation , Filtration, Distillation , Drying, and  Particle Size Reduction.

 

Somebody explain me the detailed role of a Chemical Engineer in Technology Transfer department (Transfer of the process from R&D to Plant level) in pharmaceutical industry.   

 

Thanking you..

Edited by sateeshkumar830, 10 September 2015 - 01:03 AM.

[breizh]

sateeshkumar830 ,

 

Go to internet and look for information about  cGMP ,  validation, qualification  ( Installation , Operation , equipment) , etc.

Go to US FDA site too .....

 

Hope this helps

 

Breizh

 

 

[sateeshkumar830]

Breizh sir, Thanks for your reply.  My query is " As a Chemical engineer what are the observations and responsibilities  to be done while transferring a process  from R&D (Research and development) to Pilot plant to commercial plant. Like in the Reaction Part, we have to observe Whether it is homogeneous or heterogeneous , Agitator selection , Material of construction required , viscosity of the Reaction mass.

 

Like wise  What are the observations to be done in '' Reaction Part, layer separations, Isolation , Filtration, Distillation , Drying, and  Particle Size Reduction. Also i am getting confusion between the roles of Chemist and Chemical Engineer in a pharmaceutical industry. Plz Explain me.

Thanking you Sir.

[breizh]

Hi ,

Here in my place , I've a chemical  engineer doing transposition from lab to pilot and eventually to production and doing the qualification and validation of all the steps to ensure the quality of the product as per standard through protocols . At the R&D level all the parameters should be defined , in particular the critical ones which could affect the quality .

 

hope this helps,

 

Breizh

[sateeshkumar830]

Hi ,

Here in my place , I've a chemical  engineer doing transposition from lab to pilot and eventually to production and doing the qualification and validation of all the steps to ensure the quality of the product as per standard through protocols . At the R&D level all the parameters should be defined , in particular the critical ones which could affect the quality .

 

hope this helps,

 

Breizh

Thank you sir.