Technology Transfer a Complete procedure



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Hi friends, in this article i am explaining tech transfer process only in short.    

Technology transfer is a process to transfer information and technologies necessary to manufacture quality drug product .  
Investment in R&D is a necessary but not a sufficient condition for economic growth. Productivity gains only result from the natural diffusion of innovation to the marketplace (technology transfer). Responsible departments for successful technology transfer of a product in pharmaceutical industry are
1) R&D,
2)Production,
3) Engineering, 
4)QC
5)QA.  

for technology transfer following team required 
1) Chemist  
       Qualification – MSc in Chemistry 
                      Role – Develop Reaction 
2) QC officer   
Qualification – MSc in Chemistry 

                      Role – Analytical method  
3) Chemical Engineer 
Qualification – BE Chemical 

                      Role – Develop Technology and HOZZAP study 
                                Material Balance , Energy Balance , Utility calculation 
 4) Doctor
           Qualification – P Hd in Chemistry  
                      Role – Monitor Overall project   
Above team is of tech transfer project .


Suppose A is commercial batch size 
Then we need to following stage to developed technology 
1) Research theoretical (only Study About reaction )
     In this stage you have to study all reaction related information , collect the Patent ,
     study the reaction mechanism , safety parameters , chemical related information ETC
2) Bench Scale 
           batch size = (1/1000 ) x A
           Suppose A is commercial batch size 
3) Lab trail 
      In this level you can use following formula to select batch size 
       batch size = (1/100) x A
    you need to validate batch on this size with generating proper validation documents,
    do proper HAZOP, and then plan for next stage. 
4) Pilot Plant Trail (Scale Up)
  to select batch size use this formula = (1/10)x A
do all trails with proper planning , do material balance and also energy balance ,
  Validate batch,  
5) Production level trails (commercial )
This is final stage of tech transfer process , in this level you can take batch size is A

after successfully 

What is HAZOP-Hazard and operability study 



About Author 
Pharma-Guide 
Qualification – B Tech In Chemical Engineering, 
Exp – 6+ 

Role – Project/process/Procurement

Our Service 

1) Job Solution 
2) Interview Guide  
3) Video tutorial 
4) Auto-Cad Drawing 
5) Procurement Help  
6) Technology information 
7) Give utility requirement  calculation 
8) Help in equipment selection and sizing 
9) Line sizing 
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