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
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 .
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
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
please give feed back on comment box to improve our our process,
script async src="https://pagead2.googlesyndication.com/pagead/js/adsbygoogle.js">