Lecture 1

Question 1

What’s the different between continous process and continuous manufacturing?

Answer 1

CP one has a long runtime without interruption, while in CM the troughput of material is constant

Question 2

Different classes of the MCS

Answer 2

C1 DC
C2 DG
C3 WG

Question 3

Classification of Class 3

Answer 3

C3.1 FBG
C3.2 LSG
C3.3 HSG
C3.4 WG where the API is first dissolved in the granulation fluid

Question 4

What is the main advantage of CM

Answer 4

Reduced cost and increase of product quality

Question 5

What are continous manufacturing?

Answer 5

dynamic systems

Question 6

defination of a dynamic system?

Answer 6

one has a range in which the process paramters defind

Question 7

What’s the different between the Steady state and the control state?

Answer 7

Steady state, where no variation is obversed, constanst value
Control State: the value are within defind the CQA range

Question 8

when is a Diversion needed?

Answer 8

During the control state and not the steady state

Question 9

what is material traceability?

Answer 9

the ability to preserve and access the identity and attribute of a material throughout the system

Question 10

what have to be consider during the RA?

Answer 10

process understanding of the integrated system and aswell as each unit operation

Question 11

what is the one common approach for characterization?

Answer 11

Residence time distribution (RTD)

Question 12

For which system is RTD needed?

Answer 12

for the individual unit operations and integrated system

Question 13

Defination of RTD?

Answer 13

is a probability distribution that describes the amount of time a mass or fluid element remains in a process

Question 14

what does the shape of RTD reflects?

Answer 14

the degree of axial dispersion or back mixing

Question 15

Which paramters are affected by the RTD

Answer 15

propagation of distrubances, material traceability and control strategy

Question 16

On what does the RTD depends on?

Answer 16

input material attributes, mass flow rates, process paramters, equipment design and operation

Question 17

RTD is important for which factors?

Answer 17

for material traceability, sampling plans and control strategy

Question 18

How is batch in CM defind?

Answer 18

based on the production period, quantity of material processed, quantity of material produced or producction variation

Question 19

what is important while defind the batch?

Answer 19

it has to be establisched prior to the initiation of each production run

Question 20

definition of Control strategy, continued process verification and distrubance

Answer 20

CS is a planned set of controls, which assures process and perfomance and product quality
CPV: Assurance the proces remians in a state of control
Distribance: Change to the input to the process