Translate

Pharmaceutical Interview Questions 7 contains questions about HEPA filter, High Efficiency Particulate Air filter, HVAC system, MACO, 


61. What is the maximum time allowed after cleaning with water as last rinse?
62. What is the efficiency of the High Efficiency Particulate Air (HEPA) filter?
63. What is the micron size of HEPA filter?
64. Do you have any idea about schematic diagram of HVAC system?
65. If two different products are manufacturing in two modules of one production block, then will you accept the common air handling unit for both pharma area? Write “Yes” or “No” with reason?
66. Why blending validation is required? What quality parameters of product are considered for validation and what parameters of equipment are to be considered during validation?
67. What is the formula for calculation of “Air changes per hour” during HVAC validation?
68. During the performance qualification in the vacuum tray dryer, how many temperature probes used?
69. What is the formula for the calculation of “MACO” while cleaning between one API to another API?
70. What is the limit for “Individual unknown Impurity” in API as per ICH Q2A?
[ads id="ads1"]

61. What is the maximum time allowed after cleaning with water as last rinse?

Equipment should not be left with water it after cleaning. The last step of the cleaning procedures involve drying with solvent or flushing with nitrogen, thus ensuring that there is no opportunity for microbial growth.

62. What is the efficiency of the High Efficiency Particulate Air (HEPA) filter?

This type of air filter can remove at least 99.97% particles in air up to 0.3μm in diameter.

63. What is the micron size of HEPA filter?

The micron size of HEPA filter is 0.3μm
[ads id="ads1"]

64. Do you have any idea about schematic diagram of HVAC system?



Pharmaceutical Interview Questions 7

65. If two different products are manufacturing in two modules of one production block, then will you accept the common air handling unit for both pharma area? Write “Yes” or “No” with reason?

No, because of cross-contamination (if re-circulation of return air)
Yes, if 100% of fresh air is circulated through the respective area.
[ads id="ads1"]

66. Why blending validation is required? What quality parameters of product are considered for validation and what parameters of equipment are to be considered during validation?

Because of to provide sufficient documented evidence to assure that the blending operation of product is capable of repeatedly and reliably producing a homogeneous material to meet established specifications when operated under defined standard conditions.

The following Quality parameters are to be considered, but not limited:
a) Loss on Drying / Water content
b) Bulk density / tapped density
c) Residual solvent
d) Particle size
The following parameters are to be considered for the equipment during validation, but not limited:
a) Blender capacity
b) RPM of the blender
c) Occupancy of the blender
d) Number of individual batches to be taken for each blend
e) Mixing time

67. What is the formula for calculation of “Air changes per hour” during HVAC validation?

Air changes per hour= [Total CFM of the blower/Filter x 60]/ Total room volume
[ads id="ads1"]

68. During the performance qualification in the vacuum tray dryer, how many temperature probes used?

Total 16 to 24 temperature probes are to be kept during the performance qualification of the vacuum tray dryer (or number of probes specified in the protocol)
[ads id="ads1"]

69. What is the formula for the calculation of “MACO” while cleaning between one API to another API?

MACO = [Minimum therapeutic dosage of previous product X Minimum batch size of next product] / [Safety factor X Maximum therapeutic dosage of the next product]

70. What is the limit for “Individual unknown Impurity” in API as per ICH Q2A?

The limit of the “Any individual unknown Impurity” is not more than 0.1%
[ads id="ads1"]

Thanks for reading -Pharmaceutical Interview Questions 7
Naitik Patel
Industrial Guide

Share this blog with your friends from here 👇

Previous Post Next Post