clean rooms

Question 1

what is used to filter the air

Answer 1

HEPA high efficiency particulate air, ULPA ultra-low particulate air filters

Question 2

what environmental elements are controlled in the clean room

Answer 2

temperature, humidity, pressure

Question 3

what are personal protocals put in place

Answer 3

garbing, sanitisation and behavioral guidlines

Question 4

what is grade A classification

Answer 4

=iso class 5
high risk operations. high control
3520 particles (less than or equal to) 0.5 mu m per cubic meter

Question 5

what is grade B classification

Answer 5

=iso class 5 at rest and class 7 in oporation
aseptic prepartion, filling and compounding.
352000 particles (less than or equal to) 0.5 mu m per cubic meter

Question 6

what is grade c classification

Answer 6

=iso class 7 at rest and class 8 in oporation
less critical stages
3520000 particles (less than or equal to) 0.5 mu m per cubic meter

Question 7

what is grade d classification

Answer 7

=iso class 8
less critical stages
no pre-determined limit

Question 8

what equipment would garbing involve

Answer 8

shoe covers, hair net, face mask, gown/coverall, gloves, goggles

Question 9

what does SOP stand for

Answer 9

standard operation procedures

Question 10

how is airflow controlled

Answer 10

laminar flow so that the air doesnt settle and contaminates dont also.