aseptic oper`tions

Question 1

SALS

Answer 1

different sals are used for different products

10-6 which are for products which will be in contact with ex-owed skin
10-3 for products which will nitb

Question 2

aseptic procedure steps and checks

Answer 2

• products process operates check
• first gavel in preparation area
• during labelling and assembling check
• check in clinical area
• check before administered

Question 3

what os clean room separating

Answer 3

• there should be a positive differential pressure between teh adjacent rooms to prevent the air from the less clean room travelling to the more clean room
  this is done with HEPA - high efficiency particulate air this is used in combination with velocity test and calling coverage

Question 4

laminate flow cabinets

Answer 4

• the movement of air is streamlined so it moves in one direction
  veriticle flow is good and easier to put sesnsitjve objects near the filter
• horizontal airflow doesn’t blow air into the operators face

Question 5

clothing and personal hygiene

Answer 5

• there are certain levels of personal hygiene needed

iso7 - less clean

iso5 - more clean

Question 6

what are the physical parameters for monitors and explain

Answer 6

• particulate matter = critical environments should be measured 30cm from workspace with air flow
• differential pressure = spositive differential pressure of 10-15 pascals
• air changes - air flow should be in one direction laminar flow
• air flow velocity - 0.45 m/s + - 20%
• temp
• clean up time
• relative humidity

Question 7

what are the microbiological parameters for monitoring

Answer 7

• finger dabs = to test the cleanliness after washing hands
• active air samples - with a petri dish (contact plates) or active air samples
• swabs
• settle plates
• contact plates