Clean Room Pt 1

Question 1

Define sterile product

Prepared in _________ environment to _________ its free from _______ __________ & limited to no __________ contamination.

Answer 1

controlled; ensure; viable organisms; particulate

Question 2

Clean fashion, transferred to final container, sealed & sterilised

a. Terminally sterilised
b. Aseptically prepared & Not terminally sterilised
c. Sterile Products

Answer 2

A. Terminally sterilised

Question 3

Aseptically processed from sterile materials or sterilised by filtration before final packing in sterile containers

a. Terminally Sterilised
b. Aseptically Prepared & Not terminally sterilised
c. Sterile Products

Answer 3

b. Aseptically prepared & not terminally sterilised

Question 4

Aseptic compounding in Msia

1. CDR
2. Non CDR

true or false

Answer 4

true

Question 5

Non CDR examples (4)

Answer 5

1. TPN
2. IV admixture
3. Eye drop
4. Radiopharmaceutic

Question 6

Clean Room

Room which __________ particles ___________ is controlled & ___________ & used in a manner to ___________ introduction, ______________ & particles _____________ inside room & in which other relevant __________.

Answer 6

airborne; concentration; constructed; lowers; generation; retention; parameters

Question 7

What is controlled as necessary in clean room?

1. Temperature
2. Humidity
3. Concentration
4. Pressure

a. 1,2,3
b. 1,2,4
c. 2,3,4

Answer 7

b. 1,2,4

Question 8

Clean room features:

1. Limited _________ particles
2. Controlled air ________ & ______ flow ___________
3. Controlled ____________ & ____________
4. Controlled _____________ procedures
5. Special ______________ & materials

Answer 8

1. airborne
2. supply; air; pattern
3. temperature; humidity
4. operating
5. construction

Question 9

Possible contamination examples (5)

Room air supply… (e.g)

Answer 9

1. External air inflow
2. Operators
3. Materials
4. Equipments

Question 10

Clean room reasons: (3)

1. ________ products against particulate & _____________ contamination.
2. Provide self__________ & safe working ______________.
3. Prevent _________ contamination.

Answer 10

1. Protect; microbial
2. self-contained; environment
3. cross

Question 11

General set up of sterile production unit:

1. Storage area
2. Washing & _________ area
3. ___________ area
4. Clean area
5. _________ area

Answer 11

2. changing
3. preparation 
4. aseptic

Question 12

Grade of storage area

Answer 12

Grade D

Question 13

Grade of washing & changing area

Answer 13

Grade C

Question 14

Grade of preparation area

Answer 14

Grade B

Question 15

Clean and Aseptic area grade:

Answer 15

Grade B & A

Question 16

Anteroom consist of

1. Clean area
2. Aseptic area

True or false

Answer 16

False (clean & aseptic area is a buffer room)

Question 17

Anteroom consist of

Answer 17

1. storage are
2. wash & change area
3. preparation area

Question 18

Anteroom is (3)

Answer 18

Areas:
1. Storage
2. Washing & changing
3. Preparation

Question 19

Preparation room also known as component room

True or false

Answer 19

True

Question 20

Clean room is classified by __________ of their ____

Answer 20

cleanliness; air

Question 21

Environmental cleanliness standards :

max airborne particle more than >
defined particle size that are __________ in a given air _________

Answer 21

permitted; volume

Question 22

What is 2 classification system of Clean room?

Answer 22

1. ISO 14644 - I
2. PIC/S

Question 23

Air supply

To achieve Grade A, B, C;
air supply _________ to ________ particulate & ___________ contamination by ________ filters.

Answer 23

filtered; remove; microbial; HEPA

Question 24

What is HEPA?

Answer 24

High Efficiency Particulate Air

Question 25

1. 99.997% remove 0.3micro(m) particle 2. Air enter room thru filters in ceiling (inlet) 3. Air return from room lower part (outlet) Which filter does this?

Answer 25

HEPA filters

Question 26

Clean air supply system Fresh air intake > _____________ to remove large particles > __________ adjustment & ___________ > HEPA filters > Clean air

Answer 26

prefiltration; temp ; humidity

Question 27

Regulated carefully to avoid generating particles from clean room floor & operators What is this?

Answer 27

Air flow pattern

Question 28

Air flow pattern (3)

Answer 28

1. Unidirectional flow 2. Conventional flow 3. Combination systems

Question 29

Unidirectional Airflow system (3) 1. Expensive to construct 2. _______ used 3. Need more AC > more _________ cost

Answer 29

Rarely used Operating

Question 30

Unidirectional Airflow System is vertical laminar flow True or false

Answer 30

True ; vertical = downflow

Question 31

Conventional flow is a unidirectional flow? True or false?

Answer 31

False; its a non unidirectional flow

Question 32

Conventional Airflow System 1. Air enter clean through __________ 2. Diffuser located at _________ 3. Air exit through _________ ducts (low down) 4. __________ air ________ & mixes with ____________ air in room 5. Sterile production : directly under ___________

Answer 32

1. filters 2. ceiling 3. outlet 4. filtered; dilutes; contaminated 5. diffuser

Question 33

This system doesn’t filter the whole room. a. Unidirectional Airflow system b. Conventional Airflow system c. Combination system

Answer 33

c. Combination system

Question 34

Combination system have 1. Higher _________ 2. ____________ 3. Separate ___________ from clean room 4. Produce _________ room pressure

Answer 34

1. pressure 2. cheaper 3. compounding 4. controlled