Brainscape's Knowledge GenomeTM

Browse over 1 million classes created by top students, professors, publishers, and experts.


See full index

221 > Clean Room Pt 1 > Flashcards

Clean Room Pt 1 Flashcards

1
Q

Define sterile product

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

A

controlled; ensure; viable organisms; particulate

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q

Clean fashion, transferred to final container, sealed & sterilised

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

A

A. Terminally sterilised

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
3
Q

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

A

b. Aseptically prepared & not terminally sterilised

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
4
Q

Aseptic compounding in Msia

  1. CDR
  2. Non CDR

true or false

A

true

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
5
Q

Non CDR examples (4)

A
  1. TPN
  2. IV admixture
  3. Eye drop
  4. Radiopharmaceutic
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
6
Q

Clean Room

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

A

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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
7
Q

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

A

b. 1,2,4

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
8
Q

Clean room features:

  1. Limited _________ particles
  2. Controlled air ________ & ______ flow ___________
  3. Controlled ____________ & ____________
  4. Controlled _____________ procedures
  5. Special ______________ & materials
A
  1. airborne
  2. supply; air; pattern
  3. temperature; humidity
  4. operating
  5. construction
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q

Possible contamination examples (5)

Room air supply… (e.g)

A
  1. External air inflow
  2. Operators
  3. Materials
  4. Equipments
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q

Clean room reasons: (3)

  1. ________ products against particulate & _____________ contamination.
  2. Provide self__________ & safe working ______________.
  3. Prevent _________ contamination.
A
  1. Protect; microbial
  2. self-contained; environment
  3. cross
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
11
Q

General set up of sterile production unit:

  1. Storage area
  2. Washing & _________ area
  3. ___________ area
  4. Clean area
  5. _________ area
A
  1. changing
  2. preparation 
  3. aseptic
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
12
Q

Grade of storage area

A

Grade D

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
13
Q

Grade of washing & changing area

A

Grade C

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
14
Q

Grade of preparation area

A

Grade B

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
15
Q

Clean and Aseptic area grade:

A

Grade B & A

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
16
Q

Anteroom consist of

  1. Clean area
  2. Aseptic area

True or false

A

False (clean & aseptic area is a buffer room)

17
Q

Anteroom consist of

A
  1. storage are
  2. wash & change area
  3. preparation area
18
Q

Anteroom is (3)

A

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

19
Q

Preparation room also known as component room

True or false

A

True

20
Q

Clean room is classified by __________ of their ____

A

cleanliness; air

21
Q

Environmental cleanliness standards :

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

A

permitted; volume

22
Q

What is 2 classification system of Clean room?

A
  1. ISO 14644 - I
  2. PIC/S
23
Q

Air supply

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

A

filtered; remove; microbial; HEPA

24
Q

What is HEPA?

A

High Efficiency Particulate Air

25
Q
  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?

A

HEPA filters

26
Q

Clean air supply system

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

A

prefiltration; temp ; humidity

27
Q

Regulated carefully to avoid generating particles from clean room floor & operators

What is this?

A

Air flow pattern

28
Q

Air flow pattern (3)

A
  1. Unidirectional flow
  2. Conventional flow
  3. Combination systems
29
Q

Unidirectional Airflow system (3)

  1. Expensive to construct
  2. _______ used
  3. Need more AC > more _________ cost
A

Rarely used
Operating

30
Q

Unidirectional Airflow System is vertical laminar flow

True or false

A

True ; vertical = downflow

31
Q

Conventional flow is a unidirectional flow?

True or false?

A

False; its a non unidirectional flow

32
Q

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 ___________
A
  1. filters
  2. ceiling
  3. outlet
  4. filtered; dilutes; contaminated
  5. diffuser
33
Q

This system doesn’t filter the whole room.

a. Unidirectional Airflow system
b. Conventional Airflow system
c. Combination system

A

c. Combination system

34
Q

Combination system have

  1. Higher _________
  2. ____________
  3. Separate ___________ from clean room
  4. Produce _________ room pressure
A
  1. pressure
  2. cheaper
  3. compounding
  4. controlled

221 (2 decks)

Brainscape helps you reach your goals faster, through stronger study habits.
© 2025 Bold Learning Solutions. Terms and Conditions