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Pharmaceutical Development And Manufacture > Cleanrooms > Flashcards

Cleanrooms Flashcards

1
Q

clean rooms at rest and operations have 2 ranges, state them

A

0.5um and 5um

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2
Q

Grade A state number or particles per cubic meter at rest and when operating

A

Rest
3,500 and <1

Operating
3500 and <1

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3
Q

Grade B state number or particles per cubic meter at rest and when operating

A

Rest
3500 and <1

Operation
350000 and 2000

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4
Q

Grade C state number or particles per cubic meter at rest and when operating

A

Rest
350 000 and 2000

Operating

3.5mil and 20,000

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5
Q

Grade D state number or particles per cubic meter at rest and when operating

A

Rest

350,000 and 20,000

Operating

Varies and varies

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6
Q

Why are all surfaces of the clean room smooth?

A

Prevents accumulation of particles

Easy to cleaN

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7
Q

Are shelves present in clean rooms

A

They are reduced

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8
Q

Why should the pipes for the clean room have a filter

A

So the liquids and gases which enter the clean room are free from particles and micro organisms

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9
Q

What is the HEPA filter made from

A

Pleated fibreglass paper

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10
Q

What does HEPA stand for

A

Hi efficiency particulate air

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11
Q

What can be added to a HEPA filter to increase its life

A

The addition of a pre-filter

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12
Q

What is the airflow of a HEPA filter

A

0.45 m/s

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13
Q

What is the efficiency of a HEPA filter of removing particles of 0.3 um

A

99.97%

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14
Q

What is the initial pressure drop across the filter

A

130pa

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15
Q

State three types of airflow

A

unidirectional
non-unidirectional
combination

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16
Q

Describe unidirectional airflow

A

Expensive
Whole wall full of hepa filters
Exhaust on opposite side of air inlet

17
Q

Describe non-unidirectional air flow

A

Diffuser spreads flow
Diluted contaminated air
Air can be circulated

18
Q

Describe a combination system airflow

A

Background area is non unidirectional
Critical area unidirectional
Cheap to run

Pharmaceutical Development And Manufacture (2 decks)

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