Sterile manufaturing 2

Question 1

How are cleanrooms classified? Old way

Answer 1

FS standard = By the cleanliness of the air

Based around 0.5 micro gram standard

Old standard

Question 2

What does a class 10 room mean?

Answer 2

No more than 10 particles of 0.5 micro grams within that cubic area of testing

Question 3

British standard classification of cleanrooms

Answer 3

Define the max air you can have where you need multiple testing to cover all air and pressure intervals

New worldwide standard BS WN ISO 14644-1

Question 4

What is a cleanroom suite?

Answer 4

More than one room = a series of interlocking rooms that must have classifications within them

Question 5

Pressure cascade?

Answer 5

Increasing pressure differentials to push back dirty air to stop it getting to product within a cleanroom suite

Question 6

How are cleanrooms classified based on worldwide standard?

Answer 6

Based on equation Cn = 10n + (o.1/D)2.08

Question 7

What are the 2 most common standard cleanroom classification in pharmacy?

Answer 7

Class 100 = inside isolator or laminar flow where manipulation step is taken place

Class 10000 = outer rooms associated with the facility

These classes are a way to combine the old and new standard

Question 8

What does cleanroom classification depend on?

Answer 8

Rooms activity and use

Empty = low particulate load

Question 9

What are the 3 different stages you classify a room at?

Answer 9

As built = empty of all equipment
With equipment but no personnel
Fully operational = most important (has it worked out as planned)

Continuous monitoring of particle count to ensure we know exactly what is going on within our facility

Question 10

How to GMP guidelines effect cleanrooms?

Answer 10

Specify the building design, building material and care of personnel

Question 11

EEC Guidelines

Answer 11

take into account microorganisms

Grade A-D

Grade A is = to class 100

Question 12

How can we monitor sterile products for microbial contamination?

Answer 12

Air sampling
settle plates
Contact plates
Glove print = most important

Question 13

How does slit air sampling work?

Answer 13

Agar plate placed in device = sick’s known volume of air through it very rapidly onto surface of plate and then sent for testing

Active air sampling = active process

Question 14

How does settle plates sampling work?

Answer 14

Alternative to slit air sampling

Passive monitoring
Place plates around the room in a certain pattern
Agar plates look for flow of air into the surface and particles trap there

Difficulty = plates will dry out so particles may not stick but in fact bounce off so limits how long they can stay out/in use

Question 15

Which classification of cleanroom can parenterals be manufactured in?

Answer 15

Grade A within a grade C environment

Question 16

In which classification cleanroom can aseptic products be manufacture?

Answer 16

Grade A within a grade B environment

Question 17

In which classification cleanroom should terminally sterilised products be manufactured?

Answer 17

Grade C environment to give low microbiological and particulate counts

Question 18

How are cleanrooms validated?

Answer 18

Check that the design specifications have been met

Check at specific intervals that area continues to operate within the limits required

Question 19

What tests are carried out on cleanrooms?

Answer 19

Air pressure difference
Installation leak test
Induction leak test
Particulate contamination

Question 20

Give an example of an initial test

Answer 20

Hot DOP testing

DOP particles placed upstream of a filter and released
Monitor downstream filtration to see if particles have gone through
Calculate rate of filter to see if it work efficiently

DOP has been linked to cancer now so alternative would be sodium flame test