Pharmaceutical microbiology

Question 1

What does quality assurance involve?

Answer 1

All matters influencing quality of the product

Question 2

What does GMP involve?

Answer 2

Ensures product consistently produced and controlled to the quality standards

Question 3

What does quality control involve?

Answer 3

Sampling, specifications, testing and release of products/materials.

Question 4

What is a cleanroom?

Answer 4

‘An area with defined environmental control of particulate and microbial contamination, constructed and used in such a way as to reduce the introduction, generation and retention of contaminants within the area’

i.e a Controlled area.

Question 5

There are standards for which defined parameters?

Answer 5

Particulate no.
Microbial
Filter efficiency
Pressure differentials
Air flow
Temperature, humidity, noise and light

Question 6

Aseptic preparation and filling in a protective work unit would occur in which environment?

Answer 6

Grade A

Question 7

Filling of products at particular microbial risk would occur in which environment?

Answer 7

Grade A

Question 8

Which environment is a background to Grade A?

Answer 8

Grade B

Question 9

Preparation of solutions to be filtered would occur in which environment?

Answer 9

Grade C

Question 10

Preparation of ‘at risk’ solutions and filling of products would occur in which environment?

Answer 10

Grade C

Question 11

Storage of ingredients and components would occur in which environment?

Answer 11

Grade D

Question 12

Preparation of solutions and components for subsequent filling would occur in which environment?

Answer 12

Grade D

Question 13

HEPA filters

Answer 13

Filter air
Maintains positive pressure
Removes 99.997% of particles
Terminal to grade B environment 
Has a warning system for toxic/pathogenic materials

Question 14

Describe the layout of a clean room

Answer 14

Purpose built
Separated from other production areas
Segregation of processes
Safe/organised workflow
Suitable working environment

Smooth, unbroken surfaces
Minimize ledges and recesses

Sinks not allowed in a grade A/B environment

Question 15

What are the two types of characteristic equipment in grade A environments?

Answer 15

Laminar flow cabinets (LFC) and Isolators

Question 16

What are the two types of flow in laminar flow cabinets?

Answer 16

Vertical:

• Used for TPN and non-harmful substances
• Grade B room

Horizontal
- Used for hazardous substances

Question 17

What are the advantages of isolators?

Answer 17

Cheaper to run - lower grade cleanroom
Disturbances in air flow are not as critical
Negative pressure (better for protection of operator)
Minimum operational parameters

Question 18

Which type of pressure is needed for handling hazardous substances?

Answer 18

Negative pressure

Question 19

Leaks are less critical with which type of pressure?

Answer 19

Positive pressure

Question 20

Type 1 is which type of pressure?

Answer 20

Positive pressure

Question 21

Sterile headgear which encloses hair has to be worn in which type of environment?

Answer 21

Grade B

Question 22

Sterile face masks have to be worn in which type of environment?

Answer 22

Grade B

Question 23

a Protective suit would be worn in which type of environment?

Answer 23

Grade D and C

A sterile boiler suit would be worn in Grade B

Question 24

Sterile gloves need to be worn in which type of environment?

Answer 24

Grade B and C

Question 25

Clothing has to be worn for a single session in which type of environment?

Answer 25

Grade B

Question 26

What types of monitoring are needed in clean rooms?

Answer 26

Pressure
Air flow
Particulate (air sampling)
Microbiological

Question 27

How does monitoring occur?

Answer 27

SOPs
Alert limits
Action limits
Records
Trend analysis
Overview

Question 28

What is the impact of microbial contamination on a medicinal product?

Answer 28

Renders product unfit for use
Potential to cause harm to patient
Legal implications
Financial implications
Moral implications