Controlling microbial contamination

What is asepsis and aseptic manufacturing?

The absence of viable organisms.

Needed for sterile products that can’t be terminally sterilized

What grade are aseptic preparations done in?

Grade A

What are three containment systems?

Laminar Flow Hood (LAF)

Biological Safety Cabinet (BSC)

Isolator.

What is the function of HEPA filters?

Remove particles ≥ 0.5 microns to reduce contamination.

What is a pressure cascade?

Maintains airflow from cleaner to dirtier areas to prevent contamination.

What is the most common source of microbial contamination in cleanrooms?

People - Shedding skin squames, poor hygiene, movement.

What are the other common sources of microbial contamination in cleanrooms?

Others include:

• Workspace

• starting materials

• consumables

• storage

• aseptic process.

What must be true of cleanroom surfaces?

Hard, wipeable, with rounded edges to avoid dust.

How often is Grade A cleaned?

Before and after every session.

What is transfer disinfection?

Multi-step cleaning when moving items between rooms (e.g. wipe with alcohol and sporicide, rest in airlock).

What is the weakest link in aseptic processing?

Transfer disinfection between grades.

Why is quality assurance (QA) essential in aseptic processing?

Because terminal sterilization is not possible

QA ensures consistent product safety.

Name 4 microbial monitoring methods.

• Active air sampling

• Passive air sampling (settle plates)

• Contact plates

• Finger dabs