Asepctic Tequniques W9

Question 1

Wha are aseptic techniques

Answer 1

Aseptic techniques are set of precautions, and conditions to be followed during
manufacturing processing.

Question 2

Manufacturing processing may include :

Answer 2

o Aseptic blending/mixing.
o Aseptic filling.
o Aseptic packaging.

Question 3

Aseptic process: principal
elements

Answer 3

1.Raw and packaging materials

2.Personnel

3.Equipment

4.Facility/environmetn

5.Monitoring and verification

Question 4

1. Raw material

Answer 4

sterilised using an appropriate sterilisation method !!

Containers and closures should also be sterilised

Materials should be stored or transported in sterile containers

Question 5

Pyrogen

Answer 5

any substance that induce a febrile response (cause fever) through the activation of the innate immune system.

Microbial pyrogen - endotoxin = gram -

Microbial pyrogen - non-endotoxin = gram +

Non-microbial pyrogen = rubber or plastic particles

Question 6

2. Personnel

Answer 6

We shed 100,000 particles/micro-organisms per min
up and down and we change our skin every 28 day.
• No access for unauthorised personnel.
• Number of personnel should be kept minimal

➢Personal disinfection
o Remove all hand and wrist jewellery.
o Use soft, non-abrasive, sterile single use sponges.
o Apply antimicrobial liquid soap
o Hand scrubbing and rubbing techniques.

➢PPE
o gown
o mask
o gloves
oovershoe

Question 7

3. Equipment

Answer 7

Most of processes are carried out using automated stations to minimise personnel intervention.

Do Processes such as :
✓Mixing/blending & Filling.
✓Lyophilisation.

Made of materials that do not promote microbial growth.

Routine cleaning, disinfection and sterilisation.

Question 8

4. Facility/environment

Answer 8

Sterile manufacturing area should be separated from other facilities.
• equipment is positioned so the products remains protected from contamination.
• Sterilisers and entry ports are fitted with double-sided self –closing doors, which are interlocked to prevent simultaneous opening of both the doors.

• The floor, wall, and ceiling surface of clean rooms should be smooth, impervious, and unbroken.
• Minimum shelves, ledges, cupboards, and equipment should be present.
• Uncleanable recesses should be avoided to minimise the accumulation of contaminating particles.
• No sinks and drains.

Question 9

Three bucket system

Answer 9

• Bucket 1: sterile water for rinsing dirty mop
• Bucket 2: sterile rinse water for second rinse
• Bucket 3: disinfectant solution

Question 10

British standards institution definition of disinfection

Answer 10

not necessarily killing all microorganisms but reducing them to a level
acceptable for a defined purpose, e.g. a level which is not harmful to health nor to the quality of goods.

Question 11

Microbial resistance order to disinfection/Sterilisation:-

Answer 11

Prions (resistant)&raquo_space; Bacterial Spores&raquo_space; Mycobacteria&raquo_space; non-lipid viruses&raquo_space; fungi&raquo_space; vegetative bacteria&raquo_space; Lipid viruses (susceptible)

Question 12

Disinfectants

Answer 12

Alcoholic, phenols, aldehydes, peroxygens

Question 13

5. Environmental monitoring and verification

Answer 13

Monitoring of the environment, process and finished product is an essential part of the quality assurance of all aseptically prepared products.

• Types of monitoring:
a. Physical → Dust, light and Temperature.
b. Chemical → Organic compounds and smoke.
c. Microbiological → Pollen, Skin cells, Bacteria and Virus.

Question 14

Microbiological Monitoring Programme

Answer 14

I. Finger Dabs.
II. Air sampling
a. Settle plates (passive air samples).
b. Active air samples.
III. Surface samples
a. Contact plates
b. Swabs.