Unit 2 Aseptic Technique

Question 1

Define Asepsis

Answer 1

Complete absence of bacteria, fungi, virus and etc that could cause disease
- ideal state of performing surgical operations, preparation of parenteral, opthalmic preparation and reconstitution of pharmaceutical products

Question 2

What is sterility

Answer 2

Absence of any viable microorganism in a drug product
- Independent manufacturing process ‘ sterilisation of final product in it’s container closure or aseptic manufacturing
- terminal sterilisation involves filling and sealing product with high quality environmental conditions to minimize microbiological content

Question 3

Aseptic processing

Answer 3

Process drug components like drug product, container and excepient by precludes microbiological contamination of final sealed product

Question 4

Aseptic Technique

Answer 4

For manipulation of compounded sterile product and parenteral preparations that prevents contamination

Question 5

Aseptic Manufacturing

Answer 5

Sterility achieved through sterile filtration of the bulk using 0.2 micrometer or less membrane filter in sterile container closure system and clean area
- used when the drug substance is unstable against heat
- sterilisation in the final container closure is impossible

Question 6

Personal Hygiene Hand Washing Technique

Answer 6

1. Scrub palm to palm
2. Right palm over the left dorsum and left palm over the right dorsum
3. Palm to palm fingers interlaced
4. Back of fingers to opposing palm with fingers interlocked
5. Rotational rubbing of right thumb clasped in left palm and etc
6. Rotational rubbing, backward and forward with clasped fingers of the right hand in left palm etc
7. Rotational rubbing of right wrist and etc. Rinse and dry thoroughly

Question 7

Gowning

Answer 7

• remove make up and jewellery
• put on head cap
• put on face mask
• wash hands according to step
• wear sterile powder free gloves before
• wear jumpsuit
• dispose first glove
• wear pair of chemo gloves aseptically

Question 8

Personal Protective Equipment

Answer 8

• sterile gloves
  Non linting, long enough to cover wrist cuffs of the garment and powder free
• respirator mask
  Filters out aerosols, powder and liquid spills
• protective goggle
  Prevent exposure of cytotoxic drugs to the eye

Question 9

Gloving

Answer 9

1. Put on right glove
2. Don’t uncover the folded sleeve
3. Put on left glove by inserting fingers on the right hand under folded sleeve
4. Uncover folded sleeve of the left glove with fingers without touching the arm
5. Fold back folded sleeve on the right glove

Question 10

Entering cleaneoom procedures

Answer 10

Before enter
- remove accessories and make up
- wash hands and dry

Inside changing room
- wear shoe cover
- wash hands with appropriate disinfectants
- dry hands

Entry of grade C or grade D Clean Room
- follow steps
- wear non - sterile garment
- put on sterile gloves
- put on sterile latex chemo glove if handle cytotoxic drug

Entry into grade B Clean Room
- follow steps
- put on non - powdered gloves
- enter gowning room without touching door handle
- wear sterile garment
- wear hood first, then jumpsuit, then booties
- throw away first glove and wear sterile latex chemo gloves
- put on sterile non - powdered gloves