Intro to Aseptic Production Flashcards Preview

Stage 2, Cycle 2 - Sterility and Asepsis > Intro to Aseptic Production > Flashcards

Flashcards in Intro to Aseptic Production Deck (16):
1

Sterile production takes place on two levels. Name them

1) Industrial - Large scale licensed manufacture

2) Hospital
- Small scale licensed or unlicensed manufacture

2

Define 'Sterile'

'Free from bacteria or other living microorganisms; totally clean.'

3

To produce sterile products on an industrial scale, manufacturer's authorisation is not needed. TRUE or FALSE

FALSE. Manufacturers authorisation is needed!

4

Products produced on an industrial scale are more likely to be those with a marketing authorisation (product license). TRUE or FALSE

TRUE

5

Name 3 examples of industrial sterile products likely to have a marketing authorisation

1) Mass produced injections
2) Mass produced eye-drops
3) Mass produced dressings

6

Industrial sterile products should be produced according to good manufacturing practice (GMP) for medicinal products. TRUE or FALSE

TRUE

7

Explain Licensing

Having manufacturers authorisation to make products to sell to others

8

What are 'Specials'

Hospital small manufacture products that do not have a products license

9

Described hospital unlicensed product manufacture

Hospitals that do not make specials but order from elsewhere instead

10

GMP is part of quality control. TRUE or FALSE

FALSE. GMP is part of quality assurance

11

State 11 factors of GMP

- Processes
- Facilities
- Equipment
- Materials
- Procedures
- Storage and transport
- Training
- Record keeping
- Distribution
- Product recall
- Complaints

12

Quality control is part of GMP and includes ...

- Specifications
- Sampling
- Testing
- Record keeping
- Product release

13

GMP applies to only some medicinal products/ devices manufactured in the EEA. TRUE or FALSE

FALSE. GMP applies to ALL medicinal products/ devices ...

14

Within the GMP is a separate annex for sterile production. TRUE or FALSE

TRUE

15

State 5 classes of products that need to be produced under sterile conditions

1) Any products for injections (Needles, Syringes)

2) Eye - drops

3) Dressings

4) Irrigation solutions

5) Items used in surgery (Sutures, Implants)

16

State 3 types of typical unlicensed products

1) Chemotherapeutic agents

2) Parenteral nutrition

3) Central IntraVenous Additive Service (CIVAS)
e.g: Antibiotic solutions in mini-bags
- Analgesics; Morphine PCA Systems