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ROGO Flashcards

1
Q

General considerations for a clean room

A
  1. Logical layout
  2. Airflow + air supply
    • Clean room tech. founded upon use of high efficiency particulate air (HEPA) filters
    • HEPA filters remove 99.9997% of particles 0.3 micrometres or larger
    • HEPA filtered provides products with protection from airborne contaminants by contnuously sweeping away ‘personnel derived’ particulates from the immediate work area using laminar airflow
  3. Surfaces
    • ​​Smooth flat + impervious to minimise reservoirs/traps for particulates + microorganisms
    • Junctions between walls + ceiling should be seamless + windowsills should be avoided
  4. Ease of cleaning + disinfection
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2
Q

Personnel Training

A
  1. Good personal hygiene
  2. Clothing
  3. Personal protective equipment
  4. Good aseptic technique + good manufacturing practice
  5. Movement within manufacturing area
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3
Q

Terminal Sterilisation

A

Sterilisation is the last step in the manufacturing process once the product is sealed within final container

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4
Q

Aseptic Processing

A

Procedure in which the medicine, container and closure are sterilised separately the combined together to give the final product

  • Risk of microbial contamination > when products are terminally sterilised
  • Aseptic technique used in manufacturing products which are terminally sterilised to maintain a low level of contamination in the beginning stages of production
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5
Q

What are the main sources of contamination?

A
  1. Personnel
  2. Air in surrounding environment
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6
Q

What are clean rooms?

A

Controlled environments where parameters (e.g. airflow, microbial + particculate quality of air, equipment surfaces, room surfaces, + personnel) are all monitored + must meet all specific requirements.

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7
Q

Why is it important to specify brand of Amphotericin B used?

A

Dosage recommendations differ between brands due to differences in their pharmacodynamics + pharmacokinetics

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8
Q

What is a common cause of morbidity + mortality in cancer patients?

A

Systemic fungal infections especially those with chemotherapy induced neutropenia

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9
Q

Molecular target of AmBisome

A

Ergosterol (a component of fungal membranes)

  • Binding of amphotericin to ergosterol causes fungal cell death by induing pores to form, leading to increased membrane permeability
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10
Q

How can we prevent an allergic reaction prior to giving Amphotericin-containing products (including AmBisome)?

A

Administer a test dose of 1 mg over 10 minutes before treatment

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11
Q

How do we avoid dosage miscalculations for amphotericin B?

A

BNF states to state brand dispensed

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12
Q

AmBisome may not fully dissolve.

How do we prevent large particles entering IV bag?

A

Using a 5 micrometre needle to transfer contents

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13
Q

What is AmBisome composed of?

A

Each vial contains:

  • 50 mg of amphotericin (50,000 units) encapsulated in liposomes
  • 900 mg Sucrose
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14
Q

How sould AmBisome be administered?

A

IV infusion over 30-60 minute period

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15
Q

What is the recommended AmBisome IV concentration infusion?

A

0.20 mg/ml to 2.00 mg/ml

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16
Q

Daily dose of AmBisome

A

3.0 mg/kg of body weight + increased stepwise to 5.0 mg/kg

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17
Q

What is AmBisome compatible with?

A
  • Water for Injections
  • 5% Glucose
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18
Q

What is AmBisome incompatible with?

A
  • Saline solutions
  • Drugs
  • Electrolytes
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19
Q

What is used to transfer AmBisome into a sterile container with Glucose?

A

5 micrometre filter needle

(to filter out particles not bacteria)

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20
Q

What can cause precipitation of AmBisome

A
  • Other solutions
  • Bacteriostatic agent
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21
Q

An in-line membrane filter is used for the IV infusion of AmBisome.

What should the mean pore diameter be?

A

The mean pore diameter of the filter should not be less than 1.0 micrometres

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22
Q

How do we flush the IV line?

A

An existing IV line is flushed with 5% Glucose prior to infusion of AmBisome

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23
Q

When is it good practice NOT to dispose needles + syringes together?

A

Where a syringe has to have needle removed when attaching a transfer device or a filter then needle has to be carefully re-sheathed

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24
Q

What is the shelf life of AmBisome after reconstitution?

A

Glass vials + propylene syringes up to 7 dyas at 2-8 degrees celsius

25
Q

When is a hypodermic needle used?

A

A syringe to inject medication into the body or as part of a procedure for making meds in a SPU

26
Q

Difference between Luer-slip + Luer lock?

A

Luer slip - needle slips on + off syringe

Luer-lock - needle = screwed + locked onto syringe to create a leak-free seal

27
Q

What fitting do most SPUs have?

A

Luer-lock

28
Q

How many times can you use mos needles?

A

Single use

29
Q

How can you maintain needle sterility?

A

Protective packaging

Use-by dates

Batch/lot numbers

Aseptic technique

30
Q

Safe use of needles to avoid accidents

A

Fit needle onto syringe whilst it is still in its sheath

Unsheath + resheath using NeedleSafe

Keep hand benhind needle tip @ all times

Minimise handling, do not pass needle from hand to hand

Used needles must be placed into sharps bin

31
Q

What are Needle Stick injuries?

A

Skin punctures caused by hypodermic needles

32
Q

What is the no touch technique?

A

Never to touch any critical site when making a sterile product

33
Q

What is a critical site?

A

Any part of a sterile product/equipment used in its preparation that must remain sterile to prevent contamination of the final product

34
Q

Quality control system for Aseptic Dispensing

A

Operator Training

Standard operating procedures

Environmental monitoring

Broth transfer tests

35
Q

How many decimal places is it appropriate to work with?

A

3

No trailing zeros

36
Q

Rate what movement has the highest no. of particles dispersed/min from lowest

A
  1. Sitting still (100k particles/min)
  2. Gentle movement of arms, hand + head (500k particles/min)
  3. Active movement of arms, hands + head (1 million/min)
  4. Change from sitting to standing/reverse (2.5 million/min)
  5. Walking (10 million/min)
37
Q

When prepaing cytotoxic chemotherapy, which helps prevent operator exposure?

A

Negative pressure hoods

Full length suits when using open devices

Double gloving with nitrile rubber gloves

Chemotherapy never produced on an open bench

38
Q

What is sterility?

A

Absence of viable microorganisms

39
Q

Sterility of a product cannot be guaranteed by testing.

How can we be assured of sterility?

A

Application of a suitably validated production process

40
Q

Principles of GMP

A
  • Qualified personnel with appropriate training
  • Adequate premises
  • Suitable production equipment, designed for easy cleaning + sterilisation
  • Adequate precautions to minimise the bioburden prior to sterilisation
  • Validated procedures for all critical production steps
  • Environmental monitoring + in-process testing procedures
41
Q

Methods of terminal sterilisation

A

Steam

Dry heat

Ionising radiation

42
Q

What is the nominal pore size of a bacteria-retentive membrane?

A

0.22 micrometres or less

43
Q

How is solute loss during filtration?

A

Adsorption on to the filter

44
Q

Why is sterilisation by filtration used?

A

For solutions/liquids not stable enough to withstand terminal sterilisation by autoclaving (e.g. products which are thermo-labile)

Not a terminal sterilisation method

45
Q

Why is filtration not a terminal sterilisation method?

A

It is followed by aseptic transfer of the sterilised solution into the final container which is then sealed

46
Q

Why is filtration different from other methods of sterilisation?

A

Process physically removes microorganisms

47
Q

Major mechanisms of filtration

A
  1. Sieving particles out that are larger than the pore size
  2. Adsorption
  3. Deposition in the filter bed
  4. Retention in capillary films within the filter bed
48
Q

Factors to consider when choosing a filter

A
  1. Pore size - a pore size of 0.2 micrometres or less
  2. Inertness - filter does not shed fibres into the product during filtration. Filter should not leach chemical substances into the product.
  3. Flow rate - adequate flow rate achieved
49
Q

What are the 2 main types of filter types?

A
  1. Depth filters
  2. Membrane filters
50
Q

What is the preferred type of filtration?

A

Membrane filters

Made from cellulose esters (or other polymers)

51
Q

Membrane filters have a low dirt handling capacity. (e.g. easily clogged by particles just larger than their pore diameter)

How can we extend its working life?

A

Using a prefilter decreases blockage of final filter

52
Q

How can we reduce particulate contamination?

A

Pre-filtered water is used

Polarised light viewer/strong light with the naked eye can check for particles in pre-filtered water

53
Q

What is laminar airflow?

A

Movement of air within confined boundaries @ uniform velocity + along parallel flow lines

54
Q

What do we use to filter air supply?

A

HEPA filters

Continuous unidirectional flow of filtered air sweeps away any airborne contaminants generated by operator during manipulations within cabinet

55
Q

How can the air be displaced?

A

Horizontal

Vertical

56
Q

What happens of airflow is physically obstructed?

A

Cause downstream turbulence

This increases risk of product contamination

57
Q

Rate how much saliva travels when:

  • talking
  • coughing
  • sneezing
A

Talking = 2-3 feet

Coughing = 4-6 feet

Sneezing = 10-15 feet

58
Q

Assess operator’s aseptic technique

A

Universal operator broth transfer tests

Finger dabs

CAN (15 decks)

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