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PH3704- Pharmaceutical technology > Lec 8- Aseptics > Flashcards

Lec 8- Aseptics Flashcards

1
Q

Already

A
  • Classess of working area
  • The uniform of these environments
  • Paperwork your expected to produce dispensing and preparation record-
  • Some of the contaminants ‘microbial or non-viable’
  • Cleaning of areas
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2
Q

Grade A work areas

A
  • No difference between rest and operation
  • Not possible to get rid of all particles
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3
Q

Commonly used Grade A environements

A
  • Laminar flow
  • Isolator
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4
Q

2 types of laminar flow hoods

A
  • Vertical flow
    • Protect the person creating the material
    • Use for cytotoxic drugs
  • NB- radioactive must be in an isolator
  • Horizontal flow
    • Must be used to protect the product
    • TPN, Saline etc
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5
Q

Horizontal laminar flow hood

A
  • Clean air is driven through a HEPA filter
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6
Q

First air

A
  • Very expensive to produce
  • The most contaminant freecair in whole room
  • Ideally only first air should be exposed to a product
  • May be called laminar flow air= Literally dascribes the motion of air moving
  • As soon as the air comes in contact with anything (surface, particulate) it is no longer first air
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7
Q

Laminar flow air

A
  • Literally describes the motion of air moving- unidirectional (1 direction)
  • Friction reduces the air speed against a surface and can result in particles setting
  • Turbulence when there are objects in front of air, no air behind this object (transition zone- with no access to first air) why we don’t place items behind one another
    • The turbulence will not remove the particles
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8
Q

Question- How would you position the items in a horizontal laminar flow hood?

A
  • Spaced out
  • NOT Behind each other
  • Overlapping transition zones deposit particles on other equipment or medication
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9
Q

Isolators

A
  • Positive or negative pressure
  • GMP- sited in a minimum grade D environment
    • In practice they are placed in grade C area, if the seal breaks we dont allow the dirtiest air in the clean room into the isolator
  • Dedicated room with access control
  • No sinks allowed
  • Changing must be provided
  • Laminar flow is not required air is provided from overhead (housed) supply
  • Modern isolators use turbulent air flow, to aid particle removal
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10
Q

Positive v negative isolators

A
  • Positive or negative pressure
  • Positive= pressure much higher inside the isolator than in the clean room- this pressure prevents particles entering
  • Negative= pressure inside is much lower so air rushes into the isolator
  • We would have a negative isolator= cytotoxic or radioactive material to prevent these particles going out, air rushes into isolator so air containing cytotoxic particles will not go to technician
  • No sinks allowed- moisture= increased microbial growth
  • Chainging must be provided
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11
Q

Clean room

A
  • NB- doors must open from dirty air to clean air
  • Pressure should be higher in A than B (and B than C etc) so that when doors open the particles will be pushed into the dirtier areas
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12
Q

So far we have

A
  • Laminar flow- laminar air
  • Isolators- positive and negative
  • Locations of isolators vs laminar flow hoods
  • Contrasting air flow requirements
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13
Q

Georges Rx

Q) How long will the infusion last; Can you spot anything to query?

A
  • 1= 30 minutes
  • Teicoplanin is required to be taken ridigly(patient shouldn’t be allowed) PCA should be used
  • If PCA is the only one available MUST be a lock out period
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14
Q

Prescription checks

A
  • Aseptic prescriptions require the same care as any other prescription, but consider
  • All prescribers must be on a record of approved training (trust)
  • Rx on approved documentation (trust)
  • Administration of substances advisory committee and radioactive medicines regulation
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15
Q

Responsibility

A
  • Pharmacists are responsible for medication errors from any cause
    • Prescribing calculation
    • Diluent
    • Route or rate
    • Presentation or formulation
  • Prescription verified for patient
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16
Q

Prescription verification

A
  1. Signitureand date (authorised prescriber)
  2. Patient details
    • Name, hospital Number, the weight
  3. Calculation of BSA
  4. Dose calculation
  5. Compliance with dosage regimen
  6. Administration
    • Route, diluent, volume, rate, duration
  7. Compatibility of the constituents
  8. Stability of the formulation
  9. Correct presentation of the route of administration
  10. AND any contra-indications or drug interactions
17
Q

Aseptic entry stages

A
  1. SOP training- everything from entry to dressing and aseptic technique
  2. Prescription verification
  3. Print out labels and dispensing and preparation record
  4. Obtain stock
  5. General hand wash
  6. Gown up
  7. Retrieve stock (from spraying in)- dedicated hatch for things in and things out
  8. Move to grade A
  • NB- drugs are not just walked through the different areas- they are passed through hatches (spray-wipe-spray) then passed through the hatch into the area
  • Sepearte hatch for stock coming into the area and going out of the area
18
Q

Gloving

A
  • Open packages into first air- never cut or rip MUST peel
  • Bare hands should never come into contact with OUTSIDE of the glove
  • Only once hand is inside the glove you can use to pull glove over hand
19
Q

Spraying in

A
  • 60% of items from stores are contaminated with bacteria
  • We spray it allows us to see any cracks in the product
    • Allows disinfectant to reach all crevices
  • Allows you to check for
    • Particels- potential block
    • Bubbles- seal fail?
20
Q

Isolator spray in

A
  • Isolator has a little hatch
  • Once sprayed place into the hatch
  • Wait a minute for the air to become sterile in the hatch (was grade c or D air)
  • Pass the material into the hatch
21
Q

Critical surfaces

A
  • You should not touch critical surfaces
  • A critical surfact is any surface that will come in contact with a sterile medication (solution, powder etc)
  • Needles, top of vial, plunger top
  • Syringe must always be coupled to a needle
22
Q

Needle

A
  • Always split
  • Luer lock fitting
  • Alway try and work in mid air
  • Needle in with bevel at angle downward force
  • The straighten
  • Prevent coring of bung contaminating the vial
  • NEVER TWIST OR TURN
23
Q

VIALS

A
  • Work with vials upright
  • Be careful of hand positioning- but always remember your safety must come first
24
Q

Vial equalisation

A
  • Pressure equalisation
  1. Air in
  2. Draw solution out (now under moderate preassure)
  • Venting needle
    • Shown
    • White needle will be filter vent
    • Green to draw up

PH3704- Pharmaceutical technology (22 decks)

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