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PA30328 > Small Scale Manufacturing - Maria Connolly > Flashcards

Small Scale Manufacturing - Maria Connolly Flashcards

1
Q

What was the NHS Carter Report?

A

About being able to use part vials correctly (cost effective)

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2
Q

What does CIVAS stand for?

A

Central Intravenous Additive Service

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3
Q

What is the preferable tonicity of IV products?

A

Isotonic

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4
Q

What are the 3 types of container for IV products?

A

PVC –> DEHP containing which can cause harm, and will cause oxygen and moisture loss

EVA –> No leaching of plasticisers (like PVC), but poor barrier to oxygen

Multilayer –> Best option given the others

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5
Q

What is and isnt allowed in SC/IM/IA formulations?

A

Volume less than 2mL

Particulates are okay (unlike IV)

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6
Q

If an IV drug is hypertonic, where can it be given?

A

Central Vein –> With over 10% glucose

Peripheral Vein –> With less than 10% glucose

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7
Q

How do we calculate the maximum dose of starting material in respect to endotoxin levels?

A

M = K/EL

K = Max dose for the route (IV = 350, IA = 14)

EL = Endotoxin limit of the starting material that you’re using

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8
Q

What are the benefits of using the Cytotoxic Handbook or CIVA Handbook over Trissel?

A

Trissel –> No peer review, so may not be valid

Handbook –> Written and reviewd by aseptic pharmacists

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9
Q

What are most CIVAS drug recalls due to?

A

Labelling errors

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10
Q

Define…

Hazard

Risk

A

Hazard –> The potential to cause harm

  • Can be natural (flood/earthquake) or work (carcinogenic)

Risk –> The likelihood of harm

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11
Q

Name the 5 categories that would make a drug hazardous

A

Carcinogenicity

Teratogencity

Reproductive toxicity

Organ toxicity at low doses

Genotoxicity

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12
Q

Why is it not appropriate to wait for indisputible evidence of harm when giving cytotoxic drugs and looking for safety data?

A

As often there is a several year latency period following exposure for anything to go wrong

So need to know what may happen, as cant be waiting years after giving loads out!

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13
Q

Why do we need to consider the possibility of cytotoxics vaporising?

A

As 5-FU and cyclophosphamide are vaporised at room temeprature, and not filtered by HEPA filters

So they keep flowing round the aseptic suite –> Required external ducting or a gas adsorption system

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14
Q

What are the 4 aspects of administrative control?

A

Education and training

Avaliability of information

SOPs/Polices

Surveillance/Monitoring

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15
Q

What type of pressure is used when manufacturing cytotoxics?

A

Negative pressure

This ensures if there are gases exposed that they move away from the manufacturer

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16
Q

What are the best type of gloves?

A

Nitrile or neoprene

Best to have multi-layers

All gloves permeability will increase with time

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17
Q

What does an EU directive say about resheathing needles?

A

That it shouldnt be done in a healthcare setting! (eg, by nurses administrating it)

Once used it should be thrown in the correct bin

18
Q

Name 2 quick testing methods of an aseptically made drug, and 2 end process tests

A

Quick Test –> Flame photometry and UV absorption

End Process –> HPLC and Atomic Absorption

19
Q

Why, when filling vials, do we want as little head space as possible?

A

Improves dissolution

Makes it less viscous and so easier to remove

Reduces the amount of drug that is left in the vial (residual)

20
Q

What is the term ‘Dead Space’, in terms of filling needles?

A

The fluid remaining within the needle

And between the syringe hub and the plunger

Can use speciallsed ‘low-dead space syringes’ to reduce this, but it is always present!

21
Q

Why is air often a problem (inside the products) in the manufacturing of aseptic products?

A

Can cause air embolisms

Can result in an incorrect amount of drug being given

Can reduce stability of the drug

22
Q

What role would the following people have in radiopharmacy?

Doctor

Physicist

Chemist

A

Doctor –> Every patient needs to be looked after by a specific doctor….but not all will have a licence to request a scan

Physicist –> Maintain the imaging equipments quality

Chemist –> Often make up the chemcials which are then injected by the patient for imaging purposes

23
Q

What is the benefit of nuclear imaging over X-rays?

A

Nuclear isotopes can show us the function (not just the structure)

It’ll show the change as it occurs, as opposed to post event (look your arm is broken, thats cool!)

24
Q

How does a gamma camera work?

A

Detects gamma radiation (via a sodium iodide crystal that produces a light pulse)

A collimator absorbs any scatter to give a clearer image

25
Q

Why is Tc99m often used in radiopharmacy?

A

Easy to manufacturer –> From molidnium by passing saline through the molidnium device

Short half life (6hrs)

Decays to stable isotopes

Combines with a wide range of targetting tracers

26
Q

What are the 6 main differences between radiopharmacy and aseptic manufacture?

A

No prescription!

Aseptic technique –> Different protective clothing, and must be far away from the drug as possible

Legislation

Purchasing of goods is very different

Dose calculations –> Need to be done for the time of administration (need to account for decay)

Quality Control

27
Q

What is DMSA?

A

Dimercaptosuccinic Acid (DMSA)

Used in kidney scanning (especially in paediatrics)

Passes through the glomerulus, but is reabsorbed readily in the distal tubule

28
Q

How are radioactivity lung scans done?

A

Radioactive aerosol is inhaled (Krypton-81) and imaged

A particualte is also injected (MMA) that sticks in the alveoli (cold spots = no perfusion)

These images are then compared

29
Q

What is used for the following scans…

Thyroid

Bone

A

Thyroid –> Pertechnetate (TcO4)

Bone –> Organic phosphate complex, with its uptake dependent on bone turnover

30
Q

What are the 2 primary goals of PN?

A

Provide adequate calories and proteins whilst maintaining fluid balance

Prevent malnutrition and associated complications

31
Q

Why do you often add 400% more vitamin C (ascorbic acid) than you need to PN?

A

As oxygen will oxidise it in the bag, catalysed by copper and sunlight

32
Q

What is the solubility of Calcium and Phosphate affected by in PN?

A

The salt –> monobasic much more soluble than dibasic

Concentration

pH –> Monobasic made more readily at lower pHs

Other ingredients

33
Q

What is the maximum concentration of glucose that can be given via peripheral veins?

A

15%

20% via central veins

34
Q

What is the problem with lipids in PN?

A

Very unstable and will precipitate easily

Precipitate at low pHs (below 6)

More positivly charged molecules (Cu2+ over H+) will destabilise further, as will a decreased lipid concentration

35
Q

What is the impact of amino acids in PN?

A

Chelate with cations

Buffer TPN, whilst also stabilising other components like lipids

36
Q

When adding vitamins and trace elements to PN, where do you put them?

A

Vitamins –> Add to fat

Trace elements –> Add to AA/glucose bag

37
Q

What type of phosphate salts should be used when making PN?

A

Organic

38
Q

How should PN be stored and given?

A

Stored –> In a fridge

Administered –> At room temperature (allowed to warm for an hour before administration….otherwise can cause cardiac arrests!)

39
Q

When making a cream extemporaneously, what should the tile and other equipment be sprayed with immediately before preperation?

A

Industrial methylated spirits

40
Q

What is it important for intrathecal injections not to contain?

A

Preservatives

41
Q

If a precipitate is formed in a 3-1 PN bag, can it be seen?

A

NO

As the lipid emulsion will mask the precipitation

PA30328 (11 decks)

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