Contamination- particulate Flashcards
Contaminants in IV fluids
Particles (intrinsic and extrinsic)
Air
Microbes and their associated endotoxins
Intrinsic sources of contamination
Infusion fluids or additives Punctures/cracks in delivery containers Vacuum seal of bottles Infusion delivery sets Set ports Disinfectants and catheter dressings
Extrinsic sources of contamination
Container changes Air vents Delivery set changes Bolus or concurrent injections/infusions Catheter insertion or manipulation Connectors Drug interaction- precipitation
Particulate contamination definition
Extraneous, mobile undissolved particles, other than gas bubbles, unintentionally present in the solution
Factors associated with the patho-physiologial effects of particles
Size of infusion of particles Size of particles Dose of particles Material of particles Host factors
Systemic effects of particulates
Glass, rubber and latex particles less than 2 micrometres diameter found in pulmonary circulation of respiratory distress syndrome patients
Foreign particulate matter a causative factor in respiratory distress syndrome
Death from calcium phosphate precipitation in parenteral nutrition mixtures
Particles and parenteral nutrition
Post mortem review of infants that had been fed intravenously compared with infants who had not received any IV therapy
2 babies who had received PN had widespread granulatoma, which sometimes contained glass fragments and cotton fibres
No babies in the non-IV group had such lung damage
Air removal from filter
The IV fluid with entrained air enters the filter inlet and flows to the lower chamber
Entrained air passes through the hydrophobic filter membrane and is vented automatically
IV fluid will pass only through the hydrophilic filter membrane to the upper chamber
Future options
New technology- blow fill ampoules etc.
Official limits for all components
Filtration- manufacture, compounding, in-line
Guidelines- BPNG
Clinical use of particulates
Targeting of specific organs- controlled uptake of drug
Slow/controlled release of drug e.g. from suspension formulation IM
Instability limits
Studying negatively charged liposomes, found that 0.5% of particles found in lungs of 1 micrometre in diameter, while 30.9% were found in the lungs of 8 micrometres in diameter
BP limits
BP gives limits on the number of particulates allowed within a product, limits differ depending on size
The smaller the container is the harder to remove particulates
Harder to count particulates through a microscope as they are less sensitive so have higher limits
Depending on nature of formulation may not be able to count particulates
Counting particulates
For visual particles, hold product against different colour backgrounds for contrast
At a particle viewing station can add polarized light
Big pharma use cameras
Sources of particulates
Glass ampoule opening creates shards, can get back into ampoule and be injected into patient
Core from rubber bung on multi-dose vials or smaller broken pieces can be injected into patient
Distribution of infused particles
From central line, particulates circulate body, become trapped in organ (likely lungs) due to capillaries acting as a filter
Particles thicker than capillaries that are non-deformable will stop other material being able to pass from arteries to veins, causes problems
In lungs, will block transfer of air from alveoli to bloodstream, patient self-suffocates
