Sterile Products Flashcards
Why do products need to be sterile?
- avoid possibility of infection
- parenterally administered products
- products which are likely to be in contact with eyes, broken skin or internal organs and tissues
- microorganisms in there would bypass bodys first line of defence and cause infection
What is sterilisation?
process that kills or removes all types of viable microorganisms including bacterial spores
What is disinfection?
process that reduces the number of viable vegetative microorganisms but doesnt kill spores
What is antisepsis?
prveention of infection by appyling antimicrobial agents to tissues
less toxic and less effective than disinfectants
What is a viable cell?
one cell capable of division to form a visible colony on solid nutrient medium or visible turbidity in liquid medium
What is a dead cell?
cell not capable of division to form a visible colony on solid nutrient medium or visible turbidity in liquid medium
What is a bioburden?
expression of the number of viable organisms a batch contains
What is a batch?
homogeneous collection of sealed packages or containers, prepared in such a manner that the risk of contamination is the same for all items
What is a pyrogen?
substances that when administered results in an increase in temp
most important one is endotoxin - originating in cell wall of gram negative bacteria
What are endotoxins?
high MW lipo-polysaccharides which are water soluble, heat stable, can pass through bacteria proof filters, can be inactivated with dry heat at high temps (170-350)
What could happen if you have a non-sterile product?
- microorganism induce spoilage of products
- product/batch removed from use and destoryed
- identify issues before preparation used
OR
- used = infection
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What are examples of sterile products?
- injections
- IV infusions
- total parenteral nutrition fluids
- small volume injections
- non-injectable sterile fluid
- water
- peritoneal dialysis
- haemodialysis solutions
- opthalmic preparations
- eye drops, lotions and ointments
- dressings
- implants
- absorbale haemostats
What are requirements of containers of sterile products?
- chemically compatible
- withstand sterilisation
- maintain sterility of product
- permit safe withdrawal of product
What are the different types of containers for large volume parenterals, small volume parenterals, irrigations, eye drops and eye ointments?
large volume parenterals: rigid, flexible, glass and plastic
small volume parenterals: ampoules, vials, prefilled syringes, novel devices
irrigations: glass and plastic, sachets
eye drops: glass and plastic
eye ointments: plastics
What can you not put in intraspinal and IV injections greater than 15mL?
bactericides
so must be single use only
What are requirements of multidose containers?
period between first and last dose should not be excessively prolonged
require a bectericide
What are advantages and disadvantages of using glass as a sterile fluid container?
+
- good chemical resistance
- neither absorbs or elutes organic ingredients
- impermeable with proper closures
- easily cleaned
- transparents
- rigid and strong - resists puncture
- can be autoclaved at 121
-
- breakage during sterilisatoon esp soda glass
- attack by alkaline solution
- development of hair-line cracks in transit, allows entry of mould
- heavier than plastic
- require venting during administration
- require inspection and washing before use
- require sealing by closures of a diff material, problems during autoclaving and risk of interaction between product and closure
What are advantages and disadvantages of using plastic as a sterile fluid container?
+
- relatively unbreakable
- light
- easily fabricated
- cheap, single use
- small filling ports - less chance of contamination
- possible to completley seal by fusion
-
- used polymers should be chosen carefully to avoid
- inferior clarity compared to glass, but can achieve translucency and transparency
- cant match barrier properties of glass to moisture and oxygen
- additives in plastic: potential leaching
- container must be protected from deformation and bursting
What polymers are used for plastic containers?
- polyvinyl chloride (PVC)
- polyethylene (polythene)
Describe the use of of PVC in sterile fluid containers.
- most widely used
- polymer repeat unit is (CH2-CHCl)n
- IV tubing
- catherers
- blood bags
- LVP containers
Desccribe the use of polyethene in sterile fluid containers.
- fabrication of parenteral containers - provided high density material used
- repeat unit is (CH2-CH2)
- withstand sterilisation due to high melting temp
- loss of flexibilitiy
- increase in opacity
Describe the use of closures.
- glass ampoules closed by fusion
- glass vials and bottles - elastomeric stoppers (rubbers) with a screw
- plastic - elastomeric components in ports
- desired properties:
- compressibility
- resealability
What are factors affecting the selection of a rubber closure?
- API
- vehicle
- preservative, if any
- pH
- buffer system
- moisture/gas protection requirement
- colour
What do sterile products need to be protected from?
- contamination and degradation - patients POV
- chemical contamination
- particulate contamination
- microbiological contamination
- pyrogenic contamination
- physical damage during sterilisation and subsequent handling
- parenteral container should be completely sealed
- leaks commonly due to to thermal or mechanical cracks or faulty seals
What are BP labelling requirements for all preparations?
- name of product or approved synomn
- in case of fixed recipe: names and proportions of medicaments
- names and proportions of any preservatives additional to or alternative to recipe
- batch number
What are BP labelling requirements for injections for more than 10mL or for packaging of any injection?
- amount of active ingredient in a suitable dose volume
- normally weight of API per suitable dose volume
- name and proportion of any added bactericide/preservative
- name of any added buffering or stabilising agent
- conditions under which product should be stored
- date after which it should not be used - if within 3 years
- dose and ROA
- description
- directions for use
- contraindications
- name and address of holder of product license and retailer
- product license number
- batch reference
- manufacturers license number
- keeo out of reach of children
- POM if POM
What are labelling requirements for containers of less than 10mL?
- quanitiy
- name
- strength
- ROA
- expiry date
What are the BP labelling requirements for controlled drugs injections?
- total volume of injection should be stated
- expiry date
- batch number
- keep out of reach of children
What are the BP labelling requirements for IV infusions?
- ingredient conc
- volume of product
- name
- contained in X amount
- additional warnings
- directions for administration
- usual dosage
- storage after and before reconstitution
