Heat Sterilised Injection Flashcards
Master formula would have been developed and be on file –> what should each batch formula sheet be prepared from?
Prepared from the master and confirmed for accuracy
What is the process of preparing a heat sterilized injections after determining if its an open or closed formula?
Compound solution –> filter –> fill –> seal –> sterilisation –> inspection –> label
OR
Volume –> filling with filtration –> sealing –> inspection –> labelling
What are the conditions required for an open formula?
- There is freedom to chose the excipients
- Has to be a sterile product
- Needs to be isotonic
Who needs to check calculations and measurements of quantities?
By a second qualified person
Is the following an open or closed formula?
Adrenaline Injection is a sterile, isotonic solution containing 0.18% w/v of Adrenaline Acid Tartrate in Water for Injections.
Open = freedom to choose excipients, has to be a sterile product and needs to be isotonic
Is the following an open or closed formula?
Adrenaline 1:1,000 Injection is a sterile solution of adrenaline acid tartrate in water containing adrenaline acid tartrate 1.8mg/mL and sodium metabisulfite 1.0mg/ml as an antioxidant. The solution also contains sodium chloride 8.0mg/ml. The solution contains no antimicrobial preservatives
Closed, has excipients
> sodium chloride alters tonicity of injection
Is the following statement true or false?
Each container of an injection is filled with a volume in slight excess of the labeled “size” or that volume that is to be withdrawn
true
How is compliance with the requirements for extractable volume assured?
By filling with a volume in slight excess of the nominal volume to be withdrawn
Excess volume is determined by the characteristics (e.g. viscosity) of the product
Injections may be supplied in single-dose containers such as ampoules, cartridges or prefilled syringes filled with a volume of injection which is sufficient to permit administration of the?
Of the nominal volume declared on the label
What is the primary objective of filtration? What should a satisfactory filtering medium produce?
Primary objective or filtration is to clarify a solution –> high degree of clarity conveys the impression of high quality and purity
- satisfactory filtering medium for injections must produce a particle-free solution at a fast rate and without significant adsorption of medicament
What must be done prior to filling containers?
A filter may be inserted to prevent particulate matter contamination
- Strict requirements must be exercised to prevent contamination when filling with filtration especially if the product has been sterilised by filtration and will not be sterilised in the final container.
Sealing of glass ampoules –> each container should be sealed immediately after filling.
What are the two types of seals? How are they made?
- Tip-seals –> made by melting enough glass at the tip of the neck of an ampoule to form a bead and close the opening
- Pull-seals –> made by heating the neck of the ampoule below the tip, leaving enough of the tip for grasping with forceps or other mechanical devices
Using twin-jet burner with ampoule sealer
Air displacement with an inter gas after
What is the blow-fill-seal technique used for? How is this process done?
Can eliminate human dust and also maintain a clean environment in the vicinity of the open bottle
- The process takes place in a single machine under a controlled environment that enables the packaging of a parenteral solution in an aseptic manner
What are the advantages of the blow-fill-seal process? Provide FOUR advantages
- Less overall floor space requirement
- Lower personnel requirements
- Lower cleanroom requirements
- Lower logistical problems storage of the empty container
What does the inspection stage of preparation of heat sterilised injections involve? When is inspection done?
The injection must be examined for freedom from foreign particles, before and after sterilization
> The earlier inspection makes possible the refiltration of unsatisfactory solutions
