Flashcards
Quality Of Sterile Medicines
Cards in this deck (25)
- 1What is the most serious issue currently facing the pharmaceutical industry?Microbial contamination of parenteral products
- 2What are the 3 most common parenteral routes?Intramuscular (IM)
Subcutaneous(SC)
Intravenous (IV) - 3What three parameters does a manufacturing company need to show their product has for the MHRA to issue a Marketing Authorisation (MA)?Quality, Safety and Efficacy
- 4What parameter describes the extent to which bacterial death rate changes with temperature?Z-value
- 5What is the sterility assurance level (SAL) standard for pharmaceutical products?10^-6
- 6What genome sequencing technique allows designation of sequence types?MLST (multilocus sequence typing)
- 7What are the 4 most important features limiting analysis of a sample?Cost
Time
Staff skill base
Equipment - 8What is the lower and higher specification limit in a "Six Sigma" process?Six standard deviations from the process mean
- 9What are the reference conditions of steam sterilisation?121°C for 15 minutes at 15 P.S.I
- 10What is the standard reference dose of gamma-radiation that is needed to sterilize a product?25kGy (kilograys)
- 11Name 4 strategies available for the preservation of pharmaceutical products.Low temperature storage
PH manipulation
Water activity manipulation
Use of specific chemical preservatives - 12What is the impact of changes in preservative availability on efficacy?The concentration of the preservative
available to control the growth of
microorganisms will be reduced - 13Name 2 common applications for gaseous sterilisation?Reusable surgical instruments
Disposable medical devices - 14What are the 3 goals of validation?Suitability of the process
Uniformity of the process
Reproducibility of the process - 15What is an Operating Characteristic Curve (OCC)?A plot of the probability of accepting a batch of product against quality
- 16Name one advantage and one disadvantage of negative pressure isolators?Advantage- more protection for operator
Disadvantage- less protection for product - 17The absorbed dose of ionising radiation is measured in which unit?Grays
- 18Which sterilisation method would be most appropriate for a batch of glass bottles containing mineral oil?Dry heat
- 19What is the minimum necessary time and temperature needed to destroy pyrogens?30 minutes at 250°C
- 20What does HACCP stand for in relation to product sterility and quality?Hazard Analysis Of Critical Control Points
- 21What is the indicator organism employed for demonstrating the integrity of membrane filters?brevundimonas diminuta
- 22What is a "special product"?An unlicensed product made by manufactures with a specific licence, for use when there are special clinical circumstances
- 23What preservative group does benzalkonium chloride belong to?Quaternary ammonium compounds
- 24What is the Endotoxin Limit (EL) for an IV or IM injection?5 EU/kg/hr
- 25What Endotoxin Unit (EU) do humans begin to develop symptoms?5 EU/kg