16360886
Description
Flashcards by Simeon Crane, updated more than 1 year ago
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Created by Simeon Crane
almost 6 years ago
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| Question | Answer |
| What is the most serious issue currently facing the pharmaceutical industry? | Microbial contamination of parenteral products |
| What are the 3 most common parenteral routes? | Intramuscular (IM) Subcutaneous(SC) Intravenous (IV) |
| What 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 |
| What parameter describes the extent to which bacterial death rate changes with temperature? | Z-value |
| What is the sterility assurance level (SAL) standard for pharmaceutical products? | 10^-6 |
| What genome sequencing technique allows designation of sequence types? | MLST (multilocus sequence typing) |
| What are the 4 most important features limiting analysis of a sample? | Cost Time Staff skill base Equipment |
| What is the lower and higher specification limit in a "Six Sigma" process? | Six standard deviations from the process mean |
| What are the reference conditions of steam sterilisation? | 121°C for 15 minutes at 15 P.S.I |
| What is the standard reference dose of gamma-radiation that is needed to sterilize a product? | 25kGy (kilograys) |
| Name 4 strategies available for the preservation of pharmaceutical products. | Low temperature storage PH manipulation Water activity manipulation Use of specific chemical preservatives |
| What 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 |
| Name 2 common applications for gaseous sterilisation? | Reusable surgical instruments Disposable medical devices |
| What are the 3 goals of validation? | Suitability of the process Uniformity of the process Reproducibility of the process |
| What is an Operating Characteristic Curve (OCC)? | A plot of the probability of accepting a batch of product against quality |
| Name one advantage and one disadvantage of negative pressure isolators? | Advantage- more protection for operator Disadvantage- less protection for product |
| The absorbed dose of ionising radiation is measured in which unit? | Grays |
| Which sterilisation method would be most appropriate for a batch of glass bottles containing mineral oil? | Dry heat |
| What is the minimum necessary time and temperature needed to destroy pyrogens? | 30 minutes at 250°C |
| What does HACCP stand for in relation to product sterility and quality? | Hazard Analysis Of Critical Control Points |
| What is the indicator organism employed for demonstrating the integrity of membrane filters? | brevundimonas diminuta |
| What is a "special product"? | An unlicensed product made by manufactures with a specific licence, for use when there are special clinical circumstances |
| What preservative group does benzalkonium chloride belong to? | Quaternary ammonium compounds |
| What is the Endotoxin Limit (EL) for an IV or IM injection? | 5 EU/kg/hr |
| What Endotoxin Unit (EU) do humans begin to develop symptoms? | 5 EU/kg |
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