Clean Room Design and Parenteral Nutrition Formulation Quiz

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18 Questions

What are the disease states that usually coexist with malnutrition, which is considered a major risk factor for refeeding syndrome?

Malnutrition, a major risk factor for refeeding syndrome, is often observed in different disease states including cancer, Marasmus/Kwashiorkor, neurological problems, respiratory diseases, and gastrointestinal and liver diseases.

How does the body shift its metabolism upon refeeding, and what is the potential consequence of such rapid change?

Upon refeeding, particularly with carbohydrate, the body quickly shifts back to carbohydrate metabolism, a state of anabolism, which can lead to the development of refeeding syndrome.

Explain the concept of Good Manufacturing Practice (GMP) and how it relates to preventing microbial contamination in aseptic units.

Good Manufacturing Practice (GMP) focuses on building quality into all working procedures to minimize the risk of errors. In aseptic units, GMP ensures the prevention against micro-organisms, thus maintaining the quality standards appropriate to their intended use and marketing authorization.

Discuss the potential risks for contamination associated with using gravity fill methods for manufacturing parenteral nutrition formulations.

The gravity fill method may pose higher risks for contamination since it relies on manual intervention. Consequently, the potential for introducing microorganisms is higher compared to automated compounded devices or vacuum fill chambers.

Describe the importance of monitoring biochemistry in preventing refeeding problems and how electrolyte management plays a role in this process.

Monitoring biochemistry closely in patients at risk of refeeding problems is essential to prevent complications. Electrolyte management, especially monitoring and correcting electrolyte imbalances, is crucial in maintaining fluid balance and preventing the development of refeeding syndrome.

Explain the significance of lipid and chemical stability in the manufacturing of parenteral nutrition formulations.

Maintaining lipid and chemical stability in parenteral nutrition formulations is crucial to avoid lipid peroxidation, precipitation, and degradation of active components, ensuring consistent efficacy and safety of the administered nutritional therapy.

What is the primary concern with calcium and phosphate salt formation in Parenteral Nutrition formulations?

Precipitation, which poses a risk to the patient.

What factor increases the risk of calcium and phosphate precipitation in Parenteral Nutrition formulations?

Increasing pH, increasing Ca++ concentration, and increasing phosphate concentration.

What is the first stage of destabilization of lipid emulsions in Parenteral Nutrition mixtures?

Creaming, characterized by the appearance of a visible layer of lipid droplets on top of the mixture.

Why must CaCl not be used in compounding PN formulations?

It increases the risk of calcium and phosphate precipitation.

What measure should be taken to prevent the destabilization of lipid emulsions in Parenteral Nutrition mixtures during storage?

Refrigeration, and administration within 24 hours of rewarming.

What is an important aspect of Contamination Control in Parenteral Nutrition formulation?

HEPA filter and clean room design, as well as hygiene and gowning.

What is the result of lipid emulsions becoming seriously destabilized in a mixture?

The result is the formation of a dense layer that cannot be redispersed, leading to the 'cracking' of the emulsion and visible free oil deposits on the surface of the mixture.

Why is it important to protect PN bags from light during storage?

To prevent degradation of the lipids and maintain chemical stability.

What is the maximum hang time for a PN bag due to stability concerns?

48 hours, with 24 hours being the ideal hang time.

What is the consequence of not handling PN bags properly on the ward?

Contamination and destabilization of the emulsion, leading to an unfit product.

Why is it important to inspect PN bags for leaks and damages?

To prevent contamination and destabilization of the emulsion.

What is the purpose of priming the line before attaching it to a patient?

To remove any air and prevent the introduction of air into the patient's bloodstream.

Test your knowledge on topics related to air handling, clean room design, HEPA filters, contamination control, hygiene gowning, cleaning, parenteral nutrition formulation, chemical stability, electrolytes, and chemical compounds.

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