Introduction: The preparation of dried human plasma and plasma substitutes is a crucial topic for B. Pharm students studying pharmaceutical technology, blood products, and transfusion medicine. This area covers lyophilization (freeze-drying), spray-drying, plasma fractionation, stabilizers and lyoprotectants (e.g., sucrose, trehalose), viral inactivation, quality control tests, reconstitution procedures, and clinical indications. Understanding formulation variables, coagulation factor stability, storage conditions, and regulatory standards is essential for safe product development and handling. Knowledge of plasma substitutes—colloids (albumin, gelatin, dextran), crystalloids, and hemoglobin-based carriers—helps students evaluate therapeutic choices for volume resuscitation. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. Which drying method is most widely used to prepare dried human plasma while preserving labile coagulation factors?
- Lyophilization (freeze-drying)
- Spray-drying
- Oven drying
- Air drying
Correct Answer: Lyophilization (freeze-drying)
Q2. Which excipient is commonly used as a lyoprotectant to stabilize proteins during freeze-drying of plasma?
- Sodium chloride
- Trehalose
- Polyethylene glycol
- Potassium phosphate
Correct Answer: Trehalose
Q3. During lyophilization, the primary drying phase primarily removes water by which mechanism?
- Condensation
- Sublimation
- Evaporation at atmospheric pressure
- Osmosis
Correct Answer: Sublimation
Q4. Which parameter is most critical to prevent protein denaturation during freeze-drying?
- Heating rate during primary drying
- Freezing rate and glass transition temperature
- Atmospheric humidity in the manufacturing room
- Color of the container
Correct Answer: Freezing rate and glass transition temperature
Q5. Which pathogen-reduction technique is commonly applied to plasma before drying to enhance safety?
- Gamma irradiation after drying
- Solvent/detergent treatment
- Autoclaving
- UV-B exposure without photosensitizer
Correct Answer: Solvent/detergent treatment
Q6. Spray-dried plasma has an advantage over freeze-dried plasma mainly because it:
- Preserves coagulation factors better
- Requires lower processing temperatures and is gentler
- Offers faster and continuous processing at scale
- Eliminates need for lyoprotectants
Correct Answer: Offers faster and continuous processing at scale
Q7. Which quality control test is essential to assess functional hemostatic activity in dried plasma?
- Protein electrophoresis only
- Prothrombin time (PT) and activated partial thromboplastin time (aPTT)
- Glucose assay
- pH only
Correct Answer: Prothrombin time (PT) and activated partial thromboplastin time (aPTT)
Q8. Which container closure consideration is most important for storing dried plasma?
- Color of the vial cap
- Moisture vapor transmission rate and airtight seal
- Label font size
- Type of external carton only
Correct Answer: Moisture vapor transmission rate and airtight seal
Q9. What is the primary reason for adding stabilizers like albumin or sugars to plasma formulations before drying?
- To increase viscosity for easier filling
- To protect proteins and coagulation factors from denaturation
- To reduce osmolarity
- To inactivate viruses
Correct Answer: To protect proteins and coagulation factors from denaturation
Q10. Which dried plasma product is specifically rich in fibrinogen and useful for bleeding management?
- Cryoprecipitate
- Albumin powder
- Spray-dried albumin
- Dextran solution
Correct Answer: Cryoprecipitate
Q11. Which plasma substitute is a natural human protein used as a colloid volume expander?
- Hydroxyethyl starch (HES)
- Human serum albumin
- Dextran 70
- Normal saline
Correct Answer: Human serum albumin
Q12. Hemoglobin-based oxygen carriers (HBOCs) are designed primarily to:
- Act as anticoagulants
- Provide oncotic pressure similar to plasma proteins
- Carry and deliver oxygen in place of red blood cells
- Function as antibiotics
Correct Answer: Carry and deliver oxygen in place of red blood cells
Q13. Which factor is most sensitive to damage during freezing and thawing of plasma?
- Albumin concentration
- Factor VIII activity
- Sodium content
- pH
Correct Answer: Factor VIII activity
Q14. Which regulatory requirement is critical for dried plasma intended for transfusion?
- Proof of non-human origin
- Demonstrated sterility, viral safety, and validated pathogen reduction
- Use of synthetic excipients only
- Minimum 10-year shelf-life without testing
Correct Answer: Demonstrated sterility, viral safety, and validated pathogen reduction
Q15. Reconstitution of lyophilized plasma should be performed using:
- Distilled water at boiling temperature
- Sterile water or appropriate isotonic diluent at controlled temperature
- Any available IV fluid without regard to compatibility
- Alcohol-based diluent
Correct Answer: Sterile water or appropriate isotonic diluent at controlled temperature
Q16. Which measurement indicates adequate concentration of total protein in reconstituted plasma?
- Colony forming units per mL
- Total protein assay (g/dL)
- Lipase activity
- Colorimetric glucose level
Correct Answer: Total protein assay (g/dL)
Q17. Lyophilized plasma intended for military use is often valued because it:
- Requires complex cold-chain logistics
- Is bulky and heavy
- Is lightweight, stable at ambient temperatures, and rapidly reconstitutable
- Has shorter shelf-life than liquid plasma
Correct Answer: Is lightweight, stable at ambient temperatures, and rapidly reconstitutable
Q18. Which adverse event is most associated with plasma transfusion rather than plasma substitutes?
- Transfusion-related acute lung injury (TRALI)
- Hypokalemia
- Osmotic demyelination syndrome
- Excessive sedation
Correct Answer: Transfusion-related acute lung injury (TRALI)
Q19. Which component separation method historically underpins plasma fractionation for therapeutic proteins?
- Cohn cold ethanol fractionation
- High-temperature denaturation
- Ionizing radiation precipitation
- Simple gravity filtration
Correct Answer: Cohn cold ethanol fractionation
Q20. Which analytical test assesses the presence of endotoxin contamination in plasma products?
- Limulus amebocyte lysate (LAL) assay
- Bradford protein assay
- ELISA for albumin only
- Nitric oxide assay
Correct Answer: Limulus amebocyte lysate (LAL) assay
Q21. Which characteristic of plasma substitutes helps maintain intravascular volume most effectively?
- High molecular weight and colloid osmotic pressure
- Low pH
- Lipid solubility
- Ability to cross the blood‑brain barrier
Correct Answer: High molecular weight and colloid osmotic pressure
Q22. Which excipient can lower the glass transition temperature (Tg’) and compromise freeze-drying stability if used improperly?
- Sucrose at optimal concentration
- High concentrations of salts
- Trehalose within stabilizing range
- Properly buffered phosphate
Correct Answer: High concentrations of salts
Q23. Which practice reduces the risk of viral transmission in pooled plasma products?
- Minimizing donor screening
- Omitting pathogen-reduction steps
- Implementing donor screening, NAT testing, and pathogen inactivation
- Using expired plasma for pooling
Correct Answer: Implementing donor screening, NAT testing, and pathogen inactivation
Q24. Which property is typically lower in crystalloids compared with colloid plasma substitutes?
- Ability to expand intravascular volume for prolonged periods
- Electrolyte content
- Sterility
- pH
Correct Answer: Ability to expand intravascular volume for prolonged periods
Q25. What is a major limitation of hydroxyethyl starch (HES) as a plasma substitute?
- It is universally cheap and safe
- Risk of kidney injury and coagulopathy in some patients
- It provides oxygen-carrying capacity
- It is completely non-immunogenic
Correct Answer: Risk of kidney injury and coagulopathy in some patients
Q26. Which storage condition is generally recommended for lyophilized plasma to maximize shelf-life?
- Room temperature with high humidity
- Controlled low humidity and recommended temperature per label
- Direct sunlight exposure
- Open vial storage
Correct Answer: Controlled low humidity and recommended temperature per label
Q27. Which test confirms functional fibrinogen in reconstituted dried plasma?
- Fibrinogen assay (Clauss method)
- Serum creatinine
- Lipid profile
- Glucose tolerance test
Correct Answer: Fibrinogen assay (Clauss method)
Q28. Which property distinguishes spray-dried plasma particles from lyophilized cake?
- Spray-dried particles form a porous cake
- Spray-dried particles are typically fine powders with high surface area
- Lyophilized product is always a fine powder
- Both have identical reconstitution times
Correct Answer: Spray-dried particles are typically fine powders with high surface area
Q29. Which factor is most important when selecting a diluent for reconstituting dried plasma for transfusion?
- Color of the diluent
- Isotonicity and compatibility with plasma components
- Ability to support bacterial growth
- High glucose concentration regardless of osmolarity
Correct Answer: Isotonicity and compatibility with plasma components
Q30. Which emerging technology aims to provide small, stable, synthetic oxygen carriers as plasma substitutes?
- Traditional albumin fractionation
- Hemoglobin-based oxygen carriers (HBOCs) and nanoparticle oxygen therapeutics
- Simple saline solutions
- Unfractionated plasma pooling only
Correct Answer: Hemoglobin-based oxygen carriers (HBOCs) and nanoparticle oxygen therapeutics
I am a Registered Pharmacist under the Pharmacy Act, 1948, and the founder of PharmacyFreak.com. I hold a Bachelor of Pharmacy degree from Rungta College of Pharmaceutical Science and Research. With a strong academic foundation and practical knowledge, I am committed to providing accurate, easy-to-understand content to support pharmacy students and professionals. My aim is to make complex pharmaceutical concepts accessible and useful for real-world application.
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