QC testing for ophthalmic and surgical products MCQs With Answer

Introduction

This quiz compilation focuses on quality control testing for ophthalmic and surgical products, tailored for M.Pharm students. It covers critical analytical and microbiological tests such as sterility, bacterial endotoxin, particulate matter, pH, osmolality, preservative efficacy, container-closure integrity, and sterilization validation methods. Questions also probe regulatory references, acceptance criteria, and practical aspects of sample handling, bioburden limits, and sterilization assurance levels specific to ophthalmic solutions, eye drops, and sterile surgical devices. Use these MCQs to strengthen conceptual understanding and practical decision-making for QC laboratories, regulatory submissions, and validation activities in sterile dosage form manufacturing.

Q1. Which USP chapter primarily describes the test and acceptance criteria for bacterial endotoxins used for parenteral and ophthalmic products?

• USP Chapter 71 Sterility Tests
• USP Chapter 85 Bacterial Endotoxins Test
• USP Chapter 66 Microbiological Examination of Nonsterile Products
• USP Chapter 161 Weighing on an Analytical Balance

Correct Answer: USP Chapter 85 Bacterial Endotoxins Test

Q2. For ophthalmic solutions, why is osmolality testing important?

• To determine preservative concentration only
• To ensure isotonicity with tear fluid and minimize irritation
• To test sterility of the product
• To evaluate container-closure integrity

Correct Answer: To ensure isotonicity with tear fluid and minimize irritation

Q3. Which test is most appropriate to detect visible and sub-visible particles in sterile ophthalmic solutions?

• Preservative Efficacy Test (PET)
• Particulate Matter Test (light obscuration) and visual inspection
• Bacterial Endotoxin Test
• pH Measurement

Correct Answer: Particulate Matter Test (light obscuration) and visual inspection

Q4. What is the usual acceptance limit for bacterial endotoxin in ophthalmic solutions expressed as Endotoxin Units (EU) per mL for products administered to the eye?

• Not more than 0.25 EU/mL for intrathecal delivery
• Generally not more than 0.5 EU/mL for ophthalmic solutions unless specified
• No limit for ophthalmic products
• 10 EU/mL for topical eye drops

Correct Answer: Generally not more than 0.5 EU/mL for ophthalmic solutions unless specified

Q5. Which sterilization method is most suitable for heat-sensitive ophthalmic devices such as contact lenses and some surgical single-use items?

• Moist heat autoclaving
• Gamma irradiation or ethylene oxide sterilization depending on material compatibility
• Dry heat sterilization at 180°C
• Boiling in water for 30 minutes

Correct Answer: Gamma irradiation or ethylene oxide sterilization depending on material compatibility

Q6. In sterility testing of ophthalmic products (USP Chapter 71), what is the typical sample size requirement for batch testing by membrane filtration when product is filterable?

• 1 mL only
• At least 10% of batch or a minimum of 2 units or 2 containers per batch
• All containers in the batch must be tested individually
• Only one container irrespective of batch size

Correct Answer: At least 10% of batch or a minimum of 2 units or 2 containers per batch

Q7. Which test assesses the ability of a preservative system in multi-dose ophthalmic products to inhibit microbial growth?

• Container-Closure Integrity Test
• Preservative Efficacy Test (PET) / Antimicrobial Effectiveness Test
• Bacterial Endotoxin Test
• pH and Osmolality testing

Correct Answer: Preservative Efficacy Test (PET) / Antimicrobial Effectiveness Test

Q8. For sterile surgical implants and devices, what does SAL 10^-6 represent?

• Surface area limit of 10^-6 m²
• A sterility assurance level indicating a one in a million probability of a viable microorganism surviving sterilization
• Temperature in Kelvin used during sterilization
• Pressure unit used during steam sterilization

Correct Answer: A sterility assurance level indicating a one in a million probability of a viable microorganism surviving sterilization

Q9. Which method is recommended to evaluate container-closure integrity (CCI) for ophthalmic dropper bottles to ensure sterility maintenance?

• Visual inspection only
• Deterministic methods such as helium leak testing, vacuum decay, or high voltage leak detection depending on materials
• Only sterility testing after storage
• Residual moisture content analysis

Correct Answer: Deterministic methods such as helium leak testing, vacuum decay, or high voltage leak detection depending on materials

Q10. Which of the following is the most appropriate test to detect pyrogenic substances from Gram-negative bacteria in ophthalmic solutions?

• Visual particulate inspection
• Limulus Amebocyte Lysate (LAL) assay or equivalent endotoxin test
• Sterility test (growth in culture media)
• pH and osmolarity measurement

Correct Answer: Limulus Amebocyte Lysate (LAL) assay or equivalent endotoxin test

Q11. During validation of a steam sterilization (autoclave) cycle for surgical instruments, which biological indicator is commonly used to demonstrate microbial inactivation?

• Escherichia coli culture count
• Geobacillus stearothermophilus spores
• Staphylococcus aureus vegetative cells
• Pseudomonas aeruginosa biofilm

Correct Answer: Geobacillus stearothermophilus spores

Q12. For ophthalmic suspensions, which QC parameter critically affects ocular comfort and dispersion of particles?

• Melting point of drug
• Viscosity and particle size distribution
• Color intensity only
• Tablet hardness

Correct Answer: Viscosity and particle size distribution

Q13. Which regulatory document provides guidance on sterilization validation and routine monitoring for healthcare products including surgical devices?

• ICH Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
• ISO 11135 (EO) and ISO 11137 (radiation) together with ISO 14937 general sterilization standards
• Pharmacopoeial chapter for topical creams only
• Guidance on color additives

Correct Answer: ISO 11135 (EO) and ISO 11137 (radiation) together with ISO 14937 general sterilization standards

Q14. In performing the bacterial endotoxin test using LAL, what is the purpose of the “limit test” approach?

• To quantify the exact bacterial species present
• To determine whether endotoxin content is below a specified limit rather than determine exact concentration
• To replace sterility testing
• To measure preservative efficacy

Correct Answer: To determine whether endotoxin content is below a specified limit rather than determine exact concentration

Q15. What is the significance of performing bioburden testing on raw medical textile dressings prior to terminal sterilization?

• It defines label claim for active ingredient concentration
• It provides baseline microbial load to design/validate sterilization cycle and estimate SAL achievement
• To determine particle count in the fabric
• To assess mechanical strength only

Correct Answer: It provides baseline microbial load to design/validate sterilization cycle and estimate SAL achievement

Q16. Which test must be performed on ophthalmic multi-dose containers to confirm that preservatives remain effective throughout shelf life?

• Accelerated dissolution testing
• Preservative Efficacy Test at initial, intermediate, and shelf-life time points
• Only initial sterility test is sufficient
• Metal content analysis

Correct Answer: Preservative Efficacy Test at initial, intermediate, and shelf-life time points

Q17. When evaluating residual ethylene oxide (EO) on sterilized surgical devices, which analytes are typically measured for safety assessment?

• Only total aerobic bacterial count
• Ethylene oxide, ethylene chlorohydrin (ECH), and ethylene glycol (EG) residues
• Only pH of rinse solution
• Protein content of packaging

Correct Answer: Ethylene oxide, ethylene chlorohydrin (ECH), and ethylene glycol (EG) residues

Q18. For ophthalmic parenteral injections (intraocular), which additional QC parameter is most stringently controlled compared to topical eye drops?

• Viscosity only
• Endotoxin limits and sterility are far more stringent; endotoxin often has lower acceptable EU limits
• Color matching
• Container weight

Correct Answer: Endotoxin limits and sterility are far more stringent; endotoxin often has lower acceptable EU limits

Q19. Which analytical approach is commonly used to characterize leachables and extractables from ophthalmic container-closure systems?

• Only visual inspection
• Chromatographic techniques (GC-MS, LC-MS) combined with TOC and targeted assays
• Sterility test replaces leachables testing
• Osmolality measurement alone

Correct Answer: Chromatographic techniques (GC-MS, LC-MS) combined with TOC and targeted assays

Q20. During quality control of a sterile ophthalmic solution, a viscosity increase and particulate formation are observed after accelerated stability. Which investigation steps are most appropriate?

• Ignore since accelerated conditions are irrelevant
• Perform microbial testing, particle analysis, identification of insoluble matter, pH/osmolality checks, and investigate packaging/compatibility and degradation products
• Only re-test pH and release the batch if pH is within limits
• Immediately recall all marketed products without investigation

Correct Answer: Perform microbial testing, particle analysis, identification of insoluble matter, pH/osmolality checks, and investigate packaging/compatibility and degradation products

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