Filling and packaging of liquid orals MCQs With Answer

Filling and packaging of liquid orals MCQs With Answer is a focused review for B.Pharm students covering principles and practice in formulation filling, container-closure systems, and packaging operations. This topic emphasizes filling machines, volumetric and peristaltic dosing, aseptic technique, contamination control, product stability, preservatives, viscosity management, and choice of bottles, ampoules, and vials. Key quality attributes include dosing accuracy, seal integrity, labeling, and compliance with SOPs, GMP, and microbial limits. Understanding inspection, cleaning, sterilization, and packaging materials ensures patient safety and regulatory compliance. This introduction prepares students for practical questions on equipment, process validation, troubleshooting, and quality control. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. Which filling mechanism is best suited for viscous oral syrups to ensure accurate volumetric dosing?

• Piston filler
• Gravity filler
• Aeration filler
• Flow-through viscometer

Correct Answer: Piston filler

Q2. What is the primary reason for using amber glass bottles for certain liquid orals?

• To reduce packaging cost
• To protect light-sensitive drugs from photodegradation
• To increase oxygen permeability
• To improve product viscosity

Correct Answer: To protect light-sensitive drugs from photodegradation

Q3. Which parameter is most critical during filling to ensure content uniformity and patient safety?

• Machine color
• Dosing accuracy / fill volume precision
• Operator height
• Label font size

Correct Answer: Dosing accuracy / fill volume precision

Q4. In aseptic filling of sterile oral solutions, what is the purpose of a laminar flow hood?

• To warm the product before filling
• To provide unidirectional clean airflow to minimize contamination
• To sterilize the container by heat
• To mix preservatives into the formulation

Correct Answer: To provide unidirectional clean airflow to minimize contamination

Q5. Which cleaning method is commonly used for filling machine piping to remove residues without disassembly?

• CIP (Clean-In-Place)
• Dry ice blasting only
• Manual scrubbing every shift
• Gamma irradiation while running

Correct Answer: CIP (Clean-In-Place)

Q6. Which preservative is commonly used in acidic oral syrups to prevent microbial growth?

• Sodium benzoate
• Benzalkonium chloride
• Sodium lauryl sulfate
• Isopropyl alcohol

Correct Answer: Sodium benzoate

Q7. What is the main advantage of using peristaltic pumps in filling non-sterile liquid orals?

• They cause more shear stress than piston pumps
• Product contacts only the tubing, reducing contamination risk
• They are cheaper to operate than manual filling
• They increase air entrainment in suspensions

Correct Answer: Product contacts only the tubing, reducing contamination risk

Q8. During packaging validation, which study demonstrates consistent performance under normal operating conditions?

• IQ (Installation Qualification)
• OQ (Operational Qualification)
• PQ (Performance Qualification)
• DQ (Design Qualification)

Correct Answer: PQ (Performance Qualification)

Q9. Which test is essential to ensure container-closure integrity for liquid orals?

• pH test
• Microbial endotoxin test
• Leak / seal integrity test
• Viscosity measurement

Correct Answer: Leak / seal integrity test

Q10. For suspensions, what step before filling helps minimize content non-uniformity and dosing errors?

• Freeze-thaw cycling
• Homogenization or controlled agitation to ensure uniform dispersion
• Removing preservatives
• Adding air to aid mixing

Correct Answer: Homogenization or controlled agitation to ensure uniform dispersion

Q11. Which packaging material is most likely to leach plasticizers into alcohol-containing syrups?

• Amber glass
• HDPE without additives
• PVC (polyvinyl chloride) plasticized films
• Stainless steel

Correct Answer: PVC (polyvinyl chloride) plasticized films

Q12. What is overfill and why is it controlled in liquid oral packaging?

• Extra label information; not important
• Excess product in the container to ensure correct delivered dose; controlled to reduce waste and cost
• Air space in the bottle; increases microbial growth intentionally
• Liquid lost during transport; not measurable

Correct Answer: Excess product in the container to ensure correct delivered dose; controlled to reduce waste and cost

Q13. Which microbial test is routinely performed to ensure non-sterile liquid orals meet safety criteria?

• Sterility test for aseptic products only
• Total aerobic microbial count (TAMC) and absence of specified pathogens
• DSC thermal analysis
• Colorimetric pH strip

Correct Answer: Total aerobic microbial count (TAMC) and absence of specified pathogens

Q14. What is the effect of high viscosity on filling line operation for liquid orals?

• Improved accuracy without machine changes
• Increased back-pressure, slower fill speeds, and possible need for heated systems or piston filling
• No effect if using gravity fillers
• Guaranteed sterility improvement

Correct Answer: Increased back-pressure, slower fill speeds, and possible need for heated systems or piston filling

Q15. Which closure feature provides patient safety by showing evidence of tampering?

• Opaque color
• Tamper-evident band or seal
• Non-screw cap
• Exposed liner

Correct Answer: Tamper-evident band or seal

Q16. During filling of a preservative-containing oral solution, why must pH be carefully controlled?

• pH only affects color, not preservation
• Preservative efficacy is pH-dependent and impacts microbial stability
• Lower pH always increases viscosity
• pH controls label adhesion only

Correct Answer: Preservative efficacy is pH-dependent and impacts microbial stability

Q17. Which inspection method is commonly used to detect particulate contamination in filled bottles?

• Automated visual inspection under transmitted light
• Smell test
• Thermal imaging
• UV sterilization

Correct Answer: Automated visual inspection under transmitted light

Q18. What is the primary regulatory requirement for labeling liquid oral dosage packaging?

• Use of fluorescent inks
• Clear declaration of drug name, strength, batch number, manufacturing and expiry dates, storage instructions
• Use of child-friendly cartoons
• Label must be handwritten

Correct Answer: Clear declaration of drug name, strength, batch number, manufacturing and expiry dates, storage instructions

Q19. Which parameter is included in process validation to ensure repeatable filling performance?

• Operator eye color
• Critical process parameters like fill volume, speed, and torque monitored across runs
• Label designer name
• Packaging room wallpaper color

Correct Answer: Critical process parameters like fill volume, speed, and torque monitored across runs

Q20. For pediatric oral liquids, which packaging consideration is essential?

• Large bottle sizes only
• Child-resistant closures and accurate dosing devices (measuring cups or syringes)
• Opaque labels to hide instructions
• Use of adult-only caps

Correct Answer: Child-resistant closures and accurate dosing devices (measuring cups or syringes)

Q21. What role does deaeration play before filling liquid orals?

• Introduces oxygen to preserve color
• Removes entrained air to reduce foaming and ensure accurate fill volumes
• Raises pH for preservative activity
• Sterilizes the product

Correct Answer: Removes entrained air to reduce foaming and ensure accurate fill volumes

Q22. Which container-closure system is preferred for reclosable oral suspensions requiring frequent dosing?

• Induction-sealed single-use ampoules
• Screw-cap bottle with child-resistant closure and dosing syringe or cup
• Hermetically sealed vial with crimp cap
• Metal can

Correct Answer: Screw-cap bottle with child-resistant closure and dosing syringe or cup

Q23. Which factor most increases the risk of microbial contamination during manual filling operations?

• Excessive automation
• Poor operator hygiene and inadequate aseptic technique
• Using glass instead of plastic
• High ambient light levels

Correct Answer: Poor operator hygiene and inadequate aseptic technique

Q24. What is the main purpose of an induction liner applied to bottle necks?

• To improve bottle color
• To provide a hermetic seal and tamper evidence
• To make bottles heavier
• To absorb preservatives

Correct Answer: To provide a hermetic seal and tamper evidence

Q25. Which filling error would most likely cause under-dosing of medication in unit doses?

• Over-aggressive deaeration
• Systematic calibration drift leading to reduced fill volume
• Using amber glass
• Applying tamper-evident seals

Correct Answer: Systematic calibration drift leading to reduced fill volume

Q26. Why is in-process monitoring of viscosity important for liquid oral manufacturing?

• Viscosity affects dosing accuracy, pump selection, mixing, and stability
• Viscosity only affects label adhesion
• Viscosity ensures sterile conditions
• Viscosity controls color only

Correct Answer: Viscosity affects dosing accuracy, pump selection, mixing, and stability

Q27. Which stability concern is specific to aqueous liquid orals stored at high temperatures?

• Improved preservative activity
• Accelerated hydrolysis and decreased preservative efficacy leading to degradation
• Reduced solubility of active ingredients only in glass
• Decreased microbial growth

Correct Answer: Accelerated hydrolysis and decreased preservative efficacy leading to degradation

Q28. What is a common corrective action when visible particulate contamination is found in a filled batch?

• Ignore and release the batch
• Quarantine batch, investigate root cause, perform cleaning, re-inspect and possibly recall affected units
• Change the label to hide the issue
• Only test pH and release

Correct Answer: Quarantine batch, investigate root cause, perform cleaning, re-inspect and possibly recall affected units

Q29. Which documentation is critical to trace each filled container back to its production conditions?

• Batch manufacturing records and equipment logs including fill parameters
• Marketing brochures
• Supplier price lists
• Operator lunch menus

Correct Answer: Batch manufacturing records and equipment logs including fill parameters

Q30. For sterile liquid orals requiring sterilization, which method is incompatible with heat-labile APIs?

• Filter sterilization through 0.22 µm membranes
• Autoclaving (moist heat sterilization)
• Terminal dry heat sterilization at high temperature
• Gamma irradiation under controlled conditions

Correct Answer: Autoclaving (moist heat sterilization)

G S Sachin

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.

Mail- Sachin@pharmacyfreak.com