Multiple-Choice Questions (MCQs) & answer on cleaning validation Considering Packaging Materials & Tubing and Hoses
Questions 1: Which of the following is a primary consideration before using tubing or hoses in pharmaceutical manufacturing?
A. Color of the tubing
B. Biocompatibility and inertness with the contact material
C. Cost of the tubing
D. Manufacturer’s brand name
Answer: B
Questions 2.: Transfer tubing and hoses used in manufacturing processes must comply with which regulatory standard?
A.ISO 14644
B. EU Annex 1
C. U.S. FDA 21 CFR Part 177.2600
D. OSHA 1910
Answer: C
Questions 3: The FDA rule for transfer tubing and hoses is applied in combination with which additional standards?
A.ISO 13485 and ICH Q9
B. ISO 10993-1 and USP Class I–VI plastics tests
C. USP <788> and <790>
D. ICH Q7 and Q10
Answer: B
Questions 4: An effective cleaning procedure for tubing should:
A. Use only cold water
B. Expose all product contact surfaces and the internal bore to detergent and rinsing solution
C. Avoid turbulent flow to protect tubing integrity
D. Use only manual wiping
Answer: B
Questions 5: Why is turbulent flow important during cleaning of tubing and hoses?
A. It helps reduce water use
B. It increases the temperature of the cleaning solution
C. It enhances removal of residues from the internal surface
D. It prevents corrosion
Answer: C
Questions 6: What device may be used to visually inspect the internal bore of tubing for residue removal efficiency?
A. Thermometer
B. Borescope
C. Endotoxin meter
D. Tachometer
Answer: B
Questions 7: What is recommended for tubing and hoses when they are not in use?
A. Keep them filled with water
B. Store them at high temperature
C. Drain them of any water or residual solution
D. Close both ends tightly to retain moisture
Answer: C
Questions 8: Tubing or hoses that are cleaned in place (CIP) while attached to equipment:
A. Are cleaned separately with a different regimen
B. Receive the same cleaning regimen as the main equipment
C. Do not require cleaning
D. Must be removed before cleaning
Answer: B
Questions 9.: When selecting a cleaning detergent or procedure, priority is given to:
A. The tubing and hoses
B. The attached equipment
C. The operator’s preference
D. Cost of the detergent
Answer: B
Questions 10: Shorter tubing length may improve cleaning because it helps with:
A. Reducing material costs only
B. Enhancing drainage and storage management
C. Increasing internal pressure
D. Improving color uniformity
Answer: B
Questions 11: Automated hose washers and CIP equipment:
A. Are not recommended for tubing cleaning
B. Can be used but cannot be qualified
C. May be utilized and qualified for consistent cleaning performance
D. Are used only for stainless-steel piping
Answer: C
Questions 12: The design of tubing and hoses should consider:
A. Permanent embedding or welded connections
B. Color-coded labeling
C. Reusability only
D. Low-cost materials
Answer: A
Questions 13.: Primary packaging equipment may exert direct impact on:
A. Maintenance schedules
B. The quality of the finished product
C. Marketing requirements
D. Storage conditions
Answer: B
Questions 14: Which of the following is not listed as an example of primary packaging equipment?
A. Tablet fillers
B. Tube fillers
C. Blister machines
D. Label printers
Answer: D
Questions 15: The cleaning and validation practices for primary packaging equipment should be similar to those for:
A. Warehousing equipment
B. Direct impact manufacturing equipment
C. Secondary packaging equipment
D. Utility systems
Answer: B
Questions 16: Auxiliary equipment such as hoppers and tubing should be cleaned and validated:
A. Only once during installation
B. Less frequently than filling equipment
C. In the same manner as associated filling equipment
D. Only if contamination is detected
Answer: C
Questions 17: The design of packaging equipment should consider gentle handling primarily to minimize:
A. Labeling errors
B. Attrition and breakage of solid dosage products
C. Worker fatigue
D. Equipment downtime
Answer: B
Questions 18: For liquid products, equipment design should help minimize:
A. Water usage
B. Adsorption of liquids
C. Transport time
D. Color variation
Answer: B
Questions 19: Cleaning of dedicated primary packaging lines:
A. Always requires full validation
B. Never requires cleaning
C. May not require validation
D. Must be validated after every batch
Answer: C
Questions 20: Minimizing validation efforts for primary packaging lines can be achieved by:
A. Reducing staff training
B. Improving batch documentation
C. Careful design of equipment and cleaning procedures
D. Increasing product volume
Answer: C
Questions 21: Preferential transfer of residues from packaging equipment to the initial product can be reduced by:
A. Increasing equipment speed
B. Reducing cleaning frequency
C. Discarding an initial portion of processed product
D. Storing product at lower temperatures
Answer: C
Questions 22: Primary packaging equipment includes machinery that has:
A. No contact with product
B. Direct finished dosage product contact
C. Only indirect contact with product
D. Contact only with secondary packaging
Answer: B
Questions 23: What is the key design consideration for secondary packaging equipment?
A. Maximum product throughput
B. Allowing only minimal inevitable residuals from the packaging process
C. Reducing machine noise
D. Ensuring full sterility
Answer: B
Questions 24: Although secondary packaging equipment does not directly impact product quality, appropriate attention must be given to:
A. HVAC requirements
B. Documenting cleaning
C. Equipment color-coding
D. Operator training levels
Answer B
Questions 25: Once the drug substance is sealed in primary packaging, the risk of cross-contamination is generally:
A. Extremely high
B. Moderate
C. Relatively low
D. Unpredictable
Answer: C
Questions 26: Cleaning processes used after primary packaging on packaging lines:
A. Require full cleaning validation
B. Do not require cleaning validation
C. Are optional
D. Must be performed only annually
Answer: B
Questions 27: The main concern with cross-contamination after primary packaging involves:
A. Incorrect labeling
B. A compromised primary package releasing product
C. Temperature fluctuations
D. Damaged secondary packaging
Answer: B
Questions 28: Contamination after primary packaging typically affects:
A. Internal product quality only
B. The outside of the primary package
C. The product formulation
D. Only secondary packaging
Answer: B
Questions 29: The need for cleaning validation in this context should be based on:
A. Cost of cleaning products
B. The risk to patients or people handling the vials
C. Manufacturing throughput
D. Operator preferences
Answer: B
Questions 30: In cases involving highly hazardous products (e.g., genotoxic APIs), an appropriate measure may include:
A. Reducing primary packaging thickness
B. Using a dedicated line
C. Eliminating cleaning steps
D. Shortening production shifts
Answer: B
Questions 31: When a cleaning step is used to remove or deactivate a hazardous API, effectiveness should be confirmed by:
A. Operator observation
B. Equipment vendor reports
C. A laboratory study showing degradation or inactivation
D. Visual inspection only
Answer: C
Reference: PDA-Cleaning-Validation -Technical Report No. 29 (Revised 2012).