The Packing of drugs is a very crucial part because the safety of drugs is a must at every stage from manufacturing to packaging. Packaging helps the drugs to prevent from the external environment. Today there is numerous job available in the pharmaceutical field, and you have lots of option to choose your carrier in pharma according to your interest.
Pharma packaging has a waste opportunity to work, but you need to be well prepared before getting into it. We have prepared the list of all Questions Related to Pharma Packing/production. Questions and answers are prepared based on Fresher and Experienced Persons that are generally asked in Pharmaceutical Interviews. Packing questions are Related to Machinery and Technical rounds.
NOTE-more Questions will be added periodically, so visit again for more:
Packing questions for Freshers:
Q1. What are the Packing and types of packing in pharmaceuticals?
Ans: Packing is an art and technology of enclosing or protecting products for distribution, storage, sales, and use.
Packing mainly of three types.
- Primary packaging is the material that carries the drug product.
- Secondary packaging is after the primary, outside of primary Packing to primary group packing.
- Tertiary used for bulk handling of dugs like storage in a warehouse.
Q2. The objective of packaging?
The main purpose of drugs packaging is the protection of drugs from;
- Physical protection
- Barrier protection
- Containment or agglomeration
- Portion control
Q3. What is the primary Packing material used for the blister pack:
Ans: Lidding foil likes aluminum foil, paper aluminum foil, glasin paper foil.
Base foil- PVC( polyvinyl chloride) and PVDC (polyvinylidene chloride).
Q4. Advantage and Disadvantage of PVC:
Ans: Advantage: Low coast and Easy of thermoforming
Disadvantage: Poor barrier against moisture ingress and oxygen ingress.
Q5. How do we overcome the lack of barrier properties of PVC?
Ans: To overcome this PVC done coating with PVDC/ laminated to PCTFE (Polychlorotrifluoroethylene) or COC (Cyclic olefin copolymers) to increase protective properties.
Q6. What are WVTR and OTR?
Ans: WVTR is water vapor transmission Rate
OTR is an oxygen transmission rate.
Q7. WVTR and OTR of PVC?
Ans: WVTR 250 Micro PVC =3.0g/m2/day at 38 °C/90% RH.
OTR around =20 ml/m2/day.
Q8. What is GSM?
Ans: GSM is Gram per square meter, coating of PVC expressed in GSM, more GSM means more barrier property against moisture and gases.
Q9. How to calculate GSM?
weight of sample ✕ 1000/ area of the sample
Q10. What is thermoforming and cold forming?
Ans: Thermoforming– PVC/PVDC passage through a heating station, then PVC/PVDC took desired shape at a temperature of around 115°C to 130 °C. The heating temperature may vary according to pocket size and shape.
Cold forming is the formation of pockets without heating PVC. Cold forming PVC is soft made of aluminum between PVC and polyamide.
Packing Question for experienced pharma professionals:
Q11. The machine used for blister pack and strip pack?
Ans: BQS (blister quickly through servo) and elmach mainly used in the case of product pack by using PVC/PVDC material. ALU-ALU(arithmetic logical unit) machine used for strip packing(aluminum foil used for both sides)
Q12. Dismantle parts of the blister machine?
- Forming dia set
- Web index Roller
- Guide track
- Heater (PSR)
- Printing (BCP)
- Printing gears
- Perforation guide track
- Perforation tool
- Embossing tool
- Punching tool
- Cutting gears
- Sealing gear
- Punching indexing roller
Q13. Different types of machines used for tablets in primary Packing?
- Blister machine eg. alu-alu (BQS), elmach EPI 2000,2500,3010,3015 and 3522 grand etc.
- Stripe Packing machine.
Q14. Some important Terms and full form:
Ans: BFR– Blister forming Roller, CSR– Counter sealing Roller, PHR– Peripheral Heating Roller, PSR– Pressure sealing Roller, BCP– Batch Coding and Printing, PRC– Print Registration control,
Q15. Checking of dispensing raw and packing materials:
Ans: Follow FEFO (First expiry first out) rule, AR.No. (analytical report number), the quantity of material, product code, and affix of approved labels from quality control.
Q16. Pharmaceutical barcode system:
Ans: Barcode is an image of lines and lines denoted with a specific number; lines may be thick, wide, and thin lines.
The code represents a sequence of lines for a particular number. A bar code symbol typically consists of five-zone, a quiet zone, a start character, data digits, a stop character, and another quiet zone.
Q17. Track and trace system in pharmaceuticals:
Ans: Track and trace systems are effectively used for the serialization in pharmaceutical, identification, and prevent counterfeit drugs throughout the supply chain.
Q18. Difference between 1D, 2D, and 3D Bar-code:
Also called one dimension barcode consists of a parallel linear line with a white background.it stores 8-15 character data information
Also called two dimensions or matrix barcode having box types structure.it can stores up to 2000 characters.
Uses the peak of the lines to insert information. The information in the 3D barcode is mostly correct and can’t be seen by the eye. This makes it tamper-proof and a great aid for business set-ups. 3D barcode is a superb resolution for rectifying varied issues, like inaccurate valuation, inventory errors, and overstocking, that is common within the case of 2D barcodes.
Q19. Explain 2D Barcode:
Ans: It looks like squares or rectangular with small dots.
Q20. How many sensors were used in the BQS machine:
- Lidding foil sensor
- Sensor for forming foil
- Inlet water sensor
- Hopper sensor for check product level
- Heating plate sensor
Q21. Name of Sensors used in cartonator machine:
Ans: Product magazine sensor, product count sensor, carton call, low carton call, pusher call, loading safety, a sensor for rotary, the in-counter sensor for the position, hand-wheel sensor, hand wheel out sensor, empty carton rejection sensor.
22. Principle of Blister packing machine (BQS)?
Ans: For BQS (in the case of the heating plate and sealing plate) works on the Principle of flat sealing and flat forming.
For blister machine (in the case of the heating plate and sealing Roller) works on flat forming and roller sealing.
23. How Many Servo motors are in the Blister machine?
Ans: Blister Quick Through (BQS) has a total of 5 servo motors:
- Main cam
- Feeding drum
- Printing drum
- Puller drum
- Punching cam
Q24. How many Challenge tests for the Camera vision system:
Ans: challenge test for Empty cavity, Broken Tablet, Discolored tablet, and foreign Particles.
Q25. Thermal Test for thermally affected Blister:
Ans: Stop the machine and mark all the blisters which are contacted with a hot or sealing plate / Roller with a marker. Ensure that all contacted blisters are rejected.
Q26. What is knurling
Ans: Dotes are found on blister /strips, which comes during sealing of blister/ Strips due to the presence of dotes on the Sealing plate/Roller. Knurling prevents the failure of leak test and also contribute towards maintaining good quality blisters.
Q27. Types of knurling
Ans: Knurling types: Cross net type, dote type, and Diamond shape
Q28. What is stiffener, and why is it used?
Ans: Presence of extra empty pockets or grooves on Blister is known as stiffener is used for protection of products to get damaged during Packing and transport
Q29. Which Test is done to test for PVDC:
Ans: Morpholine test is done for checking PVDC layer, use one drop of morpholine solution on either PVDC to check the property if the color of foil change to yellowish its means it passes the Test.
Q30. What is NFD stand for?
ANS: NFD stands for non-fill detector
Q31. What is the Role of a Pinhole detector?
Ans: The pinhole detection system uses to identify holes as small as 25 microns (0.001 inches). It has high infrared-sensitive radiation to detect a very small hole.
Q32. Tell the name of Ink used to detect leakage in Blister:
Ans: Methylene blue solution is used during the leak test process. The percentage of uses is 2% v/v.
Q33. How many blister/strips were used for the leak test?
Ans: It depends on the number of pockets present in sealing plates/rollers.
Q34. How do a challenge test for leak test apparatus?
Ans: Puncher the blister/strips with the help of a small sharp needle and perform leak test process, then visually check by opening blister/strips, if tablet found leak Means Test is a pass.
Q35. How much vacuum is required for the check leak test?
Ans: The standard vacuum used for leak test apparatus is 280±10. It may vary from region to region.
Q36. What is the frequency of the leak test?
- Start of batch and then after every one hour
- After the change of printing./PVC/pvdc foil.
- After every break
- At the start of the shift
- After power failure
Q37. The setting of weight limit for cartons:
Ans: Take individual 20 cartons weight and calculate avg. Weight of 20 cartons, now take half weight of blister/strips and leaflets (lower in weight).
Q38. How to calculate the minimum and maximum weight of carton:
Ans: Minimum weight: standard weight of carton- 50% weight of blister/leaflet (lower in weight)
Maximum weight: standard weight of carton+ 50% weight of blister/leaflet (lower in weight)
Q39. Die Depth of forming Roller?
Ans: In case of PVC: At for Flat forming and sealing- 12mm
In case of Alu- Alu: Cold forming- 09mm
Q40. Rubber Stereo Size used in Packing?
Ans: Generally used rubber stereo size is 1.75 to 2.5mm.
Q41. Types of Rubber stereo used in Packing
Ans: Flate and Groove
Q42. Monthly Calibration of weighing balance done for?
Ans: Monthly Calibration of weighing balance is done for Accuracy, Reproducibility, and Eccentricity.
Q43. Why do the Calibration of balance?
Ans: Calibration is done for measurement accuracy of the instrument compared to specified limits.
Q44. Defects Related to Blister Pack
Ans: Empty Blister, cut pocket, knurling defects, printing defects on foil, overprinting defects, embossing defects, pocket cut, I mark defects, cutting defects, and pinhole.
Q45. Validation criteria for batch packing
Ans: Validate the batch as per the given validation protocol. Some common criteria are:
High forming, high sealing, and low machine speed.
Low forming, Low sealing, and High machine speed
Moderate forming and sealing with moderate speed
Perform in-process and leak test at every stage and fill details in BPR.
Q46. How to create a batch in camera vision system
Q47. Which coating is done on Heating drums and their purposes?
Ans: Teflon coating is done to prevent the sticking of thermoplastic foil with a heating roller or plate.
Note: More Pharma packing questions for the interview will be added soon here. Comment if any Questions to get an answer and also share valuable information.