30+ Pharma technical interview questions and answer for the packing department

Pharma technical interview questions and answer for the packing department?

Qus.1. What are the Packing and types of packing in pharmaceuticals?

Ans: Packing is an art and technology of enclosing or protecting products for handling, distribution, storage, sales, and uses for patients. Packing are mainly three types are use in pharmaceutical industry. 

1. Primary packaging:- Primary packaging is the material that carries the drug product. Its direct contact to the product for protection.
   
2. Secondary packaging:- Secondary packaging is after the primary, outside of primary Packing to primary group packing.
3. Tertiary Packing:- Tertiary used for bulk handling of dugs like storage in a warehouse or transportation.
   

Qus.2. What is morpholine solution test?

Ans. 1 drop of morpholine solution dropped on PVDC (Poly vinyl diene chloride) layer it give yellow colour appears.

Qus.3. What is challenge test for PVC (Poly vinyl chloride)?

Ans. PVC film shall be dissolvein Tetrahydrofuran.

Qus.4. Why mainly PVDC is used to pack blister in blister packing?

Ans.

1. Because PVC compare with PVDC, there WVTR and OTR are very low.

2. PVDC is water based coating often used to improve barrier and reduce permeability.

Qus.5. What is WVTR and OTR?

Ans.

WVTR- Water Vapour Transmission Rate

OTR- Oxygen Transmission Rate

Qus.6. What is the size of stereo used in packing?

Ans. 1.75 mm to 2.5 mm

Qus.7. What is reason if sealing is not proper?

Ans.

• Check sealing pressure
• Check sealing temperature
• Knurling problems
• Foil problems
• Heater damage

Qus.8. What is reason if Forming is not proper?

Ans.

• Check forming temperature
• Vacuum pressure
• Cooling problems
• Heater damege
• PVC / PVDC problems

Qus.9. What is the principal of BQS, blister packing machine and how many servo motor in BQS ?

Ans. "Flat Forming and Flat sealing"

Forming area- 240 × 180 mm

Maximum speed - 45

Depth cavity (Forming depth) :- For Alu-Alu (Cold Forming) - 9 mm and For PVC, PVDC (Thermo Forming) - 12 mm

Forming speed - Upto 8.1 meter/min.

Forming Cycles :- For Thermo Forming Foil - Upto 45 cycle /min. and For Cold Foil - Upto 35 cycle /min.

Roll diameter (PVC Foil)- Max. 400 mm

Roll diameter (Lidding Foil)- Max. 250 mm

Punching Cycles- Max 180 cycle/min.

Qus.10. How mainy servo motor in BQS blister packing machine?

Ans. In BQS "5" servo motor

1. Main cam servo

2. Drum Feeding Servo

3. Punching Servo

4. Printing Servo

5. Pulling Servo

Qus.11.  What is the principal of EPI 2500 blister packing machine?

Ans. EPI 2500 Principal :- "Rotory Sealing and Rotory Forming" (depth cavity - 10 mm) and (maximum speed - 150)

Qus.12. What is the principal of
EPI 3010 blister packing machine and how many servo motor?

Ans. EPI 3010 (Two Track) Principal :- Same as BQS principal "Flat Forming and Flat sealing" (Maximum speed - 40)

In 3010 (4 Servo Motor are there)

Qus.13. Name of Blister packing machine change parts?

Ans. Blister Packing Machine Change Parts:-

1. BFR (Blister Forming Roller)

2. CSR (Counter Sealing Roller)

3. Feeding Channel

4. BCP Unit

5. Cutting gear

6. Guide Track

7. Punching Tool

Qus.14. What is the main objective of packing?

Ans. The main purpose of drug packaging is the protection of drug from:-

1. Physical protection
2. Barrier protection from open environment
3. Containment or agglomeration

4. Security
5. Portion control
6. Convenience.

Qus.15. 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. 

Qus.16. 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 from environment.

Qus.17. How to calculate GSM? 

Ans. weight of sample ✕ 1000 / area of the sample 

Qus.18. What is thermoforming and cold forming blister? 

Ans. Thermoforming:- PVC / PVDC passage through a heating station, then PVC / PVDC took desired shape at a temperature of around 110°C to 140 °C. The heating temperature may vary according to pocket size and shape.  

Cold forming:- Cold forming is the formation of pockets without heating PVC. Cold forming PVC is soft made of aluminum between PVC and polyamide.

Qus.19. 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 are used for both sides to pack drug product)

Qus.20. What solution 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.

Qus.21. Dismantle parts of the blister machine?

Ans. Dismantle parts of the blister packing machine are:

Forming die set

Web index Roller 

Channel 

Guide track 

CSR

Heater (PSR) 

Printing (BCP) 

Printing gears 

Perforation guide track 

Perforation tool 

Embossing tool 

Punching tool 

Cutting gears 

Sealing gear 

Punching indexing roller

Qus.22. What is pharmaceutical bar code 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.
Qus.23. What is 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.

Qus.24. What 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 in blister etc.

Qus.25. 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) in foil or blister. It has high infrared-sensitive radiation to detect a very small hole.
Qus.26. How many blister/strips were used for the leak test?
Ans. It depends on the number of pockets present in sealing plates/rollers.
Qus.27. 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. After completion of process visually check by opening blister/strips, if tablet found leak it means test is pass.
Qus.28. 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.
Qus.29. What is the frequency of the leak test?

Ans. Frequency of the leak test :

• Start of batch and then every one hour and end of batch
  
• After the change of printing./PVC/pvdc foil
• After every break
• At the start of the shift
• After power failure

Qus.30. 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 during blisters/strips packing.
Qus.31. How many Types of knurling?
Ans. Knurling types:

1. Cross Net Type Knurling
2. Dote Type Knurling
3. Diamond Shape Knurling