Interview Questions for Pharmaceutical industry related jobs (QA,QC,Production,RA,f&d) for B.pharma /M.pharma (Part 8)

Requested By: for KVR Sudhir
Organization: Pharmaceuticals
Category : Parenterals

Questions

A.     VIAL WASHING  MACHINE QUESTIONS

1. What is purpose of vial washing machine?

Objective: Cleaning of Vial externally and internally to reduce the bio-burden.

Note:  It is used as a primary packing material.

2. Why compressed air and recirculated water used for washing?

Compressed air used to air dry the container.

Re-circulated water is used to reduce the wastage of Purified water during intermediate wash. As recommended by regulatory guidelines final wash will be by using WFI.  

3. Why we have to maintain 60 degree for water for injection?

Greater than 65 °C is recommended by WHO 970 annex 2 to maintain the required specification.

4. In our company we are using macofar 600 vial washing machine, why 600 series

May be 600, it talks about speed. See vendor recommendations online.

5. Principle of vial washing machine?

External wash and internal wash by using recirculation, Purified and WFI to remove debris and achieve minimum 3 log reduction

B.  TUNNEL MACHINE QUESTIONS

1.      For 10 ml vial we use conveyor speed 180mm and for 50 ml vial we use  conveyor speed 160 mm why?

As per tunnel base temperature it is recommended to keep the Vial 30 min for 250 deg C, based on diameter of vial it depends how fast it will move through conveyor. At the same time we have to calculate how much time it should to be exposed in tunnel hot zone to achieve targeted Fh value.   

2.       Purpose of tunnel sterilization

Depyrogenation and sterilization of primary container for destruction of endotoxin

3.      Why we have  maintain 340 degree temp in tunnel?
Vials size, Temperature, conveyor speed, Timing are main responsible factors for the tunnel qualification. Temperature may be the range from 250-345 degree.

4.      In tunnel first vial enter in hot zone, next to cool zone then to in feed filling machine table?
 No in tunnel, First vial enter into preheating Zone to Sterilization zone (Hot zone)  & then to  cool zone.

C Hphv bung processor

1.      What is bung process

Processing of bungs (electrometric closures for drug containers) is of high concern since they play a significant role in the quality and life of the final product.

The need for correct processing technology is even more important considering the complexities in the compounding of the rubber used for the closures and the non-compliance to GMP by the manufacturers of the electrometric closures.

Constructional developments :

Rotating carriage: Since uniformity of operation on the entire lot of bungs is critical, the rotating carriage that has a triangular cassette sections with perforated sides for hooking the bungs.

Sprinkling manifold: The machine is provided with sprinkling manifold arrangement over the rotating carriage that enables uniform sprinkling over the entire lot.

Fluidisation manifold: For rigorous fluidization in the processes of washing and rinsing, the Fluidization manifold causes turbulence in the water soaked bungs for effective cleaning.

Technique:

The stages of bung processing that will be addressed will be loading, washing with detergent, rinsing, siliconization, sterilization and drying.

2.      In our company we maintain temp 122 for 30 min, we studied in b.pharm 121 for 15 how they increase temp followed with time

Industrial practice is to perform 12 log reductions, basically it is an over kill approach to achieve targeted SAL value. It is nothing but over burn approach for better assurance. So, time consumption is more. acceptable temperature range for steam sterilizer is 121 -124 deg C, above 124 deg C consider as Overshoot temperature
Note: It is applicable where over burn will not cause any damage to your article.

3.      How to calculate fo value

Link provided

4.      Importance of load pattern in HPHV

Link provided

5.      When overshoot temp is seen in rubber plugs we raise deviation why for rubber plugs why not any other load

Based on the impact on the product, we should raise an incident to determine the impact on the quality of the material because it’s may affect your packing material specification.

D Washing area questions

1.Why NAOH is used as neutrailisation for cepha drugs
NaOH is used as neutralising agent because it is  a strong caustic agent

2. Why NAOH is used decontaminating solution for dipping mops and sterile garments?

As a strong caustic agent, it is used for decontamination.

3.NVPC monitoring  we consider  0.5 micron and 5 micron?

Generally HEPA filters retain particles 0.3 microns and above the concept behind 0.5 and 5.0 micron are based on worst case and any microorganism requires some medium/carrier to travel from one place to another & 0.5 micron is the minimum size requires traveling any microbe. Hence it is necessary to monitor 0.5 micron particles in classified areas.

Note: Please go though the Online test for better understanding on topic. Click Here