July 6, 2021: Pharmaceutical Interview Questions and Answers
1. What is the chemical composition of OHNS steel?
2. How much is the life span of the die and punches?
The life span punches and dies is purely depending on materials of construction (MoC) as well as usage and handling.
OHNS Punches and HCHC Dies: 4 million tablets
HCHC Punches and HCHC Dies: 8 Million tablets Complete hard chrome plating punches and
HCHC dies: 10 Million tablets
3. How to maintain Punches and Dies?
The maintenance of compression tooling becomes easy by following these mentioned steps:
Step 1: Cleaning during every product change over or in periodic basis. They can be washed in water and dried using a lint free cloth.
Step 2: Periodic evaluation to increase their shelf life. Industry practice is to
Step 3: The regular visually inspection of the tooling should be done after each cleaning to check for physical damages to head, tip, die, and embossing, debossing using Magnifying glass.
Step 4: Periodic inspection of punch set should be done using measuring tools. Frequency for die and punch inspection should be such that first inspection after procurement should be done after 3 million tablet compression using each tool set and subsequently after each million.
Step 5: Compression punch set should be lubricated to decrease friction and enhance the operational activity of the tablet compression machine. A non-toxic, FDA approved oils and greases should be used for preservation and lubrication purposes. Storage of tooling should be done in the safe and moisture-free place.
4. What should be available in punch set/ tablet tooling inspection kit?
|Dial gauge compactor stand with a least count of 0.001 inch
|Micrometer Range from 0.25 mm with least count : 0.01 mm
|Punch holding bushes for B type punch and D type of punch
|Punch height gauge
|Die Outer diameter block for all types of die i.e. D, B, BB, DB etc.
|Magnetic V – block
|GO – NO GO gauges
|Die Pocket Cleaner
5. Explain about punch set/ tablet tooling inspection program?
i. Height uniformity of the punches
ii. Punch body to punch tip concentricity
iii. Die bore Go / No go status
iv. Other dimensions as per the drawing
v. Punch tip to die before clearance
vi. Hollow penetration of the punches
vii. Die outdoor diameter consistency
viii. Die height regularity
ix. Die hole GO and NO GO examination
x. Die internal diameter to outer diameter concentricity