July 5, 2021: Pharmaceutical Interview Questions and Answers
1. Describe about tablet tooling standards?
There are two types of standards for tablet tooling:
i. US specification provided by Tableting Specification Manual (TSM) (This is the only tooling specifications are the only published standards for the tablet compression industry). The standard is established by the American Pharmacists Association (APhA),
ii. European standard known as the EU, or “Euronorm” standard.
EU, or Euronorm standard tool configurations are not published or governed by an organization or association. The EU standard is the most common tooling configuration used outside the U.S. [Reference: 7]
2. Differences between TSM and EU Tooling Configurations
|Tableting Specification Manual (TSM) Tooling Configurations||EU Tooling Configurations|
|Angled top profile||Domed head profile|
|Inside head angle for “B” punches is 37°||Inside head angle for “B” punches is 30°|
|Overall head thickness is greater in both “B” and “D”||Overall head thickness is lesser in both “B” and “D”|
|Overall punch length of the TSM tool is 0.010 inches shorter than the EU||Overall punch length of the EU tool is 0.010 inches longer than the TSM|
3. What are the type of tablet tooling for compression machine with die and punch dimension?
There are following six types of tablet tooling and its dimentions.
|Nominal punch barrel diameter (mm)||Nominal punch die diameter (mm)||Maximum tablet diameter for round tablet (mm)||Maximum tablet diameter for shaped tablet (mm)|
|TSM or EU B||19||30.16||16||16|
|TSM or EU D||25.35||38.1||25||25|
|TSM or EU BB||19||24||13||14|
|TSM or EU DB||25.35||30.16||19||19|
|TSM or EU BBS||19||21||12||13|
|TSM or EU A||12.7||17||8||8|
4. What is the choice for material of construction (MoC) of Die and Punch?
i. OHNS (T) Oil Hardened Non shrinking steel (Tungsten) – AISI 01 (American Iron and Steel Institute)
ii. HCHC – High carbon High chromium steel – AISI D3
5. What is the choice for material of construction (MoC) of Turret?
Three piece turret having the center die table of SS 316 and the Upper and lower piece of Spheroidal Graphite Iron (SG Iron) with ELNP (ELECTROLESS NICKEL PLATING) Coating.
Pharmaceutical Quality by Design: A Practical Approach (Advances in Pharmaceutical Technology)