September 3, 2021: Pharmaceutical Interview Questions and Answers
#LaminarAirFlowSystemAirSpeed #ParticleMonitoringSystemTubing #PressureDifferentialBetweenDifferentAreaGrades #WhyFumigation
1. What should be the laminar air flow systems air speed for Grade A area? Why?
Laminar air flow systems should provide a homogeneous air speed in a range of 0.36 – 0.54 m/s (guidance value) at the working position in open clean room applications.
2. Why length of tubing and the radii is important for particle monitoring system?
The length of tubing and the radii of any bends in the tubing must be considered in the context of particle losses in the tubing.
3. What should be pressure differential between adjacent rooms of different grades?
Adjacent rooms of different grades should have a pressure differential of 10 – 15 pascals.
4. What is the recommended temperature for Water for injections storage and distribution? Why?
Water for injections should be produced, stored and distributed in a manner which prevents microbial growth, for example by constant circulation at a temperature above 70°C.
5. For what types of areas, fumigation is useful?
Fumigation of clean areas may be useful for reducing microbiological contamination in inaccessible places.
Reference: EudraLex – The Rules Governing Medicinal Products in the European Union Volume 4, EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, Annex 1 – Manufacture of Sterile Medicinal Products – 01 March 2009