API production and quality assurance interview questions

ISO 9001:2008 : The  ISO 9000  family of  quality management systems  (QMS) is a set of standards that helps  organizations  ensure they meet customers and other stakeholder needs within statutory and regulatory requirements related to a product or service. [1]   ISO  9000 deals with the fundamentals of quality management systems, [2]  including the seven quality management principles that underlie the family of standards.ISO 9001 deals with the requirements that organizations wishing to meet the standard must fulfil. Third-party certification bodies provide independent confirmation that organizations meet the requirements of ISO 9001. Over one million organizations worldwide [6]  are independently certified, making ISO 9001 one of the most widely used management tools in the world today. However, the ISO certification process has been criticized as being wasteful and not being useful for all organizations.

MATERIAL SAFETY DATA SHEET : what type of information should MSDS have 1.chemical identification 2.chemical composition and data on components 3.hazard identification 4.first aid measures 5.fire fighting measures 6.accidental release measures 7.handling and storage 8.exposure control and personal protection 9.physical and chemical properties 10.stability and reactivity 11.toxicological information 12.ecological information 13.disposal consideration 14.transport information 15.regulatory information 16.other information

WORK PERMIT SYSTEM : work permit system is a formal written system used to control certain types of work,which are identified as non-routine work and potentially hazardous.it is also a means of communication among site personnel to ensure all necessary safety precautions are taken before commencing such work. types of work permits are: 1.cold/general work permit 2.hot work permit 3.first line break permit 4.entry into confined space 5.work at height permit 6.excavation permit

VACUUM TRAY DRYER : Vacuum  drying  is the  mass transfer  operation in which the moisture present in a substance, usually a wet solid, is removed by means of creating a  vacuum . In chemical processing industries like food processing, pharmacology, agriculture, and textiles, drying is an essential unit operation to remove moisture. [1]  Vacuum drying is generally used for the drying of substances which are  hygroscopic  and heat sensitive, and is based on the principle of creating a vacuum to decrease the chamber pressure below the vapor pressure of the water, causing it to boil. With the help of vacuum pumps, the pressure is reduced around the substance to be dried. This decreases the  boiling point  of water inside that product and thereby increases the rate of  evaporation  significantly. The result is a significantly increased drying rate of the product. [2]  The pressure maintained in vacuum drying is generally 0.0...

ROTOCONE VACUUM DRYER : Before startup the rcvd operation check the following equipment cleaning status rcvd cone bulb cloth integrity and validity of the bag.( 90 days or 55+-5 batches) utilities ( hot water,nitrogen and vacuum ) ensure sensor is working or not  ensure the cyclone separator and vacuum receiver  Before charging the material ensure butterfly value is closed  charge the material through scoop and ensure earthing connected to rcvd and scoop switch on the rcvd and open the utilities like vacuum and hotwater. follow the vacuum and temperature limits as per the bpcrs cyclone separator :

FLUID BED DRYER : Fluid bed dryer works on a principle of fluidization of the materials. In fluidization process, hot air or gas flow is introduced through the bed of solid particulates. This gas or air will move upwards through the spaces between the particles. As the velocity increases, upward drag forces on the particles increase and at a stage become equal to the gravitational forces beneath. Hence the bed is said to be fluidized and the particles are suspended in the fluid. There are various advantages of fluid bed dryer in pharmaceutical industries. Some of them are as follows. Advantages of Fluid Bed Dryer High thermal efficiency is achieved when the thermal energy is supplied by internal heat exchanger Low Capital Cost Ease of Maintenance and Control High Heat and Mass Transfer Rates In a  fluid bed dryer used for powder drying , initially the air is sucked inside from the surroundings with a fan run with electric motor inside the dryer. The air then passes t...

TYPES OF VALVES  What is Valve? Valve is a device that regulates, controls or directs the flow of a fluid by opening, closing, or partially obstructing fluid flow. Sound bit complicated? Ok, let me further simplified this.  A valve is a mechanical device that controls the flow and pressure of fluid within a system or Process.  So basically, it controls flow & pressure. Types of Valves In piping following types of valves are used depending on the requirements. The cost of Valve in the piping system is up to 20 to 30% of the overall piping cost. And the cost of a given type and size of the valve can vary 100%. It means that if you choose ball valve over butterfly valve for the same function. It can cost you more. So, the selection of valves is essential to the economics, as well as operation, of the process plants. Gate Valve Globe Valve Check Valve Plug valve Ball Valve Butterfly Valve Needle Valve Pinch Valve Pressure Relief Valve Gate valve ...

 NUTSCHE FILTER : Nutsche filter/dryers can  effectively perform the separation of solid matter from a liquid under pressure or vacuum, in a closed system . The ability to isolate the product not only reduces product handling but also minimizes operator exposure and serves as environmental protection against solvent.

sparkler filter: 1.sparkler filter design parameters: material of construction design pressure design area sparkler filter design pressure depends on the filtration area.design pressure inversely proportional to the filtration area. at ocpl sf design pressure 3-4 kg/cm2 sparkler filters are used for clarifying (removal) slurry containing low suspended solids. the filter plates are arranged one above the other so that large filtration area is available in a compact volume. the plates are available in 8'',13",18"&33" diameter made in s.s 304 or 316 construction or as per the the requirement. the filter plates assembly is placed in a tank with openable topk. the tank can be either jacketed or otherwise and made out same material as the filter plates. the liquid to be filtered is pumped to the sparkler filter where it enters the central channel and flows over the filter media (cloth/paper ) uniformly under the force of the circulating pump. the...

sop's related to scrubber: 1.operation of BF3 scrubber 2.operation of ammonia scrubber 3.operation of H2S scrubber 4.operation of HCL/acid scrubber 5.operation of cl2 scrubber 6.operation of PCL3 scrubber scrubber media solution reacts with gas forming salts. eg: HCL+NAOH --------->NaCl +H2O H2S+2NAOH ------->Na2S+2H2O Scrubbers are commonly used in process air application to eliminate potentially harmful dust,gas and pollutants. A liquid in general water added with active chemicals suitable to the process is sprayed into the air flow. Scrubber systems are a diverse group of air pollution control devices that can be used to remove come particulates and or gases from industrial exhaust streams. The exhaust gases may contain substances considered harmful to the environment,and it is the job scrubber to either remove those substance from the exhaust gas stream or to neutralize those substances so that they cannot do harm to the environment/peoples as part of...

1. REACTOR Types of reactor :ssr,glr,hastolly reactor Types of condensers :sheel and tube Types of jackets: shell and limpet type Moc: ss316,ss316 contains 16-18%chromium and 11-14% nickel and remaining iron. ss reactor suitable for pH 7.0 to 14 and glr suitable for pH 1.0 to 7.0 Types of agitator s:anchor,propeller,turbine Baffles: paddle type baffles,using onside and two opposite sides in reactor Reactor capacity and part : as per batch size and urs   1.motor 2.gear box 3.agitator 4.bottom value 5.jacket 6.temperature sensor 7.safety value 8.nitrogen line 9.manhole or hand hole 10.flame arrester 11. reflux line Guages: 1.pressure guage: Measured the unit of forcesurface area.pressure is measured in kg/cm2 or lb/cm2 2.vacuum guage :A vacuum is a space in which the pressure of a gas is low compared to the atmospheric pressure. The measure of vacuum is associated with pressure. Vacuum gauges and instruments are used in conjunction with vacuum senso...

LIST OF TOPICS FOR INTERVIEW: LIST OF EQUIPMENT USED IN THE API INDUSTRY: 1. REACTOR 2. SPARKLER FILTER 3. NUTSCH FILTER 4. FBD 5. RCVD 6. CENTRIFUGE 6. VTD 7. MILLING 8. SIFTER 9. MICRONIZER 10. BLENDER 11. RVPD 12. METAL DETECTOR 13. AIR JET MILL 12. UTILITIES 13. PREVENTIVE MAINTENANCE 14. QUALIFICATION 15. VALIDATION 16. CHANGE CONTROL 17. HAZOP STUDY 18. OOS 19. OOT 20. TYPES OF FIRE EXTINGUISHERS 21. CLASSIFICATION OF FIRE 22. 5S 23. EXOTHERMIC REACTIONS AND ENDOTHERMIC REACTIONS 24. HYDROPHOBIC AND HYDROPHILIC 25. HYDROGENATION – PALLADIUM CATALYST 50%MOISTURE 26. CHLORINATION 27. GRIGNARD REACTION 28. DIBAL 29. CLEAN ROOM CLASSIFICATION 30. HYGROSCOPIC MATERIALS 31. FISHBONE DIAGRAM 32. FLAMEPROOF EQUIPMENT 33. 5Y, FISH BONE, AND ROOT CAUSE ANALYSIS –TOOLS USED FOR INVESTIGATION 34. ERP 35. DIFFERENCE BETWEEN LOD AND MOISTURE CONTENT 36. TLC 37. DIFFERENCE BETWEEN HUMIDITY AND RELATIVE HUMIDITY 38. HP...