BPUT Sample Paper for Modern Manufacturing Process
NO1 ALL QUESTIONS ARE COMPULSORY.
ANY FIVE FROM THE REST
ANSWER THE FOLLOWING QUESTIONS.
1(a)what are various factors that you will keep in mind, while selecting pattern material?
Ans : (i) number of castings to be made.
ii)method of moulding to be used i.e hand or machine.
iii) type of casting method to be used.
iv) degree of accuracy in dimension and the quality of surface finish required in the casting.
v) design of casting
(b)what is parting sand ?
Ans: This term denotes that sand which is sprinkled on the pattern and the parting surfaces of the mould so that the sand mass of one flask does not stick to that of the other or the pattern . The burnt sand and dry silica sand are used for this purpose
(c)what are the main constituents of moulding sand ?
Ans: The main constituents are :
i) silica sand, ii) binder, iii) additives, iv) water
(d)Differentiate between normal strain or natural strain ?
Ans: Normal strain is the change in length with respect to original length where as natural strain is the change on length with respect to constant a news length.
(e) why chills are used in moulds?
Ans: chills are used in moulds for achieving directional solidification
(f) Expain how can we find bearing number or bearing size?
Ans. We can find bearing number or bearing size through a commercial catalog for some companies like SKF or by reading the size on the cylinder block
(g) What “psi” represent?
Ans. psi is an abbreviation for pounds force per square inch and can be commonly seen on pressure gauges as unit.
(h) Define four stroke engine?
Ans. In four stroke engine there are two valves i.e. one is inlet and another is exhaust. The stroke is done one by one in sequence as suction, compression, power and exhaust and for every four stroke there is one power.
(I). Differentiate between a pipe and tube?
Ans. Pipe is usually denoted by OD x gauge. Pipe is used to transfer liquid or gas. Pipe is flexible. Pipe is disignated with its Inner dia.
Tube is denoted by ID which is NB x sch.Tube is used to transfer Heat. Tube is Rigid and is designated with Outer Diameter.
(j) What will be the consequence when water flowing through pipe is suddenly cut?
Ans. When water flowing through a pipe is suddenly stopped, a pressure wave eqiuvalent to sound will get created and will move to and fro. It causes damage to pipe by suddenly hitting the pipe wall which is known as water hammering
2) Do the CGMPs require a firm to retain the equipment status identification labels with the batch record or other file? Assuming each major piece of equipment has a unique “Cleaning and Use Log” that is adequately retained, is it acceptable to discard these ‘quick reference’ equipment labels?
Ans: The CGMP regulations for finished pharmaceuticals require the retention of cleaning and use logs for non-dedicated equipment, but no similar requirement exists for retaining what are intended to be “quick reference” or temporary status labels. Examples of these kinds of status labels include “mixing lot ###”; “clean, ready for use as of d/M/y”; “not clean.” We see no value in the retention of such labels in addition to the required equipment log or batch record documentation. The labels serve a valuable, temporary purpose of positively identifying the current status of equipment and the material under process. Any status label should be correct, legible, readily visible, and associated with the correct piece of equipment. The information on the temporary status label should correspond with the information recorded in the equipment cleaning and use log, or the previous batch record for non-dedicated equipment.
Labels are merely one way to display temporary status information about a piece of equipment. It is considered acceptable practice to display temporary equipment status information on dry-erase boards or chalkboards. And it would be appropriate for an FDA investigator to verify that the information on a temporary status label is consistent with the log.
3) Can Leptospira species penetrate sterilizing-grade filters? If so, what should manufacturers keep in mind in their ongoing lifecycle risk management efforts to assure microbial control?
Ans: FDA is aware of a recent report [ref. 2, below] of Leptospira licerasiae contamination in cell cultures. There is no indication that this bacterium ultimately contaminated either the finished drug substance or drug product. This bacterium has been found to pass through 0.1 µm pore size rated sterilizing-grade membrane filters. While this specific species was the identified contaminant in this case, other Leptospira species also are capable of passing through 0.1 µm pore size rated filters [ref. 3, below]. Compendial microbiological test methods typically used in association with upstream biotechnology and pharmaceutical production are not capable of detecting this type of bacteria. Whether this apparently rare contamination risk may be more widespread is unknown, and we are sharing this information so that manufacturers can consider whether this hazard may be relevant to their operations.
Leptospira are Gram-negative aerobic spirochetes that are flexible, highly motile, and spiral-shaped with internal flagella. The bacteria measure 1μm in diameter and 10-20 μm in length. Leptospira are obligate aerobes that use oxygen as the electron receptor and long-chain fatty acids as a major source of energy. While some of the Leptospira are harmless fresh-water saprophytes, other species are pathogenic and can cause leptosporosis, a significant disease in humans and animals [ref. 4-6, below).
Based on current information, Leptospira contamination does not appear to occur frequently, and purification steps that follow cell culture in a typical biotechnology operation would be expected to prevent carryover to the finished drug substance. Testing of bulk drug substances produced in the reported cases did not detectLeptospira spp., and no evidence of deleterious effects on in-process product were observed in the known case study. However, we are providing this communication to alert manufacturers that these types of bacteria can potentially:
penetrate sterilizing-grade membrane filters
be present in the manufacturing site environment
impact in-process production (e.g., production yields, impurity levels, process performance)
go undetected due to the limitations of current compendial bioburden tests in detecting this microbial genus
As a general principle, manufacturers should use sound risk management and be aware of unusual microbial reported in the literature that may impact their manufacturing processes (e.g., cell culture biotechnology, conventional sterile drug manufacturing).
Manufacturers should assess their operations, be aware of potential risks, and apply appropriate risk management based on an understanding of possible or emerging contamination risks [ref. 1 (see Section 18.3)]. As appropriate, preventive measures should be implemented during the product and process lifecycle.
To illustrate, if leptospiral contamination is considered possible, or has occurred, risk mitigation procedures and practices for this microorganism should include at least the following:
Review of available published articles from the scientific literature and technical reports by related industry organizations that may provide further understanding on how to mitigate this contamination hazard.
Use of molecular or nonconventional microbial monitoring methods at appropriate intervals to detect microbial flora that may exist in processing steps or in the immediate environment, but are not readily detected by current routine methods. Such expanded testing should be used to modify the strategy (e.g., timing, frequency, types of tests) of detection and control in the event of newly-identified risk posed by the viable, but not easily cultured, microorganism.
a. Use of specialized media such as EMJH [ref. 7, below] or other suitable media [ref. 8, below]. It should be noted that these bacteria typically grow very slowly.
b. Use of validated PCR methods (e.g., as an investigative tool) for rapid screening and detection of spirochete bacteria.
c. Consideration of special stain techniques or other means to identify the presence of Leptospira [ref. 9, below].
3. Use of conventional approaches. Firms should continue to properly employ basic, standard microbiology laboratory practices to detect contamination. For example, the laboratory should ensure that microscopic examination is part of its routine cell culture process control program, as it provides an important means of detecting microbial contaminants that may not readily grow on conventional media.
4. Implementing such quality risk-management measures into the initial design (i.e., preventive actions), and promptly implementing an appropriate corrective action plan in response to newly-identified contamination sources, throughout the lifecycle of the product.
4.Calculate the diameter of punch and press capacity for 50mm diameter disc to be punched out from a carbon steel sheet 1 mm thick Also Calculate the punch size and dia size (ulternate shear stress S=42 kg f/mm2)
Soln: Data given
D =50 mm , t= 1mm
Shear length = πd =157.05
Shear area =πDt=157.05 mm2
Press capacity in tomnage required
=πDt×S /1000=157.05×42/1000=6596 ton
Empenical formula for Clearance
ԏ=mat 1. Shear stress in Mpa 42 kg f/mm2
t=sheet thickness mm
For blanking component size=Die size clearance will be on the punch
Die size=50 mm
5.Spot welding of two 1 mm thickness sheet of steel is carried successfully by pasing a certain amount
Of current from 0.1 second through the electrodes.The resultant weld nugget formed is 5 mm india 1.5 mm thick calculate the amount of current passing through electrode?
Content heat of fusion=hf=1400 kj/kg
Resistance of welding operation=200 micro ohm=200×10-6 ohm
Sol:As per the data given in the question
Volume of nugget is=(π/4×d2×t)=π/4×52×15 mm3
Amount of heat required to melting
=1400kj/k×8000 kg/m3×29.4375×10-9=329.7 joule
But in spot welding
6.Calculate the welds per minute work speed and Rpm of circular electrode of 220 mm dia
for caring out seam welding at 4 welds per cm on 1.6 mm thick mild steel tube welding cycle consists of 3 cycle’ on ‘and 2 cycle’ off’ power supply is at 50Hz.Also calculate energy requirement effective resistance between electrodes as 100 micro ohm.
Soln:As per given data
Cycles for weld=3
Welds required per cm=4
Electrode diameter=220 mm
Welds per minute=Frequency×60/cycles for weld+interval cycles
Works speed (mm/min)=welds/min/welds requird/min
RPM of electrode=work speed(mm/min)/π×electrode dia
For 1.6 mm thick M.S plate current requirement is 10,000 amp
7.Classification of welding process ,there uses, advantages disadvantages and application?
Ans:Classification of welding process:
(4)Solid state welding
(5)Thermo chemical welding
(6)Radiant energy welding
(a)Air acetylene welding
(b)oxy- acetylene welding
(d)pressure gas welding
(a)carbon arc welding
(b)Flux cored arc welding
(c)submerged arc welding
(d)Plasma arc welding
(e)Electro slag welding
(f)stud arc welding
(d)Flash butt welding
(4)Solid state welding:
(5)Thermo chemical welding:
(b)Atomic hydrogen welding
(6)Radiant energy welding:
(a)Electron beam welding
(b)Lasen beam welding
used in base metals where welding can be used:
Advantages of welding:
(1)A good weld is as strong as base metal
(2)repair by welding is very easy
(3)it is a very cost effective process because or low equipment cost
Disadvantages of welding:
(1)welding produces harmful fumes,radiations and spatters
(2)a skilled technician is required
(3)edge preparation is required before welding
Application of welding:
(7)piping and pipe lines
(8)material handling equipments
8.Write shots notes on
(1)2 high rolling mills
(2)3 high rolling mills
(3)4 high rolling mills
(4)cluster rolling mills
(1)2 high rolling mills:
in this mill the shelter bar to be rolled is placed between the 2 rolls are placed exactly are over another.in some rolling mills,both rolls are adjustable where as in some,one roll is fixed and other is adjustable.The 2 rolls are rotating in opposite direction.The work piece is passed through the rolls and is taken over the rolls and returns to the original position for re polling.
(2)3 high rolling mills:
it consists of 3 rolls,positioned directly are over another.The direction of rotation of the intermediate is opposite to the upper and lower roller.in this top and bottom rolls are power drive where as middle roll rotates only by friction.First stage rolling is done with one pair of rolls and the same material is rolled again through other pain on rolls simultaneously.
(3)4 high rolling mills:
it consists of 4 rolls.two rolls are small in diameter and are used to roll the work
piece so called working rolls.Other 2 rolls are large in diameter and are used to provide the support to the working rolls so called back of rolls.Smaller diameter working rolls are used to reduce to the rolling force required to roll the work
(4)Custer rolling mills:
it consists of 2 working rolls back up by means of 4 back up rolls.it provides better back up and rigidity to the mills.
Forging is the operation where metal is heated and then a load is applied to manipulate the metal in such a way that the desired shape is obtained with the help of punch and die.
2.Uniformity of qualities for parts subject to high stress
5.high rate of production
1.high tool cost and maintenance
2.limitation in size and shape
forging operation can be classified in to 2 groups
1.Open die forging
2.Close die forging
1.Open die forging:
when the die is open that means work piece is not closed by die members then this forging is termed as open die forging.
2.Close die forging:
when the desired shape is obtained by the shape of upper and lower die and the work piece is completely closed in between the 2 dies.