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Файл:Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_5428_Библиотеки_им_академика_М_И_Перельмана
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(b)
(c)
(d)
6.
(a)
(b)
(c)
(d)
7.
(a)
(b)
(c)
(d)
8.
(a)
(b)
(c)
(d)
9.
(a)
(b)
(c)
(d)
10.
(a)
(b)
The protective clothing provided must be changed weekly and when necessary
throughout the week.
The protective clothing provided must be washed and changed weekly and when
necessary throughout the week.
The protective clothing provided must be washed when necessary throughout the
month.
Which of the following statement is correct?
Soiled laundry (dress) is to be left in the production area.
No soiled or dirty laundry (dress) is to be left in the production area.
Dirty laundry (dress) is to be left in the production area.
Soiled or dirty laundry (dress) is to be left in the production area.
Which of the following statements is correct?
Females working in the production area must wear a protective hair net.
Males working in the production area and having hair fall tendency should wear a
protective hair net.
Every personnel working in the production area must wear a protective hair net.
The persons working in sterile area of a pharmaceutical industry must wear a
protective hair net.
Which one of the statements is false?
Protective clothing is not to be worn in the lunchroom, washrooms or outside the
building
Protective clothing is not to be worn in the lunchroom,
Protective clothing is not to be worn in the washrooms or outside the building
Protective clothing is to be worn while going for lunch, to wash
The location of a pharmaceutical industry is selected on the basis of the following
Near to the source of power operation
Near to market place
Near the stacking of garbage place
None of the above
The management of a pharmaceutical manufacturing company expects that
Manufacturing loss due to waste and spoilage should be more
Cost of maintenance and replacement should be high
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(c)
(d)
11.
(a)
(b)
(c)
(d)
12.
(a)
(b)
(b)
(d)
13.
(a)
(b)
(c)
(d)
14.
(a)
(b)
(c)
(d)
15.
(a)
(b)
(c)
(d)
16.
The quality of product should be the highest
There should not be movement of materials and man during the business
The equipments should be installed in a pharmaceutical manufacturing unit in such a
way that
The maintenance of the equipments become easy
During production the equipments can be used conveniently
Cleaning of the equipments become easy
All of the above
All the pipelines and equipments used All the pipelines and equipments used should
be made of should be made of
Copper
Stainless-steel
Mild steel
Brass
The function of the materials management is to
Arrange materials as per production requirements
Purchase the materials of quality even at higher price
Run the production in time
Test the finished products in time
Which of following practices is considered as the WHO good distribution practices
(WHOGDPs)?
Quality control system of the company
Quality system of the company
Production scheduling system of the company
Maintenance system being followed by the company
The selection of the type of forecasting depends on;
Effective materials planning and control
Type of lifestyle
Type of product
Type of the company
The company demand can be quantitatively calculated as
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(a)
(b)
(c)
(d)
17.
(a)
(b)
(c)
(d)
18.
(a)
(b)
(c)
(d)
19.
(a)
(b)
(c)
(d)
20.
(a)
(b)
(c)
(d)
1.
Market demand + Supply
Market share + demand
Market demand + Company’s market share
Market demand × Company’s market share
Which of the following is an internal factor for sales forecast?
Response of the suppliers
Policy actions of the government
Response of the distributors
Industrial relations of the company
Which of the following statements is correct with respect to an effective budgeting
system?
An efficient budgeting system with definite goals can control the business
activities effectively.
The budget system may not fit the company’s operational requirements.
Cost control is also known as budgeting system
Budgeting system is not a management process
The industrial relations can be defined as
The relations and interactions existing in an industry especially between the labor
and the government
The relations and interactions existing in an industry especially between the labor
and the management
The relations and interactions existing in an industry especially between the labors
All of the above
Implementation of the concept of Total Quality Management (TQM) improves
Quality of product
Consistent quality of product
Quality of product and service
The cost of the product
Short Questions Carrying 3 – 5 Marks
Why the good manufacturing practices/current good manufacturing practices are to be
followed in a pharmaceutical industry?
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2.
3.
4.
5.
6.
7.
8.
9.
10.
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
What should the persons do to maintain good personal hygiene within the company?
What is meant by the term, cross-contamination?
What are expectations of the employees and of the management of a pharmaceutical
company?
What do you understand by production management?
Write down the objectives of materials management to be made in pharmaceutical
industry.
Define term ‘inventory’. What are different types of inventory?
Write down the objectives of production, planning and control with respect to
pharmaceutical manufacturing.
Briefly explain the objectives of industrial relations in pharmaceutical manufacturing
industry.
What are the characteristics of good leader according to the TQM in a pharmaceutical
manufacturing industry?
Long Questions Carrying 7 – 9 marks
Describe about the personnel hygiene to be maintained in a pharmaceutical
manufacturing company.
What are requirements for ideal building layout for pharmaceutical manufacturing?
Briefly explain the parameters of pharmaceutical production management.
Discuss the functions of materials management in pharmaceutical manufacturing
company.
Discuss the problems in procurement planning in a pharmaceutical manufacturing
company.
What are good distribution practices to be followed in a pharmaceutical manufacturing
company?
Explain in short, the different types of inventory systems followed in pharmaceutical
manufacturing industry.
What is meant by sales forecasting? What are different types of sales forecasting?
What are issues for customer satisfaction? Describe how can the customers’
satisfaction be evaluated.
Explain the concept of total quality management with reference to pharmaceutical
manufacturing industry
Answers
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20
c a b d a b c d a c d b a b c d d a b c
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CHAPTER 5
Compression and Compaction
Physics of tablet compression, compression, consolidation, effect of friction, distribution of
forces, compaction profiles, solubility.
Physics of Tablet Compression
The most common and convenient route of drug administration is the oral route for systemic
effects. The neutral drugs are widely used for this purpose. Tablets, capsules are popular and
convenient dosage forms; next oral dosage forms are syrups, drops, emulsions, and powders.
Tablets and capsules are the unit dosage form containing an accurate dose of a drug for rapid
and systemic absorption
1-3
. For this reason, the patient compliance is more and about 70 –
80% of the marketed products is tablet 4 .
Fig. 5.1 Relationship between various solid dosage
However, directly compressible powders, granules, pellets, film coated multiple units can be
used to prepare tablet. To make tablet, compression of the material is required and hence,
good compressibility of the powders or granules would be required. The direct compression
is simple and can be an easy method to prepare tablets. In this method, the drug and
excipients with limited moisture content are mixed and compressed. However, this process
can be made successful, if the
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Fig. 5.2 Various steps involved in compression of powders under an applied compression force
mixture of powders has adequate flowability, low tendency of segregation, high
compressibility. Powders are sometimes, agglomerated are agglomerated into larger
particles. These particles have higher porosity. There are different granulation methods – dry,
wet, and special wet granulation to produce almost spherical granules or agglomerates, such
as pellets, or extruded mass – spheronization’. Therefore, in pharmaceutical manufacture of
tablets, the compression is an important unit operation. During manufacture the in-process
control tests, such as the density, hardness and friability(strength) are performed. These tests
represent the physical and mechanical properties of the tablets. Both bioavailability and
integrity of the tablet would be related to its compression process. In fact, the preparation of
compressed tablets is a complex process. It depends on many variables as well as
engineering principles. It also depends on complete understanding of the physics of
compression‘. The characteristics of the powder to be compressed, such as particle size, size
distribution, crystal habit, crystallinity, polymorphism, pseudo morphism, amorphism, and
moisture content of the crystalline powders can influence the compression characteristics.
Compression of a material may be a mixture of powders or granules into a strong tablet
depends on the different variables of the process such as the rate of transfer of force,
deformation behavior of the particles, and attractive forces among the particles 7 . The
relationship between compression force and the tensile strength of the tablet should be
observed, when poorly compressible and high dose of the drug is present in the tablet,
although the relationship is nonlinear. Hence, the study of compression physics of tablet
becomes important. Subsequently these cause problems in tableting such as capping,
lamination, sticking, and picking, particularly when high-speed compression machine is
used. Since most of the pharmaceutical tablets show time-dependent deformation, the chance
of structural failure of tablets may be increased due to the reduction of dwelling time on high
speed tableting machines. Moreover, the properties and quality of the tablet compressed may
be affected based on the type and amounts of excipients used in the formulation
(composition), and other process-related factors. For example, the dose of paracetamol,
mefenamic acid, ibuprofen, acetazolamide, metformin, etc. are high and these are also
poorly compressible drugs. If the parameters of compression such as compression force,
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displacement of punch, porosity, and tensile strength of the tablets prepared could be
identified and the compression related problems are known, understanding of such problems
and their solution become possible.
The way by which the tablets work is usually very complex and greater scientific effort has
been made to analyze the compression of single component tablets. In research on tableting
the use of instruments suggest that an in-depth understanding of physical process of tableting
is required. The force-time and force-displacement can be measured from the punches and
dies attached to the instrument. When this data is put in mathematical equations, the
compaction behavior can be calculated. The final quality of a given sample can be
understood when the results obtained from the mathematical treatment of compaction are
used.
Properties of powders
The tablet prepared and its performance cannot be completely forecasted by the physical
properties of pharmaceutical solids.
Fig. 5.3 Phases of compression operation
Surface characteristics
These exert a major impact on the flowability and intermolecular attraction among the
particles. Different distribution of intermolecular and intramolecular bonding forces within
the particle can be noted if atoms or ions are located at the surface. This occurs due to
unsatisfied attractive molecular forces extending out to small distance beyond the solid
surface. As a result, free surface energy of the solids indicating a major role in
interparticulate interaction 8 is produced. The forces of attraction oppose the constituent
particles from their differential movement when exposed to an external force. Due to the
electrostatic forces, adsorbed moisture, and residual solvent on the surface of solid particles,
the relative movements of particles can also resist.
Porosity
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The ratio of total void volume (V V ) to the bulk volume (V b ) of the material can be defined
as the porosity of powder, E’.
Thus,
The total void volume, V V can be expressed as
Where V t is the true volume.
So, the porosity of powder,
It is a method used to determine the compressibility of a powder bed. It measures the degree
of volume reduction by applying the pressure, related to porosity. The reaction of this
method is a first order reaction
10
.
Flow property
For compression it is necessary to fill the die properly with the powder. Thus, a
pharmaceutical powder should have a good flow property that can help the powder to flow
from hopper to die cavity. If high percentage of fines are present in the powder mix, or the
moisture content is high, or if there is inadequate amount of lubricants, and/or development
of electrostatic charge in the powder, the flow property of the powder mix would be poor
11,12
.
Fig. 5.4 Angle of repose
To measure the flow property of powder, commonly angle of repose, Ø is used. The angle
between the plane of powder and horizontal surface as shown in Fig 5.3 is called the angle of
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repose. When the value of Φ is less than 30 o , it is free flowing material, when the material
shows the angle of repose up to 40 o , it has reasonable flow property. Above 50 o , the flow
property of the powder is not good
13
. The angle of repose is generally measured by
calculating the value of height, h to radius, r of the heap.
That is, the angle of repose,
If the cohesive property of a powder is more, its bulk density can be increased. The ratio
between bulk density and tapped density as represented by Hausner ratio (H) and Carr’s
index (CI) indicates the flow property of a powder. The Hausner ratio being the ratio of
tapped density to bulk density varies from 1.2 for a free-flowing powder to 1.6 for cohesive
powder.
Carr’s index can be used to calculate the percentage compressibility. Carr’s index × 29 is 100
times the ratio of the difference between tapped density and bulk density to the tapped
density. If Carr’s index lie within 5 – 12%, the powder is free flowing, if it is within 23 –
35%, the powder shows poor flow, and if the Carr’s index is more than 40%, the powder is
found to have extremely poor flow property.
Theresistance to movement of particles particularly for granular powder with poor
cohesiveness can be used to determine the rate of flow. The compressibility index, CI can be
used to express the flow property of a powder. It can be expressed as:
Where V t = the volume after tapping, and V o = the volume of the powder before tapping.
The value of CI less than 15% indicates good flow property, but if its value is more than
25%, it indicates that flow property is poor
14
.
Compaction
Compaction is defined as the compression and consolidation of a particulate solid–gas
system when a force is applied . During compression the bulk volume of the powder mass is
reduced due to reduction of gaseous phase. The main mechanism for reduction of initial
volume is that the powder particles rearrange themselves to closely pack. If the applied force
is further increased, rearrangement of particles becomes difficult and particle deformation
occurs. Subsequently the process of consolidation starts. In this stage the mechanical
strength increases as a result of particle-particle interaction. When the particles come closer
to one another causing reduction of volume, bonding between the particles occur. The nature
of bonds formed is like those of the interior molecular structure. However, the actual surface
area involved is small because of the roughness of the particle-surface. The various steps
involved in powder compaction have been illustrated in Fig 5.2. Different authors have been
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