Industrial Training Report for B. Pharma Students

1. in Partial Fulfillment of the Requirements
for the Degree of
BACHELOR OF PHARMACY
by
Shesh Narayan Sharma
(Roll no.1201250040)
Under the guidance of
Mr. JITENDRA JENA Dr. Emdad Hossain
(Assistant Professor) Principal
Pharmacy College, Azamgarh Pharmacy College, Azamgarh
(DR. A.P.J. ABDUL KALAM TECHNICAL UNIVERSITY)
LUCKNOW
April 2016

2. PHARMACY COLLEGE, AZAMGARH
CERTIFICATE
It is to Certified that Shesh Narayan Sharma (1201250040) has carried out the
report on “INDUSTRIAL TRAINING” under the supervision of Mr.
JITENDRA JENA, ASSISTANT PROFESSOR, Pharmacy College,
Azamgarh. The report embodies result of original work and studies are carried
out by the student himself and the content of report do not form the basis for the
award of any other degree to the candidate or to anybody else from this or any
other University/Institution.

3. PHARMACY COLLEGE, AZAMGARH
CERTIFICATE
It is to certify that Mr. Shesh Narayan Sharma (1201250040) has prepared
and submitted a INDUSTRIAL TRAINING report under the Supervision of
Mr. JITENDRA JENA, ASSISTANTPROFESSOR, Pharmacy College,
Azamgarh.

4. PHARMACY COLLEGE, AZAMGARH
CERTIFICATE
This is to certify that Mr. Shesh Narayan Sharma (1201250040) S/o Mr.
Prem Narayan Sharma is studying in B. Pharm. Third Year during Session
2015-16. He has submitted his Industrial training report for the partial
fulfillment of requirement for the degree of Bachelor of Pharmacy in Pharmacy
College, Azamgarh.

5. ACKNOWLEDGEMENT
Success is the sweet and succulent fruit of vision, inspiration, guidance and
execution. An acknowledgement sheet with a few words inscribe as it may not
be enough to describe the kind of help I have received in the form of guidance
and inspiration from several person, during the tenure of my work.
As I commence this project, I would like to humbly acknowledge my
profound gratitude to my guide Mr Vivek Tyagi, Vinca Life Plot No. 1178, Vill.
Bhud, Baddi (H.P.) Himanchal Pradesh, India. If this work has any credit it’s due
to the over enthusiastic, Endeavour from them and honestly it’s just beyond my
capabilities to express my heartful thanks and regards to them or the great intent
they have shown, with their kind of guidance, able supervision, constant
encouragement as well as omnipresence in every aspect of project work.
I am greatly obliged to our director Prof.Dr. Kishu Tripathi Pharmacy
College, Azamgarh for their guidance and kind help for the completion of this
project work.
I would be very much likely to acknowledge my Teachor Mr.JITENDRA
JENA who gave all his possible efforts to help us during this training and in
completing this project work .
I am very much thankful to the teaching and non-teaching staff of my institution
for their precious suggestions and supports towards me.
My acknowledgement would be incomplete if I don’t offer my sincere to the
Almighty God and to my beloved parents and other family members for sharing
my dream for support in my life.
Shesh Narayan Sharma
Roll No. 1201250040
IIIrd
Year VI sem
Pharmacy College, Azamgarh

6. INDEXS.NO CONTENT PAGE NO.
1- Introduction 1
2- Layout 1
3- Tablet Introduction 4
4- Advantage & Disadvantage Of Tablets 5-6
5- Types Of Tablet 6
6- Manufacturing Of Tablet 7
7- Tablet Coating 15
8- Capsule Section 16
9- Capsule Introduction 17
10- Advantage & Disadvantage Of Capsule 17
11- Types Of Capsule 17-21
12- Formulation Of Capsule 24
13- Evaluation Of Capsule 24-25
14- Quality Control Section 26
15- Equipment 27-31
16- Conclusion 32
17- Reference 33

7. Vinca Life Science
Vinca Life Sciences is a professionally managed organization engaged in the field of
manufacturing, exporting and supplying a broad range of medicines for human being.
Walking on the ethical business policies and under the guidance of our Directors Mr Vivek
Tyagi & Mr Himanshu Tyagi, I have marked a recommendable position in the industry. It is
situated at Plot No. 1178, Vill. Bhud, Baddi (H.P.). Just 45 k.m. away from chandigarh.

8. PRODUCT LIST OF VINCA LIFE SCIENCE
Koldnic Syrup Acniflox Syrup Norniv-M Syrup
Ferriniv Syrup Nivrex-AP Syrup Beniv-L Syrup
Lactiniv Syrup Acnizyme Nivrex Syrup

9. Acnicold Syrup Acnipol Acnizyme
Norniv – TZ Acnivit Drops Acniflox-OZ
Acnispas Pantoniv DSR Acniflam Lyconiv

10. Introduction:-
A tablet is a pharmaceutical dosage form. Tablets may be defined as the solid unit dosage
form of medicament or medicaments with or without suitable diluents and prepared either by
molding or by compression. It comprises a mixture of active substances and excipients,
usually in powder form, pressed or compacted from a powder into a solid dose. The
excipients can include diluents, binders or granulating agents, glidants (flow aids) and
lubricants to ensure efficient tabletting; disintegrants to promote tablet break-up in the
digestive tract; sweeteners or flavours to enhance taste; and pigments to make the tablets
visually attractive. A polymer coating is often applied to make the tablet smoother and easier
to swallow, to control the release rate of the active ingredient, to make it more resistant to the
environment (extending its shelf life), or to enhance the tablet's appearance.
The compressed tablet is the most popular dosage form in use today. About two-thirds of
all prescriptions are dispensed as solid dosage forms, and half of these are compressed
tablets. A tablet can be formulated to deliver an accurate dosage to a specific site; it is usually
taken orally, but can be administered sublingually, buccally, rectally or intravaginally. The
tablet is just one of the many forms that an oral drug can take such
as syrups, elixirs, suspensions, and emulsions. Medicinal tablets were originally made in the
shape of a disk of whatever color their components determined, but are now made in many
shapes and colors to help distinguish different medicines. Tablets are often stamped with
symbols, letters, and numbers, which enable them to be identified. The Sizes of tablets is to
be swallowed range from a few millimeters to about a centimeter.

11.  Advantages of Tablets
1.They are unit dosage form and offer the greatest capabilities of all oral dosage form for
the greatest dose precision and the least content variability.
2. Cost is lowest of all oral dosage form.
3. Lighter and compact.
4. Easiest and cheapest to package and strip.
5. Easy to swallowing with least tendency for hang‐up.
6. Sustained release product is possible by enteric coating.
7. Objectionable odour and bitter taste can be masked by coating technique.
8. Suitable for large scale production.

12. 9. Greatest chemical and microbial stability over all oral dosage form.
10. Product identification is easy and rapid requiring no additional steps when employing
an embossed and/or monogrammed punch face.
 Disadvantages of Tablet
1.Difficult to swallow in case of children and unconscious patients.
2. Some drugs resist compression into dense compacts, owing to amorphous nature, low densi
ty character.
3. Drugs with poor wetting, slow dissolution properties, optimum absorption high in GIT may
be difficult to formulate or manufacture as a tablet that will still provide adequate or full dru
g bioavailability.
4. Bitter testing drugs, drugs with an objectionable odor or drugs that are sensitive to oxygen
may require encapsulation or coating. In such cases, capsule may offer the best and lowest co
st.
 Types
Tablets are classified according to their route of administration or function. The
following are the four main classification groups:
(A) Tablets ingested orally:
(i) Compressed tablets (ii) Multiple compressed tablets (iii) Enteric coated tablets
(iv) Sugar coated tablets (v) Film coated tablets (vi) Chewable tablets
(B) Tablets used in the oral cavities:
(i) Buccal cavities (ii) Sublingual tablets (iii) Lozenges
(iv) Dental cone
(C) Tablets administered by other routes:
(i) Implantation tablets (ii) Vaginal tablets
(D) Tablets used to prepare solutions:
(i) Effervescent tablets (ii) Dispensing tablets (iii) Hypodermic tablets
(iv) Tablet triturates

13.  Manufacturing
Manufacture of the tableting blend
In the tablet pressing process, the main guideline is to ensure that the appropriate amount of
active ingredient is in each tablet. Hence, all the ingredients should be well-mixed. If a
sufficiently homogenous mix of the components cannot be obtained with simple blending
processes, the ingredients must be granulated prior to compression to assure an even
distribution of the active compound in the final tablet. Two basic techniques are used to
granulate powders for compression into a tablet: wet granulation and dry granulation.
Powders that can be mixed well do not require granulation and can be compressed into tablets
through direct compression.
(A)Wet granulation
Introduction
The most widely used process of agglomeration in pharmaceutical industry is wet
granulation. Wet granulation process simply involves wet massing of the powder blend with a
granulating liquid, wet sizing and drying.
Important steps involved in the wet granulation
Process
i) Mixing of the drug(s) and excipients
ii) Preparation of binder solution
iii) Mixing of binder solution with powder mixture to form wet mass.
iv) Drying of moist granules
v) Mixing of screened granules with disintegrant, glidant, and lubricant.
Advantages
(a) permits mechanical handling of powders without loss of mix quality:
(b) improves the flow of powders by increasing particle size and sphericity:
(c) increases and improves the uniformity of powder density:
(d) improves cohesion during and after compaction:
(e) reduces air entrapment:
(f) reduces the level of dust and cross-contamination:
(g) allows for the addition of a liquid phase to powders (wet process only): and
(h) Makes hydrophobic surfaces hydrophilic.

14. Limitation of wet granulation
i) The greatest disadvantage of wet granulation is its cost. It is an expensive process
because of labor, time, equipment, energy and
space requirements.
ii) Loss of material during various stages of processing
iii) Stability may be major concern for moisture sensitive or thermo labile drugs
iv) Multiple processing steps add complexity and make validation and control difficult
v) An inherent limitation of wet granulation is that any incompatibility between formulation
components is aggravated.
[B] Dry granulation
Introduction
In dry granulation process the powder mixture is compressed without the use of heat and
solvent. It is the least desirable of all methods of granulation. The two basic procedures are to
form a compact of material by compression and then to mill the compact to obtain a granules.
Two methods are used for dry granulation. The more widely used method is slugging, where
the powder is recompressed and the resulting tablet or slug are milled to yield the granules.
The other method is to precompress the powder with pressure rolls using a machine such as
Chilosonator.
Roller compaction
The compaction of powder by means of pressure roll can also be accomplished by a machine
called chilsonator. Unlike tablet machine, the chilsonator turns out a compacted mass in a
steady continuous flow. The powder is fed down between the rollers from the hopper which
contains a spiral auger to feed the powder into the compaction zone. Like slugs, the
aggregates are screened or milled for production into granules.
Use: Use in the production of directly compressible excipients, the compaction of drugs and
drug formulations, the granulation of inorganic materials, the granulation of dry herbal
material and the production of immediate/sustained release formulations.
Processing steps:
Weighing of raw material-screening-mixing-compression to slugs-milling-mixing-
compression to finished tablets

15. Advantages:
The main advantages of dry granulation or slugging are that it uses less equipments and
space. It eliminates the need for binder solution, heavy mixing equipment and the costly and
time consuming drying step required for wet granulation. Slugging can be used for
advantages in the following situations:
i)For moisture sensitive material
ii)For heat sensitive material
iii) For improved disintegration since powder particles are not bonded together by a binder
Disadvantages:
i) It requires a specialized heavy duty tablet press to form slug
ii) It does not permit uniform colour distribution as can be
iii) Achieved with wet granulation where the dye can be incorporated into binder liquid.
iv) The process tends to create more dust than wet granulation, increasing the potential
contamination.
[D] The direct compression process
This method is used when a group of ingredients can be blended and placed in a tablet press
to make a tablet without any of the ingredients having to be changed. This is not very
common because many tablets have active pharmaceutical ingredients which will not allow
for direct compression due to their concentration or the excipients used in formulation are not
conducive to direct compression. Granulation is the process of collecting particles together by
creating bonds between them. There are several different methods of granulation. The most
popular, which is used by over 70% of formulation in tablet manufacture is wet granulation.
Dry granulation is another method used to form granules.
Advantages of Direct Compression
1. Cost Effectiveness
The prime advantage of direct compression over wet granulation is economic since the direct
compression requires fewer unit operations. This means less equipment, lower power
consumption, less space, less time and less labor leading to reduced production cost of
tablets.

16. 2. Stability
Direct compression is more suitable for moisture and heat sensitive APIs, since it eliminates
wetting and drying steps and increases the stability of active ingredients by reducing
detrimental effects. Changes in dissolution profiles are less likely to occur in tablets made by
direct compression on storage than in those made from granulations5. This is extremely
important because the official compendium now requires dissolution specifications in most
solid dosage forms10.
3. Faster Dissolution
Disintegration or dissolution is the rate limiting step in absorption in the case of tablets of
poorly soluble API prepared by wet granulation. The tablets prepared by direct compression
disintegrate into API particles instead of granules that directly come into contact with
dissolution fluid and exhibits comparatively faster dissolution.
4. Less wears & tears of punches
The high compaction pressure involved in the production of tablets by slugging or roller
compaction can be avoided by adopting direct compression. The chances of wear and tear of
punches and dies are less.
5. Simplified Validation
Materials are "in process" for a shorter period of time, resulting in less chance for
contamination or cross contamination, and making it easier to meet the requirement of current
good manufacturing practices. Due to fewer unit operations, the validation and
documentation requirements are reduced. Due to the absence of water in granulation, chance
of microbial growth is minimal in tablets prepared by direct compression.
Limitations of direct compression
1. Segregation
Direct compression is more prone to segregation due to the difference in density of the API
and excipients. The dry state of the material during mixing may induce static charge and lead
to segregation. This may lead to the problems like weight variation and content uniformity.
2.Cost
Directly compressible excipients are the speciality products produced by patented spray
drying, fluid bed drying, roller drying or co-crystallization Hence, the products are relatively
costly than the respective raw materials.

17. 3. Low dilution potential
Most of the directly compressible materials can accommodate only 30-40 % of the poorly
compressible active ingredients like acetaminophen that means the weight of the final tablet
to deliver the 500 mg of acetaminophen would be more than 1300 mg. The large tablets may
create difficulty in swallowing.
4. Re-workability
All the spray-dried directly compressible adjutants show poor rework ability since on
preparation of tablets the original spherical nature of the excipient particles is lost. API that
has poor flow properties and/or low bulk density is difficult to process by direct compression.
5. Lubricant sensitivity
Lubricants have a more adverse effect on the filler, which exhibit almost no fracture or shear
on compression (e.g. starch 1500). The softening effects as well as the hydrophobic effect of
alkaline stearates can be controlled by optimizing the length of blending time to as little as 2-
5 min.
6. Variation in functionality
There is a lack of awareness in some situations that the excipient behave differently,
depending upon the vendor so much so that substitution from one source to that of another is
not possible. Hence, there is a need for greater quality control in purchasing of raw material
to assure batch uniformity.
Granule lubrication
After granulation, a final lubrication step is used to ensure that the tableting blend does not
stick to the equipment during the tableting process. This usually involves low shear blending
of the granules with a powdered lubricant, such as magnesium stearate or stearic acid.

18.  FORMULATION For 300mg
BRAND NAME - NORVIN – TZ TABLET
COMPOSITION: -
Ingredients quantity for 5 lakh tablets
1. Mixing
Tinidazole 153 kg
Starch 20 kg
D.c.p. (di calcium phosphate) 10 kg
2. Paste
Starch 6 kg
Gelatin 800gm
Tetrazine 150gm
Glycerin 750gm
Methyl paraben 200gm
3. Lubrication
Starch 2.5kg
Sod.starch glycolate 2.5gm
Talc 500gm
Mag. Stearate 500gm
Manufacture of the tablets
First, the powder is filled into the die from above. The mass of powder is determined by the
position of the lower punch in the die, the cross-sectional area of the die, and the powder
density. At this stage, adjustments to the tablet weight are normally made by repositioning the
lower punch. After die filling, the upper punch is lowered into the die and the powder is
uniaxially compressed to a porosity of between 5 and 20%. The compression can take place
in one or two stages (main compression, and, sometimes, pre-compression or tamping) and
for commercial production occurs very fast (500–50 ms per tablet). Finally, the upper punch
is pulled up and out of the die (decompression), and the tablet is ejected from the die by
lifting the lower punch until its upper surface is flush with the top face of the die. This
process is repeated for each tablet.

19. Common problems encountered during tablet manufacturing operations include:
 Fluctuations in tablet weight, usually caused by uneven powder flow into the die due to
poor powder flow properties.
 Fluctuations in dosage of the Active Pharmaceutical Ingredient, caused by uneven
distribution of the API in the tableting blend (either due to poor mixing or separation in
process).
 Sticking of the powder blend to the tablet tooling, due to inadequate lubrication, worn or
dirty tooling, or a sticky powder formulation
 Capping, lamination or chipping. This is caused by air being compressed with the tablet
formulation and then expanding when the punch is released: if this breaks the tablet apart,
it can be due to incorrect machine settings, or due to incorrect formulation: either because
the tablet formulation is too brittle or not adhesive enough, or because the powder being
fed to the tablet press contains too much air (has too low bulk density).
 Capping can also occur due to high moisture content.
Tablet compaction simulator
Tablet formulations are designed and tested using a laboratory machine called a Tablet
Compaction Simulator or Powder Compaction Simulator. This is a computer controlled
device that can measure the punch positions, punch pressures, friction forces, die wall
pressures, and sometimes the tablet internal temperature during the compaction event.
Numerous experiments with small quantities of different mixtures can be performed to
optimize a formulation. Mathematically corrected punch motions can be programmed to
simulate any type and model of production tablet press. Initial quantities of active
pharmaceutical ingredients are very expensive to produce, and using a Compaction Simulator
reduces the amount of powder required for product development.

20. Tablet presses
Fig-An old Cadmach rotary tablet press
Tablet presses, also called tableting machines, range from small, inexpensive bench-top
models that make one tablet at a time (single-station presses), with only around a half-ton
pressure, to large, computerized, industrial models (multi-station rotary presses) that can
make hundreds of thousands to millions of tablets an hour with much greater pressure. The
tablet press is an essential piece of machinery for any pharmaceutical and nutraceutical
manufacturer. Common manufacturers of tablet presses include Stokes, Fette Compacting,
Korsch, Kikusui, Manesty, B&D, PTK, IMA and Courtoy. Tablet presses must allow the
operator to adjust the position of the lower and upper punches accurately, so that the tablet
weight, thickness and density can each be controlled. This is achieved using a series of cams,
rollers, and/or tracks that act on the tablet tooling (punches).
Tablet coating
The materials used for coating may largely comprise sucrose(sugarcoating), water‐soluble
film‐ forming polymers (film coating) or substances which are soluble in the intestinal
secretions but not in those of the stomach (enteric coating). These types of coating can all be
applied by the pan or fluid ‐bed processes; the compression coating technique is suitable for
sugar and enteric coatings, but not for film coating. The tablet coating contains the use of
polymer, colors (lakes and dyes ). The polymers such as HPMC along with talc and titanium
dioxide (anti oxidant ) IPA, methylene chloride were mixed with the help of stirrer for about
30 minute after stirring the mixture was transferred into steel container .Tablet coated with
spray coating machine with the help of compressor the mixture is sprayed on the tablet .The
coating machine contains a blower the contains hot air for drying that are blown on the tablet.
Process is continued for 3 – 4 hours a duck is provided for absorbing the evolved powder and
other materials during coating.

22. CAPSULE:-
“Capsules are the solid preparation with hard and soft shell of various shapes and capacities
usually containing a single dose of active ingredients.”
OR
‘Capsules are solid dosage form in which the drug substances are enclosed in water soluble
shell on an envelope. A capsule shell is made from gelatin. The capsule is available both as
hard capsule and soft capsule.”
ADVANTAGES OF CAPSULE:-
 Capsules are tasteless,odourlessand can be easily administered.
 They are attractive in appearance.
 They are economical.
 They are easy to be handled and carried.
 They can be filled quickly.
 Micro capsulation provides the sustained released dosage form.
 They are smooth, become very slippery when moist and can be easily swallowed.
DISADVANTAGES OF CAPSULE:-
 The hygroscopic drug cannot be filled in capsule. They absorb water present in the
capsule shell and hence make it very brittle which ultimately break into pieces.
 Capsule could not be used for highly effervescent or deliquescent material.
 Effervescent material may cause the capsule to soften.
TYPES OF CAPSULE:-
1. Hard gelatin capsule.
2. Soft gelatin capsule.

23. 1. HARD GELATIN CAPSULE:-
These are used for administration of solid medicament. The capsule shell is prepared
from gelatin, colour and titaniumdioxide to make it opaque.
It consists of two part- body and cap.
The powered material is filled into the cylindrical body of capsule and then the cap is
placed over it.
The empty capsule are available in various size, they are numbered according to the
capacity of the capsule.
The numbers start from 000 and goes upto 5.
CAPSULE NUMBER AND ITS APPROXIMATE CAPACITY:-
CAPSULE NUMBER APPROXIMATE CAPSULE IN (mg)
000 950
00 650
0 450
1 300
2 250
3 200
4 150
5 100

24. RAW MATERIALS FOR GELATIN CAPSULE:-
The raw material used in manufacture is similar for both hard and soft gelatin capsule
GELATIN:-
Gelatine is the major component of capsule.
Non toxic in nature.
Widely used in foodstuff.
Readily soluble in biological fluids at body temperature.
Good film forming material.
PLASTICIZERS:-
 The most important component of formulation is plasticizers.
It decreased in intermolecular forces along the polymer chain by relieving molecular
rigidity.
It breaking down polymer – polymer interaction
EXAMPLE:-- Glycerol, Propylene glycol, Polyethylene glycol
COLOURANTS:-
Objectives of using colors
(i) It makes the tablet more esthetic in appearance.
(ii) Colour helps the manufacturer to identify the product during its preparation.
All colorants used in pharmaceuticals must be approved and certified by the FDA (food &
Drug Administration). Dyes are generally listed as FD&C (food, Drug & Cosmetic Dyes)
dyes and D&C (Drug & Cosmetic Dyes).
Colorants are obtained in two forms dyes and lakes.
Dyes are dissolved in the binding solution prior to the granulating process. However,
during drying their color may migrate to the surface and may produce mottling of the
tablet.
 So another approach is to adsorb the dye on starch or calcium sulfate from its aqueous
solution; the resultant powder is dried and blended with other ingredients.
Color lakes are dyes which are adsorbed onto a hydrous oxide of a heavy metal (like
aluminium) resulting in an insoluble form of the dye.

25. PRESERVATIVE:-
Preservative mostly prevent the micro-biological contamination during the manufacture.
EXAMPLE-Methyl Paraben, Propyl baraben.
FORMULATION OF HARD GELATIN CAPSULES:-
The materials to be filled in hard capsule may need the formulation to a certain extent and
the following additives may have to be incorporated.
1.Diluents 2.Protective solvents 3.Gliders 4.Anti-dusting compound
1. DILUENTS:-
The substances used to make up bulk weight gram fill materials.
Quantitative of diluents depends on the dose of medicaments and capsule size.
 But there may also be occasion when it is too small in bulk falling for short of the
quantitative needed for smallest available capsule size.
EXAMPLE:-
Lactose,Mannitol,Sorbitol,Starch
2.PROTECTIVE SORBENTS:-
This is used to prevent the absorption of moisture by hygroscopic substances.
In some cases inclusion of inert materials may be called for to be physically separate
incompatibility or eutectic substances.
EXAMPLE:-
 Oxide, carbonate, magnesium, calcium.
3.GLIDERS:-
This is used to regulate the flow of powder to capsule bodies.
EXAMPLE:-
Talcum, calcium and mag. stearate
4.ANTIDUSTING COMPOUNDS:-
It is used to removal of dust from equipment.

26. EXAMPLE:-Inertedibleoil
2. SOFT GELATIN CAPSULES:-
soft gelatin capsules consist of a single unit. These are rounded, oval, and cube like structure.
Process of manufacturing capsule:-
weighed the material and pass through sieve no.40
transferred the sieved material in to planetary mixture, cover it and blend it for 30
minutes.
Send to q.c. for testing of drug under sample testing.
transfer the bulk of p.v.c. bags contained in fiber drum like the bags cover & label.
On receipt of the report from q.c. transfer the material to production area
Encapsulatepowder onthe basis of drugcontent,reportingbyq.c.insemi automatic performa.
Send setting advice to q.c. for drawing sample on printed performa.
Stored the fill capsule in p.v.c. bag contained in fibers drums.
Tie the bags, cover the drums & labeled in quarantine.
STORAGE CONDITION:-
The capsule shell should be stored under control condition of temperature and
humidity.
The normal moisture content of shell is 10-15%.
Under the condition of low humidity they may soften and grow tacky.
Ideally range of storage room is 30-40%.

27. HAND FILLING CAPSULE MACHINE:-
Figure No. 2: HAND FILLING CAPSULE MACHINE
It consists of-
Capsule bed with 200-300 holes.
Loading tray with 200-300 holes.
Powder tray.
Pin plate with 200-300 pins.
Sealing plate with rubber tap.
A Lever.
Cam handle.
PROCEDURE:-
Empty capsule filed in loading tray and placed over the capsule bed.
By using handle, body capsule is locked and cap is separated.
Weighed amount of powder to be filled in capsule is placed in powder tray.
Spread the powder with the help of powder spreader.
Lower the pin plate and move downward to place drug.

28. In the body remove the powder tray and placed cap handling tray over the capsule bed.
Press the capsule with the help of plate with the rubber top means of under unlocked
the cap body of capsule in body.
CAPACITY:-
200 holes machine produce-5000 capsules/hrs.
300 holes machine produce-7500 capsule/hrs.
 FORMULATION
BRAND NAME - LYCONIV
Contents:Each hard gelatin capsule contains:
Lycopene 6% 5000mcg.
 Vitamin A (As acetate) 1500 I.U.
 Vitamin E (50% Powder) 5mg.
 Vitamin D3 (stabilized) 200 i.u.
 Vitamin B1 monohydrate 1000mcg.
 Vitamin B2 1500mcg.
 Vitamin B6 1000mcg.
 Folic Acid 500mcg.
 Niacinamide 25mg
 Vitamin C (Coated) 25mg
 Vitamin B12 5mcg.
 Calcium Pantothenate 25mg.
 Magnesium 2 mg.
 Iodine 500mcg
 Copper 2 mg.
 Zinc Sulphate Monohydrate 22.5mg
 Selenium 40 mcg.
 Lactic Acid Bacillus 40 Million Spores
STORAGE:-It should be Store in a cool dark & dry place.

29. EVALUATION OF CAPSULE:-
1- DISINTIGRATION TEST:-For performing disintegration test on capsule the tablet
disintegration test apparatus is used but the guiding disc may not be used except
that the capsule float on top of water.
One capsule is placed in each tube which are then suspended in the beakers to move
up and down for 30 minutes , unless stated in the monograph.
Thecapsule passes the test if no residue of drug or other than fragments of shell
remains on no-10 mesh screen of the tube.
2- DISSOLUTION TEST:-Dissolution time are run on the line of compressed tablet .
Any of the standard apparatus available for dissolution test can be employed .The
determination of dissolution time is important since absorption of drug depends
upon their dissolution time.
3- WEIGHT VARIATION TEST:-Twenty capsule are taken at random are weighed .
The average weight is calculated. Then each capsule is weighed individually and
their weight noted. The capsule pass the test if the weight of individual capsule
falls within 90-110% of the average weight.
If the requirement is met then the weight of content for each individual capsule is
determined and compared with the average weight of content. The content from
the shell can be removed just by emptying or with the help of small brush. The
remained content is removed by washing with suitable solvents. After drying the
shells they weighed and the content weight of the individual capsule are calculated.
4- DRUG CONTENT UNIFORMITY:-A number of capsule should be selected and
assayed for drug content individually .Pharmacopoeia specify 30 capsule out of
which 10 should be should be assayed individually in the first instance out of these
at least 9 should be within 15 of average and non should be beyond 25%. If 1-3
capsule out of the 10 assayed originally fall outside 15% the remaining 20 should
be assayed out of total 30 capsules at least 27 should be within 15% and no capsule
be beyond 250%.

30. QUALITY CONTROL
QUALITY CONTROL SECTION
It is the essay method in substances such as drugs, packaging, material, raw materials,
adjuvant; containers are checked according to the monograms as per standards given
the pharmacopoeias.
Equipment’s used:-
 Magnetic stirrer
 M.P. apparatus
 Electronic & Simple Balance
 Capsule disintegration tester
 Dissolution test apparatus
 pH meter
 UV & Visible Spectrophotometer
 Autoclave

31.  Hot Air Oven
AUTOCLAVE
autoclave is a device used to sterilize equipment and supplies by subjecting them to
high pressure saturated steam at 121 °C for around 15–20 minutes An depending on the
size of the load and the contents. It was invented by Charles Chamber land in 1879,
although a precursor known as the steam digester was created by Denis Pepin in 1679.
The name comes from Greek auto-, ultimately meaning self and Latin clevis meaning
key—a self-locking device.

32. pH-METER
A pH meter is an electronic device used for measuring the pH (acidity or alkalinity) of a
liquid (though special probes are sometimes used to measure the pH of semi-solid
substances). A typical pH meter consists of a special measuring probe (a glass electrode)
connected to an electronic meter that measures and displays the pH reading.
The pH probe measures pH as the activity of the hydrogen cations surrounding a thin-
walled glass bulb at its tip. The probe produces a small voltage (about 0.06 volt per pH
unit) that is measured and displayed as pH units by the meter. For more information
about pH probes, see glass electrode.
ULTRA VIOLET SPECTROMETER

33. Ultraviolet and visible spectrometers have been in general use for the last 35 years and over
this period have become the mostimportant analytical instrument in the modern day
laboratory. In many applications other techniques could be employed but nonerival UV-
Visible spectrometry for its simplicity, versatility, speed, accuracy and cost-
effectiveness.This description outlines the basic principles for those new to UV-Visible
spectrometry. It is intended purely as a brief introduction to the technique and it is
Thermo Spectronic's policy to continually add to this range of documentation for
further details, as they become Available.
UV Range 200-1000nm
CAPSULE DISINTEGRATION TEST APPARATUS
Microprocessor based Tablet Disintegration Machine is used for testing the
disintegration time for tablets, capsules, and other solid dosage forms. Tablet
Disintegration Machine is designed to meet the specifications of USP/IP/BP
pharmacopoeia.Acrylic Tank is placed on the platform. A square shaped immersion
Heater is also fitted to this acrylic water bath. Two 1000 cc capacity beakers supplied
with the equipment are filled with water and placed on the stand in the water tank. The
water in the water bath is maintained at 37°C with an accuracy ± 0.3°C. Temperature
setting is not required.The built-in RTD sensor maintains the bath temperature.
Temperature and time indicators have both combined in one display unit thereby
providing accurate digital indication of both parameters. The equipment can carry out
two disintegration test of tablets simultaneously. It works on 230 volts single phase A.C.
50 Hz.

34. Features
 Digital Temperature and Timer
 Splash proof panel with LCD display
 Smooth up and down movement
 Water bath for uniform temperature
 Fluorescent tube light for better viewing of tablet disintegration
 With Water Circulation System (Optional)
Technical Specification:
 Temperature : 25.0° C To 40.0° C
 Accuracy : ± 0.3° C
 Power: 230 V 50 Hz.
 Heating System 300Watt 230 V, Accuracy ± 0.5° C
 Timer: 1 min to 99 hrs. 59 min 59 sec
 Strokes : 30 strokes/min
DISSOLUTIO

35. N TEST APPARATUS
Dissolution apparatus has had a relatively short history since its proposal by Beckett et
al & its incorporation into the United States Pharmacopoeia (USP) in 1991 as apparatus
3 for drug release testing of extended- release products as an alternative to the basket,
USP apparatus 1, & paddle, USP apparatus 2. The development of USP apparatus 1 & 2
may be significantly affected y shaft wobble, location, centering, & coning. USP
apparatus 3 offers the advantages of mimicking the changes in physiochemical
conditions & the mechanical forces experienced by products in the gastrointestinal
tract.
General Procedure:-
Single tablet is taken & placed in wire mesh basket connected to variable speed motor
by means of a shaft this basket is immersed in the dissolution medium contain in 100 ml
flask. The flask is maintained at 37± 0.5c by means of constant temperature bath. Moto
is adjusted to specified speed & samples of fluid are withdrawn at regular time interval
to determine amount of drug in solution.

36. CONCLUSION:-
In the end I am glad to tell you that training in Vinca Life Sciences, Plot No.
1178, Vill. Bhud, Baddi (H.P.), India., India.was an excellent experience during
training I actually learned about Pharmaceutical Company & above its working
the theoretical knowledge is worth for getting a degree. & it is accessible in the
book. We can only imagine about thing we read but practical life is always
different.
Similarly a practically a pharmaceutical company is very difficult. During the
training session I tried my level best to gain practical knowledge as much as I
can. I improve basic classified my doubts & also understood the importance of
maintaining quality of products in pharmaceutical company.
As per knowledge Vinca Life Sciences, Plot No. 1178, Vill. Bhud, Baddi (H.P.),
India.
is one of the best companies. I have ever seen the due to co-operative company
staff I was successfully able to complete my short venture of training.
I hope my training report fulfills the intended requirement.

37. REFERENCES-
1. Mehta R.M, “Pharmaceutics-I” IVTH
edition VallabhPrakashan (page
no-269-274).
2. Leon lachman,Herbert A Lieberman, “The Theory And Practice Of
Industrial Pharmacy” Special Indian Edition-2009 CBS Publisher &
Distributors pvt.ltd (page no-374,392 )
3. Aulton M.E “Pharmaceutics” Churchill livingstone publication IInd
edition( page no-449)
4. www.wikipedia.org
5. Kibbe, A.H., ed. Handbook of Pharmaceutical Excipients. 3rd Edition ed.
2000, American Pharmaceutical Association & Pharmaceutical Press:
Washington, DC & London, UK.
6. Hiestand, E.N., 2003. Mechanics and physical principles for powders and
compacts, SSCI Inc., West Lafayette, In, USA.
7. United States Pharmacopeia, United States Pharmacopeia / National
Formulary (USP25/NF20). 2002, Rockville, MD: United States
Pharmacopeia Convention Inc.
8. http://4my3939.blogspot.in/