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Prabhat Report

The Practice School Training Report details the training experience of Prabhat Kumar Uikey at Bro-Shell Remedies (P) Ltd. in Sagar, M.P., during the 2023-24 session. It includes a declaration of authenticity, acknowledgments, and a comprehensive overview of the company's profile, vision, and various pharmaceutical manufacturing processes, including tablet and capsule processing. The report serves as a reflection of the skills and knowledge gained during the training period.

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Prabhat Uikey
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0% found this document useful (0 votes)
392 views26 pages

Prabhat Report

The Practice School Training Report details the training experience of Prabhat Kumar Uikey at Bro-Shell Remedies (P) Ltd. in Sagar, M.P., during the 2023-24 session. It includes a declaration of authenticity, acknowledgments, and a comprehensive overview of the company's profile, vision, and various pharmaceutical manufacturing processes, including tablet and capsule processing. The report serves as a reflection of the skills and knowledge gained during the training period.

Uploaded by

Prabhat Uikey
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd

1

PRACTICE SCHOOL TRAINING REPORT

(PHS-CC-7108)

Session :2023-24

PLACE OF TRAINING

Bro-Shell Remedies(P) Ltd. Sagar (M.P)

Submitted by:
Prabhat Kumar Uikey
Y20150071
B. Pharm. 7th sem.

Department Of Pharmaceutical Sciences


Dr. Harisingh Gour Vishwavidyalaya, Sagar, (M.P.)-470003
(A Central University)
2

DECLARATION

I affirm that the content presented in the Practice School


Training Report is a reflection of the knowledge and skills
acquired during my training at BRO-SHELL Remedies(P)
Ltd., Sagar (M.P). I declare that the report is an authentic
representation of my own work and that I have not copied
or reproduced it from any prior works submitted by
others.

PLACE: Sagar (M.P).


DATE: 07/12/2023

Prabhat Kumar Uikey


3

ACKNOWLEDGEMENT
I am truly grateful for the opportunity to undergo training with BRO-
SHELL Remedies(P) Ltd., Sagar (M.P). It has been a privilege to learn
from this esteemed company, and I consider myself fortunate to have
gained valuable insights for both my personal and professional growth.
The experience of meeting and working alongside wonderful people and
pharmacy professionals during the training period has been particularly
enriching. Their guidance has been instrumental in navigating through the
learning process, and I am appreciative of the collaborative environment
fostered by the BRO-SHELL Remedies(P) Ltd. team.
I express my deepest thanks to Professor Vandana Soni, Head of the
Department of Pharmaceutical Sciences and the mentor for this
internship, Dr. Dharmendra Jain for guiding and helping me in finding
out the best place for practice school training.
It is my radiant sentiment to place on record my best regards, deepest
sense of gratitude to Mr. Yash Sharma and his team, for their careful
and precious guidance which were extremely necessary for my theoretical
as well as practical knowledge.
I view this opportunity as a significant milestone in my professional
growth. I am committed to applying the skills and knowledge acquired
to the best of my abilities, and I am dedicated to continually enhancing
and refining them.
Thanking you
Prabhat Kumar Uikey
Y20150071
B. Pharm. 7th Sem.
4

CERTIFICATE OF TRAINING
5

CONTENT TABLE
[Link]. TITLE
1. INTRODUCTION TO BRO-SHELL REMEDIES

1.1 Company’s Profile


1.2 Vision
1.3 People
1.4 Material Cycle in Bro-Shell Remedies
1.5 Various Label Systems and Color Coding
1.6 Dispensing Procedure
1.7 Products
2. TABLET PROCESSING

2.1 Methods Of Tablet Manufacturing


2.2 Machineries For Tablets Manufacturing
2.3 Evaluation Of Tablets
3. CAPSULE PROCESSING
3.1 Classification of capsules
3.2 Filling of capsules
4. PACKAGING OF TABLET AND CAPSULES

4.1 Types of packaging


5. ORAL LIQUIDS

5.1 Syrups
5.2 Suspension
4.3 Machineries for oral liquids
4.4 Steps for Capsule Processing
Conclusion
6

1. INTRODUCTION TO BRO- SHELL REMEDIES

1.1 COMPANY’S PROFILE:

Founded in 1988, Bro-Shell Remedies emerged as a stalwart in the pharmaceutical sector,


originally established as Sonex Laboratories. In a transformative move in 2001, the
company transitioned to its present identity as Bro Shell Remedies. Operating under the
dedicated proprietorship of Mrs. K. Jain, a seasoned professional holding a [Link]. and [Link].
in Chemistry, the company has consistently upheld its commitment to producing a diverse
range of high-quality drugs. As a testament to its dedication to quality, Bro Shell Remedies
proudly holds the distinction of being a GMP Certified pharmaceutical entity, ensuring the
utmost standards in its manufacturing processes. Company has undergone a transformative
evolution from Sonex Laboratories to Bro Shell Remedies in 2001. This change symbolizes
our commitment to adaptability, growth, and a renewed focus on delivering pharmaceutical
solutions that cater to the dynamic needs of the healthcare landscape

1.2 VISION:
Bro Shell Remedies having a vision to achieve significant business in proprietary prescription
products.

1.3 PEOPLE:
The Company’s business based on market sales and company is giving an employment for 8-
10 peoples.

1.4 MATERIAL CYCLE IN BRO-SHELL REMEDIES:


Purchase → Procurement → WH → Entry of material WH

• Physical verifications

• Approved vendors
7

GRN Run (Goods receipt note) Shown by QA



Sampling

Under test sticker


Approved by QA/QC

Approved label on material Dispensing

1.5 VARIOUS LABEL SYSTEMS AND COLOR CODING:


• Green - Approved
• Pink - Rejected
• Yellow - Under test

1.6 DISPENSING PROCEDURE:


• Proper entry and exit procedure
• Dispensing done under
1. Pre-filters 5mm to 15mm
2. HEPA filters-0.3mm Use of 2% NaOH solution for cleaning.

1.7 PRODUCTS:

Having a very long experience in Manufacturing, company is providing a good


manufacturing facility.
8

Tablets:
S. No. Product Name Pack
1 Abdamol 10*10
2 Abdamol Loose 10*100
3 Albron Tab 40*1
4 Alpiz 0.25 tab 10*10
5 Alpiz 0.5 tab 10*10
6 Bactinor 200 Tab 10*10
7 Bactinor 400 Tab 10*10
8 Bactinor TZ Tab 10*10
9 Betameth 60*10
10 Brodox Tab 10*10
11 Broflame Tab 20*10
12 Broflox 100 Tab 10*10
13 Broflox 200 Tab 10*10
14 Broflox 400 Tab 10*10
15 Broflox TZ Tab 10*10
16 Brogesic Tab 20*10
17 Bronac Tab 10*10
18 Broquine- 250 10*10
19 Broquine- 500 10*10
20 Brospar 200 Tab 10*10
21 Brovit Tab 10*10
23 Calcib-500 10*10
24 Cefad 250 Tab 10*10
25 Cefad500 Tab 10*10
26 Cetozen Tab 20*10
27 Cetrazine -L 10*10
28 Cipronex-250 Tab 10*10
29 Cipronex-500 Tab 10*10
30 Cipronex-TZ Tab 10*10
31 Famod-20 10*10
32 Famod-40 10*10
33 Fevimol Tab 20*100
34 Fevimol Tab 120*10
35 Fixim 100 Tab 1*10
36 Fixim 200 Tab 1*10
37 Gatibro-200 10*10
9

38 Gatibro-400 10*10
39 Lansobra 30 Cap 10*10
40 Levof-250 10*10
41 Levof-500 10*10
42 New Calfine 40*2
43 Nimcin-Plus
44 Numed Plus 10*10
45 Numed Tab 10*10
46 Omepro Cap 10*10
47 P-Zol 40 Tab 10*10
48 Q-S 300 Tab 10*10
49 Q-S 600 Tab 10*10
50 Salbuphylline 10*10
51 Sonac 10*10
52 Sonac-Plus 10*10
53 Sonadex 50*10
54 Sonaprim DS 10*10
55 Sonaprim SS 10*10
56 Songgesic-K 100*10
57 Songgesic-K 250*10
58 Songgesic-K 400*10
59 Songgesic-Plus 100*10
60 Songgesic-Plus 250*10
61 Songgesic-Plus 400*10
62 SonuSul-Lb Cap 100*10
63 Sonyflame Tab 10*10
64 Sonyflame Tab 400*10
65 Sonyflame Tab 100*10
66 Sonyflame Tab 200*10
67 Sonyflame Tab 100*10
68 Superzole-200 10*100
69 Superzole-400 10*100

Liquids:

1 Albron Susp Albendazole Susp. 10 ml


2 Bactinor M Susp Norfloxacin + Metronidazole 30ml
10

3 Bro Up Syp B Complex + Iron Syp 100ml


4 Bro Up Syp B Complex + Iron Syp 200ml
5 Bro Up Syp. B Complex + Iron Syp 300ml
6 Bro Up Syp. B Complex + Iron Syp 500ml
7 Broflox M Susp Ofloxacin + Metranidazole Susp. 30ml
8 Broflox Susp Ofloxacin Susp. 30ml
9 Brolizer T Syp. Cyproheptadine+ Tricholine Syp. 200ml.
10 Broplex Syp B Complex + Iron Syp 300ml
11 Broquine Susp Chloroquine Susp. 50ml
12 Cefad Susp Cefadroxil 250mg Dry Syp 30ml
13 Cofexol Syp Ambroxol+guaphensin+Salbutamol+Menthol 60ml
14 Cofexol Syp Ambroxol+guaphensin+Salbutamol+Menthol 110ml
(cough syrup)
15 Corysol Susp Anti cold Suspension 60ml
16 Fevinil Syp Paracetamol Syp. 50ml
17 Fixim Dry Syrup Cefixime 30 ml
18 Numed Syp Nimesulide Susp. 50ml
19 Sonacuf Plus Syp Bromhexine+Guaphenesin+Terbuatline+menthol 60ml
(cough syrup)
20 Sonacuf Plus Syp Bromhexine+Guaphenesin+Terbuatline+menthol 110ml
(cough syrup)
21 Sonaprim Susp Trimethoprim + Sulphamethoxazole Susp. 50ml
22 Sonyflam susp Ibuprofen+Paracetamol Susp. 60ml
23 Warmazine Syp Piprazine citrate syrup 30ml

2. TABLET PROCESSING (BRO-SHELL REMEDIES)


According to the Indian Pharmacopoeia, a tablet is defined as a solid dosage form containing
medicinal substances with or without suitable diluents.
Tablets consist of one or more active pharmaceutical ingredients (APIs) along with excipients,
which may include diluents, binders, disintegrants, lubricants, glidants, and colorants. Tablets are
solid and typically flat or biconvex in shape. They may be uncoated or coated with various
materials for protection, taste-masking, or modified release.
11

2.1 METHODS OF TABLET MANUFACTURING:

A. Wet granulation:
Steps:
(1) Weighing, milling, and mixing of APIs with powdered excipients.
(2) Prepare the binder solution.
(3) Mixing binder solution with powders to create a damp mass.
(4) Wet screen the dampened powder into pellets or granules using a mesh screen.
(5) Drying of moist granules.
(6) Dry screening for size granulation.
(7) Mixing of dried granules with lubricant and disintegrants.
(8) Compression of granules into tablet.
B. Dry granulation:
Steps:
(1) Weighing and milling of formulation ingredients like drug substances
and excipients.
(2) Mixing of milled powders.
(3) Compress the mixed powders into slugs.
(4) Milling and sieving of slugs.
(5) Compression of tablets.
C. Direct compression:
Steps:
(1) Milling of therapeutic agents and excipients.
(2) Mixing of milled powders, disintegrants, and lubricants.
(3) Compression of tablets.
12

2.2 MACHINERIES (BRO- SHELL REMEDIES):

Figure 1 weighing Figure 2 Mixer Figure 3 Granulator


machine

Figure 4 Tray Dryer Figure 5 Punching Machine Figure 6 De-Dusting


Machine

Figure 7 Pan Coating


Figure 8 Packaging and Labelling Machine
13

2.3 EVALUATION OF TABLETS:

a) Appearance
Appearance is the first most required quality for the acceptance of tablet. General elegance
and its identity play a major role for the consumer acceptance. Acceptance of the
appearance of batches of the tablet has been done based on the measurement of the
following factors like size, color, shape, presence or absence of odor, taste etc.
Size and shape
Size and shape of a tablet has been determined by its thickness. As a tablet grows larger, it
becomes harder to administer, hence the size and shape of the tablet are critical factors in
patient compliance. A micrometer caliper is an instrument that is used to measure a tablet’s
thickness. If the batch is within 5% of the standard deviation, it may be considered
acceptable.
Organoleptic properties:
The organoleptic characteristic includes the color, odor, and taste of the formulation. The
color doesn’t affect the tablet’s appearance but sometimes the color is required to get
patient compliance and increase the patient’s trust in medication.
b) Hardness Test
The tablet is required some amount of hardness and strength. For this test, one of the earliest
testers was Monsanto makes the Ketan tablet hardness tester, which is used for evaluating
tablet hardness tester. The tester consists of a tube with a compressible spring placed
between two plungers. The lower plunger is placed in connection with the tablet and zero
reading is taken. The tablet eventually breaks as a result of the upper plunger being pushed
up against a spring by rotating a threaded bolt. A pointer moves along a gauge in the barrel
to measure the force as the spring is compressed. The force of the feature is recorded in
kilograms.
c) Friability Test for Tabet:
Friability testing for tablets is carried out to determine the durability of tablets. To check
the friability of the tablet the friabilator instrument is used. The friability consists of a
plastic drum attached to a machine shaft that rotates at 25 revolutions per minute for 100
rotations. 20 tablets are taken into consideration for this testing. The 20 tablets are weight
14

previous to the test. and then the tablet is put into Friabilator. After the revolutions remove
the tablet from the stabilator. and weigh the tablet again. the weight variation must not be
less than 0.5 to 1.0% for the conventional tablet.
Formula: Friability (%) = Initial weight (W1) – Final weight (W2) / Initial weight (W1)
× 100

d) Weight Variation Test for Tablet:


The USP states that the weight variation test for tablets is conducted by weighing each of
the 20 tablets separately, determining their average weight, and comparing those weights
to the average. The weight variation test gives a percentage value.

Table: limits for weight variation


USP IP Limit
130 mg or less 80 mg or less ± 10%
130 mg to 324 mg more than 80mg and less than ± 7.5 %
250 mg
more than 324mg 250 mg or more ± 5%

e) Content Uniformity Test for Tablet:


The term “content uniformity test for tablets” refers to the process of ensuring that each
tablet has the amount of pharmacological material intended with little variance among
tablets within a batch. The content uniformity test has been included in the monograph of
coated or uncoated tablets, as well as all capsules designed for oral administration when
the dosage form accessible ranges from 50 mg to smaller sizes. The tablet monograph
includes standards for content consistency. Randomly select 30 tablets.10 of these were
assayed individually.
15

If the tablet passes the test, 9 of the 10 tablets must contain not less than 85% and not more
than 115% of the labeled drug content, and the 10th table may not contain less than 75%
and more than 125 % of the labeled content. If these conditions are not met, the remaining
20 tablets are assigned individually and none may fall outside the 85 % to 115 % range.
f) Disintegration Test for Tablet:
The U.S.P. apparatus used for the disintegration test for tablets includes 6 glass tubes that
are 3″ long; open at the top, and 10 mesh screens at the bottom end. One tablet is inserted
in each tube and the basket is placed in a 1-L beaker of water, simulated gastric fluid, or
simulated stomach acid to measure the disintegration time. intestinal fluid at 37 ± 20 C
such that the tablet remains 2.5 cm below the surface of the liquid on its upward movement
and not closer than 2.5 cm from the bottom of the breaker in its downward movement.
Move the basket containing the tablets up and down through a distance of 5-6 cm at a
frequency of 28 to 32 cycles per min. Placing perforated plastic discs on each pill will stop
it from floating. The tablet must disintegrate in the time frame specified, and all fragments
must pass through the 10-mesh screen. Any residue that is still present must have a soft
mass.

3. CAPSULE PROCESSING (BRO- SHELL REMEDIES)

Bro- Shell Remedies don’t have manufacturing site for capsule shells.
Capsules are one of the essential components of the pharmaceutical sector. They are mainly used
to hold dry powder or little pellets of medication and are made using specific machinery and
techniques. The capsule's production method entails pharmaceutically active ingredients,
additives, and a cover. Every pharmaceutical business understands capsule manufacturing takes
time, and the reason is the critical measures.
Capsules are solid forms of medication in which contents are encased in either a soft or hard,
dissolving container or shells made from appropriate gelatins. Capsules have the benefit of being
palatable, readily ingested, and widely available in large numbers.

3.1 CAPSULES ARE CLASSIFIED INTO TWO CATEGORIES:


16

• Hard Gelatin Capsule


• Soft Gelatin Capsule

The fundamental difference between the two is that hard gelatin capsules are less plasticized
than soft gelatin capsules. In addition, hard gelatin capsules have two parts, the "cap" and
"body". Hard gelatin is widely used and filled with powder drugs or medicine pellets.

The Dipping Method used to manufacture hard gelatin capsules involves steps like Dipping,
Rotation, Drying, Striping, Trimming, and Joining.

3.2 FILLING OF CAPSULES (BRO- SHELL REMEDIES):

1) The Head and Body of capsules are joined manually.


2) The joined capsule shells are arranged in Semi- Automatic Capsule filling machine Tray
manually and Tray inserted back to the machine.
3) The granules to be filled are weighed as per their filling requirement and no of capsules on the
tray.
4) The granules are transferred to granule filling tray and brushed for equal distribution.

Figure 1 Sami automatic capsule filling machine


17

Figure 2Tray

5) Machine is operated manually for granule filling into the empty shells.
6) Capsules are sealed, cleaned and polished with a cloth for best finish.

Figure 3 sealed capsules


18

4. PACKAGING OF TABLET AND CAPSULES

Packaging is designed to contain a product so that it is unable to interact with the environment.
Packaging must provide the protection, identification, information against the physical damage,
loss of content or ingredients and intrusion of unwanted component of the environment such as
water vapor, oxygen and light. An important role of pharmaceutical packaging is to transform the
formulation into an attractive and marketable product. So many issues regarding the
pharmaceutical product like stability, sale, patient compliance etc. are related with the packaging
and in regard to this; present review is done on the various advancements in the packaging
techniques and selection of packaging material, machinery & labeling present article reviews the
various packaging materials, types of packaging in pharmaceutical industry.
19

4.1 TYPES OF PACKAGING AT BRO-SHELL REMEDIES:

a) Blister package:
The blister package is formed by heat-softening a sheet of thermoplastic resin and vacuum
drawing the soften sheet into a contoured mold. After cooling, the sheet is released from
the mold and proceeds to the filling station of the packaging machine. The semi-rigid blister
previously formed is filled with product and lidded with a heat-sealable backing material.
The backing material may be of two types:
(i) a push-through type or
(ii) peelable type.
Materials The blister is prepared from polyvinylchloride (PVC) PVC / polyethylene
combinations, polypropylene, polystyrene.

b) Strip package:
A strip package is a form of unit dose packaging that is commonly used for package is
formed by feeding two webs of a heat-sealable flexible film through either a heated
crimping roller or a heated reciprocating plate. The product is dropped into the pocket
formed prior to forming the final set of seals. A continuous strip is formed, generally several
packets wide. The strip packets are cut to the desired number of packets in length. The
product usually has a seal around each tablet. The seal can be rectangular, or “picture frame
format” or can be contoured to the shape of the product. Since the sealing is usually
accomplished between pressure rollers, a high degree of seal integrity is possible.
Materials: High barrier materials e.g. foil laminations, saran-coated films. For higher
barrier applications a paper/polyethylene/foil/polyethylene lamination is commonly used.
When product visibility is important a heat-sealable cellophane or polyester can be used.

c) Alu-Alu packaging:

ALU-ALU packaging involves aluminum foil for both inner and outer layers of blister
packs, providing excellent barrier properties.
Offers superior protection against moisture, light, and environmental factors. Enhances the
shelf life of pharmaceutical products.
20

d) Bottle or container packaging:

Tablets or capsules are placed in plastic or glass bottles with a secure closure, such as a
screw cap or child-resistant cap.
Allows for bulk packaging and is convenient for dispensing. Offers good protection against
moisture and light.

5. ORAL LIQUIDS

Oral liquids refer to pharmaceutical formulations that are in a liquid form and are intended to be
taken by mouth. These formulations are designed for oral administration and are commonly used
for a variety of medications, including antibiotics, cough syrups, analgesics, and pediatric
medications. Oral liquids offer advantages such as ease of administration, accurate dosing, and
faster onset of action compared to some solid dosage forms. Some common types of oral liquid
formulations are syrups, suspensions, elixirs, drops, oral solutions etc.

5.1 SYRUPS:

Syrups are pharmaceutical formulations in liquid form, typically composed of a concentrated


solution of sugar (such as sucrose or high-fructose corn syrup) and water. They are used for the
oral administration of medications and are commonly employed for a variety of therapeutic
purposes.

Here are key characteristics and considerations related to syrups:

a) Composition:
i. Sugar Base: Syrups have a high sugar content, which serves as a sweetening agent
and provides a palatable taste. The sugar also acts as a preservative, helping to
prevent the growth of microorganisms.
ii. Water: Water is the solvent used to dissolve the sugar and other components of the
syrup. It forms the liquid base of the formulation.
21

b) Applications:
i) Syrups are used for a wide range of medications, including antipyretics (fever
reducers), cough and cold medications, antihistamines, and various other liquid
medications.
ii) They are commonly employed when a liquid dosage form is preferred or when the
active ingredient is not well-suited for other formulations.
iii) The sweet taste and ease of administration make syrups particularly suitable for
children, who may find them more palatable than other dosage forms.
iv) Geriatric patients may also prefer syrups, especially if they have difficulty swallowing
solid dosage forms.

5.2 SUSPENSION:

Suspensions are pharmaceutical formulations in which solid particles are dispersed in a liquid
medium. This type of liquid dosage form is used for oral administration and is designed to provide
an even distribution of the active ingredient throughout the liquid.

Composition:

• Solid Particles: Suspensions contain solid particles (often the active pharmaceutical
ingredient) that are not completely soluble in the liquid medium. These particles are finely
dispersed throughout the liquid.
22

• Liquid Medium: The liquid component of the suspension serves as a vehicle for the
solid particles. It can be water, a combination of water and other solvents, or even an oil-
based medium.
Applications:

• Suspensions are employed for a variety of medications, including antibiotics, antifungals,


analgesics, and antacids. They are often chosen when a solid dosage form (such as tablets
or capsules) is not suitable.

• Suspensions can be well-suited for pediatric and geriatric populations, especially when
swallowing solid dosage forms is challenging. The liquid nature of suspensions makes
them easier to swallow.

5.3 MACHINERIES FOR ORAL LIQUIDS (BRO- SHELL REMEDIES):

Figure 4 Homogenizer
23

Figure 5 Filter press

Figure 6 Filling machine

Figure 7Sealing machine


24

Figure 8 Ribbon coding


machine

Figure 9 Shrink wrapping machine


25

CONCLUSION

Engaging in practical or industrial training is undeniably advantageous for individuals, offering a


unique opportunity to enhance knowledge and cultivate skills. My personal experience during
school training in the production section proved to be invaluable, providing a hands-on
understanding that complemented theoretical learning. Exploring various instruments across
departments further enriched my practical knowledge.

For pharmacy students, industrial training holds particular significance, serving as a vital platform
to gain real-world insights into pharmaceutical production and management. My time at BRO-
SHELL Remedies(P) Ltd. not only allowed me to accumulate valuable experiences but also
contributed to bridging the gap between theory and practice in the pharmaceutical field.

Discovering BRO-SHELL Remedies(P) Ltd. as a family-managed yet professionally run company


was enlightening. Their commitment to providing individualized attention to customers, coupled
with qualities like quick responsiveness, high production flexibility, and adherence to stringent
standards, positions them as an ideal outsourcing partner.

The friendly working environment at BRO-SHELL Remedies(P) Ltd. left a lasting impression,
and I believe this experience will resonate positively in my future professional endeavors. The
industrial tour not only met its goals but also provided a deep appreciation for the support received
from BRO-SHELL Remedies(P) Ltd. in shaping my practical understanding and outlook in the
pharmaceutical industry.

Prabhat Kumar Uikey


26

Y20150071

B. Pharm. 7th Sem.

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