1
.
Presented by: KOLHEKAR DHANASHREE GIRIDHAR
FINAL YEAR B.PHARMACY.
University EnRoll No: 1894
Semester :7th
Academic year : 2023-2024
Div(A) BATCH : C
Sanjivani College of Pharmaceutical Education & Research
(An Autonomous Institute)
Shinganapur Tal: Kopargaon Dist.: Ahmednagar, Maharashtra, PIN: 423 603
Presentation on
INDUSTRIAL TRAINING AT
NuLIFE PHARMACEUTICALS Pvt. Ltd.
Plot No. 63, F2 Block, MIDC, Pimpri, Pune
411018
UNDER THE GUIDANCE OF
MR. AGASTI WARE SIR.
2
Presented by_Dhanashree KOLHEKAR
INTRODUCTION
PROFILE OF ORGANIZATION
LIST OF MANUFACTURED PRODUCTS
INTRODUCTION TO DIFFERENT SECTION/ UNITS
RAW MATERIAL STORE
STORAGE AREA & WAREHOUSE
PRODUCTION AND MANUFACTURING SECTION
ENGINEERING & MAINTANANCE SECTION
QUALITY CONTROLL UNIT
QUALITY ASSURANCE SECTION
CONCLUSION
TABLE OF CONTENTS:-
3
Presented by_Dhanashree KOLHEKAR
INTRODUCTION
History
NuLife Pharmaceuticals started its journey in 1973 with the promise of providing quality medicines. Since its inception, the
company has grown and has added many divisions to its production. NuLife products enjoy a respectable market share all
over India. NuLife is actively making its presence felt in the international pharmaceutical segment.
MISSION
• To be amongst the top healthcare companies.
• Innovate continuously to develop new cutting-edge pharmaceutical and healthcare technologies and products.
• To ensure better quality of life for people by providing the best in healthcare, pharma and allied products, of the highest
standards.
VISION
 Our vision Emerge as a quality producer, visible, competitive and committed member of global health-care industry.
 To keep improving the quality of life by offering value-added novel products that are technologically innovative,
cost-effective and of superior quality, surpassing expectations of customers across the globe.
 Be a highly ethical organization.
 Commit to customer service, customer satisfaction and social responsibility.
 Emerge as one of the benchmarked companies in the healthcare industry.
Presented by_Dhanashree KOLHEKAR 4
PROFILE OF ORGANIZATION
Name of organization
• NuLife Pharmaceuticals. Pvt Ltd
PIMPRI, PUNE.
• Established in the year 1973,
Management
• J.A. Trivedi [Founder NuLife PHARMACEUTICALS]
NuLife Pharmaceuticals is the dream venture of Mr. J. A. Trivedi who wanted to leave a mark in the medical field.
Mr. J. A. Trivedi's innate knowledge about the industry, markets and products coupled with his long-nurtured desire to get into the
medically associated business turned into reality in 1973 when he started his own company, NuLife Pharmaceuticals.
• MR. Umesh Trivedi [Managing Director of NuLife]
He has extensive experience of over three decades in the field of pharmacy. As the Chairman and Managing Director, he has
been instrumental in the growth of NuLife.
Mr. Umesh Trivedi has been associated with various industry bodies and associations.
 Madurai Deshmukh [works manager]
 MR. Rajesh Jadhav [production manager]
 MRS. Shailaja Lokhande [qc manager]
 MR. Sudhir Devale [HR manager]
 MR. Prashant Saste [training Incharge]
Presented by_Dhanashree KOLHEKAR 5
LIST OF PHARMACEUTICAL PRODUCTS:
Almost more than 200 products are manufactured Some popular nutraceutical and pharmaceutical and non-pharmaceutical products of
NuLife PHARMA.
We are manufacturers of pharmaceutical specialties such as tablets, capsules, liquids, ointments and ayurvedic products.
Our brands like Soliwax Ear Drops, Selectin Paint, and Gamascab Lotion are the leading brands in their categories.
Presented by_Dhanashree KOLHEKAR 6
INTRODUCTION TO DIFFERENT DEPARTMENTS
1. Production And Manufacturing Section
2. Packing Section And finished Goods
3. Raw Material Section
4. Quality Control Section
5. Quality Assurance Section
6. Warehouse
7. Engineering And Maintenance Section
8. R&D Department & IT
9. Dermatology [ product manufacturing]
10. Ear, Nose, Throat [ product manufacturing]
11. Ophthalmic [ product manufacturing]
12. Pediatrics [ product manufacturing]
13. Orthopedics [ product manufacturing]
14. Dentistry [ product manufacturing]
15. Gynecology [ product manufacturing]
16. Ayurvedic [ product manufacturing]
17. Veterinary [ product manufacturing]
Presented by_Dhanashree KOLHEKAR 7
RAW MATERIALS STORE
Frist day I visited Raw Material Store Department where all raw material transport
form warehouse Now this material keeps in quarantine section.
Raw Material incharge do the entry of received material in register. And check
the A.R NO.. BATCH NO., MFG, and EXP. DATE.
QC Department take material for sampling to check and test the received
material. And label the containers or tanks as UNDERTEST.
After test if material is ok then they labeled it as approved. And if not labeled as
reject.
Approved material can transfer can to production department as per demand,
rejected material key given to QA manager.
Presented by_Dhanashree KOLHEKAR 8
• Dispensing material should not be more than 5days in day
store.
• Rejection room consists of rejected material and the key
of room is in QA authority.
Consists of following: -
1) Receiving Area
2) precleaning and dusting area.
3) Quarantine Area
4) sampling & Sampling booth
5) Rejection Room
6) Dispensing Booth.
Receiving raw material and packaging material.
Match material received with invoice & challan
Check material is from approved vendor
Challan / invoice no COA received status compared this
with the label
While checking physical condition of material note down
the following goods
condition/damage/loose sealed/shelf life
Mention “Not Applicable” NA whenever required
Dedusting operation
 Weighing verification
Sampling
Shifting of material to release/rejection
area green queen manager
Online rejection of material
Handling of rejection material
Dispensing Booth
Collecting the goods after packing
Presented by_Dhanashree KOLHEKAR 9
STORAGE AREA & WAREHOUSE
It contains two types of warehouses =
 For storage of starting material and packaging material
 For storage of intermediate in process material.
1. It involves storage of granules, uncoated tablets,
coated tablets etc. for tampon of material from
dispensing area to production area use of metal cases
is done by which dispensed containers are used with
label which contain all the information of this material
(like Dane of manufacturing, name of drug, target,
weight of product etc.)
2. Before entering the warehouse wear a yellow-colored
helmet for safety purpose
3. It is the area for storage of the material with their
suitable storage conditions In the warehouse first in
first out process followed.
4. In warehouse there is one record room for maintaining
record and information about storage material.
1. In process manufacturing materials.
2. Granules.
3. Uncoated tablets.
4. Coated tablets.
5. Excipients.
RULES FOR WAREHOUSING:
1. Systemic storage of the delivered goods.
2. Use air circulation and protection against rodents
3. Keeping a space at least 50cm between the rows of
pellets walls.
4. Providing each product have only one specific place.
5. On shelves clear labeling of products should be there
6. Adequate space should be provided for each good.
Presented by_Dhanashree KOLHEKAR 10
PRODUCTION AND MANUFACTURING SECTION
• A tablet (also known as a pill) is a pharmaceutical oral dosage form (oral solid dosage,
or OSD) or solid unit dosage form. Tablets may be defined as the solid unit dosage form
of medication with suitable excipients.
• It comprises a mixture of active substances and excipients, usually in powder form, that
are pressed or compacted into a solid dose.
• The main advantages of tablets are that they ensure a consistent dose of medicine that is
easy to consume. A tablets are prepared either by moulding or by compression.
• The excipients can include diluents, binders or granulating agents, glidants (flow aids)
and lubricants to ensure efficient tableting; disintegrants to promote tablet break-up in
the digestive tract; sweeteners or flavor's to enhance taste; and pigments to make the
tablets visually attractive or aid in visual identification of an unknown tablet.
• 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.
Presented by_Dhanashree KOLHEKAR 11
Common Tablet Defects:
Tablet defects occur for a variety of reasons, but many can easily be avoided. To address defects, technicians involved in tableting must
have a full understanding of both the tableting process and the materials used. Adequate training in the setting up and use of the machines
is vital if the technician is to have the necessary skills to be able to fix equipment and minimize problems in production. A professional
and experienced technician can turn an ordinary product into a high quality one whereas a novice or inexperienced operator cannot, and
might even be afraid to adjust the machine in order to prevent or correct problems. When the equipment is properly operated the tablet
production will go smoothly.
Types of tablets
Depending on the physicochemical properties of the drug, site and extent of drug absorption in the gastrointestinal (GI) tract, stability to heat, light,
or moisture, biocompatibility with other ingredients, solubility, and dose, the following types of tablets are commonly formulated
Presented by_Dhanashree KOLHEKAR 12
Unit Operations There are three methods of
preparing tablet granulations.
Such as:
(a)Wet granulation
(b)Dry granulation (also called “slugging”),
(c)Direct compression.
Each individual operation of the process is Known as
a unit operation.
WET GRANULATION
•Milling of drugs and excipients
• Mixing of milled Powders
•Preparation of binder solution.
•Mixing binder solution with powder mixture to form
wet Mass.
•Coarse screening of wet mass using 6- to 12- mesh.
•Drying moist granules.
•Screening dry Granules with lubricant and
disintegrants.
•Mixing screened granules with lubricant and
disintegrants.
• Tablet compression.
•Milling of drugs and excipients.
•Mixing of milled Powders.
•Compression into large, hard tablets called slugs.
•Screening of slugs.
•Mixing with Lubricant and disintegrating agent.
•Tablet compression.
DIRECT COMPRESSION
•Milling of drugs and Excipients.
•Mixing of ingredients.
•Tablet compression.
Presented by_Dhanashree KOLHEKAR 13
DIAGRAMATICAL REPRESENTATION METHODS OF PREPARING TABLET
GRANULATIONS.
Presented by_Dhanashree KOLHEKAR 14
MACHINES USED IN TABLET MANUFACTURING
Capacity: -250liter or 120k
Rapid Mixture Granulator
Function: - RMG used to mix
the pharmaceutical
ingredients and make the
granules before compression.
1) Rapid Mixture Granulator also
known as High Shear Mixture.
2) Fluidized Bed Dryer
(FBD)
Principle: -The Principle of
FBD If air is allowed to flow
through a bed of solid powdered
material in the upward direction
with the velocity greater than the
settling rate of the particles, the
solid particles will be blown up
and become suspended in the air
stream.
3) Octagonal Blender
(butterfly shape)
Make: - Chamunda Octagonal
Blender (butterfly shape)
Capacity: -1250lit
Function: -mixing all granules and
ingredients and lubrication
homogeneously suitable for
crystalline and granular particles.
4) Chamunda
Compression Machine
Capacity: -16staion and
20station
Principle: -compression
of tablet.
Presented by_Dhanashree KOLHEKAR 15
Make: -Mark Maker Pharma
Engineering
Function: -To remove the moisture from
the tablets. A Vacuum Tray Dryer is
widely used in the pharmaceutical
industries to dry materials that are
oxidizable, heat sensitive and
hygroscopic in nature. Condenser, heat
exchanger and vacuum pump are
primary accessories for working of
vacuum tray dryer.
Pressure: -680 to 720atm
Temperature: - 60°c for 180min.
5) Vaccum Tray Dryer 7) METAL DETECTOR:
MAKE: Techno four Electronics Pvt.
Ltd.
PRINCIPLE: The limitation of the
magnet – which is standard practice
to detect and collect the external
metal contamination. The metal
contamination may occur in food
and pharmaceutical products due the
presence of metallic pieces or
components (viz., fasteners, pins,
buds, eroded )
6) Tablet Coating Machine;
Tablet coating machines are used to coat the
surface of tablets with a thin coating of film.
The film is employed mostly to: mask the
colour, taste and smell of the drug. protect the
drug from physical or chemical harm.
•Appearance: to change the color for branding
purposes or other aesthetic reasons
•Stability: to protect the active ingredient from
moisture, light, and/or acidic environment of
the stomach
•Taste and/or odor masking: to provide an
easy to swallow tablet without the bitter taste
of many active ingredients
Presented by_Dhanashree KOLHEKAR 16
Engineering & Maintenance Section :-
Engineering and prevention maintenance :
1. They check all equipment are working properly or not
2. The frequency to check the instrument is scheduled
3. If any fault is are arise during operation, they are resolved it
4. Purification of water is done
5. DM water synthesized
6. Air maintenance and purification is done
• Electricity Unit
• Water Treatment System Water softening unit: -
Water Softening Unit It is the removal of calcium, magnesium and certain
other metal cations in hard water. The Resulting soft water is more
compatible with soap and extends the lifetime of plumbing.
Water Softening is usually achieved using lime softening or ion-exchange
Resins.
Presented by_Dhanashree KOLHEKAR 17
QUALITY CONTROL SECTION
Qc is the part of GMP concerned with sampling, specifications and
testing and with the organization, documentation and release
procedures which ensure that the necessary and relevant tests are
actually carried out and the materials are neither released for use, nor
products are used for sale & supply until their quality has been
satisfactory.
• Independence of QC from production is considered fundamental.
► QC head should have appropriate qualification and experience,
which has control over one or several labs.
► Adequate resources must be available to ensure all quality control
arrangements are effectively and reliably carried out.
• Adequate facilities, trained personnel and approved procedures
must be available for sampling, inspecting and testing of starting
materials, packaging materials and intermediate bulk and finished
products and where appropriate of monitoring environmental
conditions for GMP purpose.
Presented by_Dhanashree KOLHEKAR 18
QUALITY CONTROL
MAJORLY INCLUDES:
• Sampling
• Quality control labs
• Retained samples
• Analysis of finished products
• Validation
• Records
• Batch inspection & sampling
Chemical and testing labs
Instrumental analysis labs
Microbiology and toxicology labs
Documentation room
Relevant books
SOP’s
Trained personnel
Provision for retained samples
and stability samples
Q
C
L
A
B
O
R
A
T
O
R
I
E
S
Presented by_Dhanashree KOLHEKAR 19
BATCH
INSPECTION
AND
RELEVANT
SAMPLING
OTHER ACTIVITES OF QC
Presented by_Dhanashree KOLHEKAR 20
QUALITY ASSURANCE SECTION
• Pharmaceutical quality assurance may be defined as the sum of all activities
and responsibilities required to ensure that the medicine that reaches the
patient is safe, effective, and acceptable to the patient.
• Quality Assurance (QA) covers all aspects that could have an impact on the
quality of prescribed pharmaceutical products.
• Good Manufacturing Practices is part of Quality Assurance which ensures
that products are consistently produced and controlled to quality standards
appropriate to their intended use.
*PHARMACEUTICAL QUALITY MANAGEMENT SYSTEMS
Presented by_Dhanashree KOLHEKAR 21
22
Presented by_Dhanashree KOLHEKAR
During my training period, in the industry I acquired lots of experiences in Pharmaceutical
Production and Production management. This will help me to clarify my theory knowledge. I hope
and pray that it will help me much in my future profession.
During my training period, I had seen the various instruments and apparatus in the industry. The
highly sophisticated instruments that work precisely must be operated with intense care for
optimum use. We could acquire a lot of information regarding the latest instruments and their
working procedures. It was taught to us that, the CGMP guidelines are to be strictly followed in
the industries in each and every section. And the similar guideline was seen followed in NuLife
PHARMACEUTICALS Pvt.Ltd. PIMPRI, PUNE. It helped me to acquire knowledge on
punctuality, regularity and working environments in industries.
DUTIES ASSIGNED =
1. To go through the manufacturing of tablets.
2. To observe and perform 'in process quality control' procedures for tablet and capsules.
3. To leam the procedure of manufacturing of tablets, syrups, and capsules.
4. To check the packaging and labeling procedure of tablets, granules, syrups, and capsules.
5. To observe the labeling requirement of raw material being under test or being approved.
6. To understand the procedure of coating of tablets
CONCLUSION
Presented by_Dhanashree KOLHEKAR 23
THANK YOU

One month industrial training report.pptx

  • 1.
    1 . Presented by: KOLHEKARDHANASHREE GIRIDHAR FINAL YEAR B.PHARMACY. University EnRoll No: 1894 Semester :7th Academic year : 2023-2024 Div(A) BATCH : C Sanjivani College of Pharmaceutical Education & Research (An Autonomous Institute) Shinganapur Tal: Kopargaon Dist.: Ahmednagar, Maharashtra, PIN: 423 603 Presentation on INDUSTRIAL TRAINING AT NuLIFE PHARMACEUTICALS Pvt. Ltd. Plot No. 63, F2 Block, MIDC, Pimpri, Pune 411018 UNDER THE GUIDANCE OF MR. AGASTI WARE SIR.
  • 2.
    2 Presented by_Dhanashree KOLHEKAR INTRODUCTION PROFILEOF ORGANIZATION LIST OF MANUFACTURED PRODUCTS INTRODUCTION TO DIFFERENT SECTION/ UNITS RAW MATERIAL STORE STORAGE AREA & WAREHOUSE PRODUCTION AND MANUFACTURING SECTION ENGINEERING & MAINTANANCE SECTION QUALITY CONTROLL UNIT QUALITY ASSURANCE SECTION CONCLUSION TABLE OF CONTENTS:-
  • 3.
    3 Presented by_Dhanashree KOLHEKAR INTRODUCTION History NuLifePharmaceuticals started its journey in 1973 with the promise of providing quality medicines. Since its inception, the company has grown and has added many divisions to its production. NuLife products enjoy a respectable market share all over India. NuLife is actively making its presence felt in the international pharmaceutical segment. MISSION • To be amongst the top healthcare companies. • Innovate continuously to develop new cutting-edge pharmaceutical and healthcare technologies and products. • To ensure better quality of life for people by providing the best in healthcare, pharma and allied products, of the highest standards. VISION  Our vision Emerge as a quality producer, visible, competitive and committed member of global health-care industry.  To keep improving the quality of life by offering value-added novel products that are technologically innovative, cost-effective and of superior quality, surpassing expectations of customers across the globe.  Be a highly ethical organization.  Commit to customer service, customer satisfaction and social responsibility.  Emerge as one of the benchmarked companies in the healthcare industry.
  • 4.
    Presented by_Dhanashree KOLHEKAR4 PROFILE OF ORGANIZATION Name of organization • NuLife Pharmaceuticals. Pvt Ltd PIMPRI, PUNE. • Established in the year 1973, Management • J.A. Trivedi [Founder NuLife PHARMACEUTICALS] NuLife Pharmaceuticals is the dream venture of Mr. J. A. Trivedi who wanted to leave a mark in the medical field. Mr. J. A. Trivedi's innate knowledge about the industry, markets and products coupled with his long-nurtured desire to get into the medically associated business turned into reality in 1973 when he started his own company, NuLife Pharmaceuticals. • MR. Umesh Trivedi [Managing Director of NuLife] He has extensive experience of over three decades in the field of pharmacy. As the Chairman and Managing Director, he has been instrumental in the growth of NuLife. Mr. Umesh Trivedi has been associated with various industry bodies and associations.  Madurai Deshmukh [works manager]  MR. Rajesh Jadhav [production manager]  MRS. Shailaja Lokhande [qc manager]  MR. Sudhir Devale [HR manager]  MR. Prashant Saste [training Incharge]
  • 5.
    Presented by_Dhanashree KOLHEKAR5 LIST OF PHARMACEUTICAL PRODUCTS: Almost more than 200 products are manufactured Some popular nutraceutical and pharmaceutical and non-pharmaceutical products of NuLife PHARMA. We are manufacturers of pharmaceutical specialties such as tablets, capsules, liquids, ointments and ayurvedic products. Our brands like Soliwax Ear Drops, Selectin Paint, and Gamascab Lotion are the leading brands in their categories.
  • 6.
    Presented by_Dhanashree KOLHEKAR6 INTRODUCTION TO DIFFERENT DEPARTMENTS 1. Production And Manufacturing Section 2. Packing Section And finished Goods 3. Raw Material Section 4. Quality Control Section 5. Quality Assurance Section 6. Warehouse 7. Engineering And Maintenance Section 8. R&D Department & IT 9. Dermatology [ product manufacturing] 10. Ear, Nose, Throat [ product manufacturing] 11. Ophthalmic [ product manufacturing] 12. Pediatrics [ product manufacturing] 13. Orthopedics [ product manufacturing] 14. Dentistry [ product manufacturing] 15. Gynecology [ product manufacturing] 16. Ayurvedic [ product manufacturing] 17. Veterinary [ product manufacturing]
  • 7.
    Presented by_Dhanashree KOLHEKAR7 RAW MATERIALS STORE Frist day I visited Raw Material Store Department where all raw material transport form warehouse Now this material keeps in quarantine section. Raw Material incharge do the entry of received material in register. And check the A.R NO.. BATCH NO., MFG, and EXP. DATE. QC Department take material for sampling to check and test the received material. And label the containers or tanks as UNDERTEST. After test if material is ok then they labeled it as approved. And if not labeled as reject. Approved material can transfer can to production department as per demand, rejected material key given to QA manager.
  • 8.
    Presented by_Dhanashree KOLHEKAR8 • Dispensing material should not be more than 5days in day store. • Rejection room consists of rejected material and the key of room is in QA authority. Consists of following: - 1) Receiving Area 2) precleaning and dusting area. 3) Quarantine Area 4) sampling & Sampling booth 5) Rejection Room 6) Dispensing Booth. Receiving raw material and packaging material. Match material received with invoice & challan Check material is from approved vendor Challan / invoice no COA received status compared this with the label While checking physical condition of material note down the following goods condition/damage/loose sealed/shelf life Mention “Not Applicable” NA whenever required Dedusting operation  Weighing verification Sampling Shifting of material to release/rejection area green queen manager Online rejection of material Handling of rejection material Dispensing Booth Collecting the goods after packing
  • 9.
    Presented by_Dhanashree KOLHEKAR9 STORAGE AREA & WAREHOUSE It contains two types of warehouses =  For storage of starting material and packaging material  For storage of intermediate in process material. 1. It involves storage of granules, uncoated tablets, coated tablets etc. for tampon of material from dispensing area to production area use of metal cases is done by which dispensed containers are used with label which contain all the information of this material (like Dane of manufacturing, name of drug, target, weight of product etc.) 2. Before entering the warehouse wear a yellow-colored helmet for safety purpose 3. It is the area for storage of the material with their suitable storage conditions In the warehouse first in first out process followed. 4. In warehouse there is one record room for maintaining record and information about storage material. 1. In process manufacturing materials. 2. Granules. 3. Uncoated tablets. 4. Coated tablets. 5. Excipients. RULES FOR WAREHOUSING: 1. Systemic storage of the delivered goods. 2. Use air circulation and protection against rodents 3. Keeping a space at least 50cm between the rows of pellets walls. 4. Providing each product have only one specific place. 5. On shelves clear labeling of products should be there 6. Adequate space should be provided for each good.
  • 10.
    Presented by_Dhanashree KOLHEKAR10 PRODUCTION AND MANUFACTURING SECTION • A tablet (also known as a pill) is a pharmaceutical oral dosage form (oral solid dosage, or OSD) or solid unit dosage form. Tablets may be defined as the solid unit dosage form of medication with suitable excipients. • It comprises a mixture of active substances and excipients, usually in powder form, that are pressed or compacted into a solid dose. • The main advantages of tablets are that they ensure a consistent dose of medicine that is easy to consume. A tablets are prepared either by moulding or by compression. • The excipients can include diluents, binders or granulating agents, glidants (flow aids) and lubricants to ensure efficient tableting; disintegrants to promote tablet break-up in the digestive tract; sweeteners or flavor's to enhance taste; and pigments to make the tablets visually attractive or aid in visual identification of an unknown tablet. • 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.
  • 11.
    Presented by_Dhanashree KOLHEKAR11 Common Tablet Defects: Tablet defects occur for a variety of reasons, but many can easily be avoided. To address defects, technicians involved in tableting must have a full understanding of both the tableting process and the materials used. Adequate training in the setting up and use of the machines is vital if the technician is to have the necessary skills to be able to fix equipment and minimize problems in production. A professional and experienced technician can turn an ordinary product into a high quality one whereas a novice or inexperienced operator cannot, and might even be afraid to adjust the machine in order to prevent or correct problems. When the equipment is properly operated the tablet production will go smoothly. Types of tablets Depending on the physicochemical properties of the drug, site and extent of drug absorption in the gastrointestinal (GI) tract, stability to heat, light, or moisture, biocompatibility with other ingredients, solubility, and dose, the following types of tablets are commonly formulated
  • 12.
    Presented by_Dhanashree KOLHEKAR12 Unit Operations There are three methods of preparing tablet granulations. Such as: (a)Wet granulation (b)Dry granulation (also called “slugging”), (c)Direct compression. Each individual operation of the process is Known as a unit operation. WET GRANULATION •Milling of drugs and excipients • Mixing of milled Powders •Preparation of binder solution. •Mixing binder solution with powder mixture to form wet Mass. •Coarse screening of wet mass using 6- to 12- mesh. •Drying moist granules. •Screening dry Granules with lubricant and disintegrants. •Mixing screened granules with lubricant and disintegrants. • Tablet compression. •Milling of drugs and excipients. •Mixing of milled Powders. •Compression into large, hard tablets called slugs. •Screening of slugs. •Mixing with Lubricant and disintegrating agent. •Tablet compression. DIRECT COMPRESSION •Milling of drugs and Excipients. •Mixing of ingredients. •Tablet compression.
  • 13.
    Presented by_Dhanashree KOLHEKAR13 DIAGRAMATICAL REPRESENTATION METHODS OF PREPARING TABLET GRANULATIONS.
  • 14.
    Presented by_Dhanashree KOLHEKAR14 MACHINES USED IN TABLET MANUFACTURING Capacity: -250liter or 120k Rapid Mixture Granulator Function: - RMG used to mix the pharmaceutical ingredients and make the granules before compression. 1) Rapid Mixture Granulator also known as High Shear Mixture. 2) Fluidized Bed Dryer (FBD) Principle: -The Principle of FBD If air is allowed to flow through a bed of solid powdered material in the upward direction with the velocity greater than the settling rate of the particles, the solid particles will be blown up and become suspended in the air stream. 3) Octagonal Blender (butterfly shape) Make: - Chamunda Octagonal Blender (butterfly shape) Capacity: -1250lit Function: -mixing all granules and ingredients and lubrication homogeneously suitable for crystalline and granular particles. 4) Chamunda Compression Machine Capacity: -16staion and 20station Principle: -compression of tablet.
  • 15.
    Presented by_Dhanashree KOLHEKAR15 Make: -Mark Maker Pharma Engineering Function: -To remove the moisture from the tablets. A Vacuum Tray Dryer is widely used in the pharmaceutical industries to dry materials that are oxidizable, heat sensitive and hygroscopic in nature. Condenser, heat exchanger and vacuum pump are primary accessories for working of vacuum tray dryer. Pressure: -680 to 720atm Temperature: - 60°c for 180min. 5) Vaccum Tray Dryer 7) METAL DETECTOR: MAKE: Techno four Electronics Pvt. Ltd. PRINCIPLE: The limitation of the magnet – which is standard practice to detect and collect the external metal contamination. The metal contamination may occur in food and pharmaceutical products due the presence of metallic pieces or components (viz., fasteners, pins, buds, eroded ) 6) Tablet Coating Machine; Tablet coating machines are used to coat the surface of tablets with a thin coating of film. The film is employed mostly to: mask the colour, taste and smell of the drug. protect the drug from physical or chemical harm. •Appearance: to change the color for branding purposes or other aesthetic reasons •Stability: to protect the active ingredient from moisture, light, and/or acidic environment of the stomach •Taste and/or odor masking: to provide an easy to swallow tablet without the bitter taste of many active ingredients
  • 16.
    Presented by_Dhanashree KOLHEKAR16 Engineering & Maintenance Section :- Engineering and prevention maintenance : 1. They check all equipment are working properly or not 2. The frequency to check the instrument is scheduled 3. If any fault is are arise during operation, they are resolved it 4. Purification of water is done 5. DM water synthesized 6. Air maintenance and purification is done • Electricity Unit • Water Treatment System Water softening unit: - Water Softening Unit It is the removal of calcium, magnesium and certain other metal cations in hard water. The Resulting soft water is more compatible with soap and extends the lifetime of plumbing. Water Softening is usually achieved using lime softening or ion-exchange Resins.
  • 17.
    Presented by_Dhanashree KOLHEKAR17 QUALITY CONTROL SECTION Qc is the part of GMP concerned with sampling, specifications and testing and with the organization, documentation and release procedures which ensure that the necessary and relevant tests are actually carried out and the materials are neither released for use, nor products are used for sale & supply until their quality has been satisfactory. • Independence of QC from production is considered fundamental. ► QC head should have appropriate qualification and experience, which has control over one or several labs. ► Adequate resources must be available to ensure all quality control arrangements are effectively and reliably carried out. • Adequate facilities, trained personnel and approved procedures must be available for sampling, inspecting and testing of starting materials, packaging materials and intermediate bulk and finished products and where appropriate of monitoring environmental conditions for GMP purpose.
  • 18.
    Presented by_Dhanashree KOLHEKAR18 QUALITY CONTROL MAJORLY INCLUDES: • Sampling • Quality control labs • Retained samples • Analysis of finished products • Validation • Records • Batch inspection & sampling Chemical and testing labs Instrumental analysis labs Microbiology and toxicology labs Documentation room Relevant books SOP’s Trained personnel Provision for retained samples and stability samples Q C L A B O R A T O R I E S
  • 19.
    Presented by_Dhanashree KOLHEKAR19 BATCH INSPECTION AND RELEVANT SAMPLING OTHER ACTIVITES OF QC
  • 20.
    Presented by_Dhanashree KOLHEKAR20 QUALITY ASSURANCE SECTION • Pharmaceutical quality assurance may be defined as the sum of all activities and responsibilities required to ensure that the medicine that reaches the patient is safe, effective, and acceptable to the patient. • Quality Assurance (QA) covers all aspects that could have an impact on the quality of prescribed pharmaceutical products. • Good Manufacturing Practices is part of Quality Assurance which ensures that products are consistently produced and controlled to quality standards appropriate to their intended use. *PHARMACEUTICAL QUALITY MANAGEMENT SYSTEMS
  • 21.
  • 22.
    22 Presented by_Dhanashree KOLHEKAR Duringmy training period, in the industry I acquired lots of experiences in Pharmaceutical Production and Production management. This will help me to clarify my theory knowledge. I hope and pray that it will help me much in my future profession. During my training period, I had seen the various instruments and apparatus in the industry. The highly sophisticated instruments that work precisely must be operated with intense care for optimum use. We could acquire a lot of information regarding the latest instruments and their working procedures. It was taught to us that, the CGMP guidelines are to be strictly followed in the industries in each and every section. And the similar guideline was seen followed in NuLife PHARMACEUTICALS Pvt.Ltd. PIMPRI, PUNE. It helped me to acquire knowledge on punctuality, regularity and working environments in industries. DUTIES ASSIGNED = 1. To go through the manufacturing of tablets. 2. To observe and perform 'in process quality control' procedures for tablet and capsules. 3. To leam the procedure of manufacturing of tablets, syrups, and capsules. 4. To check the packaging and labeling procedure of tablets, granules, syrups, and capsules. 5. To observe the labeling requirement of raw material being under test or being approved. 6. To understand the procedure of coating of tablets CONCLUSION
  • 23.