Here is my industrial report based on my visit to Dr. Milton Laboratories Pvt. Ltd. in the months between January and February 2023.

1. INTERNSHIP REPORT
INTERNSHIP AT:
Dr. Miltons Laboratories Pvt. Ltd.
“PHARMACEUTICALS Caring Your
Health With Excellence”
INTERNSHIP BY:
RAJAKARTHIKEYAN. U
Shri Venkateshwara College of Pharmacy,
Ariyur, Pondicherry

2. LETTER OF TRANSMITTAL
February 17th
2022
Dr. Jeevitha Mam, M. Pharm, Ph.D.
Associate Professor,
Department of Pharmaceutics,
Shri Venkateshwara College of Pharmacy,
Ariyur, Puducherry- 605012
Respected Madam,
With due respect, I would like to inform you that, it is my great
pleasure for me to submit this internship report at Dr. Miltons Laboratories
Pvt. Ltd. Starting from January 18th
2023 to February 18th
2022. Working for
a month in Dr. Miltons Laboratories Pvt. Ltd, it helped me to fulfil the
requirements of obtaining the practical knowledge and subsequently
prepare my report.
I also got an in- depth understanding and experience while working in their
QC department. It was my great pleasure and honour that I got opportunity
working with them. I hope that this report will reflect my learning during the
internship program and you will find it quite interesting and worthy of
experience.
Sincerely yours,
RAJAKARTHIKEYAN. U
19180267
PONDICHERRY

3. DEDICATION
I have dedicated my internship work and effort to all my teachers who
found such ability in me in Dr. Miltons Laboratories Pvt. Ltd. Without their
help I was not able to do my best efforts.
DURATION: 18 Jan 2023 TO 18 Feb 2023

4. ACKNOWLEDGEMENT
I would like to express my deepest gratitude to Senior HR manager, G.
MAHENDIRAN sir for his kind support and inspiration which has immensely
strengthened my confidence during my internship program.
Knowledge has no boundaries and there is no end to it. This is what I have
come to know while preparing this report. It has been a good experience by
taking training in Dr. Miltons Laboratories Pvt. Ltd. The whole staff of
organization was cooperative and helpful. I sincerely express my thanks &
gratitude to the honorable and respected Production manager, VIJAYA
PRAKASH sir who provided me with an opportunity of internship and to
write on such a unique organization
I am obliged to intend my thanks to all staff members of Dr. Miltons
Laboratories Pvt. Ltd. for extraordinary guidance and tremendous
cooperation throughout the tenure of internship.

5. TABLE OF CONTENTS:
1. Letter of Transmittal
2. Dedication
3. Acknowledgement
4. About the company
5. Infrastructure
 Warehouse
 Production
 Quality control
 Quality assurance
6. Machines
 Coating
 Encapsulation
 Ointment
 Compression
 Granulation
7. Engineering
 HVAC
 Purified water plant
 Water plant
 Plant highlights
8. Packing
9. Research & Development
 Analytical
 Formulation
10. Discussion
11. Conclusion

6. ABOUT THE COMPANY
Dr. Miltons Laboratories Pvt. Ltd. is well professionally managed and a successful
pharmaceutical formulation company
An Indian based manufacturing corporation with unit at Puducherry State, committed to
"Deliver Quality Product for more than 10 years
Dr. Miltons Laboratories Pvt. Ltd. in its quest to be a leades in contract manufacturing
has established a eminent state of the high class infrastructure
Dr Milton Laboratories is concerned with,
VISION: Our vision is to be one of the trusted and quality organization in the pharma
industry
MISSION: Our mission is to deliver Quality Products in time with affordable cost
VALUE SYSTEM: We the Employees of "Dr. Miltons Laboratories" are committed to
being very aggressive in our attitude towards "Timely Achievement of task with
"Uncompromised Quality"

7. INFRASTRUCTURE:
Warehouse:
Storage conditions conforming to CGMP norms to ensure quality throughout the shelf
life shelf life of all materials.
Stores active raw materials, diluents, packing materials, and finished goods under
controlled temperature and humidity as per specific product demand.
The material transfers through hoist and pass box to hold area.
Sampling and dispensing of materials carried out under laminar air flow in class 100.
Quarantine, under test, approved and rejected materials segregated area. stored in a
separate recall room for storing market recall products.
Production:
Built-up capacity of the plant is 100 crore units inclusive of tablets, Capsules and
Ointment per annum.
Facility is equiped with all kind of equipments for granulation, compression, capsule
filling, coating, unit packing and bulk packing.

8. Automated and PLC based equipments like RMG, FBD, OGB, Ribbon blender, Tray
dryer, AF90, compression machines, Auto coaters, Blister, Alu-Alu and Strip packing
equipments,
Dedicated storage area for dispensed materials materials.
Dedicated AHUS and Controlled environment conditions for processing.
Quality Control:
Qualified and competent personnel with sophisticated infrastructure forms the back
bone of the quality control.
Exclusive chemical, instrumentation and microbiology labs, for the testing of API,
excipients, packaging, in-process materials and finished drug products.
Furnished with automated and most ultra-modern apparatus including UV
Spectrophotometer and HPLCs ensures simultaneous analysis of multiple products.
Periodical monitoring to achieve the environmental compliance as per the GMP norms.
Continuous review of stability data for the entire through 8000 liters Walk-in Stability
Chamber 7/8 specification.

9. The 24/7 Air conditioned retention sample room under prescribed storage conditions for
quality audit of all products at any time.
Quality Assurance:
Well qualified personnel with rich expertise committed to deliver uncompromised quality.
Quality management system conceived as per the cGMP requirements.
Stringent quality procedures and controls on the entire product life cycle from
development to shelf life.
Encompasses all the critical quality assurance tools like facility qualification, equipment
qualification, vendor qualification, product release, trend analysis, self inspection,
market complaint, product recall, out of specification, out of trend, and annual quality
review.
Deep-rooted documentation practice covering, incident reporting, deviations, change
controls with CAPA as the guiding tool.
Validation is an integral part of quality assurance, associated with every product, system
and process, Training of all employees for cGMP awareness on a continual basis.

10. Engineering:
Designed for the uninterrupted services and to support for all the process.
State of the art sophisticated detailed engineering of the entire plant is created to
provide round the clock services and support the manufacturing requirements with
respect to electrical, mechanical, steam, compressed air and allied engineering
requirements.
PLANT HIGHLIGHTS:
Built-up capacity 5500 Its / 42000 bottles per day.
Dedicated facility for Woodwards, Gripe Water (Warehousing, Manufacturing and
Packing).
Consists of Filter press, Reaction tanks, Storage Tanks, Bottle washing, Filling and
Capping Equipments, Inspection and Packing facility.

11. PURIFIED WATER PLANT:
Installed capacity of purified water system is 2 KL per Hour.
Purification process includes, Multi- grade and Activated carbon filtration, Chlorination,
RO treatment, mixed bed resin treatment and UV pass.
Distributed through continuous loop system with Zero dead leg valves.
Periodic testing and sanitization programs.
HVAC:
Exclusive service plant room for placing 17 AHUs and 10 FDV provides Air supply at
designed class, temperature and humidity for the entire facility. Dedicated Air Handling
Units for each process area to prevent cross contamination.
The required classification of the area achieved through high efficiency filters, 10 micron
Pre-filter with 90% efficiency, 3 micron Fine filter with 99% efficiency and 0.3 micron
HEPA filter with 99.97% efficiency.

12. Water Plant:
Installed capacity 5 KL purified water pershift. Fully automated from primary treatment
to delivery points.
Source water compliance to IS 10500 standard Primary treatment through multi grade
filter and softener to comply with the requirements of potable water.
PACKING:
Five packing suits for primary packing with a capacity to pack upto 2.5 million tablets
and capsules.
Equipped to handle all the packing requirements from Alu/Alu, Blister, Strip and HDPE
packing.
Most advanced Alu/Alu machine (BQS ) based on flat thermo forming and sealing,
servo mechanism.
Exclusive change parts for physician samples.
All the packing machines equipped with on line printers in the primary packing section

13. Products:
Some lists of products from of Dr. Miltons Laboratories Pharmaceutical are given below:
1. Rosuvastatin Calcium Tablets 10mg
2. Paracetamol Tablets BP 500mg
3. Gastro-resistant Omeprazole Capsules BP 20mg
4. Indomethacin Capsules BP 25mg
5. Loperamide Hydrochloride Capsules USP 2mg
6. Ciprofloxacin Tablets USP 500mg
7. Acyclovir Cream BP
8. Clotrimazole Cream USP 1% w/w
9. Amlodipine Tablets 5mg
10. Diclofenac Sodium delayed release Tablets USP 50mg

14. MACHINES:
Encapsulation:
1. Fully automated with a capacity up to 2 million per day.
2. Specific humidity control system to maintain RH below 50%.
3. Additional feature of pellet filling and tablet in capsule.
4. Equipped with all essential automated line machines from filling to polishing.
Ointment:
Flexibility: Machine with the capability to manufacture a wide range of products.
Capacity: 5.5 Million Tubes per annum.
Stability: End Products are stable, glossy and air-free with a consistent specific
weight for improved filling performance downstream.
Highly efficient processing with significantly reduced batch times and operating costs.
Heating/cooling and insulated jackets complete with temperature control and safety
equipment

15. Coating:
1. Two coating section with capacity ranging from 15 Kg to 125 Kg per lot.
2. Meets all coating requirements like film, enteric and sugar coating. Equipped with
fully automated process. GMP complaint with PLC based operation.
3. Complete flame proof design for highest safety while handling solvents.
Compression:
1. Four Suits with capacity up to 2 million tablets a shift.
2. Single rotary for smaller batches and double rotary for medium batches.
3. High speed rotary for bigger batches.
4. Bi layer & Tablet in Tablet facility to suit the specific formulation requirement.
Granulation:
Equipped with sophisticated, GMP compliant equipments. Two section with capacity
ranging from 15 kg to 300 kg. Capable for both aqueous and non-aqueous process.
Flame proof design for safety while using solvents.

16. Conventional Tray dryer for smaller batches, and Capable to blend small, medium and
large batch sizes. All required locations connected to utility lines like compressed Air,
Steam, Potable and purified water. Dust extraction system for major powder generating
equipment to avoid cross contamination.
R&D:
FORMULATION:
The state of the art Formulation development process in Chennai, is a miniature of the
production department comprising Capsulation, Granulation, Compression, Coating and
Packing
The FRnD is designed to develop various kinds of oral dosage forms like Capsules,
Tablets in single as well as Bi-layered form, uncoated, coated, dispersible, sustained,
delayed release and sub-lingual formulations.
FRnD is also equipped to handle various formulation processes including direct
compression, aqueous and non-aqueous granulation.
FRnD is fully supported by an exclusive sophisticated Analytical Research and
Developmental Lab.
ANALYTICAL:
The objective of the ARnD is to develop, the Analytical methods in house for every
formulation developed by the FRnD.
ARnD is equipped with sophisticated Equipment like UV Spectrophotometer, HPLC,
Auto titrator and multi basket dissolution apparatus.
As an internal quality bench mark, each of the in house developed analytical methods
are validated commercialization to ensure before the consistency of the product quality
is maintained everywhere, every time.
The Walk in stability chambers in ARnD provide periodical, both real time and
accelerated stability studies as per ICH guidelines.

17. DISCUSSION
Dr. Miltons Laboratories Pharmaceutical enhanced understanding of my
academic knowledge and skills. It indeed polished my knowledge and
experience. Classroom studies are confined only to books and theoretical
learning majorly. Application of these theories and lectures delivered in
classrooms differ a little from the specifically set format.
Through this internship, I not only got the opportunity to experience but I
also learnt the applications of these theories in actual the application. I got
to observe the whole working environment of pharmaceutical industry & the
important aspects regarding the production of high quality pharmaceuticals
& carrying out important quality control tests to ensure that all the
procedures carried out during production are according to GMP.
It also improved my general knowledge about equipments commonly used
in our industries.
Not only pharmacists in production areas but even workers helped me to
understand important procedures regarding the production. The entire
journey of internship allowed me to identify my strengths and weaknesses,
and use both of them to the best advantage of my career.

18. CONCLUSION
Though serving on humanity is not only a person's responsibility but also of
community. And this community comprises of all the members starting from
the very first of disposal of quality products. No work is penniless rather the
knowledge it keeps in, internship at any working area is a great learning
experience in itself. I would like to convey my thanks to Shri
Venkateshwara College of Pharmacy, Puducherry for providing me an
opportunity to gain idea of the competitive environment in the professional
field.
Thank You Dr. Miltons Laboratories Pharmaceutical for giving me chance
to learn and explore the industrial aspect of pharmacy.
THE END!