NuLife Pharmaceuticals, Pune

PROJECT REPORT

ON

ONE MONTH INPLANT TRAINING

WITH

NuLife Pharmaceuticals, Pimpri, Pune

Submitted by

Mr. Krishna govind khamkar

(B. Pharm.) (2020-2021)

RJSPM’s collage of pharmacy, Dudulgoan Pune - 412105

( RJSPM’S collage of pharmacy )

 NuLife Pharmaceuticals, Pune

ACKNOWLEDGEMENT

I express special thanks to Mr.Prashant Saste Head of training department, NuLife

Pharmaceuticals, for making available all the facilities to carry out my training successfully.

I kindly oblige for the unending love, inspiration given by my parents. I'm thankful to my
friends and all those who have directly forwarded their help towards this work.

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 NuLife Pharmaceuticals, Pune

INDEX
Contents
Sr. No. Page No.

1.
Introduction of Industry 3

2. Various departments of
Industry 5

3. 18
Summary

4. 19
Conclusion

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 NuLife Pharmaceuticals, Pune

Introduction
Overview of industry

NuLife Pharmaceutical – Manufacturing of a wide range of pharmaceutical dosage forms,

external preparation and auyrvedic formulations.

Establishment – Established in 1973.

Vision –To provide quality medicinal products and help one achieve healthier and happier
nulife.

Core Values –

• Innovation
• Quality and Patient focus
• Teamwork and Report
• Value driven
Departments –

• Changing room.
• Manufacturing of Tablets.
• Manufacturing of Capsules.
• QA/QC and IT.
• Warehouse.
• Research and Development.
• Environment Health and Safety. Annual Turnover – Rs. 5 – 10 Crore.

Certification – GMP & WHO

Area – 6 acres.

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 NuLife Pharmaceuticals, Pune
Manufacturing – ENT, Dermatology, Ophthalmic, Paediatrics, Gynaecology, Orthopaedics,
Dentistry, Ayurvedic and Veterinary.

Formulations – Tablets, Capsules, liquid oral and external preparation.

Legal status of firm – Professional Association.

Activities – Sport championship, Birthday celebration, Diwali, Navratri, Trip.

R & D – The research and development team is comprised of 12 Pharmacist, Scientists from
different fields. Microbiologists, Chemists, Pharmacologists, Physicians and Business
Administrators which from a part of NuLife Pharmaceuticals.

LAYOUT FOR TABLET PROCESSESS

Introduction of Different Departments

Changing Room:
Color Coding of Uniform;

o For Manufacturing department – Brown colour apron or White colour apron with
employee ID and company name.
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 NuLife Pharmaceuticals, Pune
o For QC & QA department – White colour apron with ID and Company name.
o For Engineering department – Grey colour apron with employee ID and company
name with Blue colour helmet.

o For Environment Health and Safety department – White colour apron with
identification of First Aider, Fire Fighters, Emergency Unit with their ID and
company name with Green colour helmet.
o For all Office staff - White colour apron with their ID and company name.
o For Dedicated area of Production – Full sleeves white apron with ID and company
name with Yellow colour helmet.
o For Warehouse – White colour apron with ID and company name.
o For Visitors – White colour apron with their ID and visitor logo and white colour
helmet with visitor label.
The pictorial diagram of gowning procedure and mirror should be displayed in change room.

Primary change room (Male and Female)

1. Pull the door of first change room.

2. Remove your street and unwanted articles like wrist watch, mobile phone, jewellery
(chain, ring) and keep them in assigned lockers.
3. Wear black coloured socks and shoes are provided by factory daily.
4. Take your protective garments like apron, cap from the lockers ane wear them are
provided by factory Monday or Tuesday or earlier if required.
5. Through mirror check out your proper gowning.
6. Provide shoes with socks or shoes cover to visitor.
7. Disposable garments may be provided to employees whenever required. First change
room (Male and Female)
1. Employee working in manufacturing and primary packaging area will enter into
primary change room.
2. Changeover of each product uniform shall be change.
3. Remove first change room shoes and keep them in locker.
4. Sanitize hands with sanitizer.
5. Cross the COB.

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 NuLife Pharmaceuticals, Pune
6. Take your lint free garments like apron, cap from the locker and wear them are
provided by factory Monday or Tuesday or earlier if required.
7. Wear the garments over the previous uniform.
8. Wear clean brown coloured shoes through the locker.
9. Brown show or additional show cover for visitor.
10. Through mirror check out your proper gowning.
11. Sanitize your hands with sanitizer.
12. Then go to respective work place such as dispensing, sampling, granulation,
compression, coating, capsule manufacturing, and primary packing.
13. Wear mask before entry in core area (Manufacturing) and primary packing. Exit from
primary change room

1. Remove lint free uniform including cap and put them in the lockers.
2. Remove primary shoes and socks and place in the lockers.
3. Cross over the bench.
4. Now wear first change shoes.

Exit from first change room

1. Remove first change room uniform and shoes and keep in the lockers.
2. Dispose off all disposable garments and shoe cover in the waste bin.
3. After working hours drop factory socks in socks bin which placed in the first change
room.
4. Now wear your street shoes and collect all your belongings.

Precaution

1. At the time of entering toilet, remove first change shoes and wear separate footwear
which provided by the factory.
2. Coming out of the toilet again wear first change shoes.

Manufacturing of Tablets:

Where actual manufacturing of tablets take place. Manufacturing plant involves majorly 4
departments as,

1. Granulation.

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 NuLife Pharmaceuticals, Pune
2. Compression.
3. Coating.
4. Packaging: Primary pack.

Instruments used in Production,

Stainless Steel Reactor.

Glass Lined Reactor.
Press Filter.
Sparkler Filter.
Leaf Filter. Centrifuge.
Tray Dryer.
Vacuum Try Dryer.
Rota Cone Vacuum Dryer.
Blender.
ANFD.

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 NuLife Pharmaceuticals, Pune
1) Granulation:-
During granulation for different product, different environmental parameters to be checked
as temperature relative humidity (RH) and pressure, is regulated by magnetic gauze.

Total 12 granulation units are present which are used depending upon type of product to be
processed. For light sensitive material yellow light is used.

During granulation LOD of granules is also verified.

GRANULATION PROCESS MACHINE

Worker safety;

Safety of worker is also considered during granulation process as instruments stars employee
who works there should be out of room and door is locked as you touch door from outside
automatically instruments stop. Or during process any problem occurs or process time over
instruments stop automatically.

2) Compression:-

Compression machine used: Korsch XT600.

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 NuLife Pharmaceuticals, Pune
Advanced high speed automatic compression machine are present. Before compression the
special instrument is present for mixing of lubricants with granules. After compression the
tablets stores at warehouse for inspection and if tablets approved then batch is forwarded for

coating .

IPQC Tests:

Separate IPQC room is present near to compression area. Different IPQC tests for tablets
which are as follows;

Disintegration Test Apparatus Friability Tester

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 NuLife Pharmaceuticals, Pune

Dissolution Apparatus

3) Coating:-

Coating machine is present for tablet coating in which spray gun is used and hot air supplied
for simultaneous drying of tablets. Different plasticizers, polymers and solvents are used for
coating. Majorly coating is carried out to masked odour and taste of tablets. Film coating is
available. Coating defects are automatically checked and verified and defected tablet reject
automatically.

COATING MACHINE

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 NuLife Pharmaceuticals, Pune

4) Packaging:-

1. Primary packaging.
a) Strip pack.
b) Blister pack.
Packaging of tablets and capsules takes place either in strips or container. Initially product
undergoes primary packing followed by secondary packing. Printing of container also take
place in process. The defects are automatically checked and defected packing is rejected by
auto sensor. After packing cartons and boxes are stored in warehouses.

During manufacturing of tablets each and process parameters is provided by R&D

department like name, amount and concentration of excipient used. Process time for
granulation, environmental factor like relative humidity, temperature and pressure
information is provided by R&D. During manufacturing documentation is also maintained
like BMR (Batch Manufacturing Record), BPR (Batch Production Record), and MPR

(Master Production Record).

STRIP PACKING

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 NuLife Pharmaceuticals, Pune

BLISTER PACKING

Manufacturing of Capsules:

Empty capsule shell are provided to company by HGC Suppliers by Capsulgel (universal)

Capsule filling and packaging is carried out automatically. During capsule manufacturing
instruments used fallows,

Capsule filling – AF 90T (Automatic filling 90 Thousand)

ZRO 200 T (Zero Relative Operation 200 Thousand)

Weight checker – IMA Active Precisa 18

The qualification of machine includes,

IQ (Instrumental Qualification)

PQ (Process Qualification)

DQ (Design Qualification)
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 NuLife Pharmaceuticals, Pune
During process different material required for capsule manufacturing is stored at warehouse.
Material includes granules, empty gelatine shell, packing material for capsules etc.

Filling of HGC shell (capsules)

 Rectification.
 Separation cap from body.
 Filling of body.
 Scrapping the excess of powder.
 Replacing the cap.
 Sealing the capsules.
 Cleaning the outside of filled capsules.
 Brushing.
Quality Assurance/ Quality Control:

QC – Involved in analysis of compounds.

QA – Involved in documentation and developments.

Departments of QA –

• IPQA (In Process Quality Assurance).

• QMS (Quality Management System).
• DQA (Development Quality Assurance).
• CQA (Corporate Quality Assurance).
• AQA (Analytical Quality Assurance).
• DQA (Documentation Quality Assurance).
• ITQA (Information Technology Quality Assurance). Instruments used in
QA/QC department;

HPLC (High Performance Liquid Chromatography).

GC (Gas Chromatography).
IR (Infra Red Spectrophotometer).
UV (Ultra Violet Spectrophotometer).

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 NuLife Pharmaceuticals, Pune
Specific Optical Rotation.
pH Meter.
Kf Titrator.
Potentiometer.
In each and every step of production QA/QC involves analysis of starting material, different
intermediate and final products. After QA/QC approval the product is sent for the further
process. Hence it plays an important role in any pharmaceutical company.

QC department includes different apparatus like HPLC, U. V., Spectrophotometry,

Dissolution and other instruments like Magnetic stirrer, weighing balance etc.

Store room – used for storage of different intermediate testing samples. The temperature of
this room control is in between 18 to 19 ºC.

Washing area – For cleaning of different apparatus.

Warehouse:

It contain two type of warehouse

1. For storage of starting material and packaging material.

2. For storage of intermediate in process material.
It involves storage of granules, uncoated tablets, coated tablets etc. for transport 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 date of
manufacturing, name of drug, target, weight of product etc.).

Before entering warehouse wear yellow coloured helmet for safety purpose.
It is the area for storage of the material with their suitable storage conditions.
In warehouse first in first out process followed.
In warehouse there is one record room for maintaining record and information about
storage material.
In warehouse following material are stored,
1. In process manufacturing materials.
2. Granules.

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 NuLife Pharmaceuticals, Pune
3. Uncoated tablets.
4. Coated tablets.
5. Excipients.
Warehouse contains following area –
1. De- dusting area.
2. Quarantine area.
3. Rejected area.
For different products different environment parameters are to be checked i.e.
temperature, humidity & pressure etc.
Everywhere HEPA filters are placed i.e. R- Return, S- Supply.
Every material used to have a product label it include wt. of container, wt. of product,
net wt. of product, signature of authorised person, unique barcode, date of mfg. &
exp.
Warehouse consists of a crane for moving a material from one place to another place.

There are coloured label which are in material barrels. Following colours indicates the
following information.
1. Yellow colour – Newly received material.
2. Orange colour – Sample taken by QC.
3. Green colour – Product is approved by QA.
During each process quality of material is carried out by QA&QC departments.
Cold storage is also available in warehouse for some products.

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UV

Gc IR

Research and Development (R&D) Department:

This department plays crucial role in manufacturing of pharmaceutical preparation. It decides
every parameter of production like excipient used with their concentration, etc.

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 NuLife Pharmaceuticals, Pune
It provides limits of various environmental factors like temperature, pressure, relative
humidity, light etc. It also provides storage conditions for different intermediate material.
R&D also gives information related to and size of tablets, capsules along with equipment's
and process to be used during manufacturing.

It also provides each and every limit which should be inspected continuously all the time
during production. Limits are given for hardness, dissolution disintegration, LOD,
compression parameter, packaging etc. And every limit is verified and checked by QA & QC
departments.

Polarimeter

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 NuLife Pharmaceuticals, Pune

PH meter

• SUMMARY
NuLife is a leading pharmaceutical company having GMP & WHO certified manufacturing
unit having world class facilities. We “NuLife Pharmaceuticals” are foremost trader of
highly effective range of Pharmaceutical Tablets, Capsules, liquid oral and external
preparation.

We deliver high-quality, cost-effective health care management through quality drugs with
greater safety, stability & effectiveness.

• CONCLUSION
After the completion of industrial training we enhanced competencies and competitiveness in
our respective area of specialization. We tried to relate the experience in the workplace with
knowledge learned in the institute and applied the knowledge on the job under supervision.

Here we gained experience and knowledge that can be used for suitable job without delay
after studies.

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 NuLife Pharmaceuticals, Pune
We learned to hone soft skills appropriate to the work environment & also get improvised
our communication skills. We assessed career ability, knowledge and confidence as well as
enhanced our marketability to be more competitive.

With experience, knowledge and skills acquired during industrial training me will be better
prepare to face changing pharmaceutical.

( RJSPM’S collage of pharmacy )

 NuLife Pharmaceuticals, Pune

( RJSPM’S collage of pharmacy )