INDUSTRIAL TRAINING REPORT

SEPTEMBER – OCTOBER 2021

AT SIEMENS HEAITHCARE PVT. LTD.

STUDENT NAME - HIMANSHU CHHOTU CHAUDHARI

PROGRAM- B PHARMACY
INSTITUTE- PSGVP MANDAL’S COLLEGE OF PHARMACY, SHAHADA, .
.. 425409,NANDURBAR, MAHARASHTRA, INDIA.
PRN - 2018015400093484
STUDENT E-MAIL - himanshuchaudhari53028@[Link]
CONTACT NO- 9527616039 , 8669295494.
ORGANISATION
NAME - SIEMENS HEALTHCARE PVT. LTD.
ADDRESS - E 14 & 15 MANJUSAR GIDC, SAVLI, VADODARA- 391776
. GUJARAT, INDIA
DEPARTMENT - PRODUCTION ( STRIPS, AUTOPAK ), QUALITY TESTING
UNDER THE GUIDANCE OF – MR. SANTOSH PAGARE

*REMARK –

Pagare Santosh 2021.12.16

+05'30'
16:38:58

______________________
Mr. Santosh Pagare
( Plant Manager )
Siemens Healthcare Pvt. Ltd.

1
 INDEX

Page

1. Acknowledgement 3

2. Preface 4

3. Abstract 5

4. Introduction 6

3.1 Defining the term of Industrial Training 7

3.2 Description of Industrial Training Organisation 7

3.2.1 Objectives of Industrial Training 8

3.2.2 Responsibilities of Trainee 9

3.2.3 Objectives of Final Report 9

5. Details of Experienced Gained 10

6. Conclusion 24

7. Learning’s 25

2
 ACKNOWLEDGMENT

I consider it a great privilege & honour to have had the opportunity to undergo the industrial
training work in Siemens Healthcare Pvt. Ltd. Hence, I would like to offer my heartiest thanks
to Mr. Santosh Pagare (Plant Manager ) and Mrs. Ramya Nair ( Location-HR). For me it was
a unique experience to be in Siemens Healthineers and to study an interesting Manufacturing
and Quality Testing skills . It also helped to get back my interest in Pharmacy, research and to
have new plans for my future career.

I am greatly indebted to Dr. S. P. Pawar (Principal) Of P.S.G.V.P Mandal’s College of

Pharmacy, Shahada, KBCNMU for enabling us to have the chance of industrial training, and
for providing the college cover letter for training.

I convey my heartiest thanks to Mr Saji Varghese (Production Head) Mr. Vrajesh Ghorpade
(Floor Assembly supervisor), Mr. Yagnesh Bhatt (AUTOPAK Production Head) , Mr.
Nishikant Bedekar (AUTOPACK Production Chemist), Mr. Paras Kamboj (AUTOPAK
Production Chemist), Mrs. Roopali Aurangabadkar (Prod. Chemist), Mr. Shreepad Panvalkar
(Manager, QA), Mr. Hiren Patel (RAQA), Mr. Dilip Patel (Quality Production technician), Mr.
Santosh Patel (Maintenance Planner ) for their most valuable suggestions, constant
encouragement, and affectionate guidance during the period of this training. We experienced
great things together and they have shown me a beautiful part of their working areas.

I owe deep gratitude to the chemists Mrs. Ketki Tanpathak, and Ms. Nidhi Patel for their
support and guide to carry out the tasks assigned to us while we are in the training. I also would
like to thank all the people that worked in the office of Siemens Healthineers in Vadodara,
Manjusar. With their patience and openness they created an enjoyable working environment.

At last I would like to thank the SIEMENS HEALTHCARE PVT. LTD. and Management
Group. And, I’m greatly thankful to all my seniors and colleagues in Siemens Healthineers for
extending their constant cooperation which went a long way towards the completion of this
Training and Report

3
 PREFACE

Pharmacy is a profession which is concerned with the art and science of preparing suitable and
convenient material for distribution and use in the treatment and prevention of disease, so it is
a fully technical profession where practical knowledge is much more important along with
theoretical knowledge.

According to curriculum of a four year integrated degree course of BACHELOR OF

PHARMACY each student has to undergo practical training for a periods of four week in
various pharmaceutical / Health care industries in India. As it is to be done during the winter
vacation of 4th year B. Pharm.

I was directed to undergo the 4th year training at "SIEMENS HEALTHCARE PVT LTD" and
this report contains a brief description of the above Healthcare industry which was observed
during the training program.

4
 ABSTRACT

This industrial training report of Himanshu Chhotu Chaudhari to undergo an industrial training
for duration of 1 month which consist of 5 weeks before completing the Degree/Diploma
courses. Starting industrial training on 27 September 2021 until 28 October 2021 at Siemens
Healthcare Pvt. Ltd.

The purpose of this program is to fulfil the course in order to complete the Degree as well
as graduate from the college. The training refers to work experience that is relevant to
professional development prior to graduate. In first chapter (Introduction) this report is defining
the term of industrial training and description on industrial training objectives. This part
explains the details of objectives of industrial training report and Final report.

The next chapter (Overview of Training) describes the summary of the duties and various
tasks in weekly of industrial training activities that carried out.

The next chapter describes the Details of Experiences gain from the company during training
period.

This training gives students a good experience in The program also aims to produce the
knowledgeable, skilled and experienced graduates, demanded by employers, who are able to
apply the knowledge acquired at university to the working world or face the working world.

Last but not least, trainee got opportunities to learn more about management and field
knowledge, good communication skills, great desire to meet companies need with great desire
to work.

5
 INTRODUCTION

This report is a short description of my one month internship carried out as compulsory
component of the B-Pharmacy. The internship was carried out within the organization Siemens
Healthcare Pvt. Ltd. Since I’m very interested in this Training opportunity to upgrade my
technical skill and to expose practical application, and to learn many more from this company.

At the beginning of the internship I formulated several learning goals, which I wanted to
achieve:
• to understand the functioning and working conditions of a organization;
• to see what is like to work in a professional environment;
• to see if this kind of work is a possibility for my future career;
• to use my gained skills and knowledge;
• to see what skills and knowledge I still need to work in a professional
environment;
• to learn about the organizing of a research project (planning, preparation,
permissions etc.)
• to learn about research methodologies (field methods/methods to analyse data)
• to get fieldwork experience/collect data in an environment unknown for me;
• to get experience in working in different country with different people from
another culture;
• to enhance my communication skills;
• to build a network.

This internship report contains my activities that have contributed to achieve a number of my
stated goals. In the following information, description of the organization Siemens Healthcare
and the activities is given. After this a reflection on my functioning, the unexpected
circumstances and the learning goals achieved during the internship are described. Finally I
give a conclusion on the internship experience according to my learning goals.

6
 • DEFINING THE TERM OF INDUSRIAL TRAINING....

The Industrial Training indicates to a program which aims to provide a managed good practical
training within a particular time frame. This training is provided by both government
organizations and in the private sector.

Industrial training offers the students with important practical knowledge and skills and
encourage them in becoming a successful and best professional engineer. The main objectives
of the industrial training is to provide the best and relevant theoretical knowledge to gain in a
particular time period. Students complete their industrial training during minimum period of 4
to 12 weeks and pass the training assessment in order to graduate. It provides the liability for
real life work and internships to choose the career options with different work environments
and publicity to the latest technologies that are currently being used by an important and
relevant industry, etc.
The aim of the Industrial Training program is only for the graduates person, who are ready to
face the professional working world. This training program also aims to provide the program
related to different and relevant knowledge, like, company internship, marketing and sales
and the HR & recruitment. The industrial training also provides opportunities for publishing it
to the professional working world, which will make graduates more focused and appreciative
of the hopes and expectations that the industry has for them. This program will also provide
students with real work experience.

• DESCRIPTION OF THE INTERNSHIP ORGANISATION

The Organisation Siemens Healthineers.(Head office- Erlangen, Germany)

At Siemens Healthineers India, the purpose is to enable healthcare providers to increase value
by empowering them on their journey towards expanding precision medicine, transforming
care delivery, and improving patient experience, all enabled by digitalizing healthcare. An
estimated five million patients globally everyday benefit from the Siemens innovative
technologies and services in the areas of diagnostic and therapeutic imaging, laboratory
diagnostics and molecular medicine, as well as digital health and enterprise services. Siemens
Healthineers is a leading medical technology company with over 170 years of experience and
18000 patents globally. With more than 48000 dedicated colleagues in over 70 countries.

7
# PRODUCT OF SIEMENS –

Angiography and interventional x ray system

Computed tomography
Radiation oncology
Laboratory diagnostics
Molecular diagnostics
Molecular imaging
Magnetic resonance imaging
Point of care diagnostics
Refurbished system service
Syngo imaging software
Ultrasound
x-ray product
On August 08, 2018, Peter Koerte, President – Point-of-Care Diagnostics, Siemens
Healthineers, inaugurated the new diagnostics manufacturing facility at Vadodara, Gujarat.
The new state-of-the-art facility, licensed as per Medical Device Regulation 2017 (MDR-17);
is spread across 3150 square meters, and is equipped with benchmarked manufacturing facility
and globally renowned processes and systems for Indian Healthcare Industry. As a part of skill
development initiative, the facility also serves as Centre of Excellence for training in
Laboratory Diagnostics, Point-of-Care Testing and Diagnostic Imaging, across South Asia
region

• OBJECTIVES OF INDUSRIAL TRAINING

1) The objective of industrial training is to provide to students the feel of the actual
working environment and to gain practical knowledge and skills, which in turn will
motivate, develop and build their confidence.
2) Industrial training is also expected to provide the students the basis to identify their key
operational area of interest
3) Industrial training at reputed Company, hospitals, laboratories, so on. so the student
learns about the standards of the particular sector and uses them accordingly in his
future.

8
 4) To gain the practical knowledge of their field and to apply it in their future working
area

• RESPONSIBILITIES OF THE TRAINEE

1) Should be punctual.
2) Should maintain the training logbook up-to-date.
3) Should be attentive and careful while doing work.
4) Should be keen to learn and maintain high standards and quality of work.
5) Should interact positively with the hotel staff.
6) Should be honest and loyal to the hotel and towards their training.
7) Should get their appraisals signed regularly from the HOD’s or training manager.
8) Gain maximum from the exposure given, to get maximum practical knowledge and
skills.
9) Should attend the training review sessions/classes regularly.
10) Should be prepared for the arduous working condition and should face them positively.
11) Should adhere to the prescribed training schedule.
12) Should take the initiative to do the work as training is the only time where you can get
maximum exposure.
13) Should, on completion of Industrial Training, hand over all the reports, appraisals,
logbook, and completion certificate to the institute.

• OBJECTIVES OF FINAL REPORT

1. To provide a work document effectively.

2. To produce students that is responsible for their work by providing enough ..
evidential documents that related to work.
3. To expose the students on how to provide a proper document.
4. To build self-confidence in the student while providing the document.
5. To complete the prerequisite for the student to pass industrial training

9
 # DETAILS OF EXPERIENCE GAINED #

• Production Department- (Strips )

# Urinalysis strip :-

# PRODUCT DESCRIPTION : ( Urinalysis Strips )

A urine test strip or dipstick is a basic diagnostic tool used to determine pathological changes
in a patient's urine in standard urinalysis. A standard urine test strip may comprise up to 10
different chemical pads or reagents which react ( change colour ) when immersed in, and then
removed from, a urine sample. The test can often be read in as little as 60 to 120 seconds after
dipping, although certain tests require longer. Routine testing of the urine with multiparameter
strips is the first step in the diagnosis of a wide range of diseases.

The analysis include testing for the presence of protein, glucose, ketone, haemoglobin,
bilirubin, Urobilinogen, acetone , nitrite and leukocytes as well as testing of PH and specific
gravity or to test for infections by different pathogens.

The test strips consist of a ribbon made of plastic or paper of about 5 millimetre wide, plastic
strips have pads impregnated with chemicals that react with the compounds present in urine
producing a characteristic colour. For the paper strips the reactants are absorbed directly onto
the paper. Paper strips are often specific to a single reaction (e.g. pH measurement), while the
strips with pads allow several determinations simultaneously

There are strips which serve different purposes, such as qualitative strips that only determine
if the sample is positive or negative, or there are semi-quantitative ones that in addition to
providing a positive or negative reaction also provide an estimation of a quantitative result, in
the latter the colour reactions are approximately proportional to the concentration of the
substance being tested for in the sample. The reading of the results is carried out by comparing
the pad colours with a colour scale provided by the manufacturer, no additional equipment is
needed.

10
# Use For Identification Of - With the aid of routine examinations early symptoms of the
following four groups can be identified:

• Diseases of the kidneys and the urinary tract

• Carbohydrate metabolism disorders (diabetes mellitus)
• Liver diseases and haemolytic disorders
• Urinary infections

# Test Method -The test method consists of immersing the test strip completely in a well
mixed sample of urine for a short period of time, then extracting it from the container and
supporting the edge of the strip over the mouth of the container to remove excess urine. The
strip is then left to stand for the time necessary for the reactions to occur (usually 1 to 2
minutes), and finally the colours that appear are compared against the chromatic scale
provided by the manufacturer.

# PRODUCT OF URINALYSIS
REAGENT USED FOR URINALYSIS STRIPS-
STRIPS PRODUCTION- 1. MULTISTIX 10SG (1-10
1) WBC (leukocytes) reagent )
2) NIT (Nitrate) 2. MSG100 (8 Except WBC
3) URO (Urobilinogen) and NIT )
4) PRO (Protein) 3. MICROALBUSTIX (2 Rea.
5) PH (Potential of hydrogen) ALB & CRE)
6) OB /BLO (Occlude Blood) 4. CT MICROALBUMIN
7) SG (Specific Gravity) (ALB, CRE, Green ID, Black
8) KET (Ketone) ID)
9) BILI (Bilirubin) 5. URISTIX 50 (PRO, GLU)
10) QNG (Quantitative . 6. URISTIX 100 (PRO , GLU)
Glucose) 7. COMBISTIX SG (SG, PH,
11) CRE (Creatinine) PRO, GLU)
12) ALB (Albumin) 8. KETODIASTIX (KETO,
13) IRB (IR Band) GLU)
9. DIASTIX (GLU)
[Link] Pouch

11
# PRODUCTION PROCESSES-
1) Lamination
2) Slitting primary packaging
3) Filling
4) Capping
5) Label coding
6) Labelling Secondary packaging
7) Packaging

# Lamination Process – ( Laminator machine is use for Lamination.)

It is a process in which the reagent paper are adhere to Polyflex backing card. Depend on
the product the reagent are also changed. And during this process the assembled reagent card
are produce of specific length (length= 10.089 -10.125) by fixed rottery cutter. It required 2
person 1 for processing and 1 for visual inspection.

# Operating Procedure Of - Laminator Machine

The 1-11 reagent are placed on laminator spool stand spindle as per product
specification.

Reels are free to rotate with spindle tension control adjusted air supply for each.

Then each reagent paper are passed under closure pressure rorrer which
presses the reagent on Polyflex

Reagent are then positioned on Polyflex Placement guide roller and placement
guide plate and the adhesion protective paper are removed over guide roller and pass
through before travelling to bobbin.

The Polyflex reel are put on controlled tension device and thread around a series
of a compound roller which feed the Polyflex to the positioned where the
reagent paper are applied.

The speed is controlled and measure in card per minute and the assembled reagent card are
cut into length of 10.089” – 10.125”

Cards are collected and checked out for tape joining on cards and reagents. Cards
which passes visual inspection are collected in trays and kept in assigned drums for further
processing.

#Note- Card length measure by Card placement Gauge

12
 # Control buttons –

• Cutter start - Green

• Clutch start – Green (for machine start)
• Re-set - Yellow (reset any fault condition if it no longer exit)
• Emergency Stop Red – (machine stop when activated and .
when the emergency stop button is reset the machine must start.

# Working Condition –

• RH – Not more than 13

• Temperature – 27°C
• Lux - WBC reagent.

# Slitting Process –
It is a process of Cutting a assembled reagent card of length 10.1” Into 5 mm strips × 50
Strips. Strips are then collected in bottle depend on bottle content (i.e. 50 or 100) . It required
2 person 1 for card filling and one for machine control.

# Operating procedure for - Slitting Machine

Switch on the main power for machine, Turn on the supply of compress air and then
turn on power of Anti static control bar

Check for contact closure ([Link]) of the safety guard are in contact

Feed the laminated cards of required product in card feeder

Set card per minute speed by pressing the pedal press position(operator control) for
dial chain speed potentiometer in clockwise to

Pneumatic system hand collect the cards and places it between running cutter blade,
Cutter blades cuts laminated cards into 50 strips

Operator collect the strips in bottle and then put it on conveyor for desiccant
insertion and capping

# Strip filling-
It is a process in which the cutted laminated cards strips are collected or filled into Respective
bottle depending on quantity mentioned i.e. filling of bottle.(operator collect single card strips
for 50 strips and 2 card strips for 100 strips)
After filling of bottle operator put the bottle on conveyor belt for desiccant insertion.

13
#Desiccant insertion – After filling of strips into bottle machine operator put bottle on belt
conveyor for desiccant insertion (for prevent material from moisture/ degradation). Another
working member insert the desiccant into bottle on conveyor and then bottle moves forward
capping process with the help of conveyor.
# Capping –
In this process after filling/inserting the product material into the bottles the bottle are
then closed with cap by using capping torque machine (adjust torque). And then the closed
bottles are collected into tray.

# Label coding –
It is process of adding a manufacturing information including Lot no , Mfg. Date, Exp.
Date, Price on a printed label or on cartons, with the help of coding machine.

# Labelling –
It is a process of sticking or adhering a product label on bottles and Cartons with the help
of Gum (Astra Gum) by using a labelling machine either by auto/manually

# Packaging –( Secondary packaging)

In this process the labelled material are packed in a cartons and then in secondary carton
and then in shipper carton. It is done in packaging area.

• AUTOPAK Department –

# AUTOPAK Biochemistry Reagents –

The AUTOPAK biochemistry reagents are used for the detection of various kidney, liver
disease by Quantitative determination of various reagent activity into the serum or plasma.
Specifically it is use with AUTOPAK analyser.

AUTOPAK reagent’s –
1. ADA (Adenosine Deaminase Assay )
2. ADA (Calibrator)
3. ASO (Anti Streptosin o-Assay)
4. ASO Calibrator
5. AMYL (Amylase)
6. ALKP (Alkaline Phosphatase)
7. BUN ( Blood Urea Nitrogen)
8. BIL (Bilirubin Total and Direct)
9. CAL (Calcium)
10. CHE (Cholinesterase)
11. Cl (Chloride)
12. Liquid Cholesterol
13. Cholesterol
14. CK (Creatine Kinase)

14
 15. CRTN ( Creatinine)
16. CRP (C- Reactive Protein Assay)
17. CRP-Cal (C- Reactive Protein Calibrator)
18. Liq. DHDL (Liquid Direct HDL)
19. Liq. DLDL (Liquid Direct LDL)
20. FLCN (Flow Clean)
21. GGTP LS
22. GLUC (Glucose Tab)
23. HDL Calibrator
24. HDL-C (HDL Cholesterol)
25. HDL-C LS (HDL Cholesterol Liquid Stable)
26. LDH (Lactate Dehydrogenase)
27. LDL- Calibrator
28. Multi-Calibrator
29. Inorganic Phosphorous
30. SGPT(ALK)
31. SGOT(
32. TRIG (Triglyceride)
33. Liq-TRIG (Liquid Triglyceride)
34. TPR (Total Protein)
35. URIC (Uric Acid)
36. URIC-LS (Uric Acid Liquid Stable)
37. UIBC (Unsaturated Iron Binding Capacity)
38. UREA (Urea).

#Areas of AUTOPAK Department :-

Aqualab – It is area for packaging of demineralised water. Reagent Grade Deionized

Water for use in Laboratory reagents preparations, research, etc.

# Process of Demineralised water Formation-

Water feed in storage tank Micron Filter’s (PSF and ACF) RO Filter

DM water storage tank Neutralizes the water Mixed Bed ion exchanger
(Cation Anion) .
Ion storage tank Ion purifier mixed ion tank .

Washing area – In this area the washing of packaging material has been done with
demineralised water and for some material acid wash is done. Washing is carried out using
rottery washing machine for bottles and then dried it in oven .

Bulk preparation area – In this area the bulk material has been prepared raw material by
different chemical processes and equipment.

DH Room – It is area for dispensing of powder material (RH – Below 13)

15
Primary packaging area – It is the area for Bulk material dispensing. In this the bulk material
are filled into bottle (Washed Material) and then the bottle are then sealed using cap it done
either by Auto filling capping machine or by manually.

Dispensing Procedure- Auto filling Machine (liquid)

Turn on the main power and turn on all controller switches

Puts bottle on Rottery Bottle Table and caps into capping machine

Bottles are moves forward with help of Belt conveyor

Then it passes from proximity sensor which detect the presence/absence of bottles

Then the bottle are moved towards Auto filling machine by peristaltic pumps and It fill’s the
bottle only when proximity sensor detect the presence. During this pressure stopper holds the
bottle in sequence.

Bottles are passes from the Bottle Counter sensor and moves towards capping .

Capping machine attached the caps to bottle and then torque is applied. And then bottle are
collected in trays. All should done in temp below 27°c

# Powder Dispensing – It is done by using powder dispensing machine, in DH Room.

Process –
Powder dispensing machine has 1 gun and controller is attached to vaccum machine

Gun has 1 pipe by which it pick the powder and the Qty of powder is set by adjuster given on
gun

By controller the powder is dispensed in vials.

Glass vials are then sealed by using plugs and caps.

Working condition- temp below 27°c and Rh below 13. Lux depend on product.

Labelling area – In this area the printing of label is carried out by machines and then the
printed label are then labelled on the packaging material either by machine or manually.

BOM (build of material) – It is the area in which raw material and packaging material ( which
are approved and ready to use) are available for secondary packaging.

Secondary Packaging area – It is the area in which the primary packed and labelled material
are assembled in kits as per product specification and then packed it into a cartons and then in
shipper cartons.

16
 • Quality Testing Department (QA,QC) –

Quality control is the part of GMP concerned with sampling, specification and testing and with
organization; documentation and release procedures which ensure that necessary and relevant
tests are carried out and that materials are not released for sale or supply, until their quality has
been judged satisfactory.

Quality Control (QC) laboratory, ensures that the products are pure, safe and effective and are
released only after thorough analysis as per stringent specifications, methods and procedures
developed according to international guidelines viz. EU cGMP, MHRA, WHO, TGA, etc. The
QA/QC department performs following activities:

1)Raw Material / packaging Material testing

2)IPQA(In process Quality Assurance) testing
3)Finished product testing

# Flow Chart For-

Raw material / Packaging material : Finished Product Analysis :

New Incoming material Completion of Batch of finished product

Intimate to QA With batch Record

Intimate to QA with challan
Verification of product
Verification of material
QA number allotted
QA number allotted
Sampling
Sampling
Testing
Testing
Result comply with specification
Result comply with specification
Yes No
Yes No
Approved label Rejected label
Approved label Rejected label

Report to store Report to production department

Use for production Corrective action Release report Reprocess/destruction

Resampling

17
 In process Quality Assurance (IPQA):
Production chemist intimate to QA with requistion Verifying/sampling Testing a
specs/ Requisition

.
Report to production chemist Label Approved Yes Result Comply with
specification

Corrective action Hold production No .

The quality control section performs different control measure and test procedures to verify the
product and material quality. The tests are performed by the QC personnel and the results are
matched with a reference standard.

Quality Testing is an essential operation of the pharmaceutical industry. Drugs must be

marketed as safe and therapeutically active formulations whose performance is consistent and
predictable. New and better medicinal agents are being produced at an accelerated rate. At the
same time more exacting and sophisticated analytical methods are being developed for their
evaluation. Requirements governing the quality control of pharmaceuticals in accordance with
the Canadian Food and Drugs Act are cited and discussed.

Different types of test are performed for different material. The types of test performed for
each material are as follows:

# Sample collection- The Number of sample are vary with material to material and it is
collected randomly from random box.

# RAW MATERIAL TESTING:-

1) Testing of 50% NaOH – (New material)

According to flow chart Quality department collect sample and follows the testing
procedure as per standards
QA Register
Challan
QA Number
Challan/DN record date
Deliver to
Name of material
Manufacturer logo
Order Number Vendors Lot Number
GST NO Venders Exp date
SR. NO Used for
Particular ( Cartons/ Box type/ Assigned to
Size/lamination type etc) Name of supplier
No. Of product Challan DN number
Quantity Date
Stamp of manufacturer QTY Record
Date of release
Remark , sign
18
Procedure: carry all testing as per mention in standard Including
Physical chemical properties (Appearance, mole wt. Mol formula Hazard statement, safety
precaution etc.)
Appearance, Identity, Equipment use, material name, method of testing, Assay %, testing
procedure (it is specific for specific sample)

Test procedure: prepared all the test and standard sample as per mentioned quantity
And start with procedure – For 50% NaOH Titration procedure is mentioned in standards.
1)Titrate 1N HCL to phenolphthalein indicator and record the volume consumed during
titration (Pink -colourless)
2)Titrate 0.1 N HCL to methyl purple solution. Record the volume (Green to purple)

Calculation-
Formula – N1V1 = N2V2
N1 – Exact normality of 1N HCL
V1 – Volume of 1N HCL consumed during 1st titration
N2 – N1V1/2
V2 – Volume of VT sample taken (4ml)

%Assay = N2×4 (1N sol × 40gm/lit)NaOH

%NaCO3= (Vol of 1N HCL consumed ×(Nor. Of 0.1 N HCL)×(0.0530)×100 .

100
After testing if result comply with release specification then Quality checker approved the
sample and labelled it Approved. And then inform to store.

2) Recontrolled testing : (PNPP) –

Every sample has specific Recontrolled period after that period store executive inform to
Quality department for Recontrolled testing with material name QA no, Date, Recontrolled
RM no etc. (For PNPP it is of 6 month)

Sampling and Recontrolled testing mentioned as per standard is done by QA chemist (for PNPP
Appearance and PNPP content test is mentioned for Recontrolled testing)
Procedure: prepare the sample test standard as per standards and test accordingly.
After testing if result comply with specification then labelled it approved and inform to store.
Documentation For Recontrolled testing-

1. Raw material testing worksheet – (it include)

Exp no, QA number, Title, Date, manufacturer, supplier, Quantity Material
code, lot no., procedure followed, instrument use, procedure, result ,
Recontrolled date, Remark ,signature. Etc.
2. Attach raw data of testing with material testing worksheet.
3. Release report with chemist sign. Assi. Manager sign
4. Print 2 copy (1 for production and 1 for store).

19
 3)Loss On Drying (LOD): ( for Silica)
For silica the Recontrolled period is 14 days after 14days LOD test is carried out.
It is done using moisture analyser. Before testing put the material in oven and next day test is
done.
Procedure-1. Note Lot no., Date, Pre weight and post weight
2. Enter the Entry in moisture analyser register
3. Put the sample in analyser (temp 200°c)
[Link] count the % LOD (it is note more than 2.5)
5. Labelled material Approved with Recontrolled date
6. Inform to production department.

# PACKAGING MATERIAL TESTING :-

1. Testing of 33 mm white bottle :-

Testing procedure- A. check the description of material as mentioned in standards
(manufacturer info, colour, shape, cavity, logo, content etc. )
B. Follow test procedure (for 33 mm white bottle measure the Size parameter include)
Bottle height, bottle width, neck inner diameter, neck outer diameter, thread diameter and
weight are measured (by Vernier caliper and weighing balance) If this all parameter result
comply with specification then QA chemist approved the sampled labelled it and then
makes a report.
*Test are vary with product to product

Documentation – challan , QA register Entry , Release report.

2. Testing of AUTOPAK Medium Box :-

The testing should carry out in same way only the difference in specification with
different material
So as per mentioned procedure testing are carried out.
[Link] for the description mentioned in standard
(For medium box mfg’r, supplier, colour, shape, height, length, width compare to 5 box.,
finishing, visual minor defect, adhesiveness, Measure GSM)
GSM for medium box should be measure by taking a cut square of box (10×10cm). And
then measure the weight. (Compare reading with specification )
GSM = 10000× sample weight (not more than 400)
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If result Comply with specification then labelled it approved and inform to store and
production.

Documentation- Challan, QA register, Report form , packaging and component material

Inspection Report.

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# IN PROCESS QUALITY ASSUARANCE (IPQA) :-

It is a process of checking the all parameter which is necessary for quality production.
During this testing we do not have to disturbed anyone into production department.
This process is done to check weather the process is going on according with maintaining
quality or not. All the detail of product are mentioned on the board only we have to check the
accuracy.
Parameter to check- temperature , RH, cleaning of floor machine is done or not, Measure
the dispense volume/quantity, lot no, QA number, material use, label detail

# Process –
Production chemist intimate to QA With batch record, QA chemist calculate verify and
assign a QA number to each, Assign lot no and assembly no. To final combination, then
sampling and testing is done.

Check all the parameter and Fill inspection report it include-

For strips- Time, Detail- Area/room no, product name, product lot no, QA no,
Stages-(lamination, slitting, foil pouch, labelling/packaging/coding.
Environmental condition(temp, Rh) ,
Material/ documents/ labels/packaging material related to previous batch has been removed.
Equipment operation parameter- pressure, tension, top, bottom, temp, empossing lux
Product parameter- card length, pad placement, strips appearance, torque
Reagent paper-all mentioned or not . Signature of chemist with date

For AUTOPAK- Date and time, Details – same as strips

Stages – washing, Bulk preparation, Dispensing/labelling, packaging
Environmental condition – (Rh, Temp)
Material/ documents/ labels/packaging material related to previous batch has been removed.
Check weight /volume of reagent
Name of reagent, Dispensed by , Dispensed volume.
Remark, Sign (QA, prod).

# ASSEMBLY CHECKING : (IPQA)

After the completion of primary packaging the product are assembled in kits or secondary
packaging should be done. During this process QA department inspect the assembly and
approved it.

PROCESS – [Link] kits inspection form is given by the production department to QA

along with batch record.
2. QA chemist fills AUTOPAK Packaging Report after inspecting assembly.
3. After inspection report completion QA chemist fill the Finished product release form and
inform to production department.

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Inspection include – physical defect, visual defect, label, lot no, mfg., Exp, fill vol., Qty, type
of tray used, triangular label, insert, plugs, forceps etc.

# FINISHED PRODUCT TESTING –

1. After assembly checking if QA chemist release /Approved it then the whole kits
are goes for packaging.
2. Packed kits are then sampled for FG testing
3. After testing the accuracy of kits QA chemist prepared a Analytical report and
finally
4. FG Release form
5. Certificate of analysis.

Testing – Testing should be done using Analyser which produce a result by taking
absorbance.
# BATCH RECORD MAINTANING -

For Strips – Batch record contain product name, Lot no., Exp Date, Under stability or not,
Ref no. , control no, Mfg. Date, Total no of bottles ,at last Date, QA chemist sign, QA
approved by sign, etc.

A. FORM FOR PRODUCTION DEPARTMENT

1. Lamination Record
2. In process Lamination check sheet
3. Slitting record
4. Slitting Check sheet
5. Strip Packing Inspection Request
6. Packaging Record
7. Lamination card Inspection form
8. Lamination card Inspection Check sheet
9. One Coded label
10. One Coded Carton
11. One Insert.

B. FORM FOR QA DEPARTMENT

1. Finished Product Testing Form
2. Strips Packaging Report
3. Finished product Release Report
4. Certificate of Analysis.

For AUTOPAK-
Batch Record include product name, lot number, Exp, Ref no. , Control no, Mfg. Date, Total
no of kits, pack size. Etc. And at last Date, Sign of QA chemist , Approved by sign.

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 A) FORM FOR PTODUCTION DEPARTMENT

1. Bulk reagent/ Dispensing/ Labelling/ Assembly

2. Coding form with sample
3. One insert
4. Kits Assembly inspection request
5. Fill weight/volume Checking History Record

B) FORM FOR QA DEPARTMENT

2. Analytical Report – a. Bulk Reagent

b. Unitized Reagent
c. Assembled kit
3. Packaging Report
4. Finished product release form
5. Certificate of analysis

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 CONCLUSION

On the whole, this internship was a useful experience. I have gained new knowledge, skills and
met many new people. I achieved several of my learning goals, however for some the
conditions did not permit. Industrial training is very much essential for Pharmacy Students. It
is also a great opportunity to acquire practical knowledge. During my training period, in the
industry I acquired lots of experiences in Pharmaceutical / Healthcare 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 our training period, we 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 GMP guidelines are to be strictly followed in the industries in each
and every section. And the same was seen to be satisfactory in the Siemens Healthcare Pvt.
Ltd , Vadodara. I experienced all the production procedure including Lamination, slitting,
capping, labelling, coding, and packaging for strips and for AUTOPAK filling, sealing,
capping, labelling, assembling, and packing of an organisation. The quality control section was
standardized, due to sufficient no. of chemists. They do the basic tests of the material like
packaging material testing, raw material testing, IPQA testing, finished product testing etc.
Perfectly. They are doing the same on the paper documents too with practice. Hence it can be
said that, the authorities are paying much importance on the quality of the products. And the
Quality is an important factor for progress of product and organisation too.

Apart from all that, the training was very interesting with lots of things to be learned. It helped
us to acquire knowledge on punctuality, regularity and working environments in industries.
The friendly working environment in Siemens Healthcare will remain in our mind in near
future. Hence, we can say that our goal of attending the industrial Training is fulfilled. We
acknowledge the great help of Siemens Healthcare Pvt. Ltd.

The internship was also good to find out what my strengths and weaknesses are. This
helped me to define what skills and knowledge I have to improve in the coming time.

At last this internship has given me new insights and motivation to pursue a career in Industrial
working.

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 LEARNING’S

# Date – 27/09/2021 to 06/10/2021 ( Strips Production)

07/10/2021 to 19/10/2021 (Quality Testing)

20/10/2021 to 28/10/2021 (AUTOPAK Reagent production)

During this period of Internship I experienced and learned functioning and working condition
of a production and Quality testing. Apart from all this I learn more about Time and Quality
management of product. It was a great experienced to choose a career option with different
work environment and publicity to the latest technologies that currently being used by
important and relevant industry. I acquired practical knowledge of the production and their
processes, It will help me to clarify my theory knowledge. We had seen many instrument and
apparatus learn about their uses and working process.

I experienced and learn all the production procedure including-

for strips production. For AUTOPAK reagent preparation

1. Lamination 1. Bulk Preparation

2. Slitting 2. Reagent Dispensing
3. Capping 3. Labelling
4. Label and carton coding 4. Assembling
5. Labelling 5. Packaging.
6. Packaging
During the training in Quality testing department I learn about the basic tests of the raw material
packaging material In process testing and finished products testing’s and how precisely they
do work which is essential to maintain the quality of product and patient safety.
Apart from all this I learn about team work, Problem solving skills, work ethics, adaptability
skill, communication skill, Responsibility, Time management, Etc.
Hence we can say that our goal of attending the training is fulfilled.

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