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STUDENT INDUSTRIAL WORK EXPERIENCE

SCHEME(SIWES)
AT
NATIONAL AGENCY FOR FOOD
AND DRUG ADMINISTRATION
CONTROL AGENCY
FROM APRIL TO SEPTEMBER
OGUNLEWE MODUPE
19010102028
BCH 388
TABLE OF CONTENTS

• INTRODUCTION
• CHEMISTRY LAB
• SEROLOGY LAB
• IN-VIVO LABORATORY
• RELEVANCE OF BIOCHEMISTRY IN THESE
LABORATORY
• CONCLUSION
• REFRENCES
INTRODUCTION

NAFDAC is the agency involved in the regulation and control ,the


Manufacture,Importation ,Exportation,Distribution,Sale ,Advertisement and Use of
Food,Drugs,Cosmetics,Medical devices,Packaged water,Chemicals and detergents
known as (Regulated Products).The agency was officially established in October 1972.
NAFDAC is ISO certified -ISO 17025
NAFDAC is WHO certified -WHOGEPPQCI
NCVLVB AND CDCL
NCVLB : has 7 active units which are 5 laboratories and 2 other units i.e Quality
Assurance Units and Central Registry.
The 5 Active labs are
Tissue Culture Laboratory
Serology Laboratory
Chemistry Laboratory
• Microbiolgy Laboratory
• IN-VIVO Laboratory
2 other units
• Quality Assurance Units
• Central Registry
CHEMISTRY LABORATORY

In chemistry laboratory , we deal with Determination Of pH


and Extractable Filling Volume and Calibration of pH
including some tests on medical devices . Medical Devices
are instruments ,apparatus,machines, appliance,material
intended by the manufacturer to be used alone or in a
combination for a medical purpose. Examples of Medical
devices are Sanitary Pads, Syringes, Hand Gloves,
Scissors, Weighing Balance,Wipes e.t.c
• In chemistry lab ,Analysis of vaccines and biologicals takes
place. Biologicals are isolated from natural sources such as
microorganism,plans,animals,and humans.They include
protein,vaccine as well as gene .Biologicals can be chemically
synthesized but nature-like in composition.
• And there are Methods of Analysis including: SOP- Standard
Operating Procedure
• Pharmacopeials is an official publication conatining list of
medicinal drugs with their effects.Pharamcopias(USP -
UNITED STATES Pharmacopeials,BP-BRITISH
Pharmacopeials, IP - INDIAN Pharmacopeials
Tests Taken In Chemistry Laboratory

• Different Tests are taken in chemistry laboratory.


• Absorbency Test or leakage tests in products like Sanitary pads
to retain water or any liquid.
• Tensile Test in products like Condom and Handgloves to test for
their Elasticity.
• There is also Flamibility Tester which is used to test how easily
a material or finished product will ignite.
• Dissolution test
• Hydrostatic test
• Determination of Weight Uniformity from Average Weight
and Individual Weights.
• Determination of pH and Extractable Filling volume
Determination of pH Using pH meter

Ph Determination is one of the simplest and most important


and crucial process in the lab. A pH meter is a scientific
instrument used to mesaure the pH value of a solution.It
measures the pH value by passing an electric current throught
the measuring solution,and the electrode registers the activity
of electrons and protons present in the solutions that posseses
the pH value in numbers from 1 to 14.
The pH meter is operated according to
the SOP or manufacturers instruction.
Calibration Of pH Meter
Aim- To Calibrate the pH Meter
Calibration of pH meter is a very important function that should be
performed every day before performing any test on the pH meter.
Calibration of pH Meter
The pH meter and electrod esystem is operated according to the
manufacturers instructions or according to the SOPs. All
measurements should be made at 20-25◦C.
The apparatus is calibrated with the buffer solution of potassium
hydrogen phthalate ( primary standard) (bufferpH4.0) and buffer
solution of 7.00 pH value and the measured pH value must not
differ by more than 0.05.
Determination of pH Meter

Aim- To determine the pH of a vaccine or sample.


Materials: pH meter, wash bottles containing distilled
water,beaker,buffer 4,7,10, cotton wool.
Test Procedure - The electrode and ATC(Automatic
Temperature Compensation) probe were rinsed with distilled
water and residual water was carefully cleaned up using
cotton wool and were immersed into the beaker contsining the
samples one after the other and each case the electrode and
probe was rinsed off using distilled water before testing the
next samples.
Result

Table 1: Showing the pH values of the analysed samples at room


temperatures

Name of Sample pH

Sample A 7.5

6.8
Sample B
8.8

SampleC
PRINCIPLE OF pH METER
A pH meter is a scientific instruments that measures the
hydrogen-ion activity in solutions, indicating its acidity or alkalinity
expressed as pH. The principle of Ph meter is the concentration of
hydrogen ions in the solution.The full form of pH is Potential of
Hydrogen.The pH meter allows us to know the nature of solvent
and therefore provides insights to take futher actions accordingly
e.g if
a product has low pH then the
manufacturer can raise the
pH with some akali solutions.
EQUIPMENTS USED IN CHEMISTRY
LABORATORY
The equipments used in chemistry laboratries are :
• Ph Meter
• UV Spectroscopy
• HPLC
• Fume Cupboard
• Flamability Tester
• Tensile Tester
• Top Load Weighing Balance
• Magnetic Stirrer and Hotplate
• Furnace
• Fridge
• Water Bath
• Beakers
• Pipette
• Burette
• Measuring Cylinder
• Reagents and Buffers
• Syringe and Infusion Sets
SEROLOGY LABORATORY

In Serology laboratory, medical devices are worked upon.


Medical devices used in the hospital laboratories re.g Malaria
tests kits , Pregnancy test kits, HIV/Syphillis test kits. Test kits are
being tested with the use of blood, urine, and stool sample to
carry out tests.
Specificity , Efficiency and Sensitivity are the major tests carried
out in this laboratory.
Sensitivity - positive sample test
Specificity- negative sample
The average of sensitivity and specificity is efficiency.
IN- VIVO LABORATORY

In IN-VIVO Laboratory , phramaceuticals are dealt with.


Biopharmaceuticals are chemically synthesized and are
blood products and products from living organism.
The tests done here are majorly ,Potency ,Safety and
Efficacy.
Animals are used in testing the potency of the vaccine.
Conclusion

• In conclusion, the knowlegde I gained at The National


Food and Drug Administration control Agency was not
only relatable to things i have learnt in school but was
also made me understand and gain practical insights of
the real world.
THANK YOU

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