PY80 TECHNOLOGY OF STERILE PRODUCTS 

L  T  P  C
13 3  0  0  3
OBJECTIVE: To impart the knowledge of the various types and stages of
process of sterile pharmaceutical products.

UNIT PARENTERALS  9
I
Sub Unit 1.1Introduction, historical perspective 1
https://www.youtube.com/watch?v=PYYm3jnypnk

https://www.youtube.com/watch?v=-DpFSRmxkv4

Sub Unit 1.2Parenteral routes of administration 2

https://www.youtube.com/watch?v=PYYm3jnypnk
https://www.youtube.com/watch?v=xnQsUgILDcU

Sub Unit 1.3Formulation additives 2

https://www.youtube.com/watch?v=KyFAmppho-8

https://www.youtube.com/watch?v=Z4CMo9hqyW8

https://www.youtube.com/watch?v=3LIS8iVk9IA

https://www.youtube.com/watch?
v=5uI8EA2cRDw&feature=youtu.be&t=1025

Sub Unit 1.4Small volume parenterals 2

https://www.youtube.com/watch?v=R0EBmAVp8yk

https://www.youtube.com/watch?v=UBuLcRcUbcw

Sub Unit 1.5Large volume parenterals. 2

https://www.youtube.com/watch?v=R0EBmAVp8yk

https://www.youtube.com/watch?v=UBuLcRcUbcw

9
UNIT STERILIZATION 
II
Sub Unit 2.1Sterilization methods 2
https://slideplayer.com/slide/6040880/
https://www.youtube.com/watch?v=ytROwA1VPlE

Sub Unit 2.2Steam 1

https://www.youtube.com/watch?v=FUJriqWs2N0
https://youtu.be/uhSWcGnv58g?t=224

Sub Unit 2.3Dry heat 1

https://youtu.be/uhSWcGnv58g?t=256
https://youtu.be/uNJFU3ul08Y?t=179
https://www.youtube.com/watch?v=0_OWjyAE1-k

Sub Unit 2.4Filtration 1

https://youtu.be/uhSWcGnv58g?t=313
https://www.youtube.com/watch?v=ToNyfq9avdE
https://www.youtube.com/watch?v=U82fQ3yrI7s

Sub Unit 2.5Gas 1

https://youtu.be/uhSWcGnv58g?t=352
https://www.youtube.com/watch?v=4ZIvNylbjZM
https://www.youtube.com/watch?v=4bZtgDC_JZw
https://youtu.be/j75KlSWls9s?t=460

Sub Unit 2.6Ionizing radiation with their advantages and 1

disadvantages
https://youtu.be/uhSWcGnv58g?t=393
https://www.youtube.com/watch?v=M53ggboAl2I
https://www.youtube.com/watch?v=enWzaJGUD6w
https://www.youtube.com/watch?v=ClQwypzQbpY

Sub Unit 2.7Validation of sterility 1

https://youtu.be/Pg7NpQlQsrQ?t=1152
https://youtu.be/kV6YIIgJj8A?t=666
https://www.youtube.com/watch?v=X0yvF4Ojebw

Sub Unit 2.8Particulate contamination 1

https://youtu.be/kV6YIIgJj8A?t=1573
 https://youtu.be/N-WHijRcJAc?t=665

UNIT INJECTIONS 9
III
Sub Unit 3.1Types of injections 2
https://www.youtube.com/watch?v=t3I9SMp2u8s

https://www.youtube.com/watch?v=nIiXblCHnCo

Sub Unit 3.2Aqueous and non- aqueous vehicles used for 1

injection
https://slideplayer.com/slide/6385013/

https://youtu.be/R0EBmAVp8yk?t=520

Sub Unit 3.3Manufacturing 2

https://slideplayer.com/slide/5277147/

https://www.youtube.com/watch?v=24S1-Gwx9rw

Sub Unit 3.4Packaging 2

https://www.youtube.com/watch?v=zXMg13jJm6o

https://www.youtube.com/watch?v=_v3TAW8aSSs

https://www.youtube.com/watch?v=9cckkyKg9yw

https://www.youtube.com/watch?v=-c_iR4Sms3A&t=51s

Sub Unit 3.5Labeling 1

https://www.youtube.com/watch?v=zXMg13jJm6o

Sub Unit 3.6Storage of injections 1

https://www.youtube.com/watch?v=7mG-Tq5tFbk

https://www.youtube.com/watch?v=KJMmRmfEXus

9
UNIT PARENTERAL SUSPENSION AND EMULSION
IV
 Sub Unit 4.1Introduction 1
https://youtu.be/ZV5HsD_z8ng?t=398

Sub Unit 4.2Need for parenteral suspension and emulsion 1

https://youtu.be/rxUTJ-OW0yc?t=265

https://youtu.be/ZV5HsD_z8ng?t=174

https://youtu.be/ZV5HsD_z8ng?t=663

https://www.youtube.com/watch?v=M8chX7WA0vY

Sub Unit 4.3Manufacturing additives 2

https://www.youtube.com/watch?v=JEqG3tsGTqY

https://www.youtube.com/watch?v=C3OC3R4ZM-4

Sub Unit 4.4Formulation of parenteral suspension and 2

emulsion
https://www.youtube.com/watch?v=JEqG3tsGTqY

Sub Unit 4.5Characterization 2

https://www.youtube.com/watch?v=N-WHijRcJAc&t=714s

https://www.youtube.com/watch?v=AItrl-X0KvY

Sub Unit 4.6Applications 1

https://youtu.be/EQxCitg-3Wk?t=580

UNIT OPHTHALMIC PRODUCTS 9

V
Sub Unit 5.1Absorption of drugs in the eye 1
https://www.youtube.com/watch?v=prpGaNnfaJQ

https://www.youtube.com/watch?v=mhXvLfsLgrQ

Sub Unit 5.2Raw materials 1

https://youtu.be/GUhcLGjDin4?t=1544

https://youtu.be/Ql1YnVxGXsU
 Sub Unit 5.3Ocular penetration enhancers 2
https://slideplayer.com/slide/7749731/

https://www.youtube.com/watch?v=9zu8uzNU770

Sub Unit 5.4General safety consideration 1

https://www.youtube.com/watch?v=dP5UDuAAcAc

Sub Unit 5.5Formulation of various ophthalmic products 2

https://www.youtube.com/watch?v=dyL2Bp3vePs

https://youtu.be/dP5UDuAAcAc?t=1109

Sub Unit 5.6Characterization 2

https://youtu.be/iC06TBYFSxU?t=622

Total : 45 Periods
OUTCOMES
 Able to understand the concepts of different types of sterile pharmaceutical
formulations.
 Able to understand the sterilisation process for the sterile products.
 Understand the technology used for formulations of various sterile products.
TEXT BOOKS
 Loyd V. Allen, Howard C. Ansel, Pharmaceutical Dosage Forms and Drug
Delivery Systems, 10thEdition, Wolters Kluwer Health 2013.
 Roop K. Khar, SP. Vyas “Lachman/Liebermans: The Theory and Practice of
Industrial Pharmacy”, 4th Edition CBS Publishers and Distributors 2013.
REFERENCES:
 James Swarbrick “Encyclopedia of Pharmaceutical Science and
Technology”, 4th Edition, CRC Press 2012.
 Sandeep Nema, Nema Sandeep, John D “Pharmaceutical Dosage Forms:
Parenteral Medications”, 3rd Edition, Informa Healthcare 2010.
EBOOKS SOURCES
 https://b-ok.asia/book/1117714/7ad518 { Development of biopharmaceutical
parenteral dosage forms John A. Bontempo}
 https://b-ok.asia/book/2173081/7955bb { Pharmaceutical dosage forms.
 Parenteral medications. Vol. 1, Formulation and packaging Sandeep
Nema, John D Ludwig}
 https://b-ok.asia/book/2842460/27be5a { Parenteral Quality Control:
Sterility, Pyrogen, Particulate, and Package Integrity Testing
 Michael K. Akers, Dan Larrimore, Dana Guazzo}
 Google Books: Parenteral Medications, Fourth Edition edited by Sandeep
Nema, John D. Ludwig
https://books.google.co.in/books?id=3wekDwAAQBAJ
 Google Books: Sterile Drug Products: Formulation, Packaging,
Manufacturing and Quality By Michael J. Akers
https://books.google.co.in/books?id=C2_LBQAAQBAJ
 Google Books: Sterile Product Development: Formulation, Process, Quality
and Regulatory edited by Parag Kolhe, Mrinal Shah, Nitin Rathore
https://books.google.co.in/books?id=k969BAAAQBAJ