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QUALITY CONTROL
TESTING OF PACKING
MATERIALS
KRISHNA UNIVERSITY
This is to certify that the dissertation entitled “QUALITY CONTROL TESTING OF PACKING MATERIAL” out is a bonafide work
carried by Ms. Loya Divya Regd No: Y19OCH245017 Under my supervision. This is submitted in partial fulfillment of the requirements
for the award of Master of sciences in Chemistry (Organic chemistry) to Krishna university Dr.M.R.A.R PG center, Nuzvid. No part of the
dissertation has been submitted for any degreediploma or any other Institution or University.
Examiner : 1.
2.
Head of the Department
ACKNOWLEDGEMENTS
I would like to express my deep sense of gratitude to Dr. SATYANARAYANA CHAVA, Chief executive officer, Laurus labs,
Visakhapatnam for providing me opportunity to work at laurus labs, Visakhapatnam. I also would like to express my sincere gratitude
to SRI.SURESH KUMAR , GENERAL MANAGER, Laurus labs, vizag for his encouragement and financial assistance for my
dissertation course.
I express my heart full thanks to Dr. LAKSHMAN KUMAR Assist General Manager and ANURAG for their suggestion and
cooperation during my project work.
I would like to express my sincere gratitude to Prof M.V.Basaveswara Rao, Head of the Department, Krishna University
Dr.M.R.A.R PG Centre, Nuzvid for making arrangements in the form of MOU with the laurus labs. I Wish to express my sincere
gratitude Sri. P. V. V. S Rama Rao, Dr. D. RAVI KUMAR and Dr. T. Nagaraju, Dr.P. B. SUDHA LAKSHMI, Dr. K. PUSHPA
LATHA and Sri. VENKATA RAO lecturer's in Chemistry for their constant encouragement.
CONTENTS
❖ INTRODUCTION
❖ WHAT IS PACKAGING
❖ CHARACTERISTIC OF PACKAGING
❖ THE ROLE OF PACKAGING
❖ LEVELS OF PACKAGING
❖ TYPES OF PACKAGING
❖ TYPES OF MATERIAL PACKAGING
❖ CONCLUSION
❖ REFERENCE
INTRODUCTION
INTRODUCTION
Packaging is a process by which the pharmaceuticals are suitably packed so that they should retain their
therapeutic effectiveness from the time of packaging till they are consumed. Packaging may be defined as the art
and science which involves preparing the articles for transport, storage display and use. Pharmaceutical
packaging is the means of providing protection, presentation,identification, information and convenience to
encourage compliance with a course of therapy.
❖ Packaging of materials is an integral part of any pharmaceutical industry.Packaging affects the quality
stability and identification of drug product.
❖ Packaging provide an adequate degree of protection, minimize the loss of constituents and should not interact
physically or chemically with the contents in a way that will alter their quality to an extent beyond the limits
given in the individual monograph, or present a risk of toxicity.
❖ Pharmaceutical packaging is the means of providing protection, presentation, identification,information and
convenience to encourage compliance with a course of therapy.
❖ The commonly used packaging materials are Container, Closure, Carton or Outer and Box.The containers may
be made of glass, plastic, matel or paper. The material for closure mayinclude Cork, Glass, Plastic, Metal or
rubber.
❖ There are various tests for determination of quality, integrity and compatibility of packaging materials. The
specification and requirement of quality testing depends on type of pharmaceutical materials used.
❖ Containers are tested by many methods of which commonly used test for glass are Crushed glass test, Whole-
Container test, Chemical resistance of test, Water Attack Test etc.
❖ Similarly test. Closure materials are tested by Transparency test Penetrability Fragmentation test Self seal
ability test, Extractive test etc.
❖ The requirement of packaging material testing is set according to specification of regulatory agencies like
WHO GMP, USFDA and ICH guidelines.
WHAT IS
PACKING
WHAT IS PACKING
The PACKING is refers to all those activities
related designing, evaluating and producing the
container for product.Simply, PACKING is store
and protect product from any physical damage
and at the same time attracting to the customer
through its appeal is called aPACKING
CHARACTERISTIC OF
PACKAGING
THE ROLE OF
PACKAGING
LEVELS OF
PACKAGING
TYPES OF
PACKAGING
Types of Packaging
TYPES OF
MATERIAL FOR
PACKAGING
CONCLUSION
CONCLUSION
❖ The testing of packaging materials is almost requirement for any pharmaceutical
industry.
❖ The material of a package affects quality, stability and efficacy of drug product.
❖ The cost of material of a package should be as low as possible without compromising
the quality of product.
❖ It should pass the specifications of tests before it reached the local markets and made
available to the consumers of product.
❖ The type of test followed should be according to requirements of regulatory agencies
REFERENCE
REFERENCE
1. “INDIAN PHARMACOPOEIA 2007”, Volume-1, published by The Commission,Central
Indian pharmacopoeia Laboratory Govt.Of India, Ministry of Health & Family Welfare
Sector-23, Raj Nagar,Ghaziabad-201 00 Page no. 363-371
2. “UNITED STATES PHARMACOPOEIA 2007”,Volume-1,Page no.661
3. Swarbrick James, “ENCYCLOPEDIA OF PHARMACEUTICAL TECHNOLOGY”, Volume -
1,Third Edition, Page no.2526-2541
4. Lachman leon, Lieberman H.A, Kanig J.L,“THE THEORY AND PRACTICE OF INDUSTRIAL
PHARMACY”, Third Indian Edition 1990, Varghese Publishing House, Dadar Bombay Page
no.711-732
5. Organization Of Pharmaceutical Producers Of India, “ QUALITY ASSURANCE GUIDE”
Fourth Edition 2001, Chapter 11.5 Page no. 1-4
6. Banker G.S, Rhodes C.S, “MODERN PHARMACEUTICS”, Fourth Edition , Published by
Marcel Dekker, Page no.587-600
7. “EUROPEAN PHARMACOPOEIA”5.0, Vol-1,page no.303-317
8. Jerkins W.A, Osborn K.J, “PACKAGING DRUGS AND PHARMACEUTICALS”, edition
1993, Technomic Publishing Co.Inc., Page
no. 1372-1389
9. Dean D.A, Evans E.R, and Hall I.H, “PHARMACEUTICAL PACKAGING TECHNOLOGY”

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Untitled presentation (1)

  • 1. QUALITY CONTROL TESTING OF PACKING MATERIALS
  • 2. KRISHNA UNIVERSITY This is to certify that the dissertation entitled “QUALITY CONTROL TESTING OF PACKING MATERIAL” out is a bonafide work carried by Ms. Loya Divya Regd No: Y19OCH245017 Under my supervision. This is submitted in partial fulfillment of the requirements for the award of Master of sciences in Chemistry (Organic chemistry) to Krishna university Dr.M.R.A.R PG center, Nuzvid. No part of the dissertation has been submitted for any degreediploma or any other Institution or University. Examiner : 1. 2. Head of the Department
  • 3. ACKNOWLEDGEMENTS I would like to express my deep sense of gratitude to Dr. SATYANARAYANA CHAVA, Chief executive officer, Laurus labs, Visakhapatnam for providing me opportunity to work at laurus labs, Visakhapatnam. I also would like to express my sincere gratitude to SRI.SURESH KUMAR , GENERAL MANAGER, Laurus labs, vizag for his encouragement and financial assistance for my dissertation course. I express my heart full thanks to Dr. LAKSHMAN KUMAR Assist General Manager and ANURAG for their suggestion and cooperation during my project work. I would like to express my sincere gratitude to Prof M.V.Basaveswara Rao, Head of the Department, Krishna University Dr.M.R.A.R PG Centre, Nuzvid for making arrangements in the form of MOU with the laurus labs. I Wish to express my sincere gratitude Sri. P. V. V. S Rama Rao, Dr. D. RAVI KUMAR and Dr. T. Nagaraju, Dr.P. B. SUDHA LAKSHMI, Dr. K. PUSHPA LATHA and Sri. VENKATA RAO lecturer's in Chemistry for their constant encouragement.
  • 4. CONTENTS ❖ INTRODUCTION ❖ WHAT IS PACKAGING ❖ CHARACTERISTIC OF PACKAGING ❖ THE ROLE OF PACKAGING ❖ LEVELS OF PACKAGING ❖ TYPES OF PACKAGING ❖ TYPES OF MATERIAL PACKAGING ❖ CONCLUSION ❖ REFERENCE
  • 6. INTRODUCTION Packaging is a process by which the pharmaceuticals are suitably packed so that they should retain their therapeutic effectiveness from the time of packaging till they are consumed. Packaging may be defined as the art and science which involves preparing the articles for transport, storage display and use. Pharmaceutical packaging is the means of providing protection, presentation,identification, information and convenience to encourage compliance with a course of therapy. ❖ Packaging of materials is an integral part of any pharmaceutical industry.Packaging affects the quality stability and identification of drug product. ❖ Packaging provide an adequate degree of protection, minimize the loss of constituents and should not interact physically or chemically with the contents in a way that will alter their quality to an extent beyond the limits given in the individual monograph, or present a risk of toxicity. ❖ Pharmaceutical packaging is the means of providing protection, presentation, identification,information and convenience to encourage compliance with a course of therapy. ❖ The commonly used packaging materials are Container, Closure, Carton or Outer and Box.The containers may be made of glass, plastic, matel or paper. The material for closure mayinclude Cork, Glass, Plastic, Metal or rubber. ❖ There are various tests for determination of quality, integrity and compatibility of packaging materials. The specification and requirement of quality testing depends on type of pharmaceutical materials used. ❖ Containers are tested by many methods of which commonly used test for glass are Crushed glass test, Whole- Container test, Chemical resistance of test, Water Attack Test etc. ❖ Similarly test. Closure materials are tested by Transparency test Penetrability Fragmentation test Self seal ability test, Extractive test etc. ❖ The requirement of packaging material testing is set according to specification of regulatory agencies like WHO GMP, USFDA and ICH guidelines.
  • 8. WHAT IS PACKING The PACKING is refers to all those activities related designing, evaluating and producing the container for product.Simply, PACKING is store and protect product from any physical damage and at the same time attracting to the customer through its appeal is called aPACKING
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  • 28. CONCLUSION ❖ The testing of packaging materials is almost requirement for any pharmaceutical industry. ❖ The material of a package affects quality, stability and efficacy of drug product. ❖ The cost of material of a package should be as low as possible without compromising the quality of product. ❖ It should pass the specifications of tests before it reached the local markets and made available to the consumers of product. ❖ The type of test followed should be according to requirements of regulatory agencies
  • 30. REFERENCE 1. “INDIAN PHARMACOPOEIA 2007”, Volume-1, published by The Commission,Central Indian pharmacopoeia Laboratory Govt.Of India, Ministry of Health & Family Welfare Sector-23, Raj Nagar,Ghaziabad-201 00 Page no. 363-371 2. “UNITED STATES PHARMACOPOEIA 2007”,Volume-1,Page no.661 3. Swarbrick James, “ENCYCLOPEDIA OF PHARMACEUTICAL TECHNOLOGY”, Volume - 1,Third Edition, Page no.2526-2541 4. Lachman leon, Lieberman H.A, Kanig J.L,“THE THEORY AND PRACTICE OF INDUSTRIAL PHARMACY”, Third Indian Edition 1990, Varghese Publishing House, Dadar Bombay Page no.711-732 5. Organization Of Pharmaceutical Producers Of India, “ QUALITY ASSURANCE GUIDE” Fourth Edition 2001, Chapter 11.5 Page no. 1-4 6. Banker G.S, Rhodes C.S, “MODERN PHARMACEUTICS”, Fourth Edition , Published by Marcel Dekker, Page no.587-600 7. “EUROPEAN PHARMACOPOEIA”5.0, Vol-1,page no.303-317 8. Jerkins W.A, Osborn K.J, “PACKAGING DRUGS AND PHARMACEUTICALS”, edition 1993, Technomic Publishing Co.Inc., Page no. 1372-1389 9. Dean D.A, Evans E.R, and Hall I.H, “PHARMACEUTICAL PACKAGING TECHNOLOGY”