b pharma 6th sem
pharmaceutical quality assurance
Introduction
Types of pharmaceutical packaging
Packaging materials
Quality control test for plastic
Quality control test for closures
Quality control of collapsible tubes
Quality control of metallic tins
QC test for secondary packaging materials
Quality control on secondary packaging materialsAnupriyaNR
Presentation on quality control tests for the secondary packaging materials. Includes the materials used for secondary packaging, ideal properties of the secondary packaging material and various test procedures used for the quality control of the packaging materials.
University Institute of Pharmaceutical Sciences is a flag bearer of excellence in Pharmaceutical education and research in the country. Here is another initiative to make study material available to everyone worldwide. Based on the new PCI guidelines and syllabus here we have a presentation dealing with "Quality control of packaging materials."
Thank you for reading.
we hope it was helpful to you.
UIPS,PU team
Quality control on secondary packaging materialsAnupriyaNR
Presentation on quality control tests for the secondary packaging materials. Includes the materials used for secondary packaging, ideal properties of the secondary packaging material and various test procedures used for the quality control of the packaging materials.
University Institute of Pharmaceutical Sciences is a flag bearer of excellence in Pharmaceutical education and research in the country. Here is another initiative to make study material available to everyone worldwide. Based on the new PCI guidelines and syllabus here we have a presentation dealing with "Quality control of packaging materials."
Thank you for reading.
we hope it was helpful to you.
UIPS,PU team
PHARMACEUTICAL QUALITY ASSURANCE SIXTH SEMSTER B PHARM
Introduction, definition and general principles of calibration, qualification
and validation, importance and scope of validation, types of validation, validation master plan. Calibration of pH meter, Qualification of UV-Visible spectrophotometer, General principles of Analytical
method Validation.
Introduction to Quality Control Tests for Containers
Quality control test for glass container, Quality control test for plastic container
Presented by
P . Sudheer Kumar
Department of Pharmaceutical Analysis
Pharmaceutical aerosols have been playing a crucial role in the health and wellbeing of millions of people throughout the world for many years. These products include pressurized metered dose inhalers (MDIs), dry powder inhalers (DPIs), nebulizers, sublingual’s, skin sprays (coolants, anaesthetics, etc.) and dental sprays. The technology’s continual advancement, the ease of use, and the more desirable pulmonary-rather-than-needle delivery for systemic drugs has increased the attraction for the pharmaceutical aerosol in recent years.
Many of the tests required for the evaluation of MDIs are similar to those used for other dosage forms. These include description, identification, and assay of the active ingredient; microbial limits; moisture content; net weight, degradation products and impurities (if any); extractable; and any other tests deemed appropriate for the active ingredient.
Packaging is the art of science & technology of enclosing or protecting products for distribution , storage, sale & use.
Pharmaceutical packaging can be defined as the economical means of providing presentation, protection, identification, information, convenience compliance, integrity & stability of the product.
PHARMACEUTICAL QUALITY ASSURANCE SIXTH SEMSTER B PHARM
Introduction, definition and general principles of calibration, qualification
and validation, importance and scope of validation, types of validation, validation master plan. Calibration of pH meter, Qualification of UV-Visible spectrophotometer, General principles of Analytical
method Validation.
Introduction to Quality Control Tests for Containers
Quality control test for glass container, Quality control test for plastic container
Presented by
P . Sudheer Kumar
Department of Pharmaceutical Analysis
Pharmaceutical aerosols have been playing a crucial role in the health and wellbeing of millions of people throughout the world for many years. These products include pressurized metered dose inhalers (MDIs), dry powder inhalers (DPIs), nebulizers, sublingual’s, skin sprays (coolants, anaesthetics, etc.) and dental sprays. The technology’s continual advancement, the ease of use, and the more desirable pulmonary-rather-than-needle delivery for systemic drugs has increased the attraction for the pharmaceutical aerosol in recent years.
Many of the tests required for the evaluation of MDIs are similar to those used for other dosage forms. These include description, identification, and assay of the active ingredient; microbial limits; moisture content; net weight, degradation products and impurities (if any); extractable; and any other tests deemed appropriate for the active ingredient.
Packaging is the art of science & technology of enclosing or protecting products for distribution , storage, sale & use.
Pharmaceutical packaging can be defined as the economical means of providing presentation, protection, identification, information, convenience compliance, integrity & stability of the product.
Quality control of packaging material.pptxEasy Concept
The selection of package begins with determination of products physical & chemical characteristics.
Quality control of a packaging component starts at design stage. All the aspects of a pack development may give rise to quality problems. It must be identified & minimized by performing quality control tests.
PACKAGING MATERIAL QUALITY CONTROL TEST AND OPERATION.pdfMayuriPawar98
packaging operation in pharmaceutical industry and material used types and quality control tests,types of container closure system ,recent trends in pharmaceutical packaging
Complete Information and knowledge about the selection criteria for packaging material and different test used for them .
All this material data is , Collected for seminar in QA SEM 2 , in the Subject of Pharmaceutical Manufacturing Technology .
Which also explain the How Quality control for Filling an pharmaceutical equipment is done.
MICROBIAL SPOILAGE
TYPES OF SPOILAGE
PHARMACEUTICAL SPOILAGE
MICROBIAL SPOILAGE OF PHARMACEUTICALS
TYPES OF MICROBIAL SPOILAGE
REASON OF CONTAMINATION
FACTORS AFFECTING SPOILAGE OF PHARMACEUTICAL PRODUCTS
B pharma
D pharma
Pharmaceutical Biotechnology
Pharmaceutics I
Immunity and Immunological Products
types of immunity
Immunology
Toxins antibody exotoxins endotoxins
Vaccine
toxoids
sera
B.C.G. vaccine.
cholera. pertussis, plague and typhoid vaccine.
typhus vaccine.
measles, small-pox. poliomyelitis and yellow fever.
diphtheria, tetanus and staphylococcus.
Diagnostic preparations containing bacterial toxins used for Schick test and tuberculin test.
Preparations containing antibodies (antiserum, and antitoxins)used to produce passive immunity
Unit 2 organization and personnel and permisies himanshuhimanshu kamboj
pharmaceutical quality assurance
b pharma 6th sem
Personnel objectives
Personnel qualifications
Personnel responsibilities
Key personnel
Responsibilities of the head of the production department
Responsibilities of the head of quality control department
Training
Personnel hygiene
Premises
Layout of pharmaceutical industry
Areas of premises
Environmental control in sterile areas
Equipment and raw materials
Stages of equipment
Cleaning and maintenance
Raw materials
Steps involved in purchase procedure
Maintenance of stores
Storage conditions
B PHARMA 6TH SEM
PHRAMACEUTICAL QUALITY ASSURANCE
Pharmaceutical documentation
Need of documentation
Objectives of documents
Scope
Documentation lifecycle
Types of documents
Characteristic of document
Documentation review
Documents model
Standard operating procedures (sop’s)
Master formula record
Batch formula record
Quality audit plan and reports
Specification and test procedures
Pharmaceutical Microbiology
What is spoilage?
Types of spoilage
Pharmaceutical spoilage
Microbial spoilage of pharmaceuticals
Types of microbial spoilage
Reason of contamination
Factors affecting spoilage of pharmaceutical products
B PHARAM 6TH SEM
PHARAMACEUTICAL QUALITY ASSURANCE
COMPLAINT
Reasons
Types of Complaint
Steps involved in Handling of complaints
Product Complaint Data Sheet
Complaint Record
Regulatory Guidelines
SOP on Complaint Handling
RECALL
Reasons
Types of Recall
Recall Classification
Levels of Recall
How to Recall the Product?
How To Notify The Consumers?
Regulatory Guidelines
SOP on Product Recall
DRUG RECALL IN 2013 AND 2014
Protein engineering and its techniques himanshuhimanshu kamboj
b pharma 6th sem
pharmaceutical biotechnology
Protein engineering
Objectives of protein engineering
Rationale of protein engineering
Protein engineering methods
Rational design -site-directed mutagenesis methods
Advantages and disadvantages of rational design
Directed evolution -random mutagenesis
Advantages and disadvantages of directed evolution
Peptidomimetics
Classification of peptidomimetics
Advantages and disadvantages of peptidomimetics
Flow cytometry
Instrumentation
Principle
components
b pharmacy
pharmaceutical biotechnology
Polymerase chain reaction
History
Purpose
Components of PCR
Steps of PCR
Denaturation of DNA template
Annealing of primers
Extension of ds DNA molecules
Reaction Condition & Experimental Protocol
General PCR Protocol
Application
b pharma 6th sem
nucleic acid extraction and quantification
pharmaceutical biotechnology
Introduction
Purpose
Isolation
Methods of isolation
Basic steps for DNA extraction
Organic extraction
Inorganic extraction
salting out
Introduction
Gel Electrophoresis
Principle of separation
Instrument and reagents
Factors affecting separation in gel electrophoresis
Applications
Electrophoresis apparatus
Buffer
Power supply
Supporting media
Detection and Quantification
Agarose
Polyacrylamide
6th sem b pharma QC,QA
pharmaceutical quality assurance
Quality Management System
Introduction to ISO 9000
Eight Quality Management Principles
ISO 9000 Series
Advantages
Clauses
Introduction to ISO 14000
Standards under ISO 14000 series
NABL accreditation ( National Accreditation Board for Testing and Calibration Laboratories)
Function of NABL
Process of NABL
Good Laboratory Practices (GLP)
History
Reason behind GLP created
Advantages and disadvantages of GLP
Objectives of GLP
Practice of GLP
b pharma 6th sem
pharmaceutical quality assurance
enzyme immobilization, pharmaceutical biotechnology, b pharam 6th sem, PCI.
history,
why immobilise
advantages and disadvantages of enzyme immobilization
methods of enzyme immobilization
physical retention
entrapment
microencapsulation
chemical bonding
adsorption
cross linking
covalent binding
ionic binding
Applications of Immobilized Enzymes
Enzyme utilization in Industry
BIOSENSOR, PHARMACEUTICAL BIOTECHNOLOGY, B PHARAM, 6TH SEM
Basic components of Biosensor
Working of Biosensor
Types of Biosensor
Electrochemical biosensor
Optical biosensor
Thermal biosensor
Resonant biosensor
Ion-sensitive biosensor
Applications of Biosensor
Nano sensors
sensing device
Father of the Biosensor
components of BIOSENSOR
BASIC PRINCIPLE OF BIOSENSOR
BIO-ELEMENT
TRANSDUCER
DETECTOR
RESPONSE FROM BIO-ELEMENT
IDEAL BIOSENSOR
BASIC CHARACTERESTICS
genetic engineering, principles, b pharma 6th sem, biotechnology
What is a gene ?
Definition
History
Process
Molecular tools of genetic engineering
Restriction enzymes
History of restriction enzyme
Mechanism of action
Types of restriction enzymes
Application of restriction enzymes
Blunt ends
Sticky ends
transgenic
cisgenic.
knockout organism.
Host organism vector
TRANSGENIC PLANTS
DOLLY THE SHIP
TRANSGENIC ANIMALS
Introduction to AI for Nonprofits with Tapp NetworkTechSoup
Dive into the world of AI! Experts Jon Hill and Tareq Monaur will guide you through AI's role in enhancing nonprofit websites and basic marketing strategies, making it easy to understand and apply.
Model Attribute Check Company Auto PropertyCeline George
In Odoo, the multi-company feature allows you to manage multiple companies within a single Odoo database instance. Each company can have its own configurations while still sharing common resources such as products, customers, and suppliers.
June 3, 2024 Anti-Semitism Letter Sent to MIT President Kornbluth and MIT Cor...Levi Shapiro
Letter from the Congress of the United States regarding Anti-Semitism sent June 3rd to MIT President Sally Kornbluth, MIT Corp Chair, Mark Gorenberg
Dear Dr. Kornbluth and Mr. Gorenberg,
The US House of Representatives is deeply concerned by ongoing and pervasive acts of antisemitic
harassment and intimidation at the Massachusetts Institute of Technology (MIT). Failing to act decisively to ensure a safe learning environment for all students would be a grave dereliction of your responsibilities as President of MIT and Chair of the MIT Corporation.
This Congress will not stand idly by and allow an environment hostile to Jewish students to persist. The House believes that your institution is in violation of Title VI of the Civil Rights Act, and the inability or
unwillingness to rectify this violation through action requires accountability.
Postsecondary education is a unique opportunity for students to learn and have their ideas and beliefs challenged. However, universities receiving hundreds of millions of federal funds annually have denied
students that opportunity and have been hijacked to become venues for the promotion of terrorism, antisemitic harassment and intimidation, unlawful encampments, and in some cases, assaults and riots.
The House of Representatives will not countenance the use of federal funds to indoctrinate students into hateful, antisemitic, anti-American supporters of terrorism. Investigations into campus antisemitism by the Committee on Education and the Workforce and the Committee on Ways and Means have been expanded into a Congress-wide probe across all relevant jurisdictions to address this national crisis. The undersigned Committees will conduct oversight into the use of federal funds at MIT and its learning environment under authorities granted to each Committee.
• The Committee on Education and the Workforce has been investigating your institution since December 7, 2023. The Committee has broad jurisdiction over postsecondary education, including its compliance with Title VI of the Civil Rights Act, campus safety concerns over disruptions to the learning environment, and the awarding of federal student aid under the Higher Education Act.
• The Committee on Oversight and Accountability is investigating the sources of funding and other support flowing to groups espousing pro-Hamas propaganda and engaged in antisemitic harassment and intimidation of students. The Committee on Oversight and Accountability is the principal oversight committee of the US House of Representatives and has broad authority to investigate “any matter” at “any time” under House Rule X.
• The Committee on Ways and Means has been investigating several universities since November 15, 2023, when the Committee held a hearing entitled From Ivory Towers to Dark Corners: Investigating the Nexus Between Antisemitism, Tax-Exempt Universities, and Terror Financing. The Committee followed the hearing with letters to those institutions on January 10, 202
A Strategic Approach: GenAI in EducationPeter Windle
Artificial Intelligence (AI) technologies such as Generative AI, Image Generators and Large Language Models have had a dramatic impact on teaching, learning and assessment over the past 18 months. The most immediate threat AI posed was to Academic Integrity with Higher Education Institutes (HEIs) focusing their efforts on combating the use of GenAI in assessment. Guidelines were developed for staff and students, policies put in place too. Innovative educators have forged paths in the use of Generative AI for teaching, learning and assessments leading to pockets of transformation springing up across HEIs, often with little or no top-down guidance, support or direction.
This Gasta posits a strategic approach to integrating AI into HEIs to prepare staff, students and the curriculum for an evolving world and workplace. We will highlight the advantages of working with these technologies beyond the realm of teaching, learning and assessment by considering prompt engineering skills, industry impact, curriculum changes, and the need for staff upskilling. In contrast, not engaging strategically with Generative AI poses risks, including falling behind peers, missed opportunities and failing to ensure our graduates remain employable. The rapid evolution of AI technologies necessitates a proactive and strategic approach if we are to remain relevant.
Synthetic Fiber Construction in lab .pptxPavel ( NSTU)
Synthetic fiber production is a fascinating and complex field that blends chemistry, engineering, and environmental science. By understanding these aspects, students can gain a comprehensive view of synthetic fiber production, its impact on society and the environment, and the potential for future innovations. Synthetic fibers play a crucial role in modern society, impacting various aspects of daily life, industry, and the environment. ynthetic fibers are integral to modern life, offering a range of benefits from cost-effectiveness and versatility to innovative applications and performance characteristics. While they pose environmental challenges, ongoing research and development aim to create more sustainable and eco-friendly alternatives. Understanding the importance of synthetic fibers helps in appreciating their role in the economy, industry, and daily life, while also emphasizing the need for sustainable practices and innovation.
2024.06.01 Introducing a competency framework for languag learning materials ...Sandy Millin
http://sandymillin.wordpress.com/iateflwebinar2024
Published classroom materials form the basis of syllabuses, drive teacher professional development, and have a potentially huge influence on learners, teachers and education systems. All teachers also create their own materials, whether a few sentences on a blackboard, a highly-structured fully-realised online course, or anything in between. Despite this, the knowledge and skills needed to create effective language learning materials are rarely part of teacher training, and are mostly learnt by trial and error.
Knowledge and skills frameworks, generally called competency frameworks, for ELT teachers, trainers and managers have existed for a few years now. However, until I created one for my MA dissertation, there wasn’t one drawing together what we need to know and do to be able to effectively produce language learning materials.
This webinar will introduce you to my framework, highlighting the key competencies I identified from my research. It will also show how anybody involved in language teaching (any language, not just English!), teacher training, managing schools or developing language learning materials can benefit from using the framework.
Qc test for plastics,metallic tins,closures, collapsible tubes, secondary packaging himanshu
1. QC test for Pharmaceutical
packaging
HIMANSHU KAMBOJ
ASSISTANT PROFESSOR
2. Contents:
2
• Introduction
• Types of pharmaceutical packaging
• Packaging materials
• Quality control test for plastic
• Quality control test for closures
• Quality control of collapsible tubes
• Quality control of metallic tins
• QC test for secondary packaging materials
3. Packaging is the process by which the pharmaceuticals are
suitably placed so that they should retain their therapeutic
effectiveness from the time of their packaging till they are
consumed.
Definition:
• “Packing is 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.
Composition of package:
(a) Container
(b) Closure
(c) Carton or Outer
(d) Box
INTRODUCTION
3
4. Primary Packaging: This is the first packaging envelope
which is in touch with the dosage form or equipment (i.e.
bottle, cap, cap liner, label etc). The packaging needs to be
such that there is no interaction with the drug and will
provide proper containment of pharmaceuticals.
E.g. Blister packages, Strip packages, etc.
Secondary Packaging: This is consecutive covering or
package which stores pharmaceuticals packages in it for
their grouping.
E.g. Cartons, boxes, etc.
Tertiary packaging: This is to provide bulk handling and
shipping of pharmaceuticals from one place to another.
E.g. Containers, barrels, etc.
Types Of Pharmaceutical Packaging:
4
5. The following materials are used for the construction of containers and
closures
1. Glass: - (i) Type-I-Borosilicate glass
(ii)Type-II-Treated sodalime glass
(iii)Type-III-Regular soda-lime glass
(iv)Type-NP-General purpose soda lime glass
(v)Coloured glass
2. Metals: (i) Tin (ii) Iron (iii) Aluminium (iv) Lead.
3. Plastics: (a) Thermosetting resins: (i) Phenolics (ii) Urea
(b) Thermoplastic resins: (i)Polyethylene
(ii)Polypropylene (iii)Polyvinylchloride (PVC)
(iv) Polystyrene (v)Polycarbonate
(vi)Polyamide (Nylon) (vii)Polyethylene terephthalate
(PET)
4. Rubber: (i) Natural rubber (ii)Neoprene rubber (iii)Butyl rubber.
Packaging Materials
5
6. According to British standards institutes plastics represents;
“ A wide range of solid composite materials which are
largely organic, usually based upon synthetic resins or upon
modified polymers of natural origin and possessing
appreciable mechanical strength. At a suitable stage in their
manufacturing, most plastics can be cast, molded or
polymerized directly into shape”.
Plastics
6
7. USES
Used for many types of pack including; rigid bottles for tablets and
capsules,
squeezable bottles for eye drops and nasal sprays, jars, flexible tubes
and strip
and blister packs.
ADVANTAGES
• Least expensive than glasses
• Ease of transportation
• No risk of breakage
• Flexible
• Light in weight
DISADVANTAGES
• They are not as chemically inert as Type -I glass.
• They are not as impermeable to gas and vapour as glass.
• They may possess an electrostatic charge which will attract particles.
7
8. Leakage test
Collapsibility test
Water permeability test for plastic containers (injectable
preparations ip 1996):
Clarity of aqueous extract
Transparency test
Biological tests
Quality control test for plastic
8
9. 1) LEAKAGE TEST:
Fill 10 containers with water, fit with intended closures and
keep them inverted at room temperature for 24hr.The test is
said to be passed if there is no signs of leakage from any
container.
Leakage test for plastic containers (non-injectables &
injectables 1996 IP):
Fill 10 plastic containers with water and fit the closure
Keep them inverted at room temperature for 24 hrs
No sign of leakage should be there from any container
10. 2) COLLAPSIBILITY TEST:
This test is applicable to the containers which are to be
squeezed for removing the contents. A container by collapsing
inward during use, yield at least 90% of its normal contents at
the required rate of flow at ambient temperature.
3) WATER PERMEABILITY TEST FOR PLASTIC
CONTAINERS (INJECTABLE PREPARATIONS IP
1996):
10
11. 4) CLARITY OF AQUEOUS EXTRACT:
Select unlabelled, unmarked and non laminated
portions from suitable containers, taken at random. Cut
these portions into strips, none of which has a total
surface area of 20sq.cm.Wash the strips free from
extraneous matter by shaking them with at least two
separate portions of distilled water for about 30sec. In
each case and drain off the water thoroughly.
Thus processed sample is taken in to the flask,
previously cleaned with chromic acid mixtures and
rinsed with several portions of distilled water and
added 250ml dist water. Cover the flask and autoclave
at 121⁰C for 30min. Carry out the blank
determination using 250ml dist water. Cool and
examine the extract, it should be colourless and free
12. 5) TRANSPARENCY TEST:
Standard suspension preparation: 1gm hydrazine
sulphate in 100ml water and set aside for 6hr. Take
25ml of this solution and add 25ml of 10%w/v
hexamine and stand for 24hr.
Test solution preparation: Sample is prepared by
16fold dilution of the standard suspension. Fill 5
containers cloudiness detectable when compared
to water filled84 containers. Absorbance is
measured at 640nm and the range is within 0.37
and 0.43.
13. 6)BIOLOGICAL TESTS:
A)Systemic Injection Test:
⚫ Test animal – Albino Mice
⚫ Inject each of 5 mice in test group with sample or blank observe the
animals immediately, again after 4hr & then at 24, 48, 72hrs.
⚫ If none of animals shows significant greater biological reactivity than the blank
the sample meets the requirements.
⚫ Limit- If abnormal behavior such as Convulsion or Prostration occurs or if body
weight loss is greater than 2g, the sample does not meet the requirements.
B)Intra Cutaneous Test:
⚫ Test animal- Rabbit
⚫ Examine the sites of for any tissue reaction like erythema, oedema, neuosis at 24,
48, 72 hours after injection.
⚫ Limit- difference between the scores of sample and blank should be lesser than 1.0.
C)Eye Irritation Test On Rabbits:
Test animal - albino rabbits
Limit- Sample extract shows no significant irritant response during the observation
period85 with blank extract.
14. CLOSURES
A closure is the part of the package which prevent the contents
from escaping and allow no substance to enter the container.
Closures are available in five basic designs:
1. Screw on, threaded or lug
2. Crimp on(crowns)
3. Press on(snap)
4. Roll on and
5. Friction
14
Quality Control Test 12/8/2018
15. QUALITY CONTROLTEST FOR CLOSURES
1. Sterility Test
2. Fragmentation Test
3. Self-Sealability
4. pH of aqueous extract
5. LightAbsorption Test
6. Reducing Substance
7. Residue on Evaporation
8. Penetrability
15
Quality Control Test 12/8/2018
16. Preparation of sample solution
Wash closure in 0.2%w/v of anionic
surfactant for 5 min.
Rinse 5 times with D.W. and add 200ml water.
Further subjected to autoclave and covering withAl foil.
Allow to cool and separate solution from closure
16
Quality Control Test 12/8/2018
17. 1. Sterility Test
Closures are subjected for sterilization
By Autoclaving at 64-66 C & pressure 0.7kPa
Further testing is carried out by using culture media.
17
Quality Control Test 12/8/2018
18. 2. Fragmentation Test
Take 12 clean vials and place closures containing 4ml of water
Allow to stand for 16 hrs.
Use hypodermic needle to
inject 1ml of water into the vial & remove 1ml of air.
Carry this operation for 4
times with new needle each time.
Pass the water present in vial through a filter with pore size of
0.5µm
Carry this operation for 4
times with new needle each time.
Pass the liquid in the vial through a filter with a pore size of
0.5micrometers
18
Quality Control Test 12/8/2018
Limit: No. of
fragments –
NMT 10(in
case of butyl
rubber) No. of
fragments –
NMT 15
19. 3. pH of Aqueous Extract
Take 20ml of sample solution and add 0.1ml of bromothymol blue
Add 0.01M of NaOH till color change from Blue to Yellow.
Volume required is measured
.
LIMITS: Vol. of NaOH – NMT 0.3 ml
4. Light Absorption Test
It must be done within 4 hr of preparing sample solution. It is filtered and its
absorbance is measured at 220nm to 360nm.
Blank is done without closure and absorbance must be
NMT-2.0
19
Quality Control Test 12/8/2018
20. 5. Reducing Substance:
20ml of sample
solution + 1M
sulphuric acid
20ml of sample
solution + 0.002M
Potassiumpermagnet
Boil for
3 min.
and cool
it.
Add 1 Kg of Potassiumiodide
Treat the solution with Na thiosulphate using
starch solution as indicator.
Blank Titration is done and difference of
sample and blank should be NMT-0.7ml
21. 6. Residue on Evaporation
The 50ml of sample solution is evaporated at 105C. Residue obtained should be
NMT 4mg.
7. Penetrability
• This is to measure the force required to make a hypodermic needle penetrate
easily through closure.
• It is measured by using piercing machine.
• The piercing force must not exceed a stated value, the hypodermic needle can get
damage as a result of undesirable hardness of closure.
8. Reducing Substances:
20ml of solution A is added with 1ml of 1M H2SO4 and 20ml of 0.002M KMnO4
and boil for 3 min then cool and add 1gm of potassium iodide which is titrated with
sodium thio-sulphate using starch as an indicator. Blank is done and the difference
between titration volumes is NMT 0.7ml.
21
Quality Control Test 12/8/2018
22. Self – sealability: This test is applicable to closures intended to be
used with water
22
Quality Control Test 12/8/2018
23. 1. LEAKAGE TEST: Water was filled in the tube and tightly closed. External
surface was wiped off and tube is kept inverted on filter paper at base. Allow to
stand for 1hr.Filterpaper shows absorption at any time during test period.
2. LACQUER CURING TEST:
A) Power of adhesion: Tube was spitted along the length and flattened. Cotton
wool soaked in acetone was rubbed over lacquer surface for 20min.Lacquer
should not lift from surface and cotton wool shall remain colorless.
B) Flexibility test: The tube was folded in such a manner that internal lacquer
surface is outside. The lacquer coating should not be peeled off when the folded
position is rubbed with finger.
3. LACQUER COMPATIBILITY TEST: 10 tubes are taken for the test. Product
was filled and crimped subjected to 45⁰C for 72hr.Tubes were allowed to cool
and cut lengthwise.
A) Product compatibility: Content should not show any discolorations or change
in colour or gas formation.
B) Lacquer compatibility: Lifting or peeling of lacquer is checked.
23 12/8/2018
Quality Control Of Collapsible Tubes
24. 1) DESCRIPTION:
Metallic tins having smooth inner surface. The upper surface is sealed consists a
clip to break the seal. The lower surface is open.
2) DIMENSIONS:
Height- Measure the height in mm of 10 metallic tin, individually from the lower
surface edge to the upper rim.
Limit- Specimen metallic tins with tolerance-170mm±10mm.
3) DIAMETER:
Inner diameter- Measure the inner diameter of 10 metallic tins. Limit- NLT
98mm.
Outer diameter: Limit-NMT 105mm.
4) CLEANLINESS CHECK:
It should not be dirty, damaged, stained or consist of any foreign particles.91
24 12/8/2018
QUALITY CONTROL OF METALLIC TINS
25. Secondary Packaging: This is consecutive covering or package which
stores pharmaceuticals packages in it for their grouping.
E.g. Cartons, boxes, etc.
• The packaging external to the primary package is known as the
secondary packaging.
• The secondary packaging mainly provides the additional physical
protection necessary to endure the safe warehousing and for refill
packaging.
25
Quality Control Test 12/8/2018
26. The test pieces of paper and board are taken for test to be carried out in
standard condition
a) Temperature: 23̊C ± 1̊C
b) Relative Humidity: 50% ± 2%
1. Moisture Content
2. Folding Endurance
3. Air Permeability
4. Tensile Strength
5. Stiffness
6. Burst Resistance
7. Tear strenght
26
Quality Control Test 12/8/2018
QC TEST FOR SECONDARY PACKAGING
MATERIALS
27. Compression: This method is used to assess the strength of erected
package.
Carton opening force: The method is used to hold the flat carton as
delivered, by its creases between thumb & first finger press.
Coefficient of friction: Both static & kinetic coefficients of friction
are determined by sliding the specimen over itself under specific
test conditions.
Crease stiffness: This involves testing a carton board piece &
folding it through 90 degree. It will then try to recover its former
position when bending force is removed.
Joint shear strength: This is a method of testing the glued lap seam
on the side of a carton for strength of the adhesive using a tensile
testing machine. 27 12/8/2018
Quality Control Tests For Cartons