This document discusses quality control testing standards and procedures for pharmaceutical packaging materials. It outlines tests for various packaging components like glass containers, plastic packaging, and rubber stoppers. Key tests described include appearance and dimensional checks, compatibility testing, chemical resistance tests like powdered glass tests and water attack tests, sterility validation tests for sterile products, and non-sterile product validation tests. The document emphasizes that quality control testing is important to ensure packaging and components are defect-free and can safely contain drug products.
Glass as a packaging material in pharmaceutical packagingShweta Shelke
This presentation gives a brief idea about the types of glasses used in pharmaceutical industry and its intended use. Different tests used for assuring its quality for intended use.
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
Glass as a packaging material in pharmaceutical packagingShweta Shelke
This presentation gives a brief idea about the types of glasses used in pharmaceutical industry and its intended use. Different tests used for assuring its quality for intended use.
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.
IPQC Tests for capsules As per IP, BP & USPPramod Ramane
IPQC- In Process Quality Control Tests for Capsules are
1. Uniformity Of Content
2. Disintigration Test
3. Weight Variation Test
4. Dissolution Test
The tests are with Acceptance limits/Criteria as per Indian Pharmacopoeia (IP), British Pharmacopoeia (BP) & United States Pharmacopoeia (USP)
Different types of dosage forms have different properties so according to their handling and storage conditions we have to select containers accordingly
IPQC cover the entire chain of operations from the receipt of raw material in the warehouse to the release of finished products from the warehouse for distribution and or sale. IPQC is a process where quality of a product is ensured that it meets the standard according to regulatory authority guidline.
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.
IPQC Tests for capsules As per IP, BP & USPPramod Ramane
IPQC- In Process Quality Control Tests for Capsules are
1. Uniformity Of Content
2. Disintigration Test
3. Weight Variation Test
4. Dissolution Test
The tests are with Acceptance limits/Criteria as per Indian Pharmacopoeia (IP), British Pharmacopoeia (BP) & United States Pharmacopoeia (USP)
Different types of dosage forms have different properties so according to their handling and storage conditions we have to select containers accordingly
IPQC cover the entire chain of operations from the receipt of raw material in the warehouse to the release of finished products from the warehouse for distribution and or sale. IPQC is a process where quality of a product is ensured that it meets the standard according to regulatory authority guidline.
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.
Qc test for plastics,metallic tins,closures, collapsible tubes, secondary pac...himanshu kamboj
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 test for containers and closure Pratik Ghivepratikghive82
Quality control test for containers and closure Pratik Ghive covers all aspects in details in sample language with animated images of containers for better understanding
content-
Glass
Properties of glass
Raw materials
Composition of glass
Manufacture of glass
Advantages
Disadvantages
Type of glass
Quality control tests for glasses
Ethanol (CH3CH2OH), or beverage alcohol, is a two-carbon alcohol
that is rapidly distributed in the body and brain. Ethanol alters many
neurochemical systems and has rewarding and addictive properties. It
is the oldest recreational drug and likely contributes to more morbidity,
mortality, and public health costs than all illicit drugs combined. The
5th edition of the Diagnostic and Statistical Manual of Mental Disorders
(DSM-5) integrates alcohol abuse and alcohol dependence into a single
disorder called alcohol use disorder (AUD), with mild, moderate,
and severe subclassifications (American Psychiatric Association, 2013).
In the DSM-5, all types of substance abuse and dependence have been
combined into a single substance use disorder (SUD) on a continuum
from mild to severe. A diagnosis of AUD requires that at least two of
the 11 DSM-5 behaviors be present within a 12-month period (mild
AUD: 2–3 criteria; moderate AUD: 4–5 criteria; severe AUD: 6–11 criteria).
The four main behavioral effects of AUD are impaired control over
drinking, negative social consequences, risky use, and altered physiological
effects (tolerance, withdrawal). This chapter presents an overview
of the prevalence and harmful consequences of AUD in the U.S.,
the systemic nature of the disease, neurocircuitry and stages of AUD,
comorbidities, fetal alcohol spectrum disorders, genetic risk factors, and
pharmacotherapies for AUD.
Prix Galien International 2024 Forum ProgramLevi Shapiro
June 20, 2024, Prix Galien International and Jerusalem Ethics Forum in ROME. Detailed agenda including panels:
- ADVANCES IN CARDIOLOGY: A NEW PARADIGM IS COMING
- WOMEN’S HEALTH: FERTILITY PRESERVATION
- WHAT’S NEW IN THE TREATMENT OF INFECTIOUS,
ONCOLOGICAL AND INFLAMMATORY SKIN DISEASES?
- ARTIFICIAL INTELLIGENCE AND ETHICS
- GENE THERAPY
- BEYOND BORDERS: GLOBAL INITIATIVES FOR DEMOCRATIZING LIFE SCIENCE TECHNOLOGIES AND PROMOTING ACCESS TO HEALTHCARE
- ETHICAL CHALLENGES IN LIFE SCIENCES
- Prix Galien International Awards Ceremony
ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
The prostate is an exocrine gland of the male mammalian reproductive system
It is a walnut-sized gland that forms part of the male reproductive system and is located in front of the rectum and just below the urinary bladder
Function is to store and secrete a clear, slightly alkaline fluid that constitutes 10-30% of the volume of the seminal fluid that along with the spermatozoa, constitutes semen
A healthy human prostate measures (4cm-vertical, by 3cm-horizontal, 2cm ant-post ).
It surrounds the urethra just below the urinary bladder. It has anterior, median, posterior and two lateral lobes
It’s work is regulated by androgens which are responsible for male sex characteristics
Generalised disease of the prostate due to hormonal derangement which leads to non malignant enlargement of the gland (increase in the number of epithelial cells and stromal tissue)to cause compression of the urethra leading to symptoms (LUTS
These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
Title: Sense of Taste
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
Report Back from SGO 2024: What’s the Latest in Cervical Cancer?bkling
Are you curious about what’s new in cervical cancer research or unsure what the findings mean? Join Dr. Emily Ko, a gynecologic oncologist at Penn Medicine, to learn about the latest updates from the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer. Dr. Ko will discuss what the research presented at the conference means for you and answer your questions about the new developments.
NVBDCP.pptx Nation vector borne disease control programSapna Thakur
NVBDCP was launched in 2003-2004 . Vector-Borne Disease: Disease that results from an infection transmitted to humans and other animals by blood-feeding arthropods, such as mosquitoes, ticks, and fleas. Examples of vector-borne diseases include Dengue fever, West Nile Virus, Lyme disease, and malaria.
Pulmonary Thromboembolism - etilogy, types, medical- Surgical and nursing man...VarunMahajani
Disruption of blood supply to lung alveoli due to blockage of one or more pulmonary blood vessels is called as Pulmonary thromboembolism. In this presentation we will discuss its causes, types and its management in depth.
- Video recording of this lecture in English language: https://youtu.be/lK81BzxMqdo
- Video recording of this lecture in Arabic language: https://youtu.be/Ve4P0COk9OI
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
263778731218 Abortion Clinic /Pills In Harare ,sisternakatoto
263778731218 Abortion Clinic /Pills In Harare ,ABORTION WOMEN’S CLINIC +27730423979 IN women clinic we believe that every woman should be able to make choices in her pregnancy. Our job is to provide compassionate care, safety,affordable and confidential services. That’s why we have won the trust from all generations of women all over the world. we use non surgical method(Abortion pills) to terminate…Dr.LISA +27730423979women Clinic is committed to providing the highest quality of obstetrical and gynecological care to women of all ages. Our dedicated staff aim to treat each patient and her health concerns with compassion and respect.Our dedicated group ABORTION WOMEN’S CLINIC +27730423979 IN women clinic we believe that every woman should be able to make choices in her pregnancy. Our job is to provide compassionate care, safety,affordable and confidential services. That’s why we have won the trust from all generations of women all over the world. we use non surgical method(Abortion pills) to terminate…Dr.LISA +27730423979women Clinic is committed to providing the highest quality of obstetrical and gynecological care to women of all ages. Our dedicated staff aim to treat each patient and her health concerns with compassion and respect.Our dedicated group of receptionists, nurses, and physicians have worked together as a teamof receptionists, nurses, and physicians have worked together as a team wwww.lisywomensclinic.co.za/
4. INTRODUCTION
• QC - backbone of pharmaceutical
industry.
• Defects in packaging – harmful
for dosage form
• Quality control of a packaging
component starts at the design
stage.
• All aspects of a pack development
that may give rise to quality
problems must be identified
and minimized by good
design.
9. QUALITY CONTROL AND TESTING
STANDARDS
• It is to first determine which batch is for testing
purposes.
• The basic testing system is the same for
both the components, primary and secondary.
• Although component compatibility and chemical
testing are required , in addition , for primary
components.
10. SETTING THE STANDARDS
Appearance Compatibility
and
Customer
usability
Dimentions Chemical
testing
Critical MinorMajor
Plastic
primary
components
Glass vials
and
ampules
Critical
Noncritical
Measuring
components Precision
Accuracy
11. Appearance
• Critical :Unacceptable at any level , eg; rogue printed items in a
delivery , incorrect printing of data such as the product name or
concentration , insects in the bottles, etc.
• Major: Acceptable at low level; standard is decided by the
pharmaceutical company. Very easy to ask for perfection if not
possible so a reasonable compromise has to be reached .
Two type standard will result in a supplier not supplying because
the standard cannot be met or a 100% inspection of each
consignment received by the pharmaceutical company.
Too low standard – excessive complaint from market-
loss of company image and orders.
• Minor: acceptable at higher level then the major appearance
defect this will detract from perfection and include marked
components , slight colour variation ,etc.
12. Dimensions
• Critical : requiring close control to insure that
the components functions correctly and can be
used satisfactorily by the packaging equipment.
• Non critical : necessary to maintain the
component shape but not requiring close control
. Eg a vial containing injectable product.
Components are brought together by filling
machine to give sterility to seal , rubber plug and
aluminium overseal .
13.
14. • Measuring component :
It is possible to accurately measure component
without trained staff and variety of measuring
equipment such as callipers , micrometer etc. the variety
and types of equipment used are determined by
materials to be measured.
1) Measuring tehniques: Even when measuring
something simple with a micromerter, such as thickness
of a sheet of metal, it is possible to measure it incorrectly
due either to not using the ratchet or using the ratchet
incorrectly.
2)Precision and accuracy: Firstly a set of recently
calibrated gauging blocks are required, together with a
certificate of calibration. The gauging blocks must cover
the full measuring range of the equipment and must be
periodically recalibrated at a frequency to be determined
by the frequency of use.
15.
16. COMPATIBILITY AND CUSTOMER
USABILITY
• This involves checking that each component
forming a pack fits together and functions
correctly.
• Consider an eye dropper pack as an example.
• The nozzle ,must have a interference fit in the bottle
and allow 1 drop at a time delivery through the hole
in the nozzle when inverted, but not leak from the
fitted position.
• The cap must screw into position and leakage must
not occur when the bottle is squeezed in the inveted
position.
17. Chemical testing
• The majority of chemical testing is required on primary
component.
• The type of testing required depends on the type of
component used.
1) glass vials and ampules: The USPXXII
requirements for glass containers are chemical
resistance and light transmission.The requirements vary
from country to country.
2) plastic primary components: The testing is
more extensive with plastic components, requiring both
biological and physicochemical test. This is because the
plastic components contain other substance such as
plasticizers , stabilizers, antioxidants, pigment,
lubricants ,etc.
18. 3) WATER ATTACK TEST
• This test is used only with containers that have been
exposed to sulphur dioxide fumes under controlled
humidity conditions. Such a treatment neutralizes the
surface alkali. Now the glass becomes chemically more
resistant. The principle involved in the water attack test
is to determine whether the alkali leached form the
surface of a container is within the specified limits or
not. Since the inner surface is under test entire container
(ampoule) has to be used. The amount of acid that is
necessary to neutralize the released alkali from the
surface is estimated, the leaching of alkali is accelerated
using elevated temperature for a specified time. Methyl
red indicator is used to determine the end point. The
basic is acid-base titration.
19. TESTS CONTAINER VOL.OF 0.02N H2SO4
Powdered glass test Type I
Type II
Type III
1.0
8.5
15.0
Water attack test
Type II(100ml or below)
Type II(above 100ml)
0.07
0.02
20. QUALITY CONTROL TESTS FOR GLASS CONTAINERS:
CHEMICAL RESISTANT OF GLASS CONTAINERS
A) POWDERED GLASS TEST :
It is done to estimate the amount of alkali leached from the powdered glass
which usually happens at the elevated temperatures. When the glass is
powdered, leaching of alkali is enhanced, which can be titrated with 0.02N
sulphuric acid using methyl red as an indicator .
o Step -1 : Preparation of glass specimen : Few containers are
rinsed thoroughly with purified water and dried with stream of clean air.
Grind the containers in a mortar to a fine powder and pass through sieve
no.20 and 50.
o Step -2 : Washing the specimen : 10gm of the above specimen is
taken into 250 ml conical flask and wash it with 30 ml acetone. Repeat the
washing, decant the acetone and dried after which it is used within 48hr.
Procedure :
10gm sample is added with 50ml of high purity water in a 250ml flask. Place
it in an autoclave at 121⁰C±2⁰C for 30min.Cool it under running water.
Decant the solution into another flask, wash again with 15ml high purity
water and again decant. Titrate immediately with 0.02N sulphuric acid
using methyl red as an indicator and record the volume.
21. 2) HYDROLYTIC RESISTANCE OF GLASS
CONTAINERS:
• Rinse each container at least 3times with CO2 free water and fill
with the same to their filling volume. Also fill & Cover the vials and
bottles and keep in autoclave. Heat to 100⁰C for 10min and allow
the steam to issue from the vent cork. Rise the temp from 100⁰C to
121⁰C over 20min. Maintain the temp at 121⁰C to 122⁰C for
60min.Lower the temp from 121⁰C to 100C over 40min venting to
prevent vacuum.
• Remove the container from autoclave, cool and combine the liquids
being examined. Measure the volume of test solution into a conical
flask and titrate with 0.01M HCl using methyl red as an indicator.
Perform blank with water and the difference between the titration
represents the volume of HCl consumed by the test solution.
22. 3) ARSENIC TEST:
• This test is for glass containers intended for aqueous
parenterals. Wash the inner and outer surface of container
with fresh distilled water for 5min.Prep test as described in
the test for hydrolytic resistance for an adequate no.of
samples to produce 50ml.pipette out 10ml solution from
combined contents of all ampoules to the flask.
• Add 10ml of HNO3 to dryness on the water bath, dry the
residue in an oven at 130⁰C for 30min cool and add 10ml
hydrogen molybdate reagent .Swirl to dissolve and heat under
water bath and reflux for 25min. Cool to room temp and
determine the absorbance at 840nm.
• Do the blank with 10ml hydrogen molybdate. The absorbance
of the test solution should not exceed the absorbance obtained
by repeating the determination using 0.1ml of arsenic
standard solution (10ppm) in place of test soln.
23. 4 ) THERMAL SHOCK TEST:
• Place the samples in upright position in a tray.
Immerse the tray into a hot water for a given
time and transfers to cold water bath, temp of
both are closely controlled. Examine cracks or
breaks before and after the test. The amount of
thermal shock a bottle can withstand depends on
its size, design and glass distribution. Small
bottles withstand a temp differential of 60 to
80⁰C and 1 pint bottle 30 to 40⁰C.A typical test
uses 45C temp difference between hot and cold
water.
24. INTERNAL BURSTING PRESSURE TEST
• The most common instrument used is American glass
research increment pressure tester .
The test bottle is filled with water and
placed inside the test chamber
A scaling head is applied and the
internal pressure automatically raised
by a series of increments each of which
is held for a set of time
The bottle can be checked for
predetermined pressure level and the
test continues unteil the container finally
bursts.
25. 6 ) LEAKAGE TEST:
• Drug filled container is placed in a container
filled with coloured solution (due to the addition
of dye)which is at high pressure compared to the
pressure inside the glass container so that the
coloured solution enters the container if any
cracks or any breakage is present.
26. QUALITY CONTROL TESTS FOR RUBBERS :
• Fragmentation test for rubber closures :
Place a 4ml of water in each of 12 clean vials. Close a vial with
closure and secure caps for 16 hrs.
Pierce the closure with 21 SWG hypodermic needle. Repeat the
operation 4 times for each closures.
Count the number of fragment visible on the rubber . Total
number of fragment should not be more than 10 except butyl
rubber
27. QUALITY CONTROL OF CLOSURES
• PREPARATION OF SAMPLE (SOL.-A) :
Wash closures
in 0.2%w/v of
anionic
surface active
agents for
5min.
Rinse 5 times with dist
water and add 200ml water
and is subjected to
autoclave at 119 to 123⁰C
for 20 to 30min covering
with aluminum foil.
Cool and
separate
solution from
closure (soln-A)
28. 1) STERILITY TEST:
• When treated closures are subjected to
sterilization test at 64-66⁰C and a pressure of
about 0.7 KPa for 24hr.
29. 2) Fragmentation test
For closures for aqueous place a vol of water corresponding to the
nominal vol minus 4 ml in each of 12 clean vials.
close the vials with the ‘prepared’ closures & allow to stand for 16
hours.
For closures for dry preparations close 12 clean vials with the
‘prepared’ closures.
Using a hypodermic needle with an external diameter of 0.8 mm
inject 1 ml of water into the vial and remove 1 ml of air.
Carry out this operation 4 times with new needle each time Pass the
liquid in the vials through a filter with a pores size of 0.5 µm.
No. of fragments is NMT 10 except in the case of butyl rubber
closures where the total no. of fragments is NMT 15
30. 3)Self – sealability test:
• This test is applicable to closures intended to be used
with water close the vials with the ‘Prepared’ closures
• For each closure, use a new hypodermic needle with an
external diameter of 0.8 mm & pierce the closure 10
times, each time at a different site.
• Immerse the vials upright in a 0.1% w/v solution of
methylene blue & reduce the external pressure by 27KPa
for 10 min.
• Restore the atmospheric pressure and leave the vials
immersed for 30 minutes. Rinse the outside of the vials.
None of the vials contains any trace of coloured solution.
31. 4 ) PH OF AQUEOUS EXTRACT:
• 20ml of solution A is added with 0.1ml
bromothymol blue when it is added with a small
amount of 0.01M NaOH which changes the
colour from blue to yellow. The volume of NaOH
required is NMT 0.3ml and if it is done with
HCl, the volume of HCl needed should NMT
0.8ml.
32. 5 ) LIGHT ABSORPTION TEST:
• It must be done within 4hrs of preparing
solution A. It is filtered through 0.5μ filter and
its absorbance is measured at 220 to
360nm.Blank is done without closures and
absorbance is NMT 2.0.
33. 6 ) REDUCING SUBSTANCES:
20ml of solution A is added with 1ml of 1M
H2SO4 and 20ml of 0.002M KMnO4 and boil
for 3min 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.
34. 7 ) RESIDUE ON EVAPORATION:
• 50ml of solution A is evaporated to dryness at
105⁰C.Then weigh the residue NMT 4mg.
35. TEST FOR PLASTIC CONTAINERS:
• 1.For non-injectable preparations:
Leakage test / Collapsibility test : Applicable to
containers which are to be squeezed in order to
remove contents. yield 90%of its contents at
required rate of flow at ambient temp. Fill 10
containers with water Fit with closures Keep them
inverted at room temp. 24hrs No signs of leakage
36. CLARITY OF AQUEOUS EXTRACT:
• Clarity of aqueous extract Select unlabelled portion
from a suitable containers Cut these portions into
strips Wash it with extraneous matter by shaking
with two separate portions of distilled water
Transfer to flask – previously washed with chromic
acid Rinse with distilled water add 250ml d.w. Cover
the flask autoclave at 121Ċ, 30min Colourless , free
from turbidity
37. NON VOLATILE RESIDUE TEST:
• Non volatile residue test 2. Injectable
preparations: a. Leakage test b. Collapsibility
test C. Transperancy: Fill 5 containers with dil.
Suspension. The cloudiness of of the diluted
suspension in each container is detectable when
viewed through the containers as compared with
a container of the same type filled with water
Evaporate 100ml extract Allow it to dry at 105Ċ
Residue weighs not more than 12.5mg
38. WATER VAPOUR PERMEABILITY:
• Fill 5 containers with nominal volume of water
and heat seal the bottles with aluminium foil.
Weigh accurately each container and allow to
stand for 14 days humidity- 60±5% temp. 20Ċ
and 25Ċ. Reweigh the containers. Loss in wt in
each container is NMT 0.2% Specifications and
tests of plastic container materials: Barium
Heavy metals Tin zinc 19
39. Quality test is designed to achieve-
1. Consistency
2. Purity
3. Stability
And to avoid-
1. Damage
2. Contaimination
3. degradation
40. Laboratory Analysis
• Visual inspection
• Identification test
• Dimentional test
• Physical test
• Chemical test
• Microbiologcal test
• Permormance measurements
41. 1. Sterile product validation:-
a) Product and pack compatibility- the
components must be washed and sterilized
through a validated procedure. The vials must be
filled with the sterile product under sterile
conditions and terminally sterilized if this is a
part of the intended product operation.
Components performance should be monitored
during the compatibility trials to ensure that
deterioration has not occurred.
b) Seal integrity- the
42. b) Seal integrity- the seals of each vial should
be examined before the experiment to ensure
that there are no defectives, and then each vial
should be inserted into a tray containing the
challenge bacteria. The samples should be cycled
through temperature and pressure changes
expected on the market for several weeks.
Careful cleaning of the vials and examination of
contents for sterility will determine the seal
quality.
43. 2. Nonsterile product validation:-
a) Water vapour permeability- the water vapour
permeability of the pack containing the product is
required. This is necessary because although the bottles
will comply with the water vapour permeability test
described in USP, permeation through the bottle wall
will depend on wheather the product has a high or low
affinity for the water. The test split into two parts to
enable the maximum amount of information to be
obtained and hence possibly eliminating the necessity to
perform further time consuming experiments.
·Bottle wall permeation
·Bottle and cap permeation
44. b) Light transmission- this test is to determine
the effect of light passing through the bottle wall
on the product stability and appearance. The
bottle wall thickness can have a significant effect
on the results obtained.
45. c) Product stability- it is unlikely that a
compatibility problem, particularly with the film
coated tablet, will occur, although it is necessary
to check up full life of the product. There is
possibility that either the smell or taste of tablets
will be affected.
46. COMPONENT SPECIFICATIONS
• Every detail concerning a component specification
must be communicated to and agreed upon with the
manufacture, including packaging, transportation,
and labeling requirements. If any of the details are
missing confusion or mistakes may occur.
• The main specifications requirements are the
component drawing, artwork (printed components
only) and the quality control testing and standards.
47. 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.