This document outlines quality control tests for various pharmaceutical packaging materials including containers, closures, and secondary packaging. It describes tests for glass, plastic, metal and rubber containers to test properties like chemical resistance, hydrolytic resistance, sterility and leakage. Tests are also described for closures to evaluate sterility, fragmentation, self-sealability and extractable substances. Finally, common tests for secondary packaging materials like paper and board are mentioned including moisture content, folding endurance and burst resistance.
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
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.
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
content-
Glass
Properties of glass
Raw materials
Composition of glass
Manufacture of glass
Advantages
Disadvantages
Type of glass
Quality control tests for glasses
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
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
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.
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
content-
Glass
Properties of glass
Raw materials
Composition of glass
Manufacture of glass
Advantages
Disadvantages
Type of glass
Quality control tests for glasses
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
A brief information about the SCOP protein database used in bioinformatics.
The Structural Classification of Proteins (SCOP) database is a comprehensive and authoritative resource for the structural and evolutionary relationships of proteins. It provides a detailed and curated classification of protein structures, grouping them into families, superfamilies, and folds based on their structural and sequence similarities.
Richard's aventures in two entangled wonderlandsRichard Gill
Since the loophole-free Bell experiments of 2020 and the Nobel prizes in physics of 2022, critics of Bell's work have retreated to the fortress of super-determinism. Now, super-determinism is a derogatory word - it just means "determinism". Palmer, Hance and Hossenfelder argue that quantum mechanics and determinism are not incompatible, using a sophisticated mathematical construction based on a subtle thinning of allowed states and measurements in quantum mechanics, such that what is left appears to make Bell's argument fail, without altering the empirical predictions of quantum mechanics. I think however that it is a smoke screen, and the slogan "lost in math" comes to my mind. I will discuss some other recent disproofs of Bell's theorem using the language of causality based on causal graphs. Causal thinking is also central to law and justice. I will mention surprising connections to my work on serial killer nurse cases, in particular the Dutch case of Lucia de Berk and the current UK case of Lucy Letby.
Introduction:
RNA interference (RNAi) or Post-Transcriptional Gene Silencing (PTGS) is an important biological process for modulating eukaryotic gene expression.
It is highly conserved process of posttranscriptional gene silencing by which double stranded RNA (dsRNA) causes sequence-specific degradation of mRNA sequences.
dsRNA-induced gene silencing (RNAi) is reported in a wide range of eukaryotes ranging from worms, insects, mammals and plants.
This process mediates resistance to both endogenous parasitic and exogenous pathogenic nucleic acids, and regulates the expression of protein-coding genes.
What are small ncRNAs?
micro RNA (miRNA)
short interfering RNA (siRNA)
Properties of small non-coding RNA:
Involved in silencing mRNA transcripts.
Called “small” because they are usually only about 21-24 nucleotides long.
Synthesized by first cutting up longer precursor sequences (like the 61nt one that Lee discovered).
Silence an mRNA by base pairing with some sequence on the mRNA.
Discovery of siRNA?
The first small RNA:
In 1993 Rosalind Lee (Victor Ambros lab) was studying a non- coding gene in C. elegans, lin-4, that was involved in silencing of another gene, lin-14, at the appropriate time in the
development of the worm C. elegans.
Two small transcripts of lin-4 (22nt and 61nt) were found to be complementary to a sequence in the 3' UTR of lin-14.
Because lin-4 encoded no protein, she deduced that it must be these transcripts that are causing the silencing by RNA-RNA interactions.
Types of RNAi ( non coding RNA)
MiRNA
Length (23-25 nt)
Trans acting
Binds with target MRNA in mismatch
Translation inhibition
Si RNA
Length 21 nt.
Cis acting
Bind with target Mrna in perfect complementary sequence
Piwi-RNA
Length ; 25 to 36 nt.
Expressed in Germ Cells
Regulates trnasposomes activity
MECHANISM OF RNAI:
First the double-stranded RNA teams up with a protein complex named Dicer, which cuts the long RNA into short pieces.
Then another protein complex called RISC (RNA-induced silencing complex) discards one of the two RNA strands.
The RISC-docked, single-stranded RNA then pairs with the homologous mRNA and destroys it.
THE RISC COMPLEX:
RISC is large(>500kD) RNA multi- protein Binding complex which triggers MRNA degradation in response to MRNA
Unwinding of double stranded Si RNA by ATP independent Helicase
Active component of RISC is Ago proteins( ENDONUCLEASE) which cleave target MRNA.
DICER: endonuclease (RNase Family III)
Argonaute: Central Component of the RNA-Induced Silencing Complex (RISC)
One strand of the dsRNA produced by Dicer is retained in the RISC complex in association with Argonaute
ARGONAUTE PROTEIN :
1.PAZ(PIWI/Argonaute/ Zwille)- Recognition of target MRNA
2.PIWI (p-element induced wimpy Testis)- breaks Phosphodiester bond of mRNA.)RNAse H activity.
MiRNA:
The Double-stranded RNAs are naturally produced in eukaryotic cells during development, and they have a key role in regulating gene expression .
This pdf is about the Schizophrenia.
For more details visit on YouTube; @SELF-EXPLANATORY;
https://www.youtube.com/channel/UCAiarMZDNhe1A3Rnpr_WkzA/videos
Thanks...!
Comparing Evolved Extractive Text Summary Scores of Bidirectional Encoder Rep...University of Maribor
Slides from:
11th International Conference on Electrical, Electronics and Computer Engineering (IcETRAN), Niš, 3-6 June 2024
Track: Artificial Intelligence
https://www.etran.rs/2024/en/home-english/
THE IMPORTANCE OF MARTIAN ATMOSPHERE SAMPLE RETURN.Sérgio Sacani
The return of a sample of near-surface atmosphere from Mars would facilitate answers to several first-order science questions surrounding the formation and evolution of the planet. One of the important aspects of terrestrial planet formation in general is the role that primary atmospheres played in influencing the chemistry and structure of the planets and their antecedents. Studies of the martian atmosphere can be used to investigate the role of a primary atmosphere in its history. Atmosphere samples would also inform our understanding of the near-surface chemistry of the planet, and ultimately the prospects for life. High-precision isotopic analyses of constituent gases are needed to address these questions, requiring that the analyses are made on returned samples rather than in situ.
Cancer cell metabolism: special Reference to Lactate PathwayAADYARAJPANDEY1
Normal Cell Metabolism:
Cellular respiration describes the series of steps that cells use to break down sugar and other chemicals to get the energy we need to function.
Energy is stored in the bonds of glucose and when glucose is broken down, much of that energy is released.
Cell utilize energy in the form of ATP.
The first step of respiration is called glycolysis. In a series of steps, glycolysis breaks glucose into two smaller molecules - a chemical called pyruvate. A small amount of ATP is formed during this process.
Most healthy cells continue the breakdown in a second process, called the Kreb's cycle. The Kreb's cycle allows cells to “burn” the pyruvates made in glycolysis to get more ATP.
The last step in the breakdown of glucose is called oxidative phosphorylation (Ox-Phos).
It takes place in specialized cell structures called mitochondria. This process produces a large amount of ATP. Importantly, cells need oxygen to complete oxidative phosphorylation.
If a cell completes only glycolysis, only 2 molecules of ATP are made per glucose. However, if the cell completes the entire respiration process (glycolysis - Kreb's - oxidative phosphorylation), about 36 molecules of ATP are created, giving it much more energy to use.
IN CANCER CELL:
Unlike healthy cells that "burn" the entire molecule of sugar to capture a large amount of energy as ATP, cancer cells are wasteful.
Cancer cells only partially break down sugar molecules. They overuse the first step of respiration, glycolysis. They frequently do not complete the second step, oxidative phosphorylation.
This results in only 2 molecules of ATP per each glucose molecule instead of the 36 or so ATPs healthy cells gain. As a result, cancer cells need to use a lot more sugar molecules to get enough energy to survive.
Unlike healthy cells that "burn" the entire molecule of sugar to capture a large amount of energy as ATP, cancer cells are wasteful.
Cancer cells only partially break down sugar molecules. They overuse the first step of respiration, glycolysis. They frequently do not complete the second step, oxidative phosphorylation.
This results in only 2 molecules of ATP per each glucose molecule instead of the 36 or so ATPs healthy cells gain. As a result, cancer cells need to use a lot more sugar molecules to get enough energy to survive.
introduction to WARBERG PHENOMENA:
WARBURG EFFECT Usually, cancer cells are highly glycolytic (glucose addiction) and take up more glucose than do normal cells from outside.
Otto Heinrich Warburg (; 8 October 1883 – 1 August 1970) In 1931 was awarded the Nobel Prize in Physiology for his "discovery of the nature and mode of action of the respiratory enzyme.
WARNBURG EFFECT : cancer cells under aerobic (well-oxygenated) conditions to metabolize glucose to lactate (aerobic glycolysis) is known as the Warburg effect. Warburg made the observation that tumor slices consume glucose and secrete lactate at a higher rate than normal tissues.
Professional air quality monitoring systems provide immediate, on-site data for analysis, compliance, and decision-making.
Monitor common gases, weather parameters, particulates.
Nutraceutical market, scope and growth: Herbal drug technologyLokesh Patil
As consumer awareness of health and wellness rises, the nutraceutical market—which includes goods like functional meals, drinks, and dietary supplements that provide health advantages beyond basic nutrition—is growing significantly. As healthcare expenses rise, the population ages, and people want natural and preventative health solutions more and more, this industry is increasing quickly. Further driving market expansion are product formulation innovations and the use of cutting-edge technology for customized nutrition. With its worldwide reach, the nutraceutical industry is expected to keep growing and provide significant chances for research and investment in a number of categories, including vitamins, minerals, probiotics, and herbal supplements.
2. CONTENT
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1. QC Test for Containers
2. QC Test for Closures
3. QC Test for Secondary Packaging Materials
3. QUALITY CONTROL TEST FORCONTAINERS
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Different types of container materials.
1. Glass Container
2. Plastic Container
3. Metal Container
4. Rubber
4. Quality Control Test for Glass Containers
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1. Chemical Resistance Test
a) Powdered Glass Test
b) Water Attack Test
2. Hydrolytic Resistance Test
3. Arsenic Test
4. Thermal Shock Test
5. Internal Bursting Pressure Test
5. 1. Chemical Resistant Test
a) Powdered Glass Test: It is done to estimate the
amount of alkali from powdered glass with happen at
elevated temperature. When glass is powdered,
leaching of alkali is enhanced, which can be titrated
with 0.02N sulphuric acid using methylred as an
indicator.
Step 1
• Preparation of glass specimen
Step 2
• Washing the specimen
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6. 10g of specimen/sample + 50ml oh highly
purified water.Autoclave it at 121C.
Test Container Vol. of 0.02N
H2SO4(ml)
Powdered Type I 1.0
Glass Test Type III 8.5
Type N.P 15
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Cool it and deacant solution in another flask
again add 15ml water and decant solution
Titrate the decant solution with 0.02N sulphuric
acid using indicator and record the volume
Limits:
7. b) Water Attack Test: This test is for Type II glass. The
principle involve in this is whether the alkali leaches from
surface of container.
Rinse thoroughly container with high purity
water. Fill it by 90% of it’s capacity with water.
Autoclave it at 121C
̊ for 30 minutes. Then it is
cooled and liquid is decanted
Decanted liquid is titrated with 0.02N Sulphuric
acid using methylred as an indicator
The volume of sulphuric acid consumed is
recorded and compare with limits
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8. Test
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Container Vol. of 0.02N
H2SO4(ml)
WaterAttack
Test
Type II 1.0
Size(ml)-100 0.7
Less than 100 0.2
Limits:
2. Leakage Test:
Drug filled container is placed in contained filled with
colored solution (methyleneblue) and autoclave at 121̊C for 1
0
min. under pressure.
Later on the container are observed whether colored get
entered in container or not.
9. 3. Hydrolytic Resistant Test
This test is only for unused glass container.
At 100C
̊ for 10
min. allow to
rise temp. to
121̊C for 60 m
i
n
.
Low down temp
to 100̊C. Cool it
Rinse the
container with
CO2 free water
for 3 times. fill
till a particular
vol. autoclave it
Specific amount
of liquid solution
is titrated with
0.01N HCL
using methylred
as an indicator.
Perform the blank with water
and difference between the
titration represents vol. of
HCL consumed by test liquid
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11. C
̊ for 30 min. & cool it
Cool the solution and determine absorbance at
840nm. Perform blank.
Wash inner and outer surface of container with
D.W. for 5 min.
Test solution is same as that of hydrolytic
resistant test (50ml)
Pipette out 10 ml and add 10ml of nitric acid on
the water bath maintaing the temperature.
Dry residue in oven at 130
& add hydrogen molybdate & refux for 25 min.
4. Arsenic Test
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12. Limits: The absorbance of test solution should not exceedthe
absorbance of arsenic standard solution of 10ppm.
The test bottle is
filled with water
and placed inside
test chamber
5. Internal Bursting Pressure Test
Instrument used American glass research increment pressure tester.
The internal
pressure
automatically raised
by series of
increment at set
time
Bottle are checked
at preselected
pressure level until
container finally
burst.
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13. 6. Thermal Shock Test
Step 1
• Place sample container in upright position in tray &
immersed tray in hot water for a given time.
Step 2 test.(45
• Transfer the container in cold water bath temp.
should be controlled. Examine cracks before & after
C
̊ temp. difference should be there.)
Step 3
• The amount of thermal shock a bottle can
withstand is based on construction.
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•Small bottles- 60 - 8
0
̊C
• Pint bottles- 30-40 ̊C
15. Quality Control Test for Metal Container
• Take 50 empty tubes filled with ointment base,
sealed & kept overnight
Step 1
Step 2
• A metal bacteriological filter assembly fitted
with filter paper & heated to melting range of
ointment base.
• Base from all tubes squeezed at certain rate &
passed through filter under vaccum. further
wash with CHCL3 and observed for particles.
Step 3
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16. Observations
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Particles 1mm and above 50
Particles 0.5mm to 1mm 10
Particles 0.2mm to 0.5mm 2
Particles less than 0.2mm Nil
Total score 62
Limits :
Lot of tube passes test if total score is less than 100.
Lot of tubes fails if total score is above 150
If it is between 100 – 150 test is repeated again with 50 more tubes
17. Quality Control Test for collapsible tubes
Quality Control Test for
collapsible tubes
Leakage Test
Power of
Adhesion
Flexibility Product
compatibility
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18. Quality Control Test for Strip and Blister packing
3/4th of water is poured in
desiccator. Strip and Blister
were placed inside
desiccators and vaccum is
applied
Later on strips, blisters
were taken out. water
present over the outer
surface were wiped out.
The content of strips and
blisters were removed
and presence of moisture
was checked
If there is no leakage,
content will not be
wetted. It indicate
perfect sealing.
18
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19. QUALITY CONTROL TEST FORCLOSURES
1. Sterility Test
2. Fragmentation Test
3. Self-Sealability
4. pH of aqueous extract
5. Light AbsorptionTest
6. Reducing Substance
7. Residue on Evaporation
8. Penetrability
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20. 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 with Al foil.
Allow to cool and separate solution
from closure
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21. 1. Sterility Test
Closures are
subjected for
sterilization
ByAutoclaving
at 64-66 C &
pressure 0.7kPa
Further testing is
carried out by
using culture
media.
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22. 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
No. of fragments of
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closure retain should be as
per the limits
2. Fragmentation Test
Limit: No. of fragments – NMT 10(in case of butyl rubber)
No. of fragments –NMT 15
23. 3. Self-Sealability
Fill 10 vials
with nominal
volume of water
and place
closures.
Pierce cap for
10 times at
different sites
with
hypodermic
needle
Immerse vials
in 0.1%w/v
solution of
methylene blue
under pressure
Keep the
container
immersed for
30 minutes
Wash the vials
& none of vials
should contain
traces of color
solution
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24. 4. 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
If HCL is used –NMT 0.8 ML
5. 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
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25. 6. 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
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26. 7. Residue on Evaporation
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The 50ml of sample solution is evaporated at 105̊C.
Residue obtained should be NMT 4mg.
8. 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.
27. QC TEST FOR SECONDARY PACKAGING
MATERIALS
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The test pieces of paper and board are taken for test to be
carried out in standard condition
a) Temperature: 23C̊ ± 1
C
̊
b) Relative Humidity: 50% ± 2%
1. Moisture Content
2. Folding Endurance
3. Air Permeability
4. Tensile Strength
5. Stiffness
6. Burst Resistance
28. REFRENCES
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1. Pharmaceuticals Packaging Technology,Taylor and Francis
by Dean D.A, Evans E.R fifth edition
page no. 188-189.
2. “Packaging”; Cooper and Gunn’s Tutorial Pharmacy, sixth
edition, CBS publicashers
page no. 139-140