This document discusses quality control tests for various pharmaceutical packaging materials. It provides details on tests for glass containers, including chemical resistance via powdered glass and water attack tests. It also describes tests for closures, such as sterility and fragmentation testing. Further tests are outlined for packaging materials like collapsible tubes, metallic tins, strips, blisters, paper and board. The document references additional sources for information on pharmaceutical packaging and quality control testing.
This topic comes under PRODUCT DEVELOPMENT AND TECHNOLOGY TRANSFER......
This is useful for M.Pharm (Pharmaceutical Quality Assurance) Students who studying in First year sem II and also for b.pharm and medical related students.
This Presentation Contain following...
#Introduction
#Objectives
#Process Flow
#Working of aseptic process
#Sterilization of Equipments
#Sterilization of Product
#Sterilization of container or packaging materials
#Aseptic packaging of Milk
#Packaging materials
#Aseptic packaging systems
#Benefits of aseptic packaging systems
#Storage
#References
This topic comes under PRODUCT DEVELOPMENT AND TECHNOLOGY TRANSFER......
This is useful for M.Pharm (Pharmaceutical Quality Assurance) Students who studying in First year sem II and also for b.pharm and medical related students.
This Presentation Contain following...
#Introduction
#Objectives
#Process Flow
#Working of aseptic process
#Sterilization of Equipments
#Sterilization of Product
#Sterilization of container or packaging materials
#Aseptic packaging of Milk
#Packaging materials
#Aseptic packaging systems
#Benefits of aseptic packaging systems
#Storage
#References
Neologic Engineers, Clean-in-place (CIP) is an automated method of cleaning the interior surfaces of pipes, tanks, lines, process equipment.(CIP) Systems Reduce Cleaning Time and Costs. CIP Controls of all important parameters like time, temperature, flow, concentration.
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
Neologic Engineers, Clean-in-place (CIP) is an automated method of cleaning the interior surfaces of pipes, tanks, lines, process equipment.(CIP) Systems Reduce Cleaning Time and Costs. CIP Controls of all important parameters like time, temperature, flow, concentration.
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
Improve Packaging Performance Using Simulation - Mabe Altair
This presentation will show how Mabe used HyperMesh, HyperCrash, RADIOSS and HyperView for impact simulation, as well as OptiStruct for packaging optimization to improve and validate packaging performance in early stages of the product development process. Some of the business impacts that will be identified include better packaging performance and cost optimization, reduced physical testing, and reduced time to market.
Biosafety is the prevention of large-scale loss of biological integrity, focusing both on ecology and human health. These prevention mechanisms include conduction of regular reviews of the biosafety in laboratory settings, as well as strict guidelines to follow. Biosafety also means safety from exposure to infectious agents.
Necessity
In order to avoid infection/biohazard to the laboratory personnel & the environment, biosafety levels are very important.
Medical writing is the activity of writing scientific documentation by someone who is a specialized writer (a medical writer) and is generally not one of the scientists or doctors whose research it was..
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
HOT NEW PRODUCT! BIG SALES FAST SHIPPING NOW FROM CHINA!! EU KU DB BK substit...GL Anaacs
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Samples will be sent for your evaluation!If you are interested in, please contact me, let's talk details.
We specializes in exporting high quality Research chemical, medical intermediate, Pharmaceutical chemicals and so on. Products are exported to USA, Canada, France, Korea, Japan,Russia, Southeast Asia and other countries.
- 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
micro teaching on communication m.sc nursing.pdfAnurag Sharma
Microteaching is a unique model of practice teaching. It is a viable instrument for the. desired change in the teaching behavior or the behavior potential which, in specified types of real. classroom situations, tends to facilitate the achievement of specified types of objectives.
Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
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Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
Recomendações da OMS sobre cuidados maternos e neonatais para uma experiência pós-natal positiva.
Em consonância com os ODS – Objetivos do Desenvolvimento Sustentável e a Estratégia Global para a Saúde das Mulheres, Crianças e Adolescentes, e aplicando uma abordagem baseada nos direitos humanos, os esforços de cuidados pós-natais devem expandir-se para além da cobertura e da simples sobrevivência, de modo a incluir cuidados de qualidade.
Estas diretrizes visam melhorar a qualidade dos cuidados pós-natais essenciais e de rotina prestados às mulheres e aos recém-nascidos, com o objetivo final de melhorar a saúde e o bem-estar materno e neonatal.
Uma “experiência pós-natal positiva” é um resultado importante para todas as mulheres que dão à luz e para os seus recém-nascidos, estabelecendo as bases para a melhoria da saúde e do bem-estar a curto e longo prazo. Uma experiência pós-natal positiva é definida como aquela em que as mulheres, pessoas que gestam, os recém-nascidos, os casais, os pais, os cuidadores e as famílias recebem informação consistente, garantia e apoio de profissionais de saúde motivados; e onde um sistema de saúde flexível e com recursos reconheça as necessidades das mulheres e dos bebês e respeite o seu contexto cultural.
Estas diretrizes consolidadas apresentam algumas recomendações novas e já bem fundamentadas sobre cuidados pós-natais de rotina para mulheres e neonatos que recebem cuidados no pós-parto em unidades de saúde ou na comunidade, independentemente dos recursos disponíveis.
É fornecido um conjunto abrangente de recomendações para cuidados durante o período puerperal, com ênfase nos cuidados essenciais que todas as mulheres e recém-nascidos devem receber, e com a devida atenção à qualidade dos cuidados; isto é, a entrega e a experiência do cuidado recebido. Estas diretrizes atualizam e ampliam as recomendações da OMS de 2014 sobre cuidados pós-natais da mãe e do recém-nascido e complementam as atuais diretrizes da OMS sobre a gestão de complicações pós-natais.
O estabelecimento da amamentação e o manejo das principais intercorrências é contemplada.
Recomendamos muito.
Vamos discutir essas recomendações no nosso curso de pós-graduação em Aleitamento no Instituto Ciclos.
Esta publicação só está disponível em inglês até o momento.
Prof. Marcus Renato de Carvalho
www.agostodourado.com
These lecture slides, by Dr Sidra Arshad, offer a quick overview of physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar leads (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...i3 Health
i3 Health is pleased to make the speaker slides from this activity available for use as a non-accredited self-study or teaching resource.
This slide deck presented by Dr. Kami Maddocks, Professor-Clinical in the Division of Hematology and
Associate Division Director for Ambulatory Operations
The Ohio State University Comprehensive Cancer Center, will provide insight into new directions in targeted therapeutic approaches for older adults with mantle cell lymphoma.
STATEMENT OF NEED
Mantle cell lymphoma (MCL) is a rare, aggressive B-cell non-Hodgkin lymphoma (NHL) accounting for 5% to 7% of all lymphomas. Its prognosis ranges from indolent disease that does not require treatment for years to very aggressive disease, which is associated with poor survival (Silkenstedt et al, 2021). Typically, MCL is diagnosed at advanced stage and in older patients who cannot tolerate intensive therapy (NCCN, 2022). Although recent advances have slightly increased remission rates, recurrence and relapse remain very common, leading to a median overall survival between 3 and 6 years (LLS, 2021). Though there are several effective options, progress is still needed towards establishing an accepted frontline approach for MCL (Castellino et al, 2022). Treatment selection and management of MCL are complicated by the heterogeneity of prognosis, advanced age and comorbidities of patients, and lack of an established standard approach for treatment, making it vital that clinicians be familiar with the latest research and advances in this area. In this activity chaired by Michael Wang, MD, Professor in the Department of Lymphoma & Myeloma at MD Anderson Cancer Center, expert faculty will discuss prognostic factors informing treatment, the promising results of recent trials in new therapeutic approaches, and the implications of treatment resistance in therapeutic selection for MCL.
Target Audience
Hematology/oncology fellows, attending faculty, and other health care professionals involved in the treatment of patients with mantle cell lymphoma (MCL).
Learning Objectives
1.) Identify clinical and biological prognostic factors that can guide treatment decision making for older adults with MCL
2.) Evaluate emerging data on targeted therapeutic approaches for treatment-naive and relapsed/refractory MCL and their applicability to older adults
3.) Assess mechanisms of resistance to targeted therapies for MCL and their implications for treatment selection
Couples presenting to the infertility clinic- Do they really have infertility...Sujoy Dasgupta
Dr Sujoy Dasgupta presented the study on "Couples presenting to the infertility clinic- Do they really have infertility? – The unexplored stories of non-consummation" in the 13th Congress of the Asia Pacific Initiative on Reproduction (ASPIRE 2024) at Manila on 24 May, 2024.
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
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
Preoperative Management of Patients on GLP-1 Receptor Agonists like Ozempic and Semiglutide
ASA GUIDELINE
NYSORA Guideline
2 Case Reports of Gastric Ultrasound
Lung Cancer: Artificial Intelligence, Synergetics, Complex System Analysis, S...Oleg Kshivets
RESULTS: Overall life span (LS) was 2252.1±1742.5 days and cumulative 5-year survival (5YS) reached 73.2%, 10 years – 64.8%, 20 years – 42.5%. 513 LCP lived more than 5 years (LS=3124.6±1525.6 days), 148 LCP – more than 10 years (LS=5054.4±1504.1 days).199 LCP died because of LC (LS=562.7±374.5 days). 5YS of LCP after bi/lobectomies was significantly superior in comparison with LCP after pneumonectomies (78.1% vs.63.7%, P=0.00001 by log-rank test). AT significantly improved 5YS (66.3% vs. 34.8%) (P=0.00000 by log-rank test) only for LCP with N1-2. Cox modeling displayed that 5YS of LCP significantly depended on: phase transition (PT) early-invasive LC in terms of synergetics, PT N0—N12, cell ratio factors (ratio between cancer cells- CC and blood cells subpopulations), G1-3, histology, glucose, AT, blood cell circuit, prothrombin index, heparin tolerance, recalcification time (P=0.000-0.038). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and PT early-invasive LC (rank=1), PT N0—N12 (rank=2), thrombocytes/CC (3), erythrocytes/CC (4), eosinophils/CC (5), healthy cells/CC (6), lymphocytes/CC (7), segmented neutrophils/CC (8), stick neutrophils/CC (9), monocytes/CC (10); leucocytes/CC (11). Correct prediction of 5YS was 100% by neural networks computing (area under ROC curve=1.0; error=0.0).
CONCLUSIONS: 5YS of LCP after radical procedures significantly depended on: 1) PT early-invasive cancer; 2) PT N0--N12; 3) cell ratio factors; 4) blood cell circuit; 5) biochemical factors; 6) hemostasis system; 7) AT; 8) LC characteristics; 9) LC cell dynamics; 10) surgery type: lobectomy/pneumonectomy; 11) anthropometric data. Optimal diagnosis and treatment strategies for LC are: 1) screening and early detection of LC; 2) availability of experienced thoracic surgeons because of complexity of radical procedures; 3) aggressive en block surgery and adequate lymph node dissection for completeness; 4) precise prediction; 5) adjuvant chemoimmunoradiotherapy for LCP with unfavorable prognosis.
Lung Cancer: Artificial Intelligence, Synergetics, Complex System Analysis, S...
Testing of Packaging materials
1. TESTING OF PHARMACEUTICAL
PACKAGING MATERIALS
NAME- ANIRBAN SAHA
M.PHARM (PHARMACEUTICS)
AMITY INSTITUTE OF PHARMACY
AMITY UNIVERSITY, NOIDA , UTTAR
PRADESH
2. QUALITY CONTROL TESTS FOR GLASSES
1) 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
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.
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.
9/18/2016 Packaging 2
3. B) WATER ATTACK TEST:
This is only for treated soda lime glass containers under the controlled humidity conditions
which neutralize the surface alkali and glass will become chemically more resistant.
Principle involved is whether the alkali leached or not from the surface of the container.
Procedure: Rinse thoroughly with high purity water. Fill each container to 90%of its overflow
capacity with water and is autoclaved at 121⁰C for 30min then it is cooled and the liquid is
decanted which is titrated with 0.02N sulphuric acid using methyl red as an indicator. The
volume of sulfuric acid consumed is the measure of the amount of alkaline oxides present in the
glass containers.
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
9/18/2016 Packaging 3
4. 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.
Nominal capacity
of container (ml)
Number of containers
to be used
Volume of test solution to be
used for titration (ml)
5 or less at least 10 50.0
6 to 30 at least 5 50.0
More than 30 at least 3 100.0
9/18/2016 Packaging 4
TABLE 1
6. 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.
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.
9/18/2016 Packaging 6
7. 5) 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 to a preselected pressure level and the test continues
until the container finally bursts.
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.
9/18/2016 Packaging 7
8. QUALITY CONTROL OF PACKING MATERIALS
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.
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.
9/18/2016 Packaging 8
9. 3) 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 from
turbidity.
4) WATER VAPOUR PERMEABILITY:
Fill 5 containers with normal volume of water and heat seal the bottles with an aluminum foil.
Weigh accurately each container and allowed to stand for 14days at a relative humidity of
60±5% and a temperature between 20 and 25⁰C.Reweigh the containers. The loss in weight in
each container is NMT 0.2%
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 filled containers. Absorbance is
measured at 640nm and the range is within 0.37 and 0.43.
9/18/2016 Packaging 9
10. 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).
1) STERILITY TEST:
When treated closures are subjected to sterilization test at 64-66⁰C and a pressure of about
0.7 KPa for 24hr.
9/18/2016 Packaging 10
11. 9/18/2016 Packaging 11
2) Fragmentation test
For closures
for aqueous
preparations
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
12. 9/18/2016 Packaging 12
3)Self – sealability
• 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.
13. 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.
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.
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.
7) RESIDUE ON EVAPORATION:
50ml of solution A is evaporated to dryness at 105⁰C.Then weigh the residue NMT 4mg.
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14. QUALITY CONTROL OF COLLAPSIBLE TUBES
1) LEAKAGE TEST:
o 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:
o 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:
o 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:
o Content should not show any discolorations or change in colour or gas formation.
B) Lacquer compatibility:
o Lifting or peeling of lacquer is checked.
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15. QUALITY CONTROL OF METALLIC TINS
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.
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16. QUALITY CONTROL OF STRIP AND BLISTERS
Procedure:
3/4th of water is poured in desiccators. The strips and blisters were placed
inside the desiccators and vacuum is applied. After sometime vacuum was
released and strips, blisters were taken out. The water present over the outer
surface of the packages was wiped off with tissue paper. The contents of strips
and blister packages were removed and the presence of moisture was
checked. If there is no leakage, the contents will not be wetted. This indicates
the perfect sealing of the packages
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17. QUALITY CONTROL OF PAPER AND BOARD
The tests pieces of paper and board are conditioned for the tests to be carried out in
standard conditions. They are: Temperature: 23⁰C±1⁰C Relative humidity: 50%±2%
Some of the tests to be performed are
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18. 1. Indian Pharmacopoeia, 2007, Government of Indian ministry of health
and family welfare, The Indian pharmacopoeia commission, Ghaziabad,
volume-1, 6.1, 6.2, 6.3, 599-609.
2. Indian Pharmacopoeia, 1996, Government of Indian ministry of health
and family welfare, The controller of publications, Delhi, volume-2,
Appendix-11, A-127-137.
3. Dean D. A., Evans E. R. and Hall I. H.: Pharmaceutical Packaging
Technology, Taylor and Francis, London and New York, First Indian
reprint, 2006, 5 and 73.
4. Carter S.J., “Packaging”; Cooper and Gunn’s Tutorial Pharmacy, sixth
edition, CBS publicashers and distributors, New Delhi, 2005, 133-136
and 139-140.
5. http://en.wikipedia.org/wiki/packaging_and_labelling
References
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