This document discusses sterile products and parenteral admixtures. It begins by defining parenteral as referring to injectable routes of drug administration other than oral. The primary parenteral routes are described as subcutaneous, intramuscular, intravenous, and venoclysis. Containers, closures, and the intravenous admixture system are then outlined. The document summarizes the processing of parenterals including cleaning, preparation, filtration, filling, sealing, and sterilization. Methods for evaluating parenteral preparations such as sterility testing, clarity testing, leakage testing, pyrogen testing, and assay are also summarized.
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.
Quality Control Tests Of Capsules dosage form.
1. Weight Variation Test
2. Content Uniformity Test
3. Dissolution Test
4. Disintegration Test
5. Leak Test
Transdermal Drug Delivery System (TDDS) is the one of the novel technology to deliver the molecules through the skin for long period of time.
Transdermal Drug Delivery System (TDDS) are defined as self contained, discrete dosage forms which are also known as “patches” 2, 3 when patches are applied to the intact skin, deliver the drug through the skin at a controlled rate to the systemic circulation
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.
Quality Control Tests Of Capsules dosage form.
1. Weight Variation Test
2. Content Uniformity Test
3. Dissolution Test
4. Disintegration Test
5. Leak Test
Transdermal Drug Delivery System (TDDS) is the one of the novel technology to deliver the molecules through the skin for long period of time.
Transdermal Drug Delivery System (TDDS) are defined as self contained, discrete dosage forms which are also known as “patches” 2, 3 when patches are applied to the intact skin, deliver the drug through the skin at a controlled rate to the systemic circulation
Parenteral,Sterile, Aseptic condition
Air classification, Quantitative layout of parental manufacturing, Equipment as per schedule-M
Environmental control zone
presented by: Eknath Vasant Unde
Rajarambapu college of pharmacy kasegaon sangali
In Process Quality Control Tests (IPQC) For Parenteral or Sterile Dosage FormsSagar Savale
These are the tests performed between QA and QC and provides for the authorization of approved raw materials for manufacturing based on actual laboratory testing generally called as IPQC such as physical, chemical, microbiologic and biologic tests.
The dimensions of healthcare quality refer to various attributes or aspects that define the standard of healthcare services. These dimensions are used to evaluate, measure, and improve the quality of care provided to patients. A comprehensive understanding of these dimensions ensures that healthcare systems can address various aspects of patient care effectively and holistically. Dimensions of Healthcare Quality and Performance of care include the following; Appropriateness, Availability, Competence, Continuity, Effectiveness, Efficiency, Efficacy, Prevention, Respect and Care, Safety as well as Timeliness.
One of the most developed cities of India, the city of Chennai is the capital of Tamilnadu and many people from different parts of India come here to earn their bread and butter. Being a metropolitan, the city is filled with towering building and beaches but the sad part as with almost every Indian city
Welcome to Secret Tantric, London’s finest VIP Massage agency. Since we first opened our doors, we have provided the ultimate erotic massage experience to innumerable clients, each one searching for the very best sensual massage in London. We come by this reputation honestly with a dynamic team of the city’s most beautiful masseuses.
CRISPR-Cas9, a revolutionary gene-editing tool, holds immense potential to reshape medicine, agriculture, and our understanding of life. But like any powerful tool, it comes with ethical considerations.
Unveiling CRISPR: This naturally occurring bacterial defense system (crRNA & Cas9 protein) fights viruses. Scientists repurposed it for precise gene editing (correction, deletion, insertion) by targeting specific DNA sequences.
The Promise: CRISPR offers exciting possibilities:
Gene Therapy: Correcting genetic diseases like cystic fibrosis.
Agriculture: Engineering crops resistant to pests and harsh environments.
Research: Studying gene function to unlock new knowledge.
The Peril: Ethical concerns demand attention:
Off-target Effects: Unintended DNA edits can have unforeseen consequences.
Eugenics: Misusing CRISPR for designer babies raises social and ethical questions.
Equity: High costs could limit access to this potentially life-saving technology.
The Path Forward: Responsible development is crucial:
International Collaboration: Clear guidelines are needed for research and human trials.
Public Education: Open discussions ensure informed decisions about CRISPR.
Prioritize Safety and Ethics: Safety and ethical principles must be paramount.
CRISPR offers a powerful tool for a better future, but responsible development and addressing ethical concerns are essential. By prioritizing safety, fostering open dialogue, and ensuring equitable access, we can harness CRISPR's power for the benefit of all. (2998 characters)
Leading the Way in Nephrology: Dr. David Greene's Work with Stem Cells for Ki...Dr. David Greene Arizona
As we watch Dr. Greene's continued efforts and research in Arizona, it's clear that stem cell therapy holds a promising key to unlocking new doors in the treatment of kidney disease. With each study and trial, we step closer to a world where kidney disease is no longer a life sentence but a treatable condition, thanks to pioneers like Dr. David Greene.
Telehealth Psychology Building Trust with Clients.pptxThe Harvest Clinic
Telehealth psychology is a digital approach that offers psychological services and mental health care to clients remotely, using technologies like video conferencing, phone calls, text messaging, and mobile apps for communication.
How many patients does case series should have In comparison to case reports.pdfpubrica101
Pubrica’s team of researchers and writers create scientific and medical research articles, which may be important resources for authors and practitioners. Pubrica medical writers assist you in creating and revising the introduction by alerting the reader to gaps in the chosen study subject. Our professionals understand the order in which the hypothesis topic is followed by the broad subject, the issue, and the backdrop.
https://pubrica.com/academy/case-study-or-series/how-many-patients-does-case-series-should-have-in-comparison-to-case-reports/
Global launch of the Healthy Ageing and Prevention Index 2nd wave – alongside...ILC- UK
The Healthy Ageing and Prevention Index is an online tool created by ILC that ranks countries on six metrics including, life span, health span, work span, income, environmental performance, and happiness. The Index helps us understand how well countries have adapted to longevity and inform decision makers on what must be done to maximise the economic benefits that comes with living well for longer.
Alongside the 77th World Health Assembly in Geneva on 28 May 2024, we launched the second version of our Index, allowing us to track progress and give new insights into what needs to be done to keep populations healthier for longer.
The speakers included:
Professor Orazio Schillaci, Minister of Health, Italy
Dr Hans Groth, Chairman of the Board, World Demographic & Ageing Forum
Professor Ilona Kickbusch, Founder and Chair, Global Health Centre, Geneva Graduate Institute and co-chair, World Health Summit Council
Dr Natasha Azzopardi Muscat, Director, Country Health Policies and Systems Division, World Health Organisation EURO
Dr Marta Lomazzi, Executive Manager, World Federation of Public Health Associations
Dr Shyam Bishen, Head, Centre for Health and Healthcare and Member of the Executive Committee, World Economic Forum
Dr Karin Tegmark Wisell, Director General, Public Health Agency of Sweden
Antibiotic Stewardship by Anushri Srivastava.pptxAnushriSrivastav
Stewardship is the act of taking good care of something.
Antimicrobial stewardship is a coordinated program that promotes the appropriate use of antimicrobials (including antibiotics), improves patient outcomes, reduces microbial resistance, and decreases the spread of infections caused by multidrug-resistant organisms.
WHO launched the Global Antimicrobial Resistance and Use Surveillance System (GLASS) in 2015 to fill knowledge gaps and inform strategies at all levels.
ACCORDING TO apic.org,
Antimicrobial stewardship is a coordinated program that promotes the appropriate use of antimicrobials (including antibiotics), improves patient outcomes, reduces microbial resistance, and decreases the spread of infections caused by multidrug-resistant organisms.
ACCORDING TO pewtrusts.org,
Antibiotic stewardship refers to efforts in doctors’ offices, hospitals, long term care facilities, and other health care settings to ensure that antibiotics are used only when necessary and appropriate
According to WHO,
Antimicrobial stewardship is a systematic approach to educate and support health care professionals to follow evidence-based guidelines for prescribing and administering antimicrobials
In 1996, John McGowan and Dale Gerding first applied the term antimicrobial stewardship, where they suggested a causal association between antimicrobial agent use and resistance. They also focused on the urgency of large-scale controlled trials of antimicrobial-use regulation employing sophisticated epidemiologic methods, molecular typing, and precise resistance mechanism analysis.
Antimicrobial Stewardship(AMS) refers to the optimal selection, dosing, and duration of antimicrobial treatment resulting in the best clinical outcome with minimal side effects to the patients and minimal impact on subsequent resistance.
According to the 2019 report, in the US, more than 2.8 million antibiotic-resistant infections occur each year, and more than 35000 people die. In addition to this, it also mentioned that 223,900 cases of Clostridoides difficile occurred in 2017, of which 12800 people died. The report did not include viruses or parasites
VISION
Being proactive
Supporting optimal animal and human health
Exploring ways to reduce overall use of antimicrobials
Using the drugs that prevent and treat disease by killing microscopic organisms in a responsible way
GOAL
to prevent the generation and spread of antimicrobial resistance (AMR). Doing so will preserve the effectiveness of these drugs in animals and humans for years to come.
being to preserve human and animal health and the effectiveness of antimicrobial medications.
to implement a multidisciplinary approach in assembling a stewardship team to include an infectious disease physician, a clinical pharmacist with infectious diseases training, infection preventionist, and a close collaboration with the staff in the clinical microbiology laboratory
to prevent antimicrobial overuse, misuse and abuse.
to minimize the developme
Medical Technology Tackles New Health Care Demand - Research Report - March 2...pchutichetpong
M Capital Group (“MCG”) predicts that with, against, despite, and even without the global pandemic, the medical technology (MedTech) industry shows signs of continuous healthy growth, driven by smaller, faster, and cheaper devices, growing demand for home-based applications, technological innovation, strategic acquisitions, investments, and SPAC listings. MCG predicts that this should reflects itself in annual growth of over 6%, well beyond 2028.
According to Chris Mouchabhani, Managing Partner at M Capital Group, “Despite all economic scenarios that one may consider, beyond overall economic shocks, medical technology should remain one of the most promising and robust sectors over the short to medium term and well beyond 2028.”
There is a movement towards home-based care for the elderly, next generation scanning and MRI devices, wearable technology, artificial intelligence incorporation, and online connectivity. Experts also see a focus on predictive, preventive, personalized, participatory, and precision medicine, with rising levels of integration of home care and technological innovation.
The average cost of treatment has been rising across the board, creating additional financial burdens to governments, healthcare providers and insurance companies. According to MCG, cost-per-inpatient-stay in the United States alone rose on average annually by over 13% between 2014 to 2021, leading MedTech to focus research efforts on optimized medical equipment at lower price points, whilst emphasizing portability and ease of use. Namely, 46% of the 1,008 medical technology companies in the 2021 MedTech Innovator (“MTI”) database are focusing on prevention, wellness, detection, or diagnosis, signaling a clear push for preventive care to also tackle costs.
In addition, there has also been a lasting impact on consumer and medical demand for home care, supported by the pandemic. Lockdowns, closure of care facilities, and healthcare systems subjected to capacity pressure, accelerated demand away from traditional inpatient care. Now, outpatient care solutions are driving industry production, with nearly 70% of recent diagnostics start-up companies producing products in areas such as ambulatory clinics, at-home care, and self-administered diagnostics.
2. Parenteral
Parenteral refers injectable route of
administration.
It derived from Greek words Para (Outside)
and enteron (Intestine).
So it is a route of administration other than
the oral route. This route of administration
bypasses the alimentary canal
3. PRIMARY PARENTERAL
ROUTES
Routes Usual volume
(mL)
Needle
commonly used
Formulation
constraints
Types of
medication
administered
SVP
Sub cutaneous 0.5-2 5/8 in. ,
23 gauge
Need to be isotonic Insulin, vaccines
Intra muscular 0.5-2 1.5 in. ,
23 gauge
Can be solutions,
emulsions, oils or
suspensions
Isotonic preferably
Nearly all drug
classes
Intra venous 1-100 Vein puncture
1.5 in. ,
20-22 gauge
Solutions, emulsions
and liposomes
Nearly all drug
classes
LVP 101 and larger
(infusion unit)
Venoclysis
1.5 in. ,
18-19 gauge
Solutions and some
emulsions
Nearly all drug
classes
4. S. No. ADVANTAGES DISVANTAGES
1. Quick onset Wrong dose or over dose can
be fatal
2. Vomiting and
unconscious patients can
take
Pain at site
3. Prolonged action by
modified formulation
( Depot)
Trained person required
4. Nutritive fluids (glucose,
electrolytes) can be given
Expensive
5. Drugs with poor
absorption or instability
from GIT
NECESSITY OF ASEPTIC
CONDITIONS IN
PRODUCTION,
COMPOUNDING AND
ADMINISTRATION
5. Containers:
1. Glass:
• Highly Resistant Borosilicate Glass
• Treated Soda lime Glass
• Regular Soda Lime Glass
• N.P (Non-parenteral) Glass
Type 4 is not used for parenteral packaging,
others all are used for parenteral packaging.
6. 2. Plastic:
Plastic containers are used but they face following problems
• Permeation
• Sorption
• Leaching
• Softening
3. Rubber:
To provide closure for multiple dose vials, IV fluid bottles, plugs for
disposable syringes and bulbs for ophthalmic pipettes, rubber is the
material of choice.
Problems associated with rubber closures are
• Incompatibility
• Chemical instability
• Physical instability
7. Closure:
• Characteristics of Good Pharmaceutical rubbers
• Good ageing qualities
• Satisfactory hardness and elasticity
• Resistance to sterilization conditions
• Impermeable to moisture and air
• Examples:
• Butyl Rubbers
• Natural Rubbers
• Neoprene Rubbers
• Polyisoprene rubbers
• Silicone Rubbers
8. Intravenous Admixture System
• “Admixture system” refers to sterile IV
solutions that are prepared by using one or
more medications or electrolytes and will be
administered via the parenteral route.
• It requires the measured addition of a
medication to a 50 ml or larger bag or bottle
of IV fluid.
• It can be provided to the patient in his/her
home.
• Many hospitals involved in compounding IV
solutions and medications to outpatient
settings.
9. Methods for safe & effective
use of IV admixture
• Proper training to nurses & pharmacist
• Instruction regarding labeling Information
for stability & compatibility to the hospital
pharmacy dept.
• Information for the formulation skills to the
pharmacist.
11. PROCESSING OF
PARENTERALS
S.No. STEPS
1. Cleaning of containers, closures and equipments
2. Collection of materials
3. Preparation of parenteral products
4. Filtration
5. Filling the preparation in final containers
6. Sealing the containers
7. Sterilization
8. Evaluation of parenteral preparation
9. Labeling and packaging
12. Formulation of parenteral
products
• In the preparation of parenteral products, the following
substances are added to make a stable preparation:
The active drug
Vehicles
Aqueous vehicle (e.g. water for injection, water for injection free
from CO2 )
Non-aqueous vehicle (e.g. Ethyl alcohol, propylene glycol, almond oil)
Adjuvants
Solubilizing agents (e.g. Tweens & polysorbates)
Stabilizers & antioxidants (e.g. thiourea, ascorbic acid, tocopherol)
Buffering agents (e.g. citric acid, sodium citrate)
Antibacterial agents (e.g. benzyl alcohol, metacresol, phenol)
Chelating agents (e.g. EDTA)
Suspending, emulsifying & wetting agents (e.g. MC, CMC)
Tonicity factor (e.g. sodium chloride, dextrose)
13. Production facilities of
parenterals
• The production area where the parenteral
preparation are manufactured can be
divided into five sections:
Clean-up area
Preparation area
Aseptic area
Quarantine area
Finishing & packaging area
14. Clean-up area:
It is not aseptic area.
All the parenteral products must be free from foreign particles
& microorganism.
Clean-up area should be withstand moisture, dust &
detergent.
This area should be kept clean so that contaminants may not
be carried out into aseptic area.
Preparation area:
In this area the ingredients of the parenteral preparation are
mixed & preparation is made for filling operation.
It is not essentially aseptic area but strict precautions are
required to prevent any contamination from outside.
15. Aseptic area:
The parenteral preparations are filtered, filled into final container
& sealed should be in aseptic area.
The entry of personnel into aseptic area should be limited &
through an air lock.
Ceiling, wall & floor of that area should be sealed & painted.
The air in the aseptic area should be free from fibers, dust and
microorganism.
The High efficiency particulate air filters (HEPA) is used for air.
UV lamps are fitted in order to maintain sterility.
16. Quarantine area:
After filling, sealing & sterilization the parenteral product
are held up in quarantine area.
Randomly samples were kept foe evaluation.
The batch or product pass the evaluation tests are transfer
in to finishing or packaging area.
Finishing & packaging area:
Parenteral products are properly labelled and packed.
Properly packing is essential to provide protection against
physical damage.
The labelled container should be packed in cardboard or
plastic container.
Ampoules should be packed in partitioned boxes
17. EVALUATION OF
PARENTERAL PREPARATIONS
• The finished parenteral products are
subjected to the following tests, in order to
maintain quality control:
• A) sterility test
• B)clarity test
• C)leakage test
• D)pyrogen test
• E)assay
18. A) sterility test
• It is a procedure carried out to detect and
conform absence of any viable form of
microbes in or on pharmacopeia preparation
or product.
1) Method of sterility testing
i ) METHOD 1 Membrane filtration method
ii) METHOD 2 Direct inoculation method
19. Membrane filtration method
(METHOD 1):
Membrane filtration Appropriate for : (advantage)
• Filterable aqueous preparations
• Alcoholic preparations
• Oily preparations
• Preparations miscible with or soluble in aqueous or
oily (solvents with no antimicrobial effect)
All steps of this procedure are performed aseptically
in a Class 100 Laminar Flow Hood
20. Membrane filter 0.45μ porosity
Filter the test solution
After filtration remove the filter
Cut the filter in to two halves
First halves (For Bacteria) Second halves (For Fungi)
Transfer in 100 ml culture media
(Fluid Thioglycollate medium)
Incubate at 30-350 C for not less then 7
days
Transfer in 100 ml culture media
(Soyabeans-Casein Digest medium)
Incubate at 20-250 C for not less then 7
days
Observe the growth in the media Observe the growth in the media
21. Direct inoculation method
(METHOD 2):
Suitable for samples with small volumes
volume of the product is not more than 10%
of the volume of the medium
suitable method for aqueous solutions, oily
liquids, ointments and creams
Direct inoculation of the culture medium
suitable quantity of the preparation to be
examined is transferred directly into the
appropriate culture medium & incubate for
not less than 14 days.
22. Observation and results
Culture media is examined during and after at the end of incubation. The
following observations are possible:
1) No evidence of growth Pass the test for sterility.
2) There is evidence of growth Re-testing is performed same
no. of sample, volume & media as in original test No
evidence of growth Pass the test for sterility.
3) There is evidence of growth isolate & identify the organism.
Re-testing is performed with twice no. of sample if:
No evidence of growth Pass the test for sterility.
23. B)clarity test
• Particulate matter is defined as unwanted mobile
insoluble matter other than gas bubble present in the
product.
• If the particle size of foreign matter is larger than the
size of R.B.C.. It can block the blood vessel.
• The permit limits of particulate matter as per I.P. are
follows:
25. C)leakage test
• The sealed ampoules are subjected to small cracks
which occur due to rapid temperature changes or due
to mechanical shocks.
Filled & sealed ampoules
Dipped in 1% Methylene blue solution
Under negative pressure in vacuum chamber
Vacuum released colored solution enter into the ampoule
Defective sealing
Vials & bottles are not suitable for this test because the
sealing material used is not rigid
26. D)pyrogen test
Pyrogen = “Pyro” (Greek = Fire) + “gen” (Greek
= beginning).
Fever producing, metabolic by-products of
microbial growth and death.
Bacterial pyrogens are called “Endotoxins”.
Gram negative bacteria produce more potent
endotoxins than gram + bacteria and fungi.
Endotoxins are heat stable lipopolysaccharides
(LPS) present in bacterial cell walls, not present
in cell-free bacterial filtrates
27. Method
Dissolve the subs being examined in, or dilute it with a pyrogen free saline
solution
Warm the liquid being examined to approx. 38.5o C temp before injection
The volume of injection is NLT 0.5ml/kg & NMT 10ml/kg of body weight
Withhold water during test
Clinical thermometer is inserted into the rectum of rabbit to record body temp
2 normal reading of rectal temp are should be taken prior to the test injection
at an interval of half an hr & its mean is calculated- initial temp
The solution under test is injected through an ear vein
Record the temp of each rabbit in an interval of 30 min for 3 hrs
The difference between initial temp & maximum temp is recorded- taken as
response
29. Limulus amebocyte lysate [LAL]
test
• Limulus amebocyte lysate [LAL] test another
method for the determination of pyrogenic
endotoxins
• In this method the test solution is combined
with a cell lysate from the ameabocyte [blood
celels] of horse shoe crab
• Any endo toxin that might be present will be
coagulated with protien fraction of the
ameabocytes and results in the formation of a
gel
• This consider to be simple,rapid and of greater
sensitivity that the rabbit test
30. E)assay
• Assay is performed according to method
given In the monograph of that parental
preperation in the pharmacopoeia
• Assay is done to check the quantity of
medicament present in the parenteral
preperation
31. References
• Encyclopedia of pharmaceutical technology by James
Swarbrick pg.no.1266-1299
• Pharmaceutical product development by N.K.JAIN
• Chemical Incompatibility of Parenteral Drug Admixtures; T.
J. Mccarthy; S.A. Medical journal 2
• The theory & pratice of “Industrial Pharmacy” Leon
Lachman ,Herbert A. Liberman.special Indian Edition 2009
Pg. No.693-680.
• Modern Pharmaceutics Fourth Edition, Revised and
Expanded, Edited By G.S.Banker & C.T.Rhodes, Marcel
Dekker pg387-389.
• The Science & practice of Pharmacy, By Remington, Vol-
01, Edi.21st, Lippincott Publication, pg-838-840.