Sterility testing is performed on pharmaceutical products that are required to be sterile, such as injections, implants, and bandages. The tests are conducted under aseptic conditions to detect any viable microorganisms. Samples are inoculated into nutrient-rich culture media and incubated for at least 14 days. If no microbial growth is observed, the product passes the sterility test and is considered sterile. However, if growth is detected, the product fails the test and is not sterile. Common culture media used include fluid thioglycolate medium and soybean-casein digest medium, which support the growth of aerobic and anaerobic microbes.
It's all about the microbiological assay of antibiotics and there has different type of microbiological assay of antibiotics.It's main purpose how to determine the potency of antibiotics.
Prof.Mr.Kiran K. Shinde (M.Pharm), Assistant professor (VNIPRC)
Pharmaceutical microbiology (Second year b.pharm) (3rd semester)
Introduction
Methods Of Different microbiological assays
Principles of Assays with Procedure
Methods For Standardization of
1. Antibiotics
2. Vitamins
3. Amino Acids
Assessment of new Antibiotic
Microbiological assay-Principles and methods of different microbiological assay.someshwar mankar
Principles and methods of different microbiological assay. Methods for standardization of
antibiotics, vitamins and amino acids. Assessment of a new antibiotic.
Microbial Assay of Antibiotics
STANDARD PREPARATION AND UNITS OF ACTIVITY
Preparation of media
Buffer solutions
Standard solution
Sample solution
Test organisms
Preparation of inoculum Method -1
Method 2
Method 3
Method 4
Determination of Inoculum
Apparatus
Assay design
Assay method
cylinder plate method
One level assay with standard curve
Estimation of potency
Turbidimetric method
It's all about the microbiological assay of antibiotics and there has different type of microbiological assay of antibiotics.It's main purpose how to determine the potency of antibiotics.
Prof.Mr.Kiran K. Shinde (M.Pharm), Assistant professor (VNIPRC)
Pharmaceutical microbiology (Second year b.pharm) (3rd semester)
Introduction
Methods Of Different microbiological assays
Principles of Assays with Procedure
Methods For Standardization of
1. Antibiotics
2. Vitamins
3. Amino Acids
Assessment of new Antibiotic
Microbiological assay-Principles and methods of different microbiological assay.someshwar mankar
Principles and methods of different microbiological assay. Methods for standardization of
antibiotics, vitamins and amino acids. Assessment of a new antibiotic.
Microbial Assay of Antibiotics
STANDARD PREPARATION AND UNITS OF ACTIVITY
Preparation of media
Buffer solutions
Standard solution
Sample solution
Test organisms
Preparation of inoculum Method -1
Method 2
Method 3
Method 4
Determination of Inoculum
Apparatus
Assay design
Assay method
cylinder plate method
One level assay with standard curve
Estimation of potency
Turbidimetric method
Sterility testing products (solids, liquids, ophthalmic and other sterile pro...Ms. Pooja Bhandare
PHARMACEUTICAL MICROBIOLOGY (BP303T)Unit-IIIPart-6 Sterility testing products (solids, liquids, ophthalmic and other sterile products) according to IP, BP, USP.
Introduction: Test for Sterility. Culture Media. Fluid Thioglycollate Medium (FTM).
Alternative Thioglycollate Medium (ATM).
Soybean Casein Digest Medium (SCDM).
Tests for Culture Media:
Sterility of Media.
Growth Promotion Test.
Test for Bacteriostatic and Fungistatic.
Sterility Test Methods. Methods A: Membrane Filtration.
Method B: Direct Inoculation Pyrogen Test Methods. Rabbit Test. LAL Test.
Evaluation of the efficiency of sterilization methods.Sterility indicatorsMs. Pooja Bhandare
Evaluation of the efficiency of sterilization methods.Sterility indicators
Sterility criteria: Bioburden ,Sensitivity of microorganisms
Death rate or Survivor curve,D- Value or Decimal reduction time,Z- value or Thermal reduction time, f- value, Q10 Value or Temperature Coefficient, Inactivation Factor:
STERILITY INDICATORS : Physical Indicators, Chemical Indicators
Biological Indicators
1. Physical Indicators: i) Moist heat Indicator ii) Dry heat iii) Radio sterilization iv) Gaseous methods v) Filtration 2.CHEMICAL INDICATORS : I) Browne’s tubes II) WITTNESS TUBES IV) Royce Sachet V) Chemical Dosimeter 3.BIOLOGICAL INDICATORS
Aseptic Area and Microbial Control. - Pharmaceutical Microbiology (SYBpharm) ...Kiran Shinde
Prof.Mr.Kiran K. Shinde (M.Pharm), Assistant professor (VNIPRC)
Pharmaceutical microbiology (Second year b.pharm) (3rd semester)
Introduction to Aseptic area & room
Designing of Aseptic Room
Laminar Airflow Equipment
Sources of Contamination & Method of Prevention
Classification of Aseptic Area-Room
Testing of Clean Aseptic Room
Two general methods are used for microbiological assays
Method A: Cylinder plate method or cup plate method.
Method B: Tube assay method or titrimetric method.
Microbiological Assay of Vitamin & Amino acid Assessment of a New Antibiotic...Ms. Pooja Bhandare
PHARMACEUTICAL MICROBIOLOGY (BP303T) Unit-IV Part-3
Microbiological Assay of Vitamin & Amino acid Assessment of a New Antibiotic: Introduction:
Principle
Microbiological Assay of Cynocobalamin (Vitamin B12):
Tritrimetric Method.
Turbidimetric Method.
Preparation of Standard Cynocobalmine stock solution:
Preparation of Basal Medium Stock Solution:
Test Solution of the material to be assayed Preparation of inoculum: Procedure of Titrimetric method: Turbidimetric Method: Microbiological assay of Amino acids. Assessment of a New Antibiotic.
Introduction:
MIC of an antibiotic is tested either by one of the following ways,
Liquid Dilution Method.
Solid Dilution Method
this presentation gives informationabout microbial assay of vitamins B2 and B12. it is based upon the guidelines of indian pharmacopoeia. this presentation highlights the principle, process and applications of microbial assay
Pyrogens include any substance capable of eliciting a febrile (or fever) response upon injection or infection
Endotoxin is a subset of pyrogens that are strictly of gram- negative bacterial origin; they occur (virtually) nowhere else in nature.
Lipopolysaccharide (LPS)is a part of endotoxin, or, endotoxin is the natural complex of LPS occurring in the outer layer of the bilayered gram-negative bacterial cell
Biochemical tests are based on reactions that takes place in various living rganisms. In microbiology these are useful for identification of various microorganisms like identification and differentiation of various bacterial species. IMViC test is a group of test that are used to differentiate between Escheritia and Enterobacter species.
Defination,test method, steps, principle, designed to demonstrate the presence or absence of extraneous viable contaminating microorganisms in biological parenterals designed for human use
The presentation describes evaluation of sterility of parenteral products. It contains principle, methods, media selection and result interpretation of sterility test. carried out for pharmaceutical sterile products.
Sterility testing products (solids, liquids, ophthalmic and other sterile pro...Ms. Pooja Bhandare
PHARMACEUTICAL MICROBIOLOGY (BP303T)Unit-IIIPart-6 Sterility testing products (solids, liquids, ophthalmic and other sterile products) according to IP, BP, USP.
Introduction: Test for Sterility. Culture Media. Fluid Thioglycollate Medium (FTM).
Alternative Thioglycollate Medium (ATM).
Soybean Casein Digest Medium (SCDM).
Tests for Culture Media:
Sterility of Media.
Growth Promotion Test.
Test for Bacteriostatic and Fungistatic.
Sterility Test Methods. Methods A: Membrane Filtration.
Method B: Direct Inoculation Pyrogen Test Methods. Rabbit Test. LAL Test.
Evaluation of the efficiency of sterilization methods.Sterility indicatorsMs. Pooja Bhandare
Evaluation of the efficiency of sterilization methods.Sterility indicators
Sterility criteria: Bioburden ,Sensitivity of microorganisms
Death rate or Survivor curve,D- Value or Decimal reduction time,Z- value or Thermal reduction time, f- value, Q10 Value or Temperature Coefficient, Inactivation Factor:
STERILITY INDICATORS : Physical Indicators, Chemical Indicators
Biological Indicators
1. Physical Indicators: i) Moist heat Indicator ii) Dry heat iii) Radio sterilization iv) Gaseous methods v) Filtration 2.CHEMICAL INDICATORS : I) Browne’s tubes II) WITTNESS TUBES IV) Royce Sachet V) Chemical Dosimeter 3.BIOLOGICAL INDICATORS
Aseptic Area and Microbial Control. - Pharmaceutical Microbiology (SYBpharm) ...Kiran Shinde
Prof.Mr.Kiran K. Shinde (M.Pharm), Assistant professor (VNIPRC)
Pharmaceutical microbiology (Second year b.pharm) (3rd semester)
Introduction to Aseptic area & room
Designing of Aseptic Room
Laminar Airflow Equipment
Sources of Contamination & Method of Prevention
Classification of Aseptic Area-Room
Testing of Clean Aseptic Room
Two general methods are used for microbiological assays
Method A: Cylinder plate method or cup plate method.
Method B: Tube assay method or titrimetric method.
Microbiological Assay of Vitamin & Amino acid Assessment of a New Antibiotic...Ms. Pooja Bhandare
PHARMACEUTICAL MICROBIOLOGY (BP303T) Unit-IV Part-3
Microbiological Assay of Vitamin & Amino acid Assessment of a New Antibiotic: Introduction:
Principle
Microbiological Assay of Cynocobalamin (Vitamin B12):
Tritrimetric Method.
Turbidimetric Method.
Preparation of Standard Cynocobalmine stock solution:
Preparation of Basal Medium Stock Solution:
Test Solution of the material to be assayed Preparation of inoculum: Procedure of Titrimetric method: Turbidimetric Method: Microbiological assay of Amino acids. Assessment of a New Antibiotic.
Introduction:
MIC of an antibiotic is tested either by one of the following ways,
Liquid Dilution Method.
Solid Dilution Method
this presentation gives informationabout microbial assay of vitamins B2 and B12. it is based upon the guidelines of indian pharmacopoeia. this presentation highlights the principle, process and applications of microbial assay
Pyrogens include any substance capable of eliciting a febrile (or fever) response upon injection or infection
Endotoxin is a subset of pyrogens that are strictly of gram- negative bacterial origin; they occur (virtually) nowhere else in nature.
Lipopolysaccharide (LPS)is a part of endotoxin, or, endotoxin is the natural complex of LPS occurring in the outer layer of the bilayered gram-negative bacterial cell
Biochemical tests are based on reactions that takes place in various living rganisms. In microbiology these are useful for identification of various microorganisms like identification and differentiation of various bacterial species. IMViC test is a group of test that are used to differentiate between Escheritia and Enterobacter species.
Defination,test method, steps, principle, designed to demonstrate the presence or absence of extraneous viable contaminating microorganisms in biological parenterals designed for human use
The presentation describes evaluation of sterility of parenteral products. It contains principle, methods, media selection and result interpretation of sterility test. carried out for pharmaceutical sterile products.
STERILITY TESTING OF PHARMACEUTICALS ppt by DR.C.P.PRINCEDR.PRINCE C P
Sterility Testing: done to detect if viable forms of micro-organisms are present or not on or in the pharmaceutical preparation.
The test is applied to substances or preparations which, according to the Pharmacopoeia, are required to be sterile. For example
✦ Injections
✦ Implants
✦ Syringes
✦ Bandages
✦ Dressings
✦ Surgical Instruments
✦ Needles
✦ Injectables
✦ Bulk Solids
✦ Ophthalmic Products..etc
If microorganisms are placed in a media that provides nutrients and water and kept at a favourable temperature the organism will grow and their growth can be indicated by turbidity in originally clear medium.
PPT prepared by:
DR.PRINCE C P
HOD &Associate Professor
Department of Microbiology,
Mother Theresa Post Graduate & Research Institute of Health Sciences (Government of Puducherry Institution)
Parenterals are the sterile preparation that is directly administered into the circulatory system avoiding the enteral route. And these preparation provide rapid onset of action that is why the administered preparation must be safe.
Stability problem arise from microbial contamination of these products so sterility and stability must be ensured for these preparations.
To ensure their sterility and stability, regulations regarding to quality control through pharmacopeial specifications has great importance.
Ipqc tests for sterile formulations are as follows :
Leakage Test
Clarity Test
pH
Particulate Matter Injection
SterilityTest
Pyrogen Test
Content Uniformity & Weight
Volume Filled
The tests For Sterile products are as per IP, BP & USP
Sterility Testing is defined as a testing which confirms that products are free from the presence of viable microorganisms. Sterility testing is very important for medical devices, pharmaceuticals, preparations, tissue materials and other materials that claim to be sterile or free from viable microorganisms.
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.
Quality control test for capsule and finish product of capsule are
■ weight variation test
■ Dissolution test
■ Disintegration test
■ moisture permeation test
■ contents uniformity test
■ blooms gelatin strength .
Knee anatomy and clinical tests 2024.pdfvimalpl1234
This includes all relevant anatomy and clinical tests compiled from standard textbooks, Campbell,netter etc..It is comprehensive and best suited for orthopaedicians and orthopaedic residents.
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
The Gram stain is a fundamental technique in microbiology used to classify bacteria based on their cell wall structure. It provides a quick and simple method to distinguish between Gram-positive and Gram-negative bacteria, which have different susceptibilities to antibiotics
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.
New Drug Discovery and Development .....NEHA GUPTA
The "New Drug Discovery and Development" process involves the identification, design, testing, and manufacturing of novel pharmaceutical compounds with the aim of introducing new and improved treatments for various medical conditions. This comprehensive endeavor encompasses various stages, including target identification, preclinical studies, clinical trials, regulatory approval, and post-market surveillance. It involves multidisciplinary collaboration among scientists, researchers, clinicians, regulatory experts, and pharmaceutical companies to bring innovative therapies to market and address unmet medical needs.
Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
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
Explore natural remedies for syphilis treatment in Singapore. Discover alternative therapies, herbal remedies, and lifestyle changes that may complement conventional treatments. Learn about holistic approaches to managing syphilis symptoms and supporting overall health.
2. INTRODUCTION
• Sterilisation:
Is the process of making something free from bacteria or other
living microorganisms.
• Sterility Testing:
Are done to detect if viable forms of micro-organisms are
present or not on or in the pharmaceutical preparations.
2
3. INTRODUCTION
Which products undergo sterility tests?
• The test is applied to substances or preparations which, according to the
Pharmacopoeia, are required to be sterile. For example
✦ Injections
✦ Implants
✦ Syringes
✦ Bandages
✦ Dressings
✦ Surgical Instruments
✦ Needles
✦ Injectables
✦ Bulk Solids
✦ Ophthalmic Products..etc
3
4. INTRODUCTION
What precautions should be taken while performing sterility tests?
• The tests for sterility are carried out in aseptic regions to avoid accidental
contamination by microorganisms.
• The working conditions in which the tests are performed are monitored
regularly by appropriate sampling of the working area and by carrying out
appropriate controls.
4
5. PRINCIPLE
• If microorganisms are placed in a media that provides nutrients and water
and kept at a favourable temperature the organism will grow and their
growth can be indicated by turbidity in originally clear medium.
• The sterility tests provide optimum conditions for the growth and
multiplication of organisms, spores, etc that might be a contaminant.
• It is not possible to claim that a batch of products is sterile unless the entire
content of each batch has been tested.
• But these conditions are not possible because the article or the preparation
under test is either made unstable (like a syringe) or is destroyed (like an
injectable solution).
• Thus only a part of the batch can be sampled for testing.
5
6. STEPS INVOLVED IN STERILITY TESTING
1. Selection of the sample size.
2. Selection of the quantity of the product.
3. Method of testing.
4. Observation and Results.
6
7. 1. SELECTION OF SAMPLE SIZE
Quantity per Container
Minimum quantity to be used for each
medium unless otherwise justified and
authorised
Parenteral preparations:
• Not more than 100 containers
• More than 100 but not more than 500
containers
• More than 500 containers
• 10 per cent or 4 containers whichever is greater
• 10 containers
• 2 per cent or 20 containers (10 containers for large-
volume parenterals) whichever is less
Ophthalmic and other non-injectable:
• Not more than 200 containers
• More than 200 containers
• If the product is presented in the form of single-
dose containers, apply the scheme shown
above for preparations for parenteral use
• 5 per cent or 2 containers whichever is greater
• 10 containers
Bulk solid products:
• Up to 4 containers
• More than 4 containers but not more than 50
containers
• More than 50 containers
• Each container
• 20 per cent or 4 containers whichever is greater
• 2 per cent or 10 containers whichever is greater
7
8. 2. SELECTION OF QUANTITY OF THE PRODUCT
Quantity per Container
Minimum quantity to be used for each medium
unless otherwise justified and authorised
Liquids:
• Less than 1ml
• 1-40ml
• Greater than 40ml and not greater
than 100ml
• Greater than 100ml
Antibiotics
• Whole contents of each container
• Half contents of each container but not less than 1ml
• 20ml
• 10 per cent of the contents of the container but not less than
20ml
• 1ml
Insoluble preparations, creams and
ointments to be suspended or
emulsified
Use the contents of each container to provide not less than
200mg
Solids:
• Less than 50mg
• 50mg or more but less than 300mg
• 300mg-5g
• Greater than 5g
• The whole contents of each container
• Half the contents of each container but not less than 50mg
• 150mg
• 500mg
8
9. 3. TEST METHODS
• Method A: Membrane Filtration method
• Method B: Direct Inoculation method
9
10. MEMBRANE FILTRATION METHOD
• Membrane has a nominal pore size not greater than 0.45 micron and diameter
of approximately 50mm.
• This method basically involves filtration of sample through membrane filters.
• The filtration is assisted under Vacuum after filtration completion the
membrane is cut into 2 halves and one halve is placed in two test tubes
containing FTM, SCDM medium.
• Incubate the media for not less than 14 days.
• Used for:
‣An oil or oily preparation.
‣Ointments that can be put into solutions.
‣Soluble powder.
‣Liquid products where volume in a container is 100ml or more.
‣Non bacteriostatic solid not readily soluble in culture media.
10
11. CULTURE MEDIUM
• Properties:
Must initiate and maintain vigorous growth of small numbers of aerobic or
anaerobic bacteria including spores.
Thus, must provide sufficient moisture, adequate pH, nutrients, suitable
Redox potential.
• Classification:
1. For detection of AEROBES:
Peptone Broth
Glucose Peptone Broth
2. For detection of ANAEROBES:
Cooked Meat Medium
Semi Fluid Meat Medium
Liver Broth
11
12. CULTURE MEDIUM
3. For both AEROBES and ANAEROBES:
Fluid Thioglycolate Media
Thioglycolate Broth Media
Corn Steep Liquor-Sodium Thioglycolate Media
Semi-FLuid Hydrosulphite Media
4. For detect of AEROBIC and LOWER FUNGI:
Soybean Caesin Digest Media
Sabourould’s Media
12
13. THIOGLYCOLATE MEDIUM
L-Cystine
Agar
Sodium chloride
Glucose monohydrate/anhydrous
Yeast extract (water-soluble)
Pancreatic digest of casein
Sodium thioglycollate or
Thioglycollic acid
Resazurin sodium solution (1 g/l of resazurin sodium), freshly p
Water R
Sterilise in autoclave at 121 C for 20 mins
pH after sterilization 6.9 to 7.3.
0.5 g
0.75 g
2.5 g
5.5/5.0 g
5.0 g
15.0 g
0.5 g
0.3 ml
1.0 ml
Upto 1000 ml
13
14. ALTERNATIVE THIOGLYCOLATE MEDIUM
• Contains no agar and Indicator.
• Used with:
Turbid suspensions and viscid products (creams).
For devices having tubes with small Lumina.
14
15. SOYBEAN CAESIN DIGEST MEDIUM
Pancreatic digest of casein
Papaic digest of soya-bean meal
Sodium chloride
Dipotassium hydrogen phosphate
Glucose monohydrate/anhydrous
Water R
pH after sterilization 7.1 to 7.5.
17.0 g
3.0 g
5.0 g
2.5 g
2.5/2.3 g
Upto 1000 ml
15
16. DIRECT INOCULATION METHOD
• It involves a direct inoculation of required volume of a sample in two test
tubes containing a culture medium that is FTM, SCDM.
• Volume of the preparation under examination is not more than 10% of the
volume of the medium.
• Incubate the inoculated media for not less than 14 days.
16
17. 4. INTERPRETATION OF RESULTS
After incubation and during the incubation period
If growth is not observed If growth is observed
Passes the sterility test (preparation sterile) Containers are reserved and re-test is performed as
in the original test
If growth is not observed (sample passed) If growth is observed
If they are not readily distinguishable from those
growing in containers reserved in the first test
If they are readily distinguishable from those
growing in containers reserved in the first test
Preparation fails the test Second re-test is performed using twice the no.
of samples
If growth is not observed If growth is observed
Preparation passes the test Preparation fails the test
17