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.
Preservation of pharmaceutical products using antimicrobial agents. PHARMACEU...Ms. Pooja Bhandare
PHARMACEUTICAL MICROBIOLOGY (BP303T)Unit-VPart-3
Preservation of pharmaceutical products using antimicrobial agents.
Introduction. Ideal Properties of Preservatives:
Antimicrobial Chemical Preservatives
Development of a Preservative System.
Factors affecting efficacy of a preservative: 1. Interaction With components of the formulation
2. Properties of the Preservatives:
3) Effect of Containers.
4) Type of microbes:
5) Influence of pH:
Challenge Test: Efficacy Test of Preservative : Medium used, Choice of test organism:
Preparation of the inoculum:
Procedure:
Interpretation of Results:
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
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.
Preservation of pharmaceutical products using antimicrobial agents. PHARMACEU...Ms. Pooja Bhandare
PHARMACEUTICAL MICROBIOLOGY (BP303T)Unit-VPart-3
Preservation of pharmaceutical products using antimicrobial agents.
Introduction. Ideal Properties of Preservatives:
Antimicrobial Chemical Preservatives
Development of a Preservative System.
Factors affecting efficacy of a preservative: 1. Interaction With components of the formulation
2. Properties of the Preservatives:
3) Effect of Containers.
4) Type of microbes:
5) Influence of pH:
Challenge Test: Efficacy Test of Preservative : Medium used, Choice of test organism:
Preparation of the inoculum:
Procedure:
Interpretation of Results:
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
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.
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
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.
Evaluation of Bactericidal and BacteriostaticRajsingh467604
What are disinfectants?
As per the definition given by WHO ( World health organization ) : a disinfectant is a chemical agent, which destroys or inhibits growth of pathogenic microorganisms in the non-sporing or vegetative state.
Why Evaluation?
Evaluation of disinfectants is used to check the ability or efficacy of any disinfectant against specific microorganisms to establish its effectiveness.
Evaluation tests of bactericide.
1. RIDEAL WALKER TEST
This test is also known as the phenol coefficient test,in which any chemical is compared with phenol for its antimicrobial activity.
The result is shown in the form of phenol coefficient.
▪ If a phenol coefficient of a given test disinfectant is less than 1, it means that disinfectant is less effective than phenol.
▪ If a phenol coefficient of a given test disinfectant is more than 1, it means that disinfectant is more effective than phenol.
Procedure
1.1 Different dilutions of the test disinfectant and phenol are prepared and 5 ml of each dilution is inoculated with 0.5ml of the 24 hour growth culture of the organisms.
1.2 All tubes(Disinfectant + organisms & phenol + organisms) are placed in a water bath ( at 17.5° C)
1.3 Subcultures of each reaction mixture are taken and transferred to 5ml sterile broth at an interval of 2.5 minutes from zero to 10 mintues.
1.4 Broth tubes are incubated at 37° C for 2 to 3 days & examined for the presence or absence of the growth.
1.5 Then the Rideal Walker coefficient is calculated :
2. CHICK MARTIN TEST.
CHICK MARTIN test is performed in the much similar way as the RIDEAL Walker test but with a little variation.
Principle : This test is carried out in the presence of organic matter like 3% human feces or dried yeast.
Procedure
2.1 Serial dilutions of test solution and phenol is prepared in distilled water.
2.2 To this 3% yeast suspension is also added.
2.3 To this solution the S. typhi is added
2.4 After contact time of 30 mins the above mixture is transferred to the freshly prepared 10 ml of broth.
2.5 The test tubes are incubated at 37°C for 48 hours.
2.6 Presence or absence of the growth is calculated.
Evaluation tests of Bacteriostatic.
1. Tube dilution & Agar plate Method
1.1 The chemical agent is incorporated into nutrient broth or agar medium and inoculated with test micro-organisms.
1.2 These tubes are incubated at 30° TO 35°C for 2 to 3 days and then the results in the form of turbidity or colonies are observed.
1.3 The results are recorded and the activity of the given disinfectant is compared.
2. Cup plate method
2.1 Agar is melted and cooled at 45° Celsius.
2.2 Then inoculated with test micro-organisms and poured into a sterile petri plate.
2.3 In the cup plate method, when the inoculated agar has solidified, holes around 8mm in diameter are cut in the medium with a steel cork borer.
2.4 Now the antimicrobial agents are directly placed in the holes.
Evaluation of Bactericidal and Bacteriostatic (Disinfectant). PHARMACEUTICAL ...Ms. Pooja Bhandare
PHARMACEUTICAL MICROBIOLOGY (BP303T) Unit-III Part-5 Evaluation of Bactericidal and Bacteriostatic (Disinfectant). The common methods used for evaluation of a disinfectant are as follows,
Tube Dilution Method.
Agar Plate Method.
Filter Paper & Cup Plate Method.
Ditch-Plate Method.
Phenol Coefficient Method.
The official phenol coefficient tests include,
Rideal-Walker Test (RW Test).
Chick-Martin Test.
United States FDA Test for Phenol Coefficient. (FDA Test)
The US Association of Official Agricultural Chemists Test (FDA Test)
A. Rideal-Walker Test:
Kelsey Sykes Method
Assessment of microbial contamination and spoilage. PHARMACEUTICAL MICROBIOLO...Ms. Pooja Bhandare
PHARMACEUTICAL MICROBIOLOGY (BP303T)Unit-VPart-2
Assessment of microbial contamination and spoilage.
Assessment of microbial contamination and spoilage
1. Physical and chemical changes:
2. Assessment of viable microorganisms in non-sterile products:
3. Sterility test:
4. Estimation of pyrogens:
Microbial Limit Tests:
Total Aerobic Microbial Count:
Membrane Filtration.
Plate Count Methods.
Pour Plate Method.
Surface spread Method.
Most Probable Number(MPN)
Types of spoilage, factors affecting the microbial spoilage of pharmaceutical...Ms. Pooja Bhandare
PHARMACEUTICAL MICROBIOLOGY (BP303T)Unit-V Part-1
Types of spoilage, factors affecting the microbial spoilage of pharmaceutical products, source and type of contaminants. Introduction: Defintion Types of Microbial Spoilage:
1. Infection induced due to contaminated pharmaceutical products: Table no. 1.1 Common pathogens spoiling pharmaceutical products:
2. Physicochemical spoilage –
i) Viable growth ii) Gas production
iii) Colouration / Decolouration
iv) Odour formation
v) Taste change
3. Physical Spoilage:
Cracking of emulsion:
Odor changes
4. Biological spoilage:
Microbial Toxins
Microbial Metabolites
5. Chemical spoilage: Table 1.2 Susceptibility of pharmaceutical ingredients to microbial contamination
Factors affecting microbial spoilage
Size of contaminant inoculum
Nutritional factors
Moisture content
pH
Storage temperature
Redox potential
Packaging design
Sources and Types Of Contamination:
Personnel,
Poor facility design,
Incoming ventilation air,
Machinery and other equipment for production,
Raw material and semi-finished material,
Packaging material,
Utilities,
Different media used in the production process as well as for cleaning and Cleanroom clothing.
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.
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.
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
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.
Evaluation of Bactericidal and BacteriostaticRajsingh467604
What are disinfectants?
As per the definition given by WHO ( World health organization ) : a disinfectant is a chemical agent, which destroys or inhibits growth of pathogenic microorganisms in the non-sporing or vegetative state.
Why Evaluation?
Evaluation of disinfectants is used to check the ability or efficacy of any disinfectant against specific microorganisms to establish its effectiveness.
Evaluation tests of bactericide.
1. RIDEAL WALKER TEST
This test is also known as the phenol coefficient test,in which any chemical is compared with phenol for its antimicrobial activity.
The result is shown in the form of phenol coefficient.
▪ If a phenol coefficient of a given test disinfectant is less than 1, it means that disinfectant is less effective than phenol.
▪ If a phenol coefficient of a given test disinfectant is more than 1, it means that disinfectant is more effective than phenol.
Procedure
1.1 Different dilutions of the test disinfectant and phenol are prepared and 5 ml of each dilution is inoculated with 0.5ml of the 24 hour growth culture of the organisms.
1.2 All tubes(Disinfectant + organisms & phenol + organisms) are placed in a water bath ( at 17.5° C)
1.3 Subcultures of each reaction mixture are taken and transferred to 5ml sterile broth at an interval of 2.5 minutes from zero to 10 mintues.
1.4 Broth tubes are incubated at 37° C for 2 to 3 days & examined for the presence or absence of the growth.
1.5 Then the Rideal Walker coefficient is calculated :
2. CHICK MARTIN TEST.
CHICK MARTIN test is performed in the much similar way as the RIDEAL Walker test but with a little variation.
Principle : This test is carried out in the presence of organic matter like 3% human feces or dried yeast.
Procedure
2.1 Serial dilutions of test solution and phenol is prepared in distilled water.
2.2 To this 3% yeast suspension is also added.
2.3 To this solution the S. typhi is added
2.4 After contact time of 30 mins the above mixture is transferred to the freshly prepared 10 ml of broth.
2.5 The test tubes are incubated at 37°C for 48 hours.
2.6 Presence or absence of the growth is calculated.
Evaluation tests of Bacteriostatic.
1. Tube dilution & Agar plate Method
1.1 The chemical agent is incorporated into nutrient broth or agar medium and inoculated with test micro-organisms.
1.2 These tubes are incubated at 30° TO 35°C for 2 to 3 days and then the results in the form of turbidity or colonies are observed.
1.3 The results are recorded and the activity of the given disinfectant is compared.
2. Cup plate method
2.1 Agar is melted and cooled at 45° Celsius.
2.2 Then inoculated with test micro-organisms and poured into a sterile petri plate.
2.3 In the cup plate method, when the inoculated agar has solidified, holes around 8mm in diameter are cut in the medium with a steel cork borer.
2.4 Now the antimicrobial agents are directly placed in the holes.
Evaluation of Bactericidal and Bacteriostatic (Disinfectant). PHARMACEUTICAL ...Ms. Pooja Bhandare
PHARMACEUTICAL MICROBIOLOGY (BP303T) Unit-III Part-5 Evaluation of Bactericidal and Bacteriostatic (Disinfectant). The common methods used for evaluation of a disinfectant are as follows,
Tube Dilution Method.
Agar Plate Method.
Filter Paper & Cup Plate Method.
Ditch-Plate Method.
Phenol Coefficient Method.
The official phenol coefficient tests include,
Rideal-Walker Test (RW Test).
Chick-Martin Test.
United States FDA Test for Phenol Coefficient. (FDA Test)
The US Association of Official Agricultural Chemists Test (FDA Test)
A. Rideal-Walker Test:
Kelsey Sykes Method
Assessment of microbial contamination and spoilage. PHARMACEUTICAL MICROBIOLO...Ms. Pooja Bhandare
PHARMACEUTICAL MICROBIOLOGY (BP303T)Unit-VPart-2
Assessment of microbial contamination and spoilage.
Assessment of microbial contamination and spoilage
1. Physical and chemical changes:
2. Assessment of viable microorganisms in non-sterile products:
3. Sterility test:
4. Estimation of pyrogens:
Microbial Limit Tests:
Total Aerobic Microbial Count:
Membrane Filtration.
Plate Count Methods.
Pour Plate Method.
Surface spread Method.
Most Probable Number(MPN)
Types of spoilage, factors affecting the microbial spoilage of pharmaceutical...Ms. Pooja Bhandare
PHARMACEUTICAL MICROBIOLOGY (BP303T)Unit-V Part-1
Types of spoilage, factors affecting the microbial spoilage of pharmaceutical products, source and type of contaminants. Introduction: Defintion Types of Microbial Spoilage:
1. Infection induced due to contaminated pharmaceutical products: Table no. 1.1 Common pathogens spoiling pharmaceutical products:
2. Physicochemical spoilage –
i) Viable growth ii) Gas production
iii) Colouration / Decolouration
iv) Odour formation
v) Taste change
3. Physical Spoilage:
Cracking of emulsion:
Odor changes
4. Biological spoilage:
Microbial Toxins
Microbial Metabolites
5. Chemical spoilage: Table 1.2 Susceptibility of pharmaceutical ingredients to microbial contamination
Factors affecting microbial spoilage
Size of contaminant inoculum
Nutritional factors
Moisture content
pH
Storage temperature
Redox potential
Packaging design
Sources and Types Of Contamination:
Personnel,
Poor facility design,
Incoming ventilation air,
Machinery and other equipment for production,
Raw material and semi-finished material,
Packaging material,
Utilities,
Different media used in the production process as well as for cleaning and Cleanroom clothing.
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.
Defination,test method, steps, principle, designed to demonstrate the presence or absence of extraneous viable contaminating microorganisms in biological parenterals designed for human use
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)
IPQC and FPQC test for semi solids dosage form....pptxMansi792999
This presentation is knowledge about the in process and finished product quality control test for semi solid dosage form e.g. Cream , ointment , suppository , gel etc. And procedure for the perform test for semi solid dosage form.
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.
Synthetic Fiber Construction in lab .pptxPavel ( NSTU)
Synthetic fiber production is a fascinating and complex field that blends chemistry, engineering, and environmental science. By understanding these aspects, students can gain a comprehensive view of synthetic fiber production, its impact on society and the environment, and the potential for future innovations. Synthetic fibers play a crucial role in modern society, impacting various aspects of daily life, industry, and the environment. ynthetic fibers are integral to modern life, offering a range of benefits from cost-effectiveness and versatility to innovative applications and performance characteristics. While they pose environmental challenges, ongoing research and development aim to create more sustainable and eco-friendly alternatives. Understanding the importance of synthetic fibers helps in appreciating their role in the economy, industry, and daily life, while also emphasizing the need for sustainable practices and innovation.
2024.06.01 Introducing a competency framework for languag learning materials ...Sandy Millin
http://sandymillin.wordpress.com/iateflwebinar2024
Published classroom materials form the basis of syllabuses, drive teacher professional development, and have a potentially huge influence on learners, teachers and education systems. All teachers also create their own materials, whether a few sentences on a blackboard, a highly-structured fully-realised online course, or anything in between. Despite this, the knowledge and skills needed to create effective language learning materials are rarely part of teacher training, and are mostly learnt by trial and error.
Knowledge and skills frameworks, generally called competency frameworks, for ELT teachers, trainers and managers have existed for a few years now. However, until I created one for my MA dissertation, there wasn’t one drawing together what we need to know and do to be able to effectively produce language learning materials.
This webinar will introduce you to my framework, highlighting the key competencies I identified from my research. It will also show how anybody involved in language teaching (any language, not just English!), teacher training, managing schools or developing language learning materials can benefit from using the framework.
How to Make a Field invisible in Odoo 17Celine George
It is possible to hide or invisible some fields in odoo. Commonly using “invisible” attribute in the field definition to invisible the fields. This slide will show how to make a field invisible in odoo 17.
Palestine last event orientationfvgnh .pptxRaedMohamed3
An EFL lesson about the current events in Palestine. It is intended to be for intermediate students who wish to increase their listening skills through a short lesson in power point.
The Art Pastor's Guide to Sabbath | Steve ThomasonSteve Thomason
What is the purpose of the Sabbath Law in the Torah. It is interesting to compare how the context of the law shifts from Exodus to Deuteronomy. Who gets to rest, and why?
Ethnobotany and Ethnopharmacology:
Ethnobotany in herbal drug evaluation,
Impact of Ethnobotany in traditional medicine,
New development in herbals,
Bio-prospecting tools for drug discovery,
Role of Ethnopharmacology in drug evaluation,
Reverse Pharmacology.
Read| The latest issue of The Challenger is here! We are thrilled to announce that our school paper has qualified for the NATIONAL SCHOOLS PRESS CONFERENCE (NSPC) 2024. Thank you for your unwavering support and trust. Dive into the stories that made us stand out!
Model Attribute Check Company Auto PropertyCeline George
In Odoo, the multi-company feature allows you to manage multiple companies within a single Odoo database instance. Each company can have its own configurations while still sharing common resources such as products, customers, and suppliers.
Students, digital devices and success - Andreas Schleicher - 27 May 2024..pptxEduSkills OECD
Andreas Schleicher presents at the OECD webinar ‘Digital devices in schools: detrimental distraction or secret to success?’ on 27 May 2024. The presentation was based on findings from PISA 2022 results and the webinar helped launch the PISA in Focus ‘Managing screen time: How to protect and equip students against distraction’ https://www.oecd-ilibrary.org/education/managing-screen-time_7c225af4-en and the OECD Education Policy Perspective ‘Students, digital devices and success’ can be found here - https://oe.cd/il/5yV
Welcome to TechSoup New Member Orientation and Q&A (May 2024).pdfTechSoup
In this webinar you will learn how your organization can access TechSoup's wide variety of product discount and donation programs. From hardware to software, we'll give you a tour of the tools available to help your nonprofit with productivity, collaboration, financial management, donor tracking, security, and more.
Operation “Blue Star” is the only event in the history of Independent India where the state went into war with its own people. Even after about 40 years it is not clear if it was culmination of states anger over people of the region, a political game of power or start of dictatorial chapter in the democratic setup.
The people of Punjab felt alienated from main stream due to denial of their just demands during a long democratic struggle since independence. As it happen all over the word, it led to militant struggle with great loss of lives of military, police and civilian personnel. Killing of Indira Gandhi and massacre of innocent Sikhs in Delhi and other India cities was also associated with this movement.
MARUTI SUZUKI- A Successful Joint Venture in India.pptx
Sterility testing of Pharmaceutical Products
1. STERILITY TESTING OF PRODUCTS
( SOLID, LIQUID,OPHTHALMIC AND OTHER
STERILE PRODUCTS AS PER IP )
ARUN G KRISHNAN
ASST. PROFESSOR
DEPT. OF PHARMACEUTICS
EZHUTHACHAN COLLEGE OF PHARMACEUTICAL SCIENCES
THIRD SEMESTER B.PHARM
2. STERILITY TESTING
• Sterility testing is defined as a testing which confirms that
products are free from the presence of viable
microorganisms.
• Such test is very important for medical devices,
Pharmaceutical preparations like ophthalmic preparations,
injections, infusions, implants, syringes, bandages,
dressings, needles, surgical instruments etc.
3. PRINCIPLE BEHIND STERILITY TESTING
• The test sterility is based upon the principle that if
microorganisms are placed in a medium which provides
nutritive material and water and kept at a favourable
temperature, the microorganism will grow and their
presence can be indicated by turbidity in the originally
clear medium.
7. Asking sterility testing????????
• Defenition of sterility
• Importance of sterility testing.
• Number of containers and batch selected for sterility
testing.
• CULTURE MEDIA.
• METHODS OF STERILITY TESTING.
• INTERPRETATION.
8. CULTURE MEDIA
1. Fluid thioglycolate medium (FTM).
2. Alternative thioglycolate medium (ATM).
3. Soyabean casein digest medium.(SCDM).
9. 1. Fluid thioglycolate medium (FTM).
• For anaerobic bacteria.
• Composition
L-Cystine
Sodium chloride
Dextrose monohydrate
Yeast extract
Pancreatic digest of casein
Sodium thioglycollate
Papaic digest of soyabean meal
Dipotassium hydrogen phosphate
Resazurin sodium soluble
Distilled water (to make 1000ml)
PH of the medium after sterilization 7.1±0.2
10. 2.Alternative thioglycolate medium (ATM).
• Used turbid or viscid products.
• Incubated, in such a way that to assure anaerobic
conditions.
• Composition
L-Cystine
Sodium chloride
Dextrose monohydrate
Yeast extract
Pancreatic digest of casein
Sodium thioglycollate
Distilled water (to make 1000ml)
PH of the medium after sterilization 7.1±0.2
11. 3. Soyabean casein digest medium.(SCDM).
• Suitable for the culturing of both fungi and anaerobic bacteria.
• Composition
L-Cystine
Sodium chloride
Dextrose monohydrate
Pancreatic digest of casein
Papaic digest of soyabean meal
Dipotassium hydrogen phosphate
Distilled water (to make 1000ml)
PH of the medium after sterilization 7.1±0.2
12. Medium 1 and 2 are adjusted to PH 7.1±0.2, medium 3
is adjusted to PH 7.3±0.2 and sterilised by autoclaving at
1210C for 20 mints.
Anaerobic condition are required for growth of some
microbial species
13.
14.
15.
16.
17. METHODS FOR STERILITY TEST
• METHOD A : MEMBRANE FILTERATION
• METHOD B : DIRECT INOCULATION
18. • Suitable for the substance like oil, an ointment that can
be put into a solution, a non-bacteriostatic solid not
readily soluble in culture medium, a soluble powder or a
liquid that possesses inherent bacteriostatic and
fungistatic prperties.
• Method A is suitable for liquid products where the
volume in the container is 100ml or more.
METHOD A : MEMBRANE FILTERATION
20. MEMBRANE FILTERATION APPARATUS FOR STERILITY TESTING
• Closed reservoir and container to collect
the filterate, between which a properly
supported membrane of appropriate
porosity is placed.
• Porosity; 0.45µm
• Diameter ; 50mm
• Flow rate ; 55-75ml/min
• Pressure ; 70mm mercury
• Cellulose nitrate membrane - For
aqueous, oily, and weakly alcoholic
solutions.
• Cellulose acetate membarne filter for
strongly alcoholic solutions.
21. MEMBRANE FILTERATION APPARATUS FOR STERILITY TESTING
• Complete unit should be free from microorganisms
inclueding the membrane, and operation should be carried
out aseptically.
22. Dilution fluids : Two types of dilution fluids are
used.
• Fluid A (Peptic digest of animal tissue+Water)
• Fluid B (Lecithin/oil+Poly sorbate)
23. Preparations Quantity in each
conatiner of injectable
preparations
Minimum quantity to be
used for each culture
medium
Liquids Less than 1ml
1-40ml
More than 40ml but not more than
100ml.
Total content of a container, half
the contents of a container but not
less than 1ml
20ml
Antibiotic liquid 1ml
Creams,Ointment The whole content of each
container(NLT 200mg)
Catgut other surgical
sutures
3 sections of strand.
Cotton/gauze 100mg
Other medical devices Whole devices
24. Method of test
• For aqueous solutions
• For Ointments and creams
• For injections other than antibiotics.
• For antibiotic injections.
25. METHOD B : DIRECT INOCULATION
• Samples directly inoculated to a culture media.
• Quantities of sample to be used is accordance with
quantity table.
26. Method of test
• For aqueous solution and suspensions.
• For oily solution.
• For oinment and creams.
