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)
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:
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.
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
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 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
Designing of aseptic area, laminar flow equipment: Study of different source ...Ms. Pooja Bhandare
Designing of aseptic area, laminar flow equipment: Study of different source of contamination in aseptic area and methods of prevention, clean area classification. PHARMACEUTICALMICROBIOLOGY (BP303T)Unit-IVPart-1
Introduction: Designing of Aseptic Area . i) The clean-up area,
ii) The compounding area,
iii) The aseptic area,
iv) The quarantine area and
v) The packaging/labelling area.
Flow diagram of aseptic area. Floors, walls and ceilings, Doors, windows and services Personnel and protective clothing Cleaning and disinfection. Air Supply. Laminar flow equipment. Vertical laminar air flow bench
Horizontal laminar air flow bench
High Efficiency Particulate Air (HEPA) Filter. Operating Instructions Uses of Laminar Air Flow.Advantages of Laminar Air Flow.Limitations of Laminar Air Flow. Air flow pattern Unidirectional airflow
Non-unidirectional airflow
Combined airflow
Different Sources of Contamination in an Aseptic Area
1) Personnel:
2) Buildings and Facilities
3) Equipment and Utensils:
4) Raw Materials
5) Manufacturing Process:
Methods of Prevention of Contamination Clean Area Classification
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:
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.
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
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 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
Designing of aseptic area, laminar flow equipment: Study of different source ...Ms. Pooja Bhandare
Designing of aseptic area, laminar flow equipment: Study of different source of contamination in aseptic area and methods of prevention, clean area classification. PHARMACEUTICALMICROBIOLOGY (BP303T)Unit-IVPart-1
Introduction: Designing of Aseptic Area . i) The clean-up area,
ii) The compounding area,
iii) The aseptic area,
iv) The quarantine area and
v) The packaging/labelling area.
Flow diagram of aseptic area. Floors, walls and ceilings, Doors, windows and services Personnel and protective clothing Cleaning and disinfection. Air Supply. Laminar flow equipment. Vertical laminar air flow bench
Horizontal laminar air flow bench
High Efficiency Particulate Air (HEPA) Filter. Operating Instructions Uses of Laminar Air Flow.Advantages of Laminar Air Flow.Limitations of Laminar Air Flow. Air flow pattern Unidirectional airflow
Non-unidirectional airflow
Combined airflow
Different Sources of Contamination in an Aseptic Area
1) Personnel:
2) Buildings and Facilities
3) Equipment and Utensils:
4) Raw Materials
5) Manufacturing Process:
Methods of Prevention of Contamination Clean Area Classification
Principles and methods of different microbiological assay, methods for standa...Ms. Pooja Bhandare
PHARMACEUTICAL MICROBIOLOGY (BP303T)Unit-IV Part-2 Principles and methods of different microbiological assay, methods for standardization of antibiotics.
Introduction: Principles Advantages of Microbial Assay: Disadvantages of Microbial Assay: MICROBIOLOGICAL ASSAY OF ANIBIOTICS PRINCIPLE Media used for antibiotics assay Standard Preparation. Buffer Solutions Preparation of the Sample Solution: Test Organisms Preparation of inoculum: Methods of preparation of test organism suspension: Assay Methods: Method A: Cup-plate or Cylinder Plate Method.
Method B: Turbidimetric or Tube assay 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
Prof.Mr.Kiran K. Shinde (M.Pharm), Assistant professor (VNIPRC)
Pharmaceutical microbiology (Second year b.pharm) (3rd semester)
Introduction
Types of Spoilage
Factors affecting the Microbial spoilage of pharmaceutical products
Sources and Types of Contamination
Assessment of microbial contamination and spoilage
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.
Designing of aseptic area including design, construction, service, flow chart,source of contamination, method of prevention of it,clean area classification as per USPDA.
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
Microbial spoilage-by S.D.Mankar types, sources of contamination, factors,Ass...someshwar mankar
Types of spoilage, factors affecting the microbial spoilage of pharmaceutical products,
sources and types of microbial contaminants, assessment of microbial contamination and
spoilage.
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.
PHARMACEUTICAL MICROBIOLOGY (BP303T) Unit-III Part-1 Study of morphology, cla...Ms. Pooja Bhandare
PHARMACEUTICAL MICROBIOLOGY (BP303T)Unit-IIIPart-1Study of morphology, classification, reproduction/replication and cultivation of fungi, Introduction fungi. Morphological Characteristics of fungi, CLASSIFICATION: Depending on cell morphology, fungi can be divided into 4 classes:
Moulds Yeasts ,Yeast like fungi and
Dimorphic fungi
Depending on their sexual spores formation fungi are divided into 4 classes:
Zygomycetes Ascomycetes
Basidiomycetes Dueteromycetes
Reproduction and sporulation;Vegetative, Asexual
and Sexual
Vegetative reproduction: Fragmentation ,Fission, budding, Sclerotia Rhizomorphs
Asexual reproduction: Zoospores
Sporangiospore, Conidia
Oidia Uredospores ,Basidiospores
Sexual reproduction:Planogametic copulation: Isogamy Heterogamy
Gametangial contact
Gametangial copulation Spermatization Somatogamy CULTIVATION OF FUNGI: Brain Heart Infusion (BHT) agar
Czapek’s agar
Mycobiotic agar Inhibitory mold agar (IMA)
Potato dextrose agar
Sabouraud’s dextrose agar (SDA):
Sabouraud’s heart infusion (SABHI) agar
Potato Flake agar
Potato dextrose-yeast extract agar (PDYA)
. Cornmeal agar
Malt extract agar (MEA)
Factors affecting action of Disinfectants and Factors Affecting Choice Of Ant...Ms. Pooja Bhandare
PHARMACEUTICAL MICROBIOLOGY (BP303T)Unit-III. Factors affecting action of Disinfectants and Factors Affecting Choice Of Antimicrobial Agent: Concentration of the disinfectant.
Chemical Structure of the disinfectant.
Formulation of the disinfectant.
Interfering substances in the environment.
pH of the surrounding.
Potentiation and antagonism of the disinfectants.
Surface Tension.
Temperature.
Time of Contact.
Type and no. of microbes present.
FACTORS AFFECTING CHOICE OF ANTIMICROBIAL AGENT:
Properties of chemical agents
Environment
Types of microorganisms
Intended application
Toxicity agents
Culture state
Principles and methods of different microbiological assay, methods for standa...Ms. Pooja Bhandare
PHARMACEUTICAL MICROBIOLOGY (BP303T)Unit-IV Part-2 Principles and methods of different microbiological assay, methods for standardization of antibiotics.
Introduction: Principles Advantages of Microbial Assay: Disadvantages of Microbial Assay: MICROBIOLOGICAL ASSAY OF ANIBIOTICS PRINCIPLE Media used for antibiotics assay Standard Preparation. Buffer Solutions Preparation of the Sample Solution: Test Organisms Preparation of inoculum: Methods of preparation of test organism suspension: Assay Methods: Method A: Cup-plate or Cylinder Plate Method.
Method B: Turbidimetric or Tube assay 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
Prof.Mr.Kiran K. Shinde (M.Pharm), Assistant professor (VNIPRC)
Pharmaceutical microbiology (Second year b.pharm) (3rd semester)
Introduction
Types of Spoilage
Factors affecting the Microbial spoilage of pharmaceutical products
Sources and Types of Contamination
Assessment of microbial contamination and spoilage
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.
Designing of aseptic area including design, construction, service, flow chart,source of contamination, method of prevention of it,clean area classification as per USPDA.
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
Microbial spoilage-by S.D.Mankar types, sources of contamination, factors,Ass...someshwar mankar
Types of spoilage, factors affecting the microbial spoilage of pharmaceutical products,
sources and types of microbial contaminants, assessment of microbial contamination and
spoilage.
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.
PHARMACEUTICAL MICROBIOLOGY (BP303T) Unit-III Part-1 Study of morphology, cla...Ms. Pooja Bhandare
PHARMACEUTICAL MICROBIOLOGY (BP303T)Unit-IIIPart-1Study of morphology, classification, reproduction/replication and cultivation of fungi, Introduction fungi. Morphological Characteristics of fungi, CLASSIFICATION: Depending on cell morphology, fungi can be divided into 4 classes:
Moulds Yeasts ,Yeast like fungi and
Dimorphic fungi
Depending on their sexual spores formation fungi are divided into 4 classes:
Zygomycetes Ascomycetes
Basidiomycetes Dueteromycetes
Reproduction and sporulation;Vegetative, Asexual
and Sexual
Vegetative reproduction: Fragmentation ,Fission, budding, Sclerotia Rhizomorphs
Asexual reproduction: Zoospores
Sporangiospore, Conidia
Oidia Uredospores ,Basidiospores
Sexual reproduction:Planogametic copulation: Isogamy Heterogamy
Gametangial contact
Gametangial copulation Spermatization Somatogamy CULTIVATION OF FUNGI: Brain Heart Infusion (BHT) agar
Czapek’s agar
Mycobiotic agar Inhibitory mold agar (IMA)
Potato dextrose agar
Sabouraud’s dextrose agar (SDA):
Sabouraud’s heart infusion (SABHI) agar
Potato Flake agar
Potato dextrose-yeast extract agar (PDYA)
. Cornmeal agar
Malt extract agar (MEA)
Factors affecting action of Disinfectants and Factors Affecting Choice Of Ant...Ms. Pooja Bhandare
PHARMACEUTICAL MICROBIOLOGY (BP303T)Unit-III. Factors affecting action of Disinfectants and Factors Affecting Choice Of Antimicrobial Agent: Concentration of the disinfectant.
Chemical Structure of the disinfectant.
Formulation of the disinfectant.
Interfering substances in the environment.
pH of the surrounding.
Potentiation and antagonism of the disinfectants.
Surface Tension.
Temperature.
Time of Contact.
Type and no. of microbes present.
FACTORS AFFECTING CHOICE OF ANTIMICROBIAL AGENT:
Properties of chemical agents
Environment
Types of microorganisms
Intended application
Toxicity agents
Culture state
ANTIBIOTIC SENSITIVITY TEST
Tube dilution and agar plate method.
Filter paper and cup plate method.
Ditch-plate method.
Phenol coefficient method.
Kelsey Sykes method.
Microbiological analysis of food products is the use of biological, biochemical, molecular or chemical methods for the detection, identification or enumeration of microorganisms in a material. Here some of the common methods have been described.
Microbial assays or microbiological assays could be a sort of bioassays designed to analyse the compounds or substances that have impact on micro-organisms. They help to estimate concentration and efficiency of antibiotics. Also facilitate in determination of the simplest anti-biotic appropriate for patient recovery.
Pharmaceutical Inorganic chemistry UNIT-V Radiopharmaceutical.pptx
Isotopes Types of decay
Alpha rays, which could barely penetrate a piece of paper
Beta rays, which could penetrate 3 mm of aluminium
Gamma rays, which could penetrate several centimetres of lead
Units of Radioactivity:
Measurement of Radioactivity
The measurement of nuclear radiation and detection is an important aspect in the identification of type of radiations (, , ) and to assay the radionuclide emitting the radiation, suitable detectors are required. The radiations are identified on the basis of their properties.
e.g. Ionization effect is measured in Ionization Chamber, Proportional Counter and Geiger Muller Counter.
The scintillation effect of radiation is measured using scintillation detector and the photographic effect is measured by Autoradiography.
Gas Filled Detectors:
Ionization Chamber:
Proportional Counters:
Geiger-Muller Counter
Properties of α, β, γ radiations
Half –life of Radioelement
Sodium Iodide (I131)
Handling and Storage of Radioactive Material:
Storage of Radioactive Substances –
Precautions For Handling Radioactive Substances
Labelling of Radioactive Substances
Pharmaceutical Application Of Radioactive Substances
Major extra and intracellular electrolytes. Pharmaceutical Inorganic chemistr...Ms. Pooja Bhandare
Major extra and intracellular electrolytes. Pharmaceutical Inorganic chemistry UNIT-II (Part-II)
Electrolyte: Intracellular fluid
Interstitial fluid
Plasma (Vascular fluid)
Anionic electrolytes- HCO₃⁻, Cl⁻, SO₄²⁻, HPO₄²⁻
Cationic electrolytes- Na⁺, K⁺, Ca²⁺, Mg²⁺
Concentration of important Electrolytes:
Electrolytes used in the replacement therapy: Sodium
chloride*, Potassium chloride, Calcium gluconate* and Oral Rehydration Salt
(ORS), Physiological acid base balance.
Acids, Bases And Buffers Pharmaceutical Inorganic chemistry UNIT-II (Part-I)
Acids, Bases are defined by Four main theories,
1.Traditional theory / concept
2.Arrhenius theory
3.Bronsted and Lowry theory
4.Lewis theory
Importance of acids and bases in pharmacy
Buffers: Buffer action
Buffer capacity Buffers system
Types of Buffers : Generally buffers are of two types:
1. Acidic buffers
2. Basic buffers
There are some other buffer system:
3. Two salts acts as acid-base pair. Ex- Potassium hydrogen phosphate and potassium dihydrogen phosphate.
4. Amphoteric electrolyte. Ex- Solution of glycine.
5. Solution of strong acid and solution of strong base. Ex- Strong HCl with KCl Mechanism of Buffer action: Mechanism of Action of acidic buffers: Buffer equation-Henderson-Hasselbalch equation:
Standard Buffer Solutions Preparation of Buffer Solutions: Buffers in pharmaceutical systems or Application of buffer: Stability of buffers Buffered isotonic solution Types of Buffer Isotonic solution
1. Isotonic Solutions:
2. Hypertonic Solutions:
3. Hypotonic Solution:
Measurement of Tonicity: 1. Hemolytic method: 2. Cryoscopic method or depression of freezing point:
Methods of adjusting the tonicity:
Class I methods:
In this type, sodium chloride or other substances are added to the solution in sufficient quantity to make it isotonic. Then the preparation is brought to its final volume withan isotonic or a buffered isotonic diluting solution.
These methods are of two types:
Cryoscopic method
Sodium chloride equivalent method.
Class II methods:
In this type, water is added in sufficient quantity make the preparation isotonic. Then the preparation is brought to its volume with an isotonic or a buffered isotonic diluting solution.
These methods are of two types:
White-Vincent method
Sprowls method.
Limt test Pharmaceutical Inorganic chemistry UNIT-I (Part-III) Limit Test.
Limit tests:- Factors affecting limit tests:
Specificity of the tests
Sensitivity
Control of personal errors (Analyst errors)
Test in which there is no visible reaction
Comparison methods
Quantitative determination
Limit test for Chloride: Principle, Procedure, observation and result.
Limit test for Sulphate: Principle, Procedure, observation and result
Limit test for Iron: Principle, Procedure, observation and result.
Limit test for Heavy metal: Principle, Procedure, observation and result.
Limit test for Lead: Principle, Procedure, observation and result.
Limit test for Arsenic: Principle, Gutzet test Procedure, detail in Gutzet Apparatus. observation and result.
Modifies Limit test for Chloride: Principle, Procedure, observation and result.
Modified Limit test for sulphate: Principle, Procedure, observation and result.
Types and Sources of impurities.pptx Pharmaceutical Inorganic chemistry UNIT-...Ms. Pooja Bhandare
Types and Sources of impurities. Pharmaceutical Inorganic chemistry UNIT-I (Part-II) Impurities:
Impure Chemical Compound
Pure Chemical Compound.
Types of impurities: Organic Impurity, Inorganic impurity, Residual solvent, Sources of Impurities in Pharmaceuticals
The different sources of impurities in pharmaceuticals are listed below:
Raw material used in manufacture
Reagents used in manufacturing process
Method/ process used in manufacture or method of manufacturing
Chemical processes used in the manufacture
Atmospheric contamination during the manufacturing process
Intermediate products in the manufacturing process
Defects in the manufacturing process
Manufacturing hazards
Inadequate Storage conditions
Decomposition of the product during storage
Accidental substitution or deliberate adulteration with spurious or useless materials.
Test for purity: Pharmacopoeia prescribes the “Test for purity” for pharmaceutical substances to check their freedom from undesirable impurities.
Pharmacopoeia will decide and fix the limit of tolerance for these impurities.
For certain common impurities for which pharmacopoeia prescribes the test of purity are:
Colour, odour, taste
Physicochemical constants (Iodine value, saponification value, melting point, refractive index etc.)
Acidity, alkalinity, pH
Humidity (Estimation of moisture)
Cations and anions
Insoluble Constituent or Residue.
Ash, Water insoluble ash
Arsenic or lead
Loss on drying
Loss on ignition.
Effect of Impurities
Introduction of Inorganic Chemistry, History of Pharmacopoeia.pptxMs. Pooja Bhandare
Introduction of Inorganic Chemistry, History of Pharmacopoeia, Pharmaceutical Chemistry, Inorganic Chemistry:
IMPORTANTS OF INORGANIC CHEMISTRY, Introduction of Pharmacopoeia, Types of Pharmacopoeia, History of pharmacopoeia, HISTROY OF INDIAN PHARMACOPOEIA
Content of pharmacopoeia Introduction including general Notices
Monographs of the official drugs
Appendices
Polyploidy, mutation and hybridization with reference to medicinal plants. PH...Ms. Pooja Bhandare
Polyploidy, mutation and hybridization with reference to medicinal plants. PHARMACOGNOSY & Phytochemistry-I (BP405T)Unit-IIPart-4
Polyploidy reference to medicinal plants.
Types Of Polyploidy
A. Euploidy
a.Autopolyploidy
b. Allopolyploidy
B. Aneuploidy
1. Causes Of Polyploidy
2. Non-disjunction in mitosis
3. Non-reduction in meiosis
4. Polyspermy
5. Endo-replication or Endo- reduplication.
Factors Promoting Polyploidy
1. Physical factor
2. Chemical factor
3. Biological factor
Physical factor:-
Temperature :- heat temperature & cold temperature
Centrifugation
X-rays
Gamma rays
Cosmic rays
Ionizing & non-ionizing radiations
UV-radiations
Chemical factor:-
Alkylating agents:- nitrogen & sulphur mustard
Acridines
Proflavins
Nitrous acid
Colchicines[6]
Colchicines (Poisonous alkaloids):-
Biological factor
Mode of reproduction
Mode of fertilization
Breeding system present (Hybridization)
Growth habit of the plant
Size of chromosomes
Application Of Polyploidy
Mutation breeding
Seedless fruits production
Bridge crossing
Ornamental & forage breeding
Disease resistance through aneuploidy
Industrial application of polyploidy
mutation reference to medicinal plants
Type of mutations:
1. Spontaneous and induced mutations.
2. Recessive and dominant mutations.
3. Somatic and germinal mutations.
4. Forward, back and suppressor mutation.
5. Chromosomal, genomic and point mutations
Application Of Mutation:
Hybridization reference to medicinal plants
The following steps are involved in hybridization of plant:
Choice Of Parents:.
Selfing Of Parents
Emasculation:.
Bagging:
Crossing Or Cross Pollination
Labelling
Collection Of Hybrid Seeds
Significance of Hybridization
PHARMACOGNOSY & Phytochemistry-I (BP405T)Unit-IIPart-2.FACTORS AFFECTING CULTIVATION
1. Altitude
2.Temperature
3. Rainfall
4. Day Length and Day Light
5. Soil
6. Soil Fertility
7. Fertilizers and Manures
a) Chemical fertilizers
(b) Manures
(c) Biofertilizers
8. Pests and Pests Control
a. Microbes
b) Insects
C) Non insect pests
d) Weeds
9. Other Factors that Affect the Cultivated Plants
a. Air Pollution
b. Herbicide
Cultivation and collections of drugs of natural origin..pptxMs. Pooja Bhandare
PHARMACOGNOSY & Phytochemistry-I (BP405T)Unit-IIPart-1Cultivation and collections of drugs of natural origin.
Advantages of cultivation
Methods of Plant Propagation
1.Sexual method (seed propagation)
2. Asexual method
Methods of sowing the seeds
Broadcasting Dibbling Miscellaneous
Special treatment to seeds
Asexual method.
Asexual method of vegetative propagation consists of three types:
a) Natural methods of vegetative propagation.
b) Artificial methods of vegetative propagation.
c) Aseptic method of micropropagation (tissue-culture).
COLLECTION OF CRUDE DRUGS
HARVESTING OF CRUDE DRUGS
DRYING OF CRUDE DRUGS
(1) natural (sun drying) and (2) artificial
Artificial Drying
Drying by artificial means includes drying the drugs in
(a) an oven; i.e. tray-dryers;
(b) vacuum dryers and
(c) spray dryers.
GARBLING (DRESSING)
PACKING OF CRUDE DRUGS
STORAGE & PRESEVATION OF CRUDE DRUGS
Quality control of Drugs of Natural Origin. PHARMACognosy & Phytochemistry-I ...Ms. Pooja Bhandare
Quality control of Drugs of Natural Origin PHARMACognosy & Phytochemistry-I (BP405T)Unit-I Part-3.
CONTENTS
Adulteration
Evaluation of adulteration
Morphological / Organoleptic evaluation
Microscopic evaluation
Quantitative evaluation
Physical evaluation
Chemical evaluation
Biological evaluation
Adulteration is of two types:
Indirect or Unintentional adulteration
Direct or Intentional adulteration
Intentional adulteration may be due to the following reasons
adulteration using manufactured substances
substitution using inferior commercial varieties
substitution using exhausted drugs
substitution of superficially similar inferior natural substance
adulteration using the vegetative part of the same plant
addition of toxic materials
adulteration of powders
addition of synthetic principles
Evaluation of Crude Drugs
1. ORGANOLEPTIC EVALUATION
2. MICROSCOPICAL EVALUATION
Stomatal index Vein-islet number
Veinlet termination number
Palisade ratio
Quantitative Microscopy (Lycopodium Spore Method)
3.CHEMICAL EVALUATION
4. Physical Evaluation
I. Solubility
II. Optical Rotation
III. Refractive Index
III. Specific Gravity
IV Viscosity
V. Melting Point
VI. Moisture Content
VII. Ultraviolet Light
VIII. Ash Values
Total ash
Acid-insoluble ash
The water-soluble ash
IX. Extractive Values
X. Foreign Organic Matters
5. BIOLOGICAL EVALUATION
Toxicity
Oxytocic activity
Microbiological assays
Classification of Crude Drugs. HARMACognosy & Phytochemistry-I (BP405T)Unit-I...Ms. Pooja Bhandare
Classification of Crude Drugs.PHARMACognosy & Phytochemistry-I (BP405T)Unit-I Part-2.
A method of classification should be:
a) simple,
b) easy to use, and
c) free from confusion and ambiguities.
TYPES OF CLASSIFICATION.
1.Alphabetical classification
2.Taxonomical classification
3.Morphological classification
4.Pharmacological classification
5.Chemical classification
6.Chemotaxonomical classification
7. Serotaxanomical Classification
Animal Cell Culture: Growth of animal cells in culture. PHARMACEUTICAL MICROB...Ms. Pooja Bhandare
PHARMACEUTICAL MICROBIOLOGY (BP303T)Unit-VPart-4
Animal Cell Culture: Growth of animal cells in culture.
Introduction: Histroy, The culture media used for animal cell culture are classified as,
Natural, Artificial, Synthesized
Natural Culture Media:
a. Blood Plasma:
b. Blood Serum:
c. Tissue Extracts:
Artificial Media
Some common examples of artificial media are,
Minimal Essential Medium (MEM),
CMRL 1066,
RPMI 1640.
Synthetic media re classified as,
Serum Containing Media.
Serum Free Media.
a. Serum Containing Media:
b. Serum Free Media:
Physicochemical Parameters needed for growth animal cell culture:
General procedure for cell Culture.
Isolation of the tissue:
Disaggregation of the Tissue:
Mechanical disaggregation
b. Enzymatic Disaggregation
. Trypsin based disaggregation or trypsinization:
Warm trypsinization:
Cold trypsinization:
Drawbacks of trypsin disaggregation:
B. Collagenase based disaggregation:
C. Chelating Agents:
3. Seeding of Culture:
Classification and mode of action of disinfectants PHARMACEUTICAL MICROBIOLOG...Ms. Pooja Bhandare
PHARMACEUTICAL MICROBIOLOGY (BP303T)Unit-III Classification and mode of action of disinfectants. DISINFECTANT
Definition: Ideal properties of disinfectants: CLASSIFICATION OF DISINFECTANTS: Based on consistency 1. Liquid (E.g., Alcohols, Phenols) 2.Gaseous (Formaldehyde vapor, Ethylene oxide). Based on spectrum of activity 1. High level disinfectant
2. Intermediate level disinfectant
3. Low level disinfectant .Based on mechanism of action: 1.Action on membrane2.Denaturation of cellular proteins 3.Damage to nucleic acids 4.Oxidation of essential sulfhydryl groups of enzymes 5.Alkylation of amino-, carboxyl- and hydroxyl group. MODE OF ACTION AND APPICATION OF DISINFECTANT
Acid and alkalies
Halogens
Heavy metals
Phenols and its derivatives
Alcohol
Aldehydes
Dyes:
Quaternary ammonium compounds
Detergents and soaps.
VIRUS PHARMACEUTICAL MICROBIOLOGY (BP303T)Unit-IIIPart-2Study of morphology, ...Ms. Pooja Bhandare
PHARMACEUTICAL MICROBIOLOGY (BP303T)Unit-IIIPart-2Study of morphology, classification, reproduction/replication and cultivation of Virus. Introduction, Def General characteristics of Viruses: small size characteristic shapes, obligate intracellular parasites no built-in metabolic machinery no ribosomes
only one type of nucleic acid
do not grow in size. Morphology of Virus: Helical, Polyhedral (Icosahedral) Viral Envelop, Complex virus, Classification of virus. Viral Replication LIFE CYCLE OF BACTIRIOPHAGES Lytic cycle: Attachment, Penetration, Biosynthesis, Maturation and Release of progeny Phage Particles. The Lysogenic Cycle, Cultivation of virus : Animal inoculation, Embryonated eggs or chick embryo method and Tissue culture or cell culture: Organ cultures Explant culture and Cell culture. Types of cell culture
1.Primary cell culture: 2. Diploid cell culture (Semi-continuous cell lines):3. Heteroploid cultures (Continuous cell lines):
MULTIPLICATION OF HUMAN VIRUS:1. Attachment of Viral Particles 2. Penetration 3. Uncoating 4. Replication Of Viral Nucleic Acids And Translation Of The Genome 5) Maturation Or Assembly Of Virions. ) 6. Release Of Virions Into The Surrounding Environment
Embracing GenAI - A Strategic ImperativePeter Windle
Artificial Intelligence (AI) technologies such as Generative AI, Image Generators and Large Language Models have had a dramatic impact on teaching, learning and assessment over the past 18 months. The most immediate threat AI posed was to Academic Integrity with Higher Education Institutes (HEIs) focusing their efforts on combating the use of GenAI in assessment. Guidelines were developed for staff and students, policies put in place too. Innovative educators have forged paths in the use of Generative AI for teaching, learning and assessments leading to pockets of transformation springing up across HEIs, often with little or no top-down guidance, support or direction.
This Gasta posits a strategic approach to integrating AI into HEIs to prepare staff, students and the curriculum for an evolving world and workplace. We will highlight the advantages of working with these technologies beyond the realm of teaching, learning and assessment by considering prompt engineering skills, industry impact, curriculum changes, and the need for staff upskilling. In contrast, not engaging strategically with Generative AI poses risks, including falling behind peers, missed opportunities and failing to ensure our graduates remain employable. The rapid evolution of AI technologies necessitates a proactive and strategic approach if we are to remain relevant.
Honest Reviews of Tim Han LMA Course Program.pptxtimhan337
Personal development courses are widely available today, with each one promising life-changing outcomes. Tim Han’s Life Mastery Achievers (LMA) Course has drawn a lot of interest. In addition to offering my frank assessment of Success Insider’s LMA Course, this piece examines the course’s effects via a variety of Tim Han LMA course reviews and Success Insider comments.
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!
Introduction to AI for Nonprofits with Tapp NetworkTechSoup
Dive into the world of AI! Experts Jon Hill and Tareq Monaur will guide you through AI's role in enhancing nonprofit websites and basic marketing strategies, making it easy to understand and apply.
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.
The Roman Empire A Historical Colossus.pdfkaushalkr1407
The Roman Empire, a vast and enduring power, stands as one of history's most remarkable civilizations, leaving an indelible imprint on the world. It emerged from the Roman Republic, transitioning into an imperial powerhouse under the leadership of Augustus Caesar in 27 BCE. This transformation marked the beginning of an era defined by unprecedented territorial expansion, architectural marvels, and profound cultural influence.
The empire's roots lie in the city of Rome, founded, according to legend, by Romulus in 753 BCE. Over centuries, Rome evolved from a small settlement to a formidable republic, characterized by a complex political system with elected officials and checks on power. However, internal strife, class conflicts, and military ambitions paved the way for the end of the Republic. Julius Caesar’s dictatorship and subsequent assassination in 44 BCE created a power vacuum, leading to a civil war. Octavian, later Augustus, emerged victorious, heralding the Roman Empire’s birth.
Under Augustus, the empire experienced the Pax Romana, a 200-year period of relative peace and stability. Augustus reformed the military, established efficient administrative systems, and initiated grand construction projects. The empire's borders expanded, encompassing territories from Britain to Egypt and from Spain to the Euphrates. Roman legions, renowned for their discipline and engineering prowess, secured and maintained these vast territories, building roads, fortifications, and cities that facilitated control and integration.
The Roman Empire’s society was hierarchical, with a rigid class system. At the top were the patricians, wealthy elites who held significant political power. Below them were the plebeians, free citizens with limited political influence, and the vast numbers of slaves who formed the backbone of the economy. The family unit was central, governed by the paterfamilias, the male head who held absolute authority.
Culturally, the Romans were eclectic, absorbing and adapting elements from the civilizations they encountered, particularly the Greeks. Roman art, literature, and philosophy reflected this synthesis, creating a rich cultural tapestry. Latin, the Roman language, became the lingua franca of the Western world, influencing numerous modern languages.
Roman architecture and engineering achievements were monumental. They perfected the arch, vault, and dome, constructing enduring structures like the Colosseum, Pantheon, and aqueducts. These engineering marvels not only showcased Roman ingenuity but also served practical purposes, from public entertainment to water supply.
Biological screening of herbal drugs: Introduction and Need for
Phyto-Pharmacological Screening, New Strategies for evaluating
Natural Products, In vitro evaluation techniques for Antioxidants, Antimicrobial and Anticancer drugs. In vivo evaluation techniques
for Anti-inflammatory, Antiulcer, Anticancer, Wound healing, Antidiabetic, Hepatoprotective, Cardio protective, Diuretics and
Antifertility, Toxicity studies as per OECD guidelines
Instructions for Submissions thorugh G- Classroom.pptxJheel Barad
This presentation provides a briefing on how to upload submissions and documents in Google Classroom. It was prepared as part of an orientation for new Sainik School in-service teacher trainees. As a training officer, my goal is to ensure that you are comfortable and proficient with this essential tool for managing assignments and fostering student engagement.
A Strategic Approach: GenAI in EducationPeter Windle
Artificial Intelligence (AI) technologies such as Generative AI, Image Generators and Large Language Models have had a dramatic impact on teaching, learning and assessment over the past 18 months. The most immediate threat AI posed was to Academic Integrity with Higher Education Institutes (HEIs) focusing their efforts on combating the use of GenAI in assessment. Guidelines were developed for staff and students, policies put in place too. Innovative educators have forged paths in the use of Generative AI for teaching, learning and assessments leading to pockets of transformation springing up across HEIs, often with little or no top-down guidance, support or direction.
This Gasta posits a strategic approach to integrating AI into HEIs to prepare staff, students and the curriculum for an evolving world and workplace. We will highlight the advantages of working with these technologies beyond the realm of teaching, learning and assessment by considering prompt engineering skills, industry impact, curriculum changes, and the need for staff upskilling. In contrast, not engaging strategically with Generative AI poses risks, including falling behind peers, missed opportunities and failing to ensure our graduates remain employable. The rapid evolution of AI technologies necessitates a proactive and strategic approach if we are to remain relevant.
June 3, 2024 Anti-Semitism Letter Sent to MIT President Kornbluth and MIT Cor...Levi Shapiro
Letter from the Congress of the United States regarding Anti-Semitism sent June 3rd to MIT President Sally Kornbluth, MIT Corp Chair, Mark Gorenberg
Dear Dr. Kornbluth and Mr. Gorenberg,
The US House of Representatives is deeply concerned by ongoing and pervasive acts of antisemitic
harassment and intimidation at the Massachusetts Institute of Technology (MIT). Failing to act decisively to ensure a safe learning environment for all students would be a grave dereliction of your responsibilities as President of MIT and Chair of the MIT Corporation.
This Congress will not stand idly by and allow an environment hostile to Jewish students to persist. The House believes that your institution is in violation of Title VI of the Civil Rights Act, and the inability or
unwillingness to rectify this violation through action requires accountability.
Postsecondary education is a unique opportunity for students to learn and have their ideas and beliefs challenged. However, universities receiving hundreds of millions of federal funds annually have denied
students that opportunity and have been hijacked to become venues for the promotion of terrorism, antisemitic harassment and intimidation, unlawful encampments, and in some cases, assaults and riots.
The House of Representatives will not countenance the use of federal funds to indoctrinate students into hateful, antisemitic, anti-American supporters of terrorism. Investigations into campus antisemitism by the Committee on Education and the Workforce and the Committee on Ways and Means have been expanded into a Congress-wide probe across all relevant jurisdictions to address this national crisis. The undersigned Committees will conduct oversight into the use of federal funds at MIT and its learning environment under authorities granted to each Committee.
• The Committee on Education and the Workforce has been investigating your institution since December 7, 2023. The Committee has broad jurisdiction over postsecondary education, including its compliance with Title VI of the Civil Rights Act, campus safety concerns over disruptions to the learning environment, and the awarding of federal student aid under the Higher Education Act.
• The Committee on Oversight and Accountability is investigating the sources of funding and other support flowing to groups espousing pro-Hamas propaganda and engaged in antisemitic harassment and intimidation of students. The Committee on Oversight and Accountability is the principal oversight committee of the US House of Representatives and has broad authority to investigate “any matter” at “any time” under House Rule X.
• The Committee on Ways and Means has been investigating several universities since November 15, 2023, when the Committee held a hearing entitled From Ivory Towers to Dark Corners: Investigating the Nexus Between Antisemitism, Tax-Exempt Universities, and Terror Financing. The Committee followed the hearing with letters to those institutions on January 10, 202
2. Assessmentof microbial contamination andspoilage
• Assessment of microbial contamination and spoilage is done as following,
1. Physical and chemical changes:
• The changes of different pharmaceutical formulations indicate microbial
contamination and spoilage.
• Change in viscosity, pH, emulsion stability and loss of surface activity of
formulation indicates microbial spoilage.
• Measurement of oxygen consumption of the product can teel us the degree of
oxidative attack and microbial growth
3. 2. Assessment of viable microorganisms in non-sterile products:
• Non-sterile products are tested for viable microorganisms for detection of pathogens
and total viable counts.
• In microbiological terms, pharmaceutical products can be divided into two groups:
sterile and nonsterile.
• Non-sterile drugs must satisfy the appropriate microbiological purity criteria by
passing Microbial limit testwhich are included in pharmacopoeial monographs.
• Pharmacopoeial studies are prepared specifically with a view to ensuring that the
medicinal product is therapeutically effective and safe for the patient.
4. 3. Sterility test:
• Sterility Testing confirms that products are free from the presence of viable
microorganisms.
• Test is conducted by competent and experienced personnel in an adequately
clean room with laminar flow cabinet facilities.
• All injectables and ophthalmic preparations are sterile hence, these
preparations are tested by the sterility test.
5. 4. Estimation of pyrogens:
• Pyrogen is a substance, typically produced by a bacterium, which produces
fever when introduced or released into the systemic circulation.
• The lipopolysaccharides and lipoproteins which comprises a major part of the
cell wall of Gram –ve bacteria are called endotoxins which are the most
commonly called pyrogens.
• To test the pyrogens presence, two tests are used
• 1. RP Test (Rabbit Pyrogen Test)
• 2. LAL Test (Limulus Amoebocyte Lysate Test).
6. Microbial Limit Tests:
• The microbial content of non sterile dosage forms, herbal products, herbs and processed
herbals are controlled by using following methods,
• Estimation of total viable aerobic microbes in a given sample (Total Viable Count).
• Detection of specific species of microbe in the sample.
• These microbial limit tests are mainly applicable to the raw materials of natural or
biological origin (e.g. Starch, Gelatin etc) and some finished products like Calamine lotion,
Dried Aluminium Hydroxide Gel, Betamethasone valerate ointments etc.
• Detection of specific microbes includes Escherichia coli, Staphylococcus aureus,
Pseudomonas aeruginosa, Salmonella, Shigella, Clostridia and Candida albicans as per
Indian Pharmacopoeia 2014.
7. Total Aerobic Microbial Count:
• The total count of viable aerobic microbes per unit weight or volume of the sample is a very commonly used
technique in microbiology.
• However, it is necessary first to determine the presence of antimicrobial substances in the sample.
• For determination of total aerobic microbial count, it is necessary to pretreat the samples as per specifications
given in I.P..
• Total aerobic count of the test samples is determined by the following methods.
• Membrane Filtration.
• Plate Count Methods.
• Pour Plate Method.
• Surface spread Method.
• Most Probable Number(MPN)
8. 1. Membrane Filtration:
• For this use: filter 50 mm in diameter and pore size not greater than 0.45µm.
• Procedure:
• Filter 10 ml or quantity of each dilution containing 1 gm of the preparation through each two membrane filters
immediately.
• If necessary the pretreated solution to be diluted to make up the volume.
• Wash each membrane by filtering it through three quantities of buffered sodium chloride peptone solution (For
fatty substances add Polysorbate 20/80 in the solution.)
• Transfer the membranes each to the surface of Casein Soybean Digest Agar plate and Sabouraud Dextrose Agar
plate with antibiotics.
• Incubate the plates @ 30 to 35 ℃ for 3-5 days for testing bacteria and 5-7 days for fungi.
• Calculate no. of microbes per gm or per ml of the sample
9.
10. 2. Plate Count Methods:
a. Pour Plate Method:
• Mix 1 ml of pretreated sample and about 15 ml of liquified Casein Soybean Digest Agar
plate or Sabouraud Dextrose Agar in petri dishes (9 cm diameter) with antibiotics @ 45 ℃.
• If necessary dilute the sample so that colony count of not more than 300 is obtained.
• Incubate the Casein Soybean Digest Agar plate @ 30 to 35 ℃ for 3-5 days.
• Incubate the Sabouraud Dextrose Agar plate @ 20 to 25 ℃ for 2-7 days.
• Select the plates containing not less than 30 and not more than 250 colonies of bacteria and
30-50 colonies of fungi.
• Calculate no. of microbes per gm or per ml of the sample.
11. 2. Surface spread Method:
• Add 15 ml of liquified Casein Soybean Digest Agar plate or Sabouraud Dextrose Agar in petri
dishes (9 cm diameter) with antibiotics @ 45 ℃ and allow to solidify them.
• Dry the plates under laminar air flow or in an incubator.
• Spread a measured volume of not less than 0.1 ml of pretreated sample over the plates.
• Use at least two plates for each sample and each strain of test microbe.
• Incubate the Casein Soybean Digest Agar plate @ 30 to 35 ℃ for 3-5 days.
• Incubate the Sabouraud Dextrose Agar plate @ 20 to 25 ℃ for 2-7 days.
• Select the plates containing not less than 30 and not more than 250 colonies of bacteria and 30-50
colonies of fungi.
• Calculate no. of microbes per gm or per ml of the sample
12.
13. 3) Most Probable Number (MPN):
• Also known as “Multiple Tube method” or “Serial Dilution
Method”.
• The accuracy is less than filtration and plate count methods and hence
is carried out only when they are not suitable.
14. Procedure:
• Prepare a series of at least three subsequent ten fold dilutions of the product as described in
the pretreatment of the sample.
• From each level of dilution, thee aliquots of 1 gm or 1ml are used to inoculate three tubes
with 9 ml of Sterile Casein Soybean Digest Broth.
• Hence if three levels of dilutions are prepares then 9 test tubes will be used and likewise.
• Incubate all the test tubes @ 30 to 35 ℃ for 3-5 days.
• Record for each level of the dilution the number of tubes are showing microbial growth.
• Determine the most probable number of bacteria per gm or per ml of the product as per
image bellow.