Designing of aseptic area including design, construction, service, flow chart,source of contamination, method of prevention of it,clean area classification as per USPDA.
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
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
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.
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)
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
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
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.
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)
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
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:
Quantitative approach to the to the factor influcing solubility of drug; (Sol...Ms. Pooja Bhandare
Quantitative approach to the to the factor influcing solubility of drugs, Temperature,Nature of solvent, The boiling point of the liquids and the melting point of solids,Crystal properties:
Particle size (surface area ) of drug particles: The influence of substituent’s in molecular structures, Molecular size:
. pH :
Fluid energy mill for pharmacy principles, construction, working, uses, meri...ASHUTOSH SENGAR
this is an slideshare for pharmacy students, principles, construction, working, uses, merits and
demerits of , fluid energy mill its for b. pharm. and M. PHARM
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.
Solubility of liquids in liquids, The term miscibility refers to the mutual solubility of the component of liquid - liquid system, Raoult’s Law, Raoult’s law may be mathematically expressed as: Ideal solution, Real solution
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.
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
Complexation and Protein Binding [Part-2](Method of analysis, Complexation a...Ms. Pooja Bhandare
Method of Analysis: Methods of continuous variation / JOB’S method of continuous variation.
pH titration method.
Distribution method.
Solubility method.
Spectroscopy and charge transfer complexation.
Miscellaneous method
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
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.
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
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:
Quantitative approach to the to the factor influcing solubility of drug; (Sol...Ms. Pooja Bhandare
Quantitative approach to the to the factor influcing solubility of drugs, Temperature,Nature of solvent, The boiling point of the liquids and the melting point of solids,Crystal properties:
Particle size (surface area ) of drug particles: The influence of substituent’s in molecular structures, Molecular size:
. pH :
Fluid energy mill for pharmacy principles, construction, working, uses, meri...ASHUTOSH SENGAR
this is an slideshare for pharmacy students, principles, construction, working, uses, merits and
demerits of , fluid energy mill its for b. pharm. and M. PHARM
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.
Solubility of liquids in liquids, The term miscibility refers to the mutual solubility of the component of liquid - liquid system, Raoult’s Law, Raoult’s law may be mathematically expressed as: Ideal solution, Real solution
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.
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
Complexation and Protein Binding [Part-2](Method of analysis, Complexation a...Ms. Pooja Bhandare
Method of Analysis: Methods of continuous variation / JOB’S method of continuous variation.
pH titration method.
Distribution method.
Solubility method.
Spectroscopy and charge transfer complexation.
Miscellaneous method
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
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.
Aseptic techniques are employed to provide protection to ophthalmic and parenteral products by preventing the entry of microbial and particulate contamination.
Prevention of microbial contamination is also required to remove pyrogens and toxic bacterial products.
Maintenance of aseptic condition, in plant tissue cultureKAUSHAL SAHU
Introduction
Aseptic technique
Sterilizing the culture vessels and instruments
Sterilization of culture media
Sterilizing Transfer area
Sterilizing culture rooms
Sterilizing Plant material
Transfer of the explants
Conclusions
References
These are the sterile preparation intended to administered other than intestinal route to bypass first pass metabolism and directly goes to systemic circulation.
These preparation give quick onset of action and site specific activity.
Suitable for drugs which are inactive in GIT environment.
Can be given unconscious or vomiting or diarrheal patient.
These are the sterile preparation intended to administered other than intestinal route to bypass first pass metabolism and directly goes to systemic circulation.
These preparation give quick onset of action and site specific activity.
Suitable for drugs which are inactive in GIT environment.
Can be given unconscious or vomiting or diarrheal patient.
Animal Cell culture by S.D.Mankar, Pravara Rural college of Pharmacysomeshwar mankar
Growth of animal cells in culture, general procedure for cell culture,
Primary, established and transformed cell cultures.
Application of cell cultures in pharmaceutical industry and research.
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.
Disinfection, Definition, classification,Mode of action, factors affecting & ...someshwar mankar
Disinfection, Definition, classification,Mode of action, factors affecting & Evaluation of disinfectant as per bacteriostatic & Bacteriocidal action
Department of Pharmaceutics,PRCOP,Loni
The French Revolution, which began in 1789, was a period of radical social and political upheaval in France. It marked the decline of absolute monarchies, the rise of secular and democratic republics, and the eventual rise of Napoleon Bonaparte. This revolutionary period is crucial in understanding the transition from feudalism to modernity in Europe.
For more information, visit-www.vavaclasses.com
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
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
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.
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.
1. Design of Aseptic Area
By S.D.Mankar
Assistant Professor
Department Of Pharmaceutics
Pravara Rural College Of Pharmacy,Pravaranagar
S.D.Mankar
2. Definition:-
Aseptic techniques are used to prevent microbial contamination or
infection in parenteral or ophthalmic preparations.
Aseptic area:-
Is a room with a clean area design, constructed, serviced and used
with the intension of preventing microbial contamination of product.
S.D.Mankar
3. Building design, Construction and Production
Facilities
•Production of sterile products should be carried out in a clean environment
with a limit for the environmental quality of microbial and dust particle
contamination.
•This limit for contamination is necessary to reduce the product
contamination.
•The production area is normally divided into the clean-up area, the
compounding area, the aseptic area, the quarantine area and the packaging
area.
S.D.Mankar
5. Floors, walls and ceilings
•All clean surfaces including the floor, walls and ceilings must be smooth,
easy to clean, disinfected and be constructed to minimize microbial and
particulate contamination.
•Flexing and non-flexing types of materials are used for construction of floor.
•Flexing floor materials are made up of synthetic elastromers of which most
commonly used are polyvinylchloride (PVC). PVC flooring is easily repaired,
cleaned, relatively cheap and simple.
•Non-flexing floors are made of hard inorganic filler substances in a matrix
material. When a concrete is used it must be adequately sealed with a
material resistant to chemicals, solvents and cleaning fluids.
S.D.Mankar
6. Floors, walls and ceilings
• Walls must be made up of non-inflammable or fire resistant material e.g: Stainless
steel, glass, enamelled steel etc.
• Generally plaster walls are easily damaged by the impact.
• For reductionof fungal growth , 1% of 8-hydroxyquinolone,
pentachlorophenol etc may be added to the paint.
• Epoxy resin paints and polyurethane paints are also used to avoid cracking and peeling.
• The ceilings are sealed to prevent the entry of microbial contaminants.
• Internal fittingssuch as a cupboards, drawers, shelves,
and equipments must be kept to a minimum.
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7. Doors, windows and services
illumination and are not for
• Doors and windows should fit flush with the walls.
• Windows if required , are solely to provide
ventilation.
• Windows should be non-openable.
• Doors should be well fitted by maintaining the positive pressure air flow and self
closing. Doors must be limited in number.
• All pipes passing through the walls of the room should be effectively sealed and
should be flush fitting and easily cleaned.
• Gas cylinders should be excluded and all gases should be piped from outside the
area.
• Sinks and drains must be excluded from the areas where aseptic procedures are
performed in clean room areas.
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8. Doors, windows and services
•Light sources in clean rooms are fitted with the ceilings to reduce the
collection of the dust and to avoid the disturbance of the air flow pattern
with in the room.
•Non essential switches such as room lighting switches should be
installed outside the clean area.
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9. Personnel and protective clothing
• The main source of contamination of clean areas arises from skin
scales which are released by the operators.
• Personnel selected to work on the preparation of the parenteral
products must be neat and reliable.
• They should be in good health and free from dermatological
conditions that might increase the microbial load.
• Operator –borne contamination can be controlled by limiting the
number of operators in clean area.
• All personnel should be trained for good manufacturing practices and
aseptic techniques.
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10. Personnel and protective clothing
• The operator should wear sterile protective clothing
including head wear, powder free rubber or plastic
gloves, a non-fibre shedding facemask and footwear.
• All protective clothing is designed to prevent the
contamination from the body.
• All protective clothing must be sterilized by moist heat
sterilization or ethylene oxide sterilization.
• Fresh sterile clothing should normally be provided each
time the person enters the aseptic area.
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11. Cleaning and disinfection
• Cleaning and disinfection procedures are used for the removal of
microbial and particulate contamination.
• Cleaning agents are the alkaline detergents, non-ionic and ionic
surfactants.
• Different types of disinfectants should be employed in rotation to
prevent the development of resistant strains of microorganisms.
• Different concentration of quarternary ammonium compounds,
sodium hypochloride, ethanol and formaldehyde solutions are used
as disinfectants in cleaning area.
• Cetrimide or chlorhexidine in 70% alcohol are suitable for use as skin
disinfectants.
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12. Air Supply
• The air supplied to a clean room must be filtered through high efficiency
particulate air (HEPA) filters.
• The HEPA filter must be positioned at the inlet of the clean room and the pre-
filter may be fitted upstream of the HEPA filters to prolong the life of final filter.
• HEPA filters are used in the construction of vertical and horizontal laminar air
flow bench.
• The air filtered from the laminar air flow is claimed to be 99.97% free from the
microbial contamination.
• These filters are supported to provide class 100 air and they should be certified
every 6 to 12 months.
• Air quality is evaluated using settle plates, microbial air sampler or by particle
counters.
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13. DOP test:- dioctylpthalate test
These is universally acceptable challenge for HEPA filters.
DOP smoke is introduced at supply plenum and photometer pro scan the
surface of filter for smoke particles.
DOP is volatile liquid and under pressure it converts to vapour or smoke of
size 0.3 to 0.4 micrometer.
Leakage of filter will permit the DOP particle to escape and this would be
detected by photometer.
Sensors are fitted upstream and down stream of the filter to indicate the
pressure difference across the pressure & alarm the steam should be used
to indicate the failure in air supply or filter blockage.
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14. Laminar flow equipment
1. Vertical laminar air flow bench
2. Horizontal laminar air flow bench
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18. Air flow pattern
The air flow pattern within the clean room must be carefully regulated
to avoid generating particles from the clean room floor, walls and
operators.
The general airflow patterns in in clean rooms are,
1. Unidirectional airflow
2. Non-unidirectional airflow
3. Combined airflow
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22. Sources of contamination in aseptic area
and method to prevention
1. Atmosphere
2. Water
3. Raw material
4. Process operators
5. Equipment
6. Building
7. Packaging
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23. Sources of contamination in aseptic area and
method to prevention
• Contamination, in broad sense, is the presence of
minor unwanted particulate matter called
contaminants in atmosphere, physical body, etc.
• Right from production to packaging almost every
sector of pharmaceutical industry comes across
contamination.
• The most common sources of contamination fall
into the following three main categories:
• Atmospheric contamination
• Fluid contamination
• Transfer contaminants
24. 1.Atmospheric contamination
• Atmospheric conditions during manufacturing as
well as during storage affects the quality of final
preparation.
• Atmosphere in and around the industrial area
contains potential contaminants like dust, silica, etc
and gases like CO2 , water vapour, etc.
• Besides the above mentioned contaminants,
microorganisms like P.aeruginosa, A.niger, etc.
• These contaminants may get incorporated into the
end product either during the process of
manufacturing or during purification.
25. Prevention:
• Prior to its entry into the working area, the air
should be initially passed through a suitable pre-
filter then treated with an electrostatic
precipitator and finally through HEPA filters.
• Periodic removal of air-borne dust settled on
walls, floors and ceilings is essential.
26. 2.Fluid contamination
• Besides serving as the most common solvent in
pharmaceutical industry, water also serves as the
greatest solvent in pharmaceutical industry.
• Although, it is deprived of most of the
contaminants yet it contains pyrogens and traces
of sulphates, chlorides and carbonates of Ca, Mg
and Na.
• Therefore, usage of water for washing the
machineries and working areas may leave traces
of these contaminants.
27. Prevention:
• Almost all of the pharmaceutical operations
should be carried out using purified water
obtained upon deionization, distillation, ionexchange,
reverse osmosis, filtration or other similar processes.
• For the preparation of parenterals, water for
injection, sterile water for injection or
bebacteriostatic water for injection must
employed.
28. 3.Transfer contaminants
• Transfer contaminants refer to the contaminants sourced
from personnel and wheels of trolleys used for transport
of goods.
• Personnel working in aseptic areas, if suffering from cold,
allergies, dermatological conditions or any similar illness
carry multiple microorganisms which upon expulsion into
atmosphere via sneezing, coughing, talking etc., can lead
to contamination.
• For example, atmospheric dust particles may get
entangled with the fibres of the clothes which can get
dislodged due to body movements and lead to
contamination.
29. Prevention:
• Personnel should be well trained and periodically
evaluated in the principles of aseptic processing
and techniques to be employed before participating
in the preparation of sterile products.
• Apart from gown, the personnel area also required
to put on face mask, head cap, gloves, foot covers
and even goggle to ensure complete coverage of all
skin areas.
• The entrance of most of the working areas is
equipped with air blowers that aid in removing any
loose dirt, lint from uniform of the operators.
30. • Those mechanical parts of the equipments that
come in contact with the parenteral products
should be demountable(removed from its
setting) which enables their easy cleaning and
sterilization.
• All the apparatus and their carriers being
carried to the aseptic areas should be sterilized
by suitable methods.
Assignment on Air sampling Method
31. Operator:-
The skin, hair & clothing of the operator are potent sources of microbial
contamination.
Poor personal hygiene can result in skin coliforms & other essential
Open wounds are a source of saprophytic & Pathogenic M.O.
The nasal passages may contain staphylococcus aureus, S.Albus &
pharynges etc.
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32. Raw Materials:-
Drug which are prepared from animal, plant or other natural sources
are frequently contaminated with bacteria, yeast & moulds.
Water is also a prime source of microbial & particulate contamination.
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33. Equipments :-
Working surface & external surfaces of equipment are also potential
sources of contamination due to sedimentation of particles and
droplets from the atmosphere.
Equipments may sterilize or disinfected by using different thinghs.
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34. Testing of clean & Aseptic Rooms:-
To provide satisfactory conditions for the proper processing of
parenterals, it is necessary to monitor the area by suitable
environmental control tests.
1.General methods:-
Used to validate HEPA filter, detect particulate contamination and
monitor the environment.
These methods include filter efficiency test, induction leak test,
particulate contamination test, air pressure test, air flow test, noise
test, lightining test, temp & humidity test.
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35. 2. Air Sampling methods:-
i) Electronic air particle counters:-
Useful in determining the number of particle/ microbes counts per
cubic feet to classify the cleanliness of a particular room or area.
ii) Settle plates:-
A nutrient agar or other suitable medium is exposed to the
in the sampling area for predetermined period.
Plates are incubated at 30 to 35 ° C for 48 hrs. and colonies are
counted.
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36. Iii) slit air sampler:-
This is a device that collects viable air born microbial & particulate
contamination.
Trypticase soy agar may be used.
Iv) Liquid impinge:-
The air sample may be drawn into measured volume of nutrient
in an impinger.
V) centrifugal air sampler:-
A device by applying centrifugal force the microbial particles are
impacted at high velocity onto agar surface of the agar strips around
the impeller blades.
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37. 3) Surface sampling methods:-
i) Rodac Plates:-
specially built convex surface petri plates.it is possible to roll the
agar surface over flat or irregular surfaces to be tested.
Ii) swab rinse test:-
Sterile cotton swab tips to sample locations. The swabs then placed
into tubes of culture media or sterile water. And sample of the water
placed on a solid agar plate.
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39. Clean area classification
Grade Maximum permitted number of particles /m3
At Rest In Operation
0.5 µm 5 µm 0.5 µm 5 µm
A 3,520 20 3,520 20
B 3,520 29 352,000 2,900
C 352,000 2,900 3,520,000 29,000
D 3,520,000 29,000 Not defined Not defined
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40. Clean Area Classification:-
Potential sources of microbial and particle contaminants occurring
within the clean room are the air supply of the room, inflow of
air & production contaminants within the room.
Class 10,000 conditions means that not more than 10,000 particles per
cubic foot of size 0.5 μm or greater.
The more stringent British standard class 1 approx. to Usfederal
standard class 100 and is the standard applicable to aseptic areas.
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