This document discusses the design and operation of an aseptic area for producing sterile pharmaceutical products. It describes the different sections of the aseptic area including the clean-up, compounding, aseptic, quarantine, and packaging/labeling areas. It provides details on airflow, filtration, surfaces, clothing, cleaning procedures, and sources of potential contamination. The goal is to maintain sterile conditions and limit contamination that could compromise the sterile products being produced.
Designing of aseptic area including design, construction, service, flow chart,source of contamination, method of prevention of it,clean area classification as per USPDA.
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
Designing of aseptic area including design, construction, service, flow chart,source of contamination, method of prevention of it,clean area classification as per USPDA.
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
Assessment of microbial contamination and spoilage. PHARMACEUTICAL MICROBIOLO...Ms. Pooja Bhandare
PHARMACEUTICAL MICROBIOLOGY (BP303T)Unit-VPart-2
Assessment of microbial contamination and spoilage.
Assessment of microbial contamination and spoilage
1. Physical and chemical changes:
2. Assessment of viable microorganisms in non-sterile products:
3. Sterility test:
4. Estimation of pyrogens:
Microbial Limit Tests:
Total Aerobic Microbial Count:
Membrane Filtration.
Plate Count Methods.
Pour Plate Method.
Surface spread Method.
Most Probable Number(MPN)
Types of spoilage, factors affecting the microbial spoilage of pharmaceutical...Ms. Pooja Bhandare
PHARMACEUTICAL MICROBIOLOGY (BP303T)Unit-V Part-1
Types of spoilage, factors affecting the microbial spoilage of pharmaceutical products, source and type of contaminants. Introduction: Defintion Types of Microbial Spoilage:
1. Infection induced due to contaminated pharmaceutical products: Table no. 1.1 Common pathogens spoiling pharmaceutical products:
2. Physicochemical spoilage –
i) Viable growth ii) Gas production
iii) Colouration / Decolouration
iv) Odour formation
v) Taste change
3. Physical Spoilage:
Cracking of emulsion:
Odor changes
4. Biological spoilage:
Microbial Toxins
Microbial Metabolites
5. Chemical spoilage: Table 1.2 Susceptibility of pharmaceutical ingredients to microbial contamination
Factors affecting microbial spoilage
Size of contaminant inoculum
Nutritional factors
Moisture content
pH
Storage temperature
Redox potential
Packaging design
Sources and Types Of Contamination:
Personnel,
Poor facility design,
Incoming ventilation air,
Machinery and other equipment for production,
Raw material and semi-finished material,
Packaging material,
Utilities,
Different media used in the production process as well as for cleaning and Cleanroom clothing.
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:
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
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
Solubility of drugs: Solubility expressions, mechanisms of solute solvent interactions, ideal solubility parameters, solvation & association, quantitative approach to the factors
influencing solubility of drugs, diffusion principles in biological systems. Solubility
of gas in liquids, solubility of liquids in liquids, (Binary solutions, ideal solutions)
Raoult’s law, real solutions. Partially miscible liquids, Critical solution temperature . Distribution law, its limitations and applications
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.
SUBJECT:-Pharmaceutical engineering 1
CONTENTS
-general study of composition
-properties
factors affecting the selection of material of pharmaceutical plant
-construction with special reference to S.S and glass
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
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.
Assessment of microbial contamination and spoilage. PHARMACEUTICAL MICROBIOLO...Ms. Pooja Bhandare
PHARMACEUTICAL MICROBIOLOGY (BP303T)Unit-VPart-2
Assessment of microbial contamination and spoilage.
Assessment of microbial contamination and spoilage
1. Physical and chemical changes:
2. Assessment of viable microorganisms in non-sterile products:
3. Sterility test:
4. Estimation of pyrogens:
Microbial Limit Tests:
Total Aerobic Microbial Count:
Membrane Filtration.
Plate Count Methods.
Pour Plate Method.
Surface spread Method.
Most Probable Number(MPN)
Types of spoilage, factors affecting the microbial spoilage of pharmaceutical...Ms. Pooja Bhandare
PHARMACEUTICAL MICROBIOLOGY (BP303T)Unit-V Part-1
Types of spoilage, factors affecting the microbial spoilage of pharmaceutical products, source and type of contaminants. Introduction: Defintion Types of Microbial Spoilage:
1. Infection induced due to contaminated pharmaceutical products: Table no. 1.1 Common pathogens spoiling pharmaceutical products:
2. Physicochemical spoilage –
i) Viable growth ii) Gas production
iii) Colouration / Decolouration
iv) Odour formation
v) Taste change
3. Physical Spoilage:
Cracking of emulsion:
Odor changes
4. Biological spoilage:
Microbial Toxins
Microbial Metabolites
5. Chemical spoilage: Table 1.2 Susceptibility of pharmaceutical ingredients to microbial contamination
Factors affecting microbial spoilage
Size of contaminant inoculum
Nutritional factors
Moisture content
pH
Storage temperature
Redox potential
Packaging design
Sources and Types Of Contamination:
Personnel,
Poor facility design,
Incoming ventilation air,
Machinery and other equipment for production,
Raw material and semi-finished material,
Packaging material,
Utilities,
Different media used in the production process as well as for cleaning and Cleanroom clothing.
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:
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
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
Solubility of drugs: Solubility expressions, mechanisms of solute solvent interactions, ideal solubility parameters, solvation & association, quantitative approach to the factors
influencing solubility of drugs, diffusion principles in biological systems. Solubility
of gas in liquids, solubility of liquids in liquids, (Binary solutions, ideal solutions)
Raoult’s law, real solutions. Partially miscible liquids, Critical solution temperature . Distribution law, its limitations and applications
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.
SUBJECT:-Pharmaceutical engineering 1
CONTENTS
-general study of composition
-properties
factors affecting the selection of material of pharmaceutical plant
-construction with special reference to S.S and glass
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
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.
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
University Institute of Pharmaceutical Sciences is a flag bearer of excellence in Pharmaceutical education and research in the country. Here is another initiative to make study material available to everyone worldwide. Based on the new PCI guidelines and syllabus here we have a presentation dealing with "Aseptic requirements for parenteral products".
Thank you for reading.
Hope it was of help to you.
UIPS,PU team
MANUFACTURING OF PARENTRALS
1. Formulation and Raw Materials:
Concept: The process begins with the formulation of the parenteral drug, determining its composition and concentration.
Raw Materials: High-quality pharmaceutical-grade raw materials, including active pharmaceutical ingredients (APIs), excipients, and solvents, are selected based on their compatibility and purity.
2. Sterilization of Raw Materials:
Concept: Due to the sterile nature of parenteral products, all raw materials, including the API and excipients, must undergo rigorous sterilization.
Methods: Common sterilization methods include autoclaving, filtration, and aseptic processing to ensure aseptic conditions throughout the manufacturing process.
3. Manufacturing Process:
Preparation: The formulation is prepared, and various components are weighed and measured precisely.
Mixing: The ingredients are mixed under controlled conditions to achieve a homogeneous blend, ensuring uniform distribution of the API and other components.
Filtration: The solution is then filtered to remove any particulate matter and ensure clarity.
Filling: The sterile drug solution is filled into vials, ampoules, or other suitable containers in a controlled environment, maintaining sterility.
4. Sterilization of Final Product:
Terminal Sterilization: The final product, in its container, undergoes terminal sterilization methods like autoclaving or gamma irradiation to eliminate any microbial contamination that may have occurred during the manufacturing process.
This is the 1st part of our "All about cleanrooms". This presentation will take you through the history of cleanrooms, types and applications of cleanrooms.
Sterilization and disinfection are the basic components of hospital infection control activities. Every day, a number of hospitals are performing various surgical procedures. Even more number of invasive procedures are being performed in different health care facilities. The medical device or the surgical instrument that comes in contact with the sterile tissue or the mucus membrane of the patient during the various processes is associated with increased risk of introduction of pathogens into the patient's body. Moreover, there is chance of transmission of infection from patient to patient; from patient or to health care personnel, and vice versa; or from the environment to the patient through the improper sterilized or disinfected devices. Hence, medical personnel, laboratory people and the health care providers should have better knowledge regarding these techniques to prevent the spread of these pathogens.
Welcome to TechSoup New Member Orientation and Q&A (May 2024).pdfTechSoup
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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.
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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.
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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.
Acetabularia Information For Class 9 .docxvaibhavrinwa19
Acetabularia acetabulum is a single-celled green alga that in its vegetative state is morphologically differentiated into a basal rhizoid and an axially elongated stalk, which bears whorls of branching hairs. The single diploid nucleus resides in the rhizoid.
2. Introduction
• 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
i)The clean-up area,
ii) The compounding area,
iii) The aseptic area,
iv) The quarantine area and
v)The packaging/labelling area.
4. Clean-up section
• The cleaning area has walls and ceilings made
up of film coating materials.
• Air inside the clean area should be free from
dust and microorganisms.
• This is ensured through high efficiency (95%)
filters.
• Air existing in the clean area should be
frequently replace (10-15 air changes per hour).
5. Compounding section
• This area contains stainless steel cabinets and
counters and is involved in the actual
compounding.
• Unlike aseptic area, maintenance of sterile
conditions is not essential, but necessary
measures should be adopted to control the dust
generated from raw material during weighing
and compounding.
6. Aseptic area
• In this area, strict control measures should be
adopted to avoid contamination of the
preparations.
• The stainless steel counters and cabinets should
be such that they should not allow dirt particles to
accumulate.
• Mixing and storage of the compounded
preparations should be done outside the aseptic
area.
• The compounded preparations are then transferred
to the aseptic area through pipelines where the
filling operation is carried out.
7. Quarantine section
• This area consists of a store where the in
process batches as well as approved batches are
stored separately.
• This area has limited access and is under the
control of a responsible person.
• Without the consent of the in charge, other
personnel cannot enter into this particular area.
8. Packing and labelling section
• In this area, the batches are packed and
labelled.
• Packing is carried out by packaging machines,
while labels are obtained by over printing
devices.
• At a time, only one product labels are printed.
• Parenteral packing plays a vital role in the
production of sterile preparations.
• Packing should be carried out in such a manner
that the sterility of the product is maintained.
9. 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.
10. • 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 reduction of 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 fittings such as a cupboards, drawers,
shelves, and equipments must be kept to a minimum.
11. Doors, windows and services
• Doors and windows should fit flush with the walls. Windows if
required, are solely to provide illumination and are not for
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.
12. • 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.
13. 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(GMP) and aseptic techniques.
• 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.
14.
15. 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.
16. 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 velocity at all parts of the filter area has to be about 0.54 m/sec
or (90+20feet/min).
• Removes the Dioctyphthalate (DOP) particles of size-0.3µm
• 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.
21. 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
26. 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
27. 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.
28. 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.
29. 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.
30. 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
bacteriostatic water for injection must be
employed.
31. 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.
32. 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.
33. • 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