The document discusses aseptic processing operations. It describes the characterization of the aseptic process including microbial environmental monitoring, testing of water and air, and media and incubation conditions. The key aspects of the aseptic process are the facility design and control systems, equipment, personnel training, process validation, and finished product testing like sterility testing. Microbiological testing of water, air and media fills is important to ensure the sterility of pharmaceutical products manufactured through aseptic processing.
Aseptic / sterile - “ A state of control attained by using an aseptic work area and performing activities in a manner that precludes microbiological contamination of the exposed sterile product”
Validation of aseptic process should be designed to provide assurance through appropriate testing that all phases and activities of the process remain sterile and it is controlled within the predetermined parameters.
Drug product, container, and closure are subject to sterilization separately, and then brought together.
Evaluation methods for drug excipients and container interactionSagar Savale
Excipients are one of the three components that in combination produce the medicine that the patient will take.
In therapeutic terms, the API is of primary importance because without it there is no treatment and no product.
In term of drug manufacturing all three of them are equally important so we cannot neglect anyone of them.
The interactions between excipients and the other two components (the API and the manufacturing process), and/or between two or more excipients, are fundamental to the transformation of an API into a medicinal product.
Tray Dryer
Principle of Tray Dryer
Construction of Tray Dryer
Working of Tray Dryer
Qualification of Tray Dryer
Installation Qualification
Operational Qualification
Performance Qualification
References
Aseptic process is very critical in drug manufacturing , Facility along with the trained persons are very much important and there handling practices play a very crucial role in the sterility and integrity of the products. First we have to assure yourself before giving assurance to others.
Aseptic / sterile - “ A state of control attained by using an aseptic work area and performing activities in a manner that precludes microbiological contamination of the exposed sterile product”
Validation of aseptic process should be designed to provide assurance through appropriate testing that all phases and activities of the process remain sterile and it is controlled within the predetermined parameters.
Drug product, container, and closure are subject to sterilization separately, and then brought together.
Evaluation methods for drug excipients and container interactionSagar Savale
Excipients are one of the three components that in combination produce the medicine that the patient will take.
In therapeutic terms, the API is of primary importance because without it there is no treatment and no product.
In term of drug manufacturing all three of them are equally important so we cannot neglect anyone of them.
The interactions between excipients and the other two components (the API and the manufacturing process), and/or between two or more excipients, are fundamental to the transformation of an API into a medicinal product.
Tray Dryer
Principle of Tray Dryer
Construction of Tray Dryer
Working of Tray Dryer
Qualification of Tray Dryer
Installation Qualification
Operational Qualification
Performance Qualification
References
Aseptic process is very critical in drug manufacturing , Facility along with the trained persons are very much important and there handling practices play a very crucial role in the sterility and integrity of the products. First we have to assure yourself before giving assurance to others.
Contoh protokol validasi metode analisis mikrobiologi #2Guide_Consulting
Disampaikan pada seminar validasi metode analisis mikrobiologi 19 sep 2013, Bogor
Untuk mendapat file nya silahkan kirimkan email beserta data (nama, perusahaan, alamat email, no telp) ke Guide Consulting | info@traininglaboratorium.com
5.1.3. Efficacy of antimicrobial preservation (EP 5.0)Guide_Consulting
Salah Satu Referensi Yang Digunakan Dalam One Day Seminar "Preservative Effectiveness Validation" 04 Desember 2014.
Detail : info@traininglaboratorium.com
Confidence has a common meaning of a certainty about handling something, such as work, family, social events, or relationships. Some have ascribed confidence as a state of being certain either that a hypothesis or prediction is correct or that a chosen course of action is the best or most effective.
Communication is the act of conveying meanings from one entity or group to another through the use of mutually understood signs, symbols, and semiotic rules. The main steps inherent to all communication are: The formation of communicative motivation or reason. Message composition. Message encoding
Pharmacy is the Science and Art of preparing and dispensing drugs
A medicine is any drug which has a definite form & dose and are therapeutically used for the treatment of diseases of living subject…
Natural or synthetic substance which (when taken into a living body) affects its functioning or structure, and is used in the diagnosis, mitigation, treatment, or prevention of a disease or relief of discomfort.
A Formulation is a mixture of drug and ingredients prepared in certain way and used for specific purpose.
TYPES: Forest ecosystem
Desert ecosystem
Grassland ecosystem
Aquatic ecosystem
FOREST ECOSYSTEM
A forest ecosystem is the one in which a tall and trees grow that support many
animals and birds. The forest are found in undisturbed areas receiving
moderate to hi rainfall. The forest occupies nearly 40%
of the world’s land area. In India it occupies only 19% of its total land area.
GRASSLAND ECOSYSTEM.
Grassland occupies about 20% of earth’s surface addition to grass
species, some trees and shrubs are/also pre in grasslands. Limited
grazing helps to improve the net primary production of the grasslands.
But, overgrazing leads degradation of these grasslands resulting in desertification
DESERT. ECOSYSTEMS
Desert occupies about 35% of our world’s land area. It is
characterized by less than 25 cm rainfall. The atmosphere is dry and hence it is a poor insulator .
AQUATIC ECOSYSTEMS
The aquatic ecosystem deals with water bodies. The major types
of organism found in aquatic environments are determined by the water’s salinity.
The maintenance of a constant environment in the body is called Homeostasis
Homeostasis is also called dynamic equilibrium
equilibrium maintained BY:
Feedback systems
Negative feedback
Positive feedback
Negative feedback: Response triggered by changed conditions serves to reverse the change
E.g., Body temperature increases
Skin blood vessels dilate
Body temperature decreases
Positive feedback: The response triggered by changing conditions serves to move the variable even further away from its steady state
E.g., uterine contractions are stimulated by oxytocin
baby moves towards cervix
more oxytocin is released
ESTIMATION OF THE RATE OF REACTION WILL BE DONE BASED ON THE POTENTIAL DIFFERENCE BETWEEN REFERENCE AND INDICATOR ELECTRODE. THE POTENTIAL OF THE REFERENCE ELECTRODE IS STABLE WHERE AS THE POTENTIAL OF THE INDICATOR ELECTRODE VARIES WITH THE POTENTIAL OF THE SOLUTION IN WHICH IT IS PLACED
Pharmaceutical Associations and Statutory CouncilsSai Datri Arige
Society
the aggregate of people living together in a more or less ordered community.
Association
an organization of persons having a common interest
associations and councils of pharmaceutical industry are work for the welfare and empowerment of its members
Public sector undertakings of pharma in IndiaSai Datri Arige
It is about the pharmaceutical companies in India which are directly headed by government of India and about the pioneers of Indian pharmaceutical industry, which max concentrate on growth of Indian Pharmaceutical Industry
How to Create Map Views in the Odoo 17 ERPCeline George
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This is a presentation by Dada Robert in a Your Skill Boost masterclass organised by the Excellence Foundation for South Sudan (EFSS) on Saturday, the 25th and Sunday, the 26th of May 2024.
He discussed the concept of quality improvement, emphasizing its applicability to various aspects of life, including personal, project, and program improvements. He defined quality as doing the right thing at the right time in the right way to achieve the best possible results and discussed the concept of the "gap" between what we know and what we do, and how this gap represents the areas we need to improve. He explained the scientific approach to quality improvement, which involves systematic performance analysis, testing and learning, and implementing change ideas. He also highlighted the importance of client focus and a team approach to quality improvement.
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.
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!
Palestine last event orientationfvgnh .pptxRaedMohamed3
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2. Introduction
Characterization of aseptic process
Microbial environmental monitoring
Microbial testing of water
Microbial testing of air
Media and incubation condition
2
3. The production of sterile drug products by bringing together
the product, container, and closure that have been subjected to
different sterilization methods separately, and assembled them
in an extremely high quality environment by skilled personnel
using the right tools.
3
7. Finished Product Testing
Sterility Testing
Particulate Testing
Container Closure Integrity Testing
Other Final Product/Release Testing
Stability Testing
Documentation
Media Fill Records
Production Batch Records
EM Trend Data
Release Testing Batch Records
Investigation
Response to Excursions
Corrective Actions
7
8. Types of water used in pharmaceutical processes:
1. Purified water
2. Water for Injections
3. Softened Water
4. Water for Final Rinse
5. Pure, or clean Steam
6. Water for cooling Autoclaves
8
Microbial testing of air and water
9. Contaminants of water (1)
There is no pure water in nature, as it can contain up to 90
possible unacceptable contaminants
Contaminant groups:
1. Inorganic compounds
2. Organic compounds
3. Solids
4. Gases
5. Micro-organisms
9
10. Contaminants of water (2)
Micro-organisms :
1. Algae
2. Protozoa
Cryptosporidium
Giardia
1. Bacteria
Pseudomonas
Gram negative, non-fermenting bacteria
Escherichia coli and coli forms
10
11. Contaminants of water (3)
1. Rainfall
2. Erosion
3. Pollution
4. Dissolution
5. Evaporation
6. Sedimentation
7. Decomposition
11
12. Objectives:
To review microbiological environmental and quality control
testing
Microbiological Environmental Monitoring
Container integrity testing
Pre-sterilization testing.
Media fill medium growth promotion testing
Sterility Testing
Other microbiological laboratory issues
12
13. Water
Water should also be tested for presence of coli forms and/or
pseudomonad's if appropriate (may cause biofilm)
Water used for parenterals should be tested for pyrogens
limit is not more than 0.25 EU/ml
Water should be tested using R2A agar (low nutrient for the
recovery of water borne organisms) incubated for at least 5
days at 30-35°C
Sampling procedures should follow those used in production
13
14. Sampling Locations
Should be based on risk of microbiological contamination
Should be clustered around areas where product or
components are exposed
At filling heads on filling lines
Loading of product into lyophilizers
Stopper bowls
Where aseptic connections are made
Where there are high levels of operator activity (but
without impacting on production)
14
Microbiological testing of Air
15. Methods
Surface monitoring
Product contact surfaces, floors, walls, and equipment
should be tested on a regular basis
Touch plates - used for flat surfaces
sample area of 25cm2
medium protrudes above sides
medium contains neutralisers
Surface Swabs - used for irregular surfaces
area approx 25cm2
is swabbed
qualitative or quantitative
15
16. • Media used for media fills should be able to support the
growth of a wide range of microorganisms (bacteria and
moulds)
• Soybean Casein Digest Medium is usually used. An
anaerobic medium may also be substituted occasionally
if environmental monitoring indicates presence.
16
• Media used for microbiological testing should be
tested for its ability to support microbial growth
Media
17. •After the media fill has been completed, it is important
to demonstrate that the media would have been able to
support the growth of organisms if they had been
present .
•containers with media should be inoculated with 10-
100 CFU of organisms such as Bacillus subtilis,
Staphylococcus aureus, Candida albicans, Aspergillus
niger. Environmental isolates should also be included
17
18. Media types:
Soybean Casein Digest medium (SCD), (also knows as
Trypticase Soy Broth(TSB)) and Fluid Thioglycollate
medium (FTM) is usually used (to detect aerobic and
anaerobic organisms)
validation studies should demonstrate that the media are
capable of supporting growth of a range of low numbers of
organisms in the presence of product. May need to
incorporate inactivators
growth should be evident after 3 days (bacteria), 5 days
(moulds)
media may be purchased or made in-house using validated
sterilization procedures
18
19. Incubation Period
At least 14 days incubation
20-25°C for SCD/TSB, 30-35°C for FTM
Test containers should be inspected at intervals
temperatures should be monitored and temperature
monitoring devices should be calibrated
if product produces suspension, flocculation or deposit in
media, suitable portions (2-5%) should be transferred to
fresh media, after 14 days, and incubated for a further 7
days
19
20. Second edition, prof. C. P. Baveja, Text book of
Microbiology : Arya publications – Reprint 2007 : page
615-620
Seventh edition, Ananthanarayan and Paniker’s, Text book
of Microbiology, Edited by CKJ Paniker, published by
orient longman PVT Ltd 2005 : page 604-609.
Guidance for industry ; Sterile Drug products produced by
aseptic processing - cGMP Sep 2004.
WHO GMP guidelines – Technical Report series 937
FDA Guidance for Industry: sterile drug products
produced by aseptic processing cGMP 2002.
20
Water used as an ingredient in the formulation of pharmaceutical products must be either of the purified water type or must be water for injections.
The most common type of water in use in a pharmaceutical factory is purified water. This is used as an ingredient for manufacture of non-sterile pharmaceuticals. It is described in pharmacopeias.
The highest quality is Water For Injections. Water for Injections is used in parenteral products. It is also described in pharmacopeias. In bulk, this type of water is also called Pyrogen Free Water, or PFW, and if sterilized, it is called Sterilized Water for Injections. For other purposes, other types of water may also be used.
Besides potable water, there is softened water, which has had its Calcium and Magnesium removed. Such a water can be used e.g. for first washing steps. Certain processes require special well-defined qualities of water.
“Water for Final Rinse” is used for rinsing equipment after washing. It must be of the same quality as the water used for manufacturing the product. In some countries this can be prepared using different equipment to the ingredient water. For example, ultra-filtered water may be used for rinsing equipment for parenteral use, but WFI must be used as the parenteral ingredient.
Pure, pyrogen-free steam (called Clean Steam) is needed for sterilization, if the steam comes into contact with parenteral product or equipment that is going to be used for preparing parenteral products.
Steam, and Water for Cooling Autoclaves, are also used and must be properly prepared if they have the potential to come into contact with sterile or non-sterile product.
Contaminants of water:
Because of the wide variation in source and because of water’s unique chemical properties, which makes it the “universal solvent”, there is no pure water in nature. A wide variety of compounds may be present. There are more than 90 possible unacceptable contaminants of potable water listed by health authorities. The trainer can expand on other contaminants that are important, or on any local requirements that are relevant. For example, in some areas hormone-like compounds may be a problem.
Contaminants can be put into the following groups:
Inorganic contaminants, such as chloramines, magnesium carbonate, calcium carbonate and sodium chloride;
Organic contaminants, such as detergent residues, solvents and plasticizers;
Solids, such as clays, sols, cols and soils;
Gases, such as nitrogen, carbon dioxide and oxygen; and
Micro-organisms. These can be particularly troublesome because of the numbers that can grow in nutrient-depleted conditions. Bacteria may even multiply in pure water.
Contaminants of water: (Contd.)
One of the major obstacles to successful treatment of water is the presence of micro-organisms. These are usually found in biofilms that develop on wet surfaces in almost any condition. The next slide explains how biofilm forms.
The major groups of contaminating micro-organisms are:
Algae: These arrive from raw water but can also grow where water is uncovered and there is a light source. Sometimes algae grow when UV lights lose their lethal effect and are emitting only visible light.
Protozoa: These include Cryptosporidium and Giardia. They can usually be easily filtered out since they are relatively large organisms.
Bacteria. Of these, the normal aquatic microflora cause the most problems. Most of these belong to the Pseudomonas family or are Gram negative, non-fermenting bacteria. Some of them easily pass through 0.2 micrometer filters and are known to cause disease. Other Gram negative bacteria that are objectionable are Escherichia coli and coli forms. These are indicator organisms pointing to faecal contamination.
Contaminants of water: (Contd.)
The type of treatment is influenced by the impurities in water. These vary because of effects such as:
Rainfall, which can dissolve acid from the atmosphere and pick up other contaminants, such as fouling from roofs upon which it collects;
Erosion, which introduces minerals, clays and soils;
Pollution, from the atmosphere and from groundwater contamination;
Dissolution, whereby minerals and solids slowly dissolve in the stored water;
Evaporation, which can concentrate and precipitate minerals;
Sedimentation, whereby dissolved minerals re-precipitate and block pipes and filters;
Decomposition, for example when contaminants arise from degraded pollutants.