The document provides an overview of aseptic processing and contamination control. It defines aseptic processing and compares it to terminal sterilization. Sources of contamination during aseptic processing are discussed, including personnel, air, and equipment. Methods to control contamination are outlined, including quality risk management, contamination control strategies, cleaning and disinfection procedures, environmental monitoring programs, media fills, and quality control testing.
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.
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.
This presentation is basic knowledge about the aseptic processing and media fill validation in pharmaceutical industry and media fill procedure. How to validate aseptic process in the powder drug products , data guidance and record for media fill validation.
“Pharmaceutical Processing is the process of drug manufacturing and can be broken down into a range of unit operations such as blending, granulation, milling, coating, tablet pressing, filling and others.
Validation is a documented program that provides high degree of assurance that a specific process, method or system consistently produces a result meeting pre-determined acceptance criteria.
Effluent Testing: Testing of BOD, COD, TOC and interpretation of results ,What is DO (dissolved oxygen)?,can we use my cod results to predict my bod?,BOD Test Procedures
This presentation is basic knowledge about the aseptic processing and media fill validation in pharmaceutical industry and media fill procedure. How to validate aseptic process in the powder drug products , data guidance and record for media fill validation.
“Pharmaceutical Processing is the process of drug manufacturing and can be broken down into a range of unit operations such as blending, granulation, milling, coating, tablet pressing, filling and others.
Validation is a documented program that provides high degree of assurance that a specific process, method or system consistently produces a result meeting pre-determined acceptance criteria.
Effluent Testing: Testing of BOD, COD, TOC and interpretation of results ,What is DO (dissolved oxygen)?,can we use my cod results to predict my bod?,BOD Test Procedures
Manufacturing Control Systems. J R Controls provides control systems for the manufacturing industry. A typical control system will monitor the progress of parts through the manufacturing and finishing process.
Production operations must follow clearly defined procedures in accordance with manufacturing and marketing authorizations, with the objective of obtaining products of the requisite quality.
Pharmaceutical Microbiology: Current and Future Challenges Tim Sandle, Ph.D.
The changing environment for pharmaceutical microbiology
Limitations of methods
Need for new (rapid) methods
Separating people form processes
Single-use technologies
Environmental monitoring programme
Best practices
Rapid methods
Contamination control strategy
Objectionable organisms
Burkholderia cepacia complex
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
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
Willie Nelson Net Worth: A Journey Through Music, Movies, and Business Venturesgreendigital
Willie Nelson is a name that resonates within the world of music and entertainment. Known for his unique voice, and masterful guitar skills. and an extraordinary career spanning several decades. Nelson has become a legend in the country music scene. But, his influence extends far beyond the realm of music. with ventures in acting, writing, activism, and business. This comprehensive article delves into Willie Nelson net worth. exploring the various facets of his career that have contributed to his large fortune.
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Introduction
Willie Nelson net worth is a testament to his enduring influence and success in many fields. Born on April 29, 1933, in Abbott, Texas. Nelson's journey from a humble beginning to becoming one of the most iconic figures in American music is nothing short of inspirational. His net worth, which estimated to be around $25 million as of 2024. reflects a career that is as diverse as it is prolific.
Early Life and Musical Beginnings
Humble Origins
Willie Hugh Nelson was born during the Great Depression. a time of significant economic hardship in the United States. Raised by his grandparents. Nelson found solace and inspiration in music from an early age. His grandmother taught him to play the guitar. setting the stage for what would become an illustrious career.
First Steps in Music
Nelson's initial foray into the music industry was fraught with challenges. He moved to Nashville, Tennessee, to pursue his dreams, but success did not come . Working as a songwriter, Nelson penned hits for other artists. which helped him gain a foothold in the competitive music scene. His songwriting skills contributed to his early earnings. laying the foundation for his net worth.
Rise to Stardom
Breakthrough Albums
The 1970s marked a turning point in Willie Nelson's career. His albums "Shotgun Willie" (1973), "Red Headed Stranger" (1975). and "Stardust" (1978) received critical acclaim and commercial success. These albums not only solidified his position in the country music genre. but also introduced his music to a broader audience. The success of these albums played a crucial role in boosting Willie Nelson net worth.
Iconic Songs
Willie Nelson net worth is also attributed to his extensive catalog of hit songs. Tracks like "Blue Eyes Crying in the Rain," "On the Road Again," and "Always on My Mind" have become timeless classics. These songs have not only earned Nelson large royalties but have also ensured his continued relevance in the music industry.
Acting and Film Career
Hollywood Ventures
In addition to his music career, Willie Nelson has also made a mark in Hollywood. His distinctive personality and on-screen presence have landed him roles in several films and television shows. Notable appearances include roles in "The Electric Horseman" (1979), "Honeysuckle Rose" (1980), and "Barbarosa" (1982). These acting gigs have added a significant amount to Willie Nelson net worth.
Television Appearances
Nelson's char
Characterization and the Kinetics of drying at the drying oven and with micro...Open Access Research Paper
The objective of this work is to contribute to valorization de Nephelium lappaceum by the characterization of kinetics of drying of seeds of Nephelium lappaceum. The seeds were dehydrated until a constant mass respectively in a drying oven and a microwawe oven. The temperatures and the powers of drying are respectively: 50, 60 and 70°C and 140, 280 and 420 W. The results show that the curves of drying of seeds of Nephelium lappaceum do not present a phase of constant kinetics. The coefficients of diffusion vary between 2.09.10-8 to 2.98. 10-8m-2/s in the interval of 50°C at 70°C and between 4.83×10-07 at 9.04×10-07 m-8/s for the powers going of 140 W with 420 W the relation between Arrhenius and a value of energy of activation of 16.49 kJ. mol-1 expressed the effect of the temperature on effective diffusivity.
Natural farming @ Dr. Siddhartha S. Jena.pptxsidjena70
A brief about organic farming/ Natural farming/ Zero budget natural farming/ Subash Palekar Natural farming which keeps us and environment safe and healthy. Next gen Agricultural practices of chemical free farming.
"Understanding the Carbon Cycle: Processes, Human Impacts, and Strategies for...MMariSelvam4
The carbon cycle is a critical component of Earth's environmental system, governing the movement and transformation of carbon through various reservoirs, including the atmosphere, oceans, soil, and living organisms. This complex cycle involves several key processes such as photosynthesis, respiration, decomposition, and carbon sequestration, each contributing to the regulation of carbon levels on the planet.
Human activities, particularly fossil fuel combustion and deforestation, have significantly altered the natural carbon cycle, leading to increased atmospheric carbon dioxide concentrations and driving climate change. Understanding the intricacies of the carbon cycle is essential for assessing the impacts of these changes and developing effective mitigation strategies.
By studying the carbon cycle, scientists can identify carbon sources and sinks, measure carbon fluxes, and predict future trends. This knowledge is crucial for crafting policies aimed at reducing carbon emissions, enhancing carbon storage, and promoting sustainable practices. The carbon cycle's interplay with climate systems, ecosystems, and human activities underscores its importance in maintaining a stable and healthy planet.
In-depth exploration of the carbon cycle reveals the delicate balance required to sustain life and the urgent need to address anthropogenic influences. Through research, education, and policy, we can work towards restoring equilibrium in the carbon cycle and ensuring a sustainable future for generations to come.
WRI’s brand new “Food Service Playbook for Promoting Sustainable Food Choices” gives food service operators the very latest strategies for creating dining environments that empower consumers to choose sustainable, plant-rich dishes. This research builds off our first guide for food service, now with industry experience and insights from nearly 350 academic trials.
Micro RNA genes and their likely influence in rice (Oryza sativa L.) dynamic ...Open Access Research Paper
Micro RNAs (miRNAs) are small non-coding RNAs molecules having approximately 18-25 nucleotides, they are present in both plants and animals genomes. MiRNAs have diverse spatial expression patterns and regulate various developmental metabolisms, stress responses and other physiological processes. The dynamic gene expression playing major roles in phenotypic differences in organisms are believed to be controlled by miRNAs. Mutations in regions of regulatory factors, such as miRNA genes or transcription factors (TF) necessitated by dynamic environmental factors or pathogen infections, have tremendous effects on structure and expression of genes. The resultant novel gene products presents potential explanations for constant evolving desirable traits that have long been bred using conventional means, biotechnology or genetic engineering. Rice grain quality, yield, disease tolerance, climate-resilience and palatability properties are not exceptional to miRN Asmutations effects. There are new insights courtesy of high-throughput sequencing and improved proteomic techniques that organisms’ complexity and adaptations are highly contributed by miRNAs containing regulatory networks. This article aims to expound on how rice miRNAs could be driving evolution of traits and highlight the latest miRNA research progress. Moreover, the review accentuates miRNAs grey areas to be addressed and gives recommendations for further studies.
Artificial Reefs by Kuddle Life Foundation - May 2024punit537210
Situated in Pondicherry, India, Kuddle Life Foundation is a charitable, non-profit and non-governmental organization (NGO) dedicated to improving the living standards of coastal communities and simultaneously placing a strong emphasis on the protection of marine ecosystems.
One of the key areas we work in is Artificial Reefs. This presentation captures our journey so far and our learnings. We hope you get as excited about marine conservation and artificial reefs as we are.
Please visit our website: https://kuddlelife.org
Our Instagram channel:
@kuddlelifefoundation
Our Linkedin Page:
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and write to us if you have any questions:
info@kuddlelife.org
UNDERSTANDING WHAT GREEN WASHING IS!.pdfJulietMogola
Many companies today use green washing to lure the public into thinking they are conserving the environment but in real sense they are doing more harm. There have been such several cases from very big companies here in Kenya and also globally. This ranges from various sectors from manufacturing and goes to consumer products. Educating people on greenwashing will enable people to make better choices based on their analysis and not on what they see on marketing sites.
Diabetes is a rapidly and serious health problem in Pakistan. This chronic condition is associated with serious long-term complications, including higher risk of heart disease and stroke. Aggressive treatment of hypertension and hyperlipideamia can result in a substantial reduction in cardiovascular events in patients with diabetes 1. Consequently pharmacist-led diabetes cardiovascular risk (DCVR) clinics have been established in both primary and secondary care sites in NHS Lothian during the past five years. An audit of the pharmaceutical care delivery at the clinics was conducted in order to evaluate practice and to standardize the pharmacists’ documentation of outcomes. Pharmaceutical care issues (PCI) and patient details were collected both prospectively and retrospectively from three DCVR clinics. The PCI`s were categorized according to a triangularised system consisting of multiple categories. These were ‘checks’, ‘changes’ (‘change in drug therapy process’ and ‘change in drug therapy’), ‘drug therapy problems’ and ‘quality assurance descriptors’ (‘timer perspective’ and ‘degree of change’). A verified medication assessment tool (MAT) for patients with chronic cardiovascular disease was applied to the patients from one of the clinics. The tool was used to quantify PCI`s and pharmacist actions that were centered on implementing or enforcing clinical guideline standards. A database was developed to be used as an assessment tool and to standardize the documentation of achievement of outcomes. Feedback on the audit of the pharmaceutical care delivery and the database was received from the DCVR clinic pharmacist at a focus group meeting.
2. Contents
• Introduction to aseptic processing,
Aseptic Processing vs. Terminal
Sterilization
• Contamination:
Sources and control
• Microbial environmental monitoring
• Media Fill
• Quality Control
• References
3. Aseptic Processing
Aseptic processing is defined as “handling of
sterile product, containers, and/or devices in
a controlled environment, in which the air
supply, materials, equipment, and personnel
are regulated to maintain sterility”
(ISO 13408-1, 2008)
4. Producing Drug Products By
Terminal sterilization
• Product containers are filled and sealed under
high-quality environmental conditions
designed to minimize contamination, but not
to guarantee sterility.
• Product in its final container is subject to a
sterilization process such as heat or
irradiation.
Aseptic processing
• Drug product, container, and closure are
subject to sterilization separately, and then
brought together.
• Because there is no process to sterilize the
product in its final container, it is critical
that containers be filled and sealed in an
extremely high –quality environment.
7. Bacteria, virus, fungi and other viable microbes
Bacterial spores and endotoxins
Non viable Particles like dust, fibers, glass and other
visible and sub-visible particulates suspended in the air
and may contaminate product.
Contaminating Agents
8. Sources of Contamination
• Personnel born contaminants
• Poor or improper Sanitization: Procedures deficient, or poorly
executed
• Air born contaminants.
• Inadequate HEPA seal (over 90% vials contaminated)
• Velocity through HEPA Filters: Variable velocities between
filters. Inadequate laminar flow resulted. Low or undetectable
velocity at work surface.
• Mechanical failure of filling tank; main pump failure; cooling
system leaks at joints.
9. Control
Quality risk management (QRM)
Holistic Contamination Control Strategy (CCS) focused on minimizing
contamination control with respect to sterile manufacturing
Reduce the risk of contamination through
10. Quality Risk Management (QRM)
Processes, equipment, facilities and manufacturing activities
should be managed in accordance with QRM principles to ensure
Prevention of microbial, particulate and pyrogen contamination in
the final product.
Proactive use of risk management
Regular review of risk assessment
Use of effective root cause and CAPA
Employing staff with expertise to undertake risk assessment
Risk assessment should not simply confined to manufacturing, it
needs to extend to packaging and to the distribution of the
finished medicinal product, thereby embracing the requirements
of Good Distribution Practice (GDP)
11. Contamination Control Strategy
(CCS)
A formal, holistic CCS which reflects the site-wide strategy
to define all critical control points and assess the
effectiveness of all the controls (design, procedural,
technical and organisational) and monitoring measures
employed to manage risks associated with contamination
respect to sterile manufacturing.
13. Premises
• Airlock for personnel
• Airlock for equipment and materials
• Technical and operational separation measures for component
preparation, product preparation and filling
• Wider use of barrier technology such as Restricted Access
Barriers Systems (RABS) or isolators
• Smooth, impervious and unbroken surfaces to minimize the
contamination and to permit proper cleaning and disinfection
• Floor drains designed to prevent back flow
14. Premises
• Maintain Pressure differentials minimum 10 pascals
• Indicators of pressure differences and warning system for failure
• Permit observation of production activities from outside the
Grade A zone and Grade B area
• No ingress of airflow from lower grade to higher grade areas
demonstrated by Airflow patterns visualization
• Clean Air and Clean Air Equipment Qualification
• Cleaning and Disinfection
15. Clean Air and Clean Air Equipment
Qualification
Qualification of cleanrooms and clean air equipment should
include
• Installed filter leakage and integrity testing
• Airflow measurement - Volume and velocity
• Air pressure difference measurement
• Airflow direction and visualization
• Microbial airborne and surface contamination
• Temperature measurement
• Relative humidity measurement
• Recovery testing
• Containment leak testing
16. Cleaning and Disinfection
Cleaning :
The process of removing product residues and contaminants such as
dirt, dust, grease from the surface. Cleaning is the first step for
sanitation
●Contaminants can be – Physical, - Microbiological, - Biological, -
Chemical agents
Disinfection:
The process by which the reduction of the number of microorganisms is
achieved by the irreversible action of a product on their structure or
metabolism, to a level judged to be appropriate for a defined purpose
• Sporicidal agent – An agent that destroys bacterial and fungal spores
when used in sufficient concentration for specified contact time
17. ISOPROPYLALCOHOL (70%)
• Powerful disinfectant
• Effectively kills bacteria and fungi
• Mode of action: denatures proteins, dissolves lipids
and can lead to cell membrane disintegration.
• But does not inactivate spores!
e.g., phenols, Alcohols, Aldehydes etc.,
Disinfectant
19. Cleaning and Disinfection
• More than one disinfectants by rotation
including one Sporicidal
• Facility independent disinfectant efficacy
testing
• Validated disinfection process covering expiry
period
• Sterile disinfectants for Grade A/B
• Assessment of microbial contamination for In
House disinfectants
• Effectively removal of disinfectant residues
20. Personnel
• Sufficient appropriate personnel
• Minimum number of personnel permitted to enter cleanroom
• Gowning Qualification for entering Grade A zone and Grade
B areas
• Minimum basic training
-Personnel Hygiene
-Gowning
-Cleanroom practices
-Contamination control
-Aseptic techniques
-Effect on patients due to loss of sterility
22. Personnel Hygiene
Personal hygiene procedures including wearing
protective clothing apply to all persons entering into
production areas:
● Full-time employees
● Temporary workers
● Contractor's employees
● Visitors
● Inspectors
23. Personnel Hygiene
Illness or open lesions:
●May affect the quality of products
●Should not handle starting materials, intermediates or finished
products, etc.
●Instruction and encouragement to report to supervisors
Direct contact between product and operator:
●Should be avoided
●Starting materials, primary packaging materials, intermediate
and bulk product
24. Personnel Hygiene
Protection of product from contamination:
●Clean clothes appropriate to personnel activities
●Including hair covering (e.g. caps)
Check change rooms/changing facilities:
●Hand washing, signs, drying of hands
●Used clothing stored in separate closed containers while
awaiting cleaning
●Laundering of clean area clothing according to an SOP and in
an appropriate facility
●Procedure for disinfecting and sterilizing when required
Activities To Be Done
25. Personnel Hygiene
●Smoking, eating and drinking not allowed in production areas,
laboratories and storage areas
●No chewing (e.g. gum), or keeping food or drinks allowed
●No plants kept inside these areas
●Rest and refreshment areas should be separate from
manufacturing and control areas
Other Activities
26. Clean Room Behaviour
• Good practice:
• gowns/PPE changed if damaged, wet or used for
long durations
• check yours and others regularly
• target max duration = 4 hours
Time
Avoid rapid movements
– creates particles
– disturbs air flows
Avoid aerosol production
personnel = contamination
https://www.youtube.com/watch?
v=yuc6cNBrbxM
28. Clean Room Behaviour
Aseptic technique must always be used wherever applicable
Fresh sterilised gloves must be worn immediately before a critical
activity and regularly sanitised
● but do not use disinfectant spray near product, components,
raw materials or env. mon. equipment
29. Clean Room Behaviour
Minimise spread of contamination during critical
activities:
● avoid touching your person or other people
● avoid touching human contact sites such as:
♦ pens bin handles
♦ keyboards paperwork
♦ keypads desks
♦ doors plugs/switches
♦ chairs any unclean equipment
♦ telephones containers (disinfectant cans?!)
●if you do make contact - sanitise gloves
30. Environmental Monitoring
The goal of the environmental monitoring program is to
provide meaningful information on the quality of the
aseptic processing environment during production as well
as environmental trends.
31. Environmental Monitoring
Non-viable count
-Particle Count
Viable Count
Active Air monitoring
- Settle Plate
Passive Air Monitoring
-Active Air plate
Surface monitoring
-Contact plate
-Swab
Personnel monitoring
-Contact Plate (Gloves and Gown)
33. Aseptic Process Simulation (APS)/
Media Fill
A simulation of the entire aseptic formulation and filling process in
order to determine the capability of the process to assure product
sterility
Used to validate the aseptic process
34. Media Fill
Use microbial growth media instead of drug product-any
contamination will result in microbial growth.
It doesn’t provide a direct relation for sterility but gives
an adequate evaluation for operational processing steps
Accessed Prefilled time as part of media fill
Accessed time limit for aseptic assembly
Maximum exposure time of Sterilized containers to
closures
35. Product Inspection
• Inspection for particulate matter
• Container Closure integrity (CCIT):
• CCIT – Needs to consider impact of transportation -GDP
• Microbial Ingress test to determine acceptable stopper height
displacement
36. Quality Control
• Examination of Raw materials based on required microbial quality
as defined in contamination control strategy .
• Strengthen sterility testing
• Sampling from the beginning middle and end of batch , plus
following any significant intervention
• Endotoxin Testing
37. Extremely heat stable – recommended conditions for
inactivation are 180 0 C for 3 hours.
Endotoxin: a pyrogenic (fever inducing) substance (e.g. lipopolysaccharide)
present in the bacterial cell wall. Endotoxin reactions range from fever to death.
Endotoxin Testing
LAL Assay (Limulus amoebocyte lysate)
ENDOTOXIN LIMIT FOR WFI IS
0.25 EU/ml
Quality Control