It is process of “Establishing documentary evidence that provide a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes”.
In the pharmaceutical industry, it is very important that in addition to final testing and compliance of products, it is also assured that the process will consistently produce the expected results.
Validation is action of proving in accordance with the principles of good manufacturing practices, that any procedure, process, equipment, material, activity or system actually leads to expected results.
Cleaning validation is documented evidence with a high degree assurance that one can consistently clean a system or a piece of equipment to predetermined and acceptable limits.
The primary regulatory concern driving the need for cleaning validation is cross contamination of the desired drug substance either by other API from previous batch runs or by residues from the cleaning agents used.
The prime purpose of validating a cleaning process is to ensure compliance with federal and other standard regulations
1. Cross contamination with active ingredients
Contamination of one batch of product with significant levels of residual active ingredients from previous batch cannot be tolerated.
In addition to the obvious problems posed by subjecting consumers or patients to unintended contaminants, potential clinically significant synergistic interactions between pharmacologically active chemicals are a real concern.
2. Contamination with unintended materials or compounds
While inert ingredients used in drug products are generally recognized as safe for human consumption, the routine use, maintenance and cleaning of equipment's provide the potential contamination with such items as equipment parts, lubricants and chemical cleaning agents3. Microbiological contamination
Maintenance , cleaning and storage conditions may provide adventitious microorganisms with the opportunity to proliferate within the processing equipment.
In this slide contains introduction, qualification, preventive maintenance, requalification method.
Presented by: Malarvannan M (Department of pharmaceutical analysis).RIPER, anantapur
This presentation explains about qualifications of HPTLC, types of qualifications, design qualification , installation qualification ,operational qualification, performance qualification ,documentation of qualification .
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.
It is process of “Establishing documentary evidence that provide a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes”.
In the pharmaceutical industry, it is very important that in addition to final testing and compliance of products, it is also assured that the process will consistently produce the expected results.
Validation is action of proving in accordance with the principles of good manufacturing practices, that any procedure, process, equipment, material, activity or system actually leads to expected results.
Cleaning validation is documented evidence with a high degree assurance that one can consistently clean a system or a piece of equipment to predetermined and acceptable limits.
The primary regulatory concern driving the need for cleaning validation is cross contamination of the desired drug substance either by other API from previous batch runs or by residues from the cleaning agents used.
The prime purpose of validating a cleaning process is to ensure compliance with federal and other standard regulations
1. Cross contamination with active ingredients
Contamination of one batch of product with significant levels of residual active ingredients from previous batch cannot be tolerated.
In addition to the obvious problems posed by subjecting consumers or patients to unintended contaminants, potential clinically significant synergistic interactions between pharmacologically active chemicals are a real concern.
2. Contamination with unintended materials or compounds
While inert ingredients used in drug products are generally recognized as safe for human consumption, the routine use, maintenance and cleaning of equipment's provide the potential contamination with such items as equipment parts, lubricants and chemical cleaning agents3. Microbiological contamination
Maintenance , cleaning and storage conditions may provide adventitious microorganisms with the opportunity to proliferate within the processing equipment.
In this slide contains introduction, qualification, preventive maintenance, requalification method.
Presented by: Malarvannan M (Department of pharmaceutical analysis).RIPER, anantapur
This presentation explains about qualifications of HPTLC, types of qualifications, design qualification , installation qualification ,operational qualification, performance qualification ,documentation of qualification .
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.
Validation of utility system (water system)ShameerAbid
these slides talked about the validation of utility systems in pharmaceutical industries
with special emphasis on the water system
helpful for pharmaceutical student
QUALIFICATION OF MANUFACTURING EQUIPMENTSANKUSH JADHAV
it gives the information about qualification of various manufacturing equipment which is used into the pharmaceutical labs. (only for information purpose)
Qualification of Dissolution Test Apparatus and Validation of Utility System this presentation will help to enhance your knowledge in validation and qualification area.
Validation: 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.
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 qualifications of HPLC which is the " High Performance Liquid Chromatography".
Thank you for reading.
Hope it was of help to you.
UIPS,PU team
CLEANING VALIDATION for M.pharm and industry personabhishek pandey
YOU CAN EASY WAY TO UNDERSTAND A PROCESS AND ANLYTICAL METHOD OF CLEANING VALIDATION
Cleaning validation is the methodology used to assure that a cleaning process removes residues of the active pharmaceutical ingredients of the product manufactured in a piece of equipment, the cleaning aids utilized in the cleaning process and the microbial attributes.[1] All residues are removed to predetermined levels to ensure the quality of the next product manufactured is not compromised by waste from the previous product and the quality of future products using the equipment, to prevent cross-contamination and as a GMP requirement.
The U.S. Food and Drug Administration (FDA) has strict regulation about the cleaning validation. For example, FDA requires firms to have written general procedures on how cleaning processes will be validated. Also, FDA expects the general validation procedures to address who is responsible for performing and approving the validation study, the acceptance criteria, and when revalidation will be required. FDA also require firms to conduct the validation studies in accordance with the protocols and to document the results of studies.The valuation of cleaning validation is also regulated strictly, which usually mainly covers the aspects of equipment design,cleaning process written, analytical methods and sampling. Each of these processes has their related strict rules and requirements. Regarding to the establishment of limits, FDA does not intend to set acceptance specifications or methods for determining whether a cleaning process is validated. But some limits that have been mentioned by industry include analytical detection levels such as 10 PPM, biological activity levels such as 1/1000 of the normal therapeutic dose and organoleptic levels.[2][3][4]
Cleaning Validation in the context of Active Pharmaceutical Ingredient manufacture may be defined as: "The process of providing documented evidence that the cleaning methods employed within a facility consistently controls potential carryover of product (including intermediates and impurities), cleaning agents and extraneous material into subsequent product to a level which is below predetermined levels".
In this slide contains details about Pharmaceutical validation of water system
Presented by: K VENKATSAI PRASAD (Department of pharmaceutical analysis and quality assurance).RIPER, anantapur
This presentation includes detail about cleaning levels,equipments for cleaning validation , steps for cleaning method validation and analytical method validation used for cleaning.
This file is just a compilation of Validation guidance and standards collected from different sources.
It contains general strategies of Qualification, HVAC validation, Water system validation, Compressed air validation, Cleaning validation and general documentation required for these processes.
Validation of utility system (water system)ShameerAbid
these slides talked about the validation of utility systems in pharmaceutical industries
with special emphasis on the water system
helpful for pharmaceutical student
QUALIFICATION OF MANUFACTURING EQUIPMENTSANKUSH JADHAV
it gives the information about qualification of various manufacturing equipment which is used into the pharmaceutical labs. (only for information purpose)
Qualification of Dissolution Test Apparatus and Validation of Utility System this presentation will help to enhance your knowledge in validation and qualification area.
Validation: 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.
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 qualifications of HPLC which is the " High Performance Liquid Chromatography".
Thank you for reading.
Hope it was of help to you.
UIPS,PU team
CLEANING VALIDATION for M.pharm and industry personabhishek pandey
YOU CAN EASY WAY TO UNDERSTAND A PROCESS AND ANLYTICAL METHOD OF CLEANING VALIDATION
Cleaning validation is the methodology used to assure that a cleaning process removes residues of the active pharmaceutical ingredients of the product manufactured in a piece of equipment, the cleaning aids utilized in the cleaning process and the microbial attributes.[1] All residues are removed to predetermined levels to ensure the quality of the next product manufactured is not compromised by waste from the previous product and the quality of future products using the equipment, to prevent cross-contamination and as a GMP requirement.
The U.S. Food and Drug Administration (FDA) has strict regulation about the cleaning validation. For example, FDA requires firms to have written general procedures on how cleaning processes will be validated. Also, FDA expects the general validation procedures to address who is responsible for performing and approving the validation study, the acceptance criteria, and when revalidation will be required. FDA also require firms to conduct the validation studies in accordance with the protocols and to document the results of studies.The valuation of cleaning validation is also regulated strictly, which usually mainly covers the aspects of equipment design,cleaning process written, analytical methods and sampling. Each of these processes has their related strict rules and requirements. Regarding to the establishment of limits, FDA does not intend to set acceptance specifications or methods for determining whether a cleaning process is validated. But some limits that have been mentioned by industry include analytical detection levels such as 10 PPM, biological activity levels such as 1/1000 of the normal therapeutic dose and organoleptic levels.[2][3][4]
Cleaning Validation in the context of Active Pharmaceutical Ingredient manufacture may be defined as: "The process of providing documented evidence that the cleaning methods employed within a facility consistently controls potential carryover of product (including intermediates and impurities), cleaning agents and extraneous material into subsequent product to a level which is below predetermined levels".
In this slide contains details about Pharmaceutical validation of water system
Presented by: K VENKATSAI PRASAD (Department of pharmaceutical analysis and quality assurance).RIPER, anantapur
This presentation includes detail about cleaning levels,equipments for cleaning validation , steps for cleaning method validation and analytical method validation used for cleaning.
This file is just a compilation of Validation guidance and standards collected from different sources.
It contains general strategies of Qualification, HVAC validation, Water system validation, Compressed air validation, Cleaning validation and general documentation required for these processes.
COMPRESSED AIR SYSTEM . ENERGY CONSERVATION OPPORTUNITIESManohar Tatwawadi
The presentation gives an idea as to how the compressed air system is designed and the performance of the compressed air system. The losses, conservation of energy, the cost of leakages etc are discussed in the presentation
Heating, ventilation, and air conditioning is the technology of indoor and vehicular environmental comfort. Its goal is to provide thermal comfort and acceptable indoor air quality.
Australasian Lab managers Conference: Gas Generation Dr Nicole Pendini 2019Nicole Renee Pendini
This presentation focus on on-site Gas Generation for the laboratory space supplying a range of analytical and specialty applications within the lab environment. I will focus on keeping green by preventing weekly cylinder and bulk supply deliveries, that waste energy offsite to generate the gas and petrol to delivery to the laboratory. The overall cost savings vs other methods (ROI < 1.5 years including service) and of course how Laboratory managers can significantly reduce their OHS/E risk with onsite Nitrogen, Hydrogen and Zero Air gas generators.
ASTM Distillation D86: A Standard Test Method for Distillation of Petroleum P...IRJESJOURNAL
Abstract :- This test method covers the atmospheric distillation of petroleum products and liquid fuels using a laboratory batch distillation unit to determine quantitatively the boiling range characteristics of such products as light and middle distillates, automotive spark ignition engine fuels with or without oxygen. This test method is designed for the analysis of distillate fuels; it is not applicable to product containing appreciable quantities of residual material .This test method covers both manual and automated instruments. The distillation characteristics of hydrocarbons have important effects on their safety and performance especially in the case of fuel and lubricants .The boiling range gives information on the composition, properties, and behavior of the fuel during storage and uses.
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
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!
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.
How to Make a Field invisible in Odoo 17Celine George
It is possible to hide or invisible some fields in odoo. Commonly using “invisible” attribute in the field definition to invisible the fields. This slide will show how to make a field invisible in odoo 17.
Synthetic Fiber Construction in lab .pptxPavel ( NSTU)
Synthetic fiber production is a fascinating and complex field that blends chemistry, engineering, and environmental science. By understanding these aspects, students can gain a comprehensive view of synthetic fiber production, its impact on society and the environment, and the potential for future innovations. Synthetic fibers play a crucial role in modern society, impacting various aspects of daily life, industry, and the environment. ynthetic fibers are integral to modern life, offering a range of benefits from cost-effectiveness and versatility to innovative applications and performance characteristics. While they pose environmental challenges, ongoing research and development aim to create more sustainable and eco-friendly alternatives. Understanding the importance of synthetic fibers helps in appreciating their role in the economy, industry, and daily life, while also emphasizing the need for sustainable practices and innovation.
Instructions for Submissions thorugh G- Classroom.pptxJheel Barad
This presentation provides a briefing on how to upload submissions and documents in Google Classroom. It was prepared as part of an orientation for new Sainik School in-service teacher trainees. As a training officer, my goal is to ensure that you are comfortable and proficient with this essential tool for managing assignments and fostering student engagement.
Unit 8 - Information and Communication Technology (Paper I).pdfThiyagu K
This slides describes the basic concepts of ICT, basics of Email, Emerging Technology and Digital Initiatives in Education. This presentations aligns with the UGC Paper I syllabus.
Welcome to TechSoup New Member Orientation and Q&A (May 2024).pdfTechSoup
In this webinar you will learn how your organization can access TechSoup's wide variety of product discount and donation programs. From hardware to software, we'll give you a tour of the tools available to help your nonprofit with productivity, collaboration, financial management, donor tracking, security, and more.
Honest Reviews of Tim Han LMA Course Program.pptxtimhan337
Personal development courses are widely available today, with each one promising life-changing outcomes. Tim Han’s Life Mastery Achievers (LMA) Course has drawn a lot of interest. In addition to offering my frank assessment of Success Insider’s LMA Course, this piece examines the course’s effects via a variety of Tim Han LMA course reviews and Success Insider comments.
Embracing GenAI - A Strategic ImperativePeter Windle
Artificial Intelligence (AI) technologies such as Generative AI, Image Generators and Large Language Models have had a dramatic impact on teaching, learning and assessment over the past 18 months. The most immediate threat AI posed was to Academic Integrity with Higher Education Institutes (HEIs) focusing their efforts on combating the use of GenAI in assessment. Guidelines were developed for staff and students, policies put in place too. Innovative educators have forged paths in the use of Generative AI for teaching, learning and assessments leading to pockets of transformation springing up across HEIs, often with little or no top-down guidance, support or direction.
This Gasta posits a strategic approach to integrating AI into HEIs to prepare staff, students and the curriculum for an evolving world and workplace. We will highlight the advantages of working with these technologies beyond the realm of teaching, learning and assessment by considering prompt engineering skills, industry impact, curriculum changes, and the need for staff upskilling. In contrast, not engaging strategically with Generative AI poses risks, including falling behind peers, missed opportunities and failing to ensure our graduates remain employable. The rapid evolution of AI technologies necessitates a proactive and strategic approach if we are to remain relevant.
A Strategic Approach: GenAI in EducationPeter Windle
Artificial Intelligence (AI) technologies such as Generative AI, Image Generators and Large Language Models have had a dramatic impact on teaching, learning and assessment over the past 18 months. The most immediate threat AI posed was to Academic Integrity with Higher Education Institutes (HEIs) focusing their efforts on combating the use of GenAI in assessment. Guidelines were developed for staff and students, policies put in place too. Innovative educators have forged paths in the use of Generative AI for teaching, learning and assessments leading to pockets of transformation springing up across HEIs, often with little or no top-down guidance, support or direction.
This Gasta posits a strategic approach to integrating AI into HEIs to prepare staff, students and the curriculum for an evolving world and workplace. We will highlight the advantages of working with these technologies beyond the realm of teaching, learning and assessment by considering prompt engineering skills, industry impact, curriculum changes, and the need for staff upskilling. In contrast, not engaging strategically with Generative AI poses risks, including falling behind peers, missed opportunities and failing to ensure our graduates remain employable. The rapid evolution of AI technologies necessitates a proactive and strategic approach if we are to remain relevant.
2. VALIDATION:
o Process of establishing documentary evidence, demonstrating
that a procedure, process or activity carried out in testing & then
production maintains the desired levels of compliance at all
stages.
Validation can be applied in
o Operation
o Training
o Manufacturing
o Maintenance
o Support services
2
3. COMPRESSED AIR:
• Air kept under a pressure that is greater than
atmospheric pressure.
• Important medium
To transfer of energy in industrial process
To operate air cylinders for automation
3
4. USES:
Used as
• Breathing gas by underwater divers.
• Pneumatics, (use of pressurized gases to work)
• HVAC control system (Heating Ventilation and
Air Conditioning)
4
5. COMPRESSED AIR VALIDATION:
It is a critical component in the production of
pharmaceutical industry and its effect is on the quality of
the end product.
Used by operatives working in a number of
industrial sectors including oil & gas, Pharmaceutical,
Manufacturing, nuclear, diving & in medical applications.
5
6. PARAMETERS TO SPECIFY THE QUALITY
OF COMPRESSED AIR:
• Dew point
• Moisture content
• Viable count
• Oil content
• Particulate matter
6
7. Nitrogen gas validation
It is a critical component in the production of
pharmaceutical industry and its effect is on the quality of
the end product.
The most common gases --Pharmaceutical Industries
It is used for providing an inert gas -vial, ampoule, used
for creating an inert pressure pad in processes.
7
8. PARAMETERS TO SPECIFY THE
QUALITY OF Nitrogen gas:
Purity
Gases such as O2 & CO2
Odour
Dew Point
Oil Content
Particulate matter
Moisture Content
Viable Count
Identification Test
8
9. DEW POINT TEMPERATURE OR
SATURATION TEMPERATURE
Temperature at which Water vapour begins to condense.
Quantity of any gas in a mixture can be expressed as a
pressure.
Gas of unknown water vapour concentration is passed
over a temperature-controlled surface. The surface is
cooled until condensation forms.
The temperature at which condensation forms is called
the “Dew Point temperature.
9
10. Dew point temperatures in compressed air range from
ambient down to -112 °F.
Dew point temperatures in nitrogen gas range from
-40°F.
10
11. Moisture content
All atmospheric air contains some water vapour which will begin
to condense into liquid water in the compressed air or gas system
The condensed moisture must be removed by a separator and
trap.
Moisture in compressed air used in a manufacturing plant causes
problems-
Operation of pneumatic air systems,
Solenoid valves
11
12. Causes –-rust and increased wear of moving parts, clogged
orifices
Moisture adversely affects the
colour,
adherence.
Corrosion of air or gas -false readings, interrupting or shutting
down plant processes.
Result -- damage to product or in costly shutdowns
Moisture content should be less than <0.01% for Compressed Air
System
Moisture content should be less than < 67ppm v/v for Nitrogen
Gas System.
12
13. Particulate matter
Compressed air /Nitrogen gas is in direct contact or
indirect contact with product
The impurities - Nitrogen/Compressed air - contaminate
the product --result in change of colour and taste, reduced
shelf life.
Compressed air, which is generated on site by pulling in
ambient air and compressing it, contains water vapour,
particulate matter
In the filtration systems --employed to protect process
equipment from large slugs of water, oil, and rust
13
14. Compressed Air has the Particulate Matter to a level less
than 0.02 mg/m3.
Nitrogen has the particulate matter of < 5 mg/m3.
14
15. Oil content
Determine the amount of Oil flowing in a Compressed
Air stream
Many Compressed air systems are supplied using
lubricated compressors.
Oil free air is generally required for a Compressed Air
System
Oil content of less than 0.01 mg/m3.(compressed air)
Oil content of less than 0.01 mg/m3.(nitrogen)
15
16. Method to determine the oil content
Presence of oil (by using oil mist detector tube).
Connect the flow meter through tubing's
Adjust the flow rate to 1 litre per minute (adjusting knob).
Break tips off a fresh Oil mist detector tube
Insert a tube into tube holder.
Attach the rubber tube holder to the flow meter outlet.
16
17. Make the connection of the Oil mist detector tube
Sample inlet from arrow G ► on the Oil mist detector tube and outlet
from another end.
Turn on the flow of compressed air and confirm the flow meter
Allow the compressed air to pass through the Oil mist detector tube
for 7 hours (420 minutes).
As soon as sampling time is elapsed turn off the flow and remove the
tube from the tube holder.
Observe the colour change 17
18. e.g. For Gastec oil mist Airtec tube colour changes from
Salmon Pink to Pale Blue.
Calculate the true concentration by the formula:
20000
True concentration (mg/m3) = Tube reading x -------------
420000
Note: If the tube reading is less than 0.2 mg/m3 report the
results as less than 0.01 mg/m3
18
19. Viable count
Microbial contaminant - adversely affect the product, including
operational characteristics.
Quality of supplied air may not be obvious unless microbiological
testing is performed.
Microbial assay –alert the manufacture –various type of viable
microorganism(present).
Manufacture of medical devices, pharmaceutical operation– free
from microorganism
For Compressed Air System, Viable count should be
<100CFU/m3(colony forming unit).
For Nitrogen Gas system, Viable count should be <1
CFU/m3.(colony forming unit)
19
20. Method to determine Microbial Evaluation
Sterilise the air sampling flask ,100 ml SCDM,(soya bean casein
digest medium)silicone tube for inlet & outlet
Sanitize the sampling site with 70% IPA(Iso propyl alcohol).
Open the valves of the compressed air system (5 minutes), allow air
to pass out.
Insert the end of the inlet silicone tube over the sampling site 20
21. Connect to flow meter
Place the outlet of silicone tube connected to flow meter in sampling
flask.
Impinge air in 100 ml of sterile SCDM for 20 minutes
Filter the whole content through 0.45 m membrane filter.
After filtration place the paper on Soybean Casein Digest Agar plate
Incubate at 30-35°C for the total viable aerobic count for 5 days.
21
22. After incubation streak a loopful on the selective media (organism-
E.coli, selective media- MacConkey's agar.).
Incubate the plates at 36-38°C for 48 hrs.
Observe the plates for colony characteristics & compare with the
standard
Brick red coloured colonies are formed with precipitation of bile.
For confirmation, carry out Gram staining.
Total Viable Aerobic Count: Alert: NMT 25 CFU/m3 Action: NMT
50 CFU/m3
22
23. Conclusion
Testing and monitoring of compressed air and other process
gases such as nitrogen, oxygen, argon, carbon dioxide that come
into direct contact with pharmaceutical products is vital to
assuring the quality and safety of those products.
It is also a component in the production of pharmaceutical
industry and effect on the quality of the end point.
Nitrogen gas is enormous cost savings compared to conventional
gas cylinders.
23
24. Reference
Senra. A, Leyva. A, Perez. Qualification and continuous
validation of a compressed air system.
Website:www.ivtnetwork.com.
Website :www.imimg.nitrogen-gas-validation-
services.com.
www.pharmaguideliness.com.
24