- 43
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Pharmaceutical resource and education services
Belgium
เข้าร่วมเมื่อ 6 เม.ย. 2018
Pharmaceutical Resource and Education Services ( PRES) is committed to provide a quality training and education services. All the content in this channel is free of cost. Its a novel mission carried out by PRES to educate the entire pharmaceutical and health care professional. Knowledge is the key of success and empower you to grow in your career.
Channel Maintain by : Palash Chandra Das , SME in sterile operation & practices (M.Pharm)
Mail id: mail2uscgmp@gmail.com,
LinkedIn : www.linkedin.com/in/palashchandradas/
FAQ:
1. Why we are different from other ?
We directly discuss about actual regulatory requirements through technical article, guidance or regulations. We help to understand better the cGMP requirements.
2. Can we include this video for institutional or organization training ?
Yes, you can utilize this educational video to your students or employees.
Channel Maintain by : Palash Chandra Das , SME in sterile operation & practices (M.Pharm)
Mail id: mail2uscgmp@gmail.com,
LinkedIn : www.linkedin.com/in/palashchandradas/
FAQ:
1. Why we are different from other ?
We directly discuss about actual regulatory requirements through technical article, guidance or regulations. We help to understand better the cGMP requirements.
2. Can we include this video for institutional or organization training ?
Yes, you can utilize this educational video to your students or employees.
Part 2: Discussion on Cleaning, Disinfection and Sterilization
Cleaning, Disinfection, and Sterilization: A Critical Overview
Cleaning, disinfection, and sterilization are essential practices in various settings, from healthcare facilities to homes. Each process plays a crucial role in preventing the spread of pathogens and maintaining a hygienic environment.
Cleaning involves the removal of visible dirt, debris, and contaminants from surfaces. This is typically achieved through the use of detergents or cleaning agents and water. While cleaning is important, it does not eliminate all microorganisms.
Disinfection goes a step further by killing most microorganisms, including bacteria and viruses. Disinfectants are chemical agents that can be applied to surfaces or objects. Common disinfectants include bleach, alcohol, and quaternary ammonium compounds.
Sterilization is the most rigorous level of microbial control. It involves the complete elimination of all microorganisms, including spores. Sterilization methods often involve heat, pressure, or chemicals. Autoclaves, which use high pressure and temperature, are commonly used for sterilizing medical equipment.
The choice of cleaning, disinfection, or sterilization method depends on the specific situation and the level of microbial control required. In healthcare settings, where the risk of infection is high, sterilization is often necessary. In household settings, cleaning and disinfection may be sufficient for most surfaces.
Understanding the differences between these three processes is essential for maintaining a safe and hygienic environment. By implementing appropriate cleaning, disinfection, and sterilization practices, we can significantly reduce the risk of disease transmission and protect public health.
This Video Presented By:
Palash Chandra Das, M.Pharm (Pharmaceutical Chemistry)
About Myself:
I have completed my B.Pharm and M.Pharm in Pharmaceutical medicinal chemistry from WBUT. In the year 2010, I started my journey in the Pharmaceutical Industry. In my career I worked with the F & D, Production and Quality Assurance department etc. I have a good exposure in several Sterile Green field and Brown field projects. Involved in various regulatory audit like CDSCO, WHO, USFDA,TGA,MHRA, GERMAN, UKRAINE, ANVISA-Brazil, INVIMA-Colombia, RUSSIA, IRAN, PMDA-Japan, South Korea etc.
Core Technical Skill:
Sterile Injectable dosages form (SVP and LVP ) with liquid and lyophilized form
Qualification & Validation , Computer System Validation, Sterility Assurance, Quality Management System, Risk Management, cGMP training, Failure Investigation , Auditing
Follow me,
Read my blog Pharmaceutical resource and educational services at: pres.net.in/blog/
Follow me at LinkedIn : www.linkedin.com/in/palashchandradas/
Follow me at Twitter : palash_das
Follow me at Instagram: pharmacistpalash
Join Me,
Admin and Member of "Global Federation of Pharmaceutical Industrial Association"
Free joining link : groups/onlinepharma
Share your queries and concern at mail2uscgmp@gmail.com
Cleaning, disinfection, and sterilization are essential practices in various settings, from healthcare facilities to homes. Each process plays a crucial role in preventing the spread of pathogens and maintaining a hygienic environment.
Cleaning involves the removal of visible dirt, debris, and contaminants from surfaces. This is typically achieved through the use of detergents or cleaning agents and water. While cleaning is important, it does not eliminate all microorganisms.
Disinfection goes a step further by killing most microorganisms, including bacteria and viruses. Disinfectants are chemical agents that can be applied to surfaces or objects. Common disinfectants include bleach, alcohol, and quaternary ammonium compounds.
Sterilization is the most rigorous level of microbial control. It involves the complete elimination of all microorganisms, including spores. Sterilization methods often involve heat, pressure, or chemicals. Autoclaves, which use high pressure and temperature, are commonly used for sterilizing medical equipment.
The choice of cleaning, disinfection, or sterilization method depends on the specific situation and the level of microbial control required. In healthcare settings, where the risk of infection is high, sterilization is often necessary. In household settings, cleaning and disinfection may be sufficient for most surfaces.
Understanding the differences between these three processes is essential for maintaining a safe and hygienic environment. By implementing appropriate cleaning, disinfection, and sterilization practices, we can significantly reduce the risk of disease transmission and protect public health.
This Video Presented By:
Palash Chandra Das, M.Pharm (Pharmaceutical Chemistry)
About Myself:
I have completed my B.Pharm and M.Pharm in Pharmaceutical medicinal chemistry from WBUT. In the year 2010, I started my journey in the Pharmaceutical Industry. In my career I worked with the F & D, Production and Quality Assurance department etc. I have a good exposure in several Sterile Green field and Brown field projects. Involved in various regulatory audit like CDSCO, WHO, USFDA,TGA,MHRA, GERMAN, UKRAINE, ANVISA-Brazil, INVIMA-Colombia, RUSSIA, IRAN, PMDA-Japan, South Korea etc.
Core Technical Skill:
Sterile Injectable dosages form (SVP and LVP ) with liquid and lyophilized form
Qualification & Validation , Computer System Validation, Sterility Assurance, Quality Management System, Risk Management, cGMP training, Failure Investigation , Auditing
Follow me,
Read my blog Pharmaceutical resource and educational services at: pres.net.in/blog/
Follow me at LinkedIn : www.linkedin.com/in/palashchandradas/
Follow me at Twitter : palash_das
Follow me at Instagram: pharmacistpalash
Join Me,
Admin and Member of "Global Federation of Pharmaceutical Industrial Association"
Free joining link : groups/onlinepharma
Share your queries and concern at mail2uscgmp@gmail.com
มุมมอง: 16
วีดีโอ
Part 1: Discussion on Cleaning, Disinfection and Sterilization
มุมมอง 85หลายเดือนก่อน
Cleaning, Disinfection, and Sterilization: A Critical Overview Cleaning, disinfection, and sterilization are essential practices in various settings, from healthcare facilities to homes. Each process plays a crucial role in preventing the spread of pathogens and maintaining a hygienic environment. Cleaning involves the removal of visible dirt, debris, and contaminants from surfaces. This is typ...
Discussion on Blow-Fill-Seal Technology
มุมมอง 99หลายเดือนก่อน
Environmental monitoring (EM) is critical for Blow-Fill-Seal (BFS) technology, a widely used aseptic manufacturing process for packaging sterile liquids such as pharmaceuticals and medical products. BFS technology involves forming, filling, and sealing containers in a continuous, automated process, which minimizes human intervention and the risk of contamination. However, even in such closed sy...
How to use artificial intelligence (AI) in Pharmaceutical Industry - Basic (Part 1)
มุมมอง 4102 หลายเดือนก่อน
Welcome to this training session on the transformative role of AI in pharmaceutical learning. As the pharmaceutical industry continues to evolve rapidly, staying ahead of the curve requires more than just traditional methods. Artificial Intelligence is revolutionizing how we approach learning and professional development in our field. This session is designed to explore how AI applications can ...
Shorts#001 - Pass boxes used in Pharmaceutical Facility
มุมมอง 11210 หลายเดือนก่อน
In pharmaceutical manufacturing industries, pass boxes are normally used to transfer a particular material between two areas generally of different cleanliness levels. The boxes can be said to transfer the materials from a high level of cleanliness to a lower level of cleanliness or vice-versa. #pharma #pharmaceutical #pharmaceutical #healthcare This Video Presented By: Palash Chandra Das, M.Ph...
F0 Value of Moist Heat Sterilization
มุมมอง 953ปีที่แล้ว
F0 is the equivalent exposure time at 121.11°C of the actual exposure time at a variable temperature, calculated for an ideal microorganism with a temperature coefficient of destruction equal to 10 °C. This Video Presented By: Palash Chandra Das, M.Pharm (Pharmaceutical Chemistry) About Myself: I have completed my B.Pharm and M.Pharm in Pharmaceutical medicinal chemistry from WBUT. In the year ...
Moist Heat Sterilization - Latest EU Annex 1
มุมมอง 5272 ปีที่แล้ว
EU Annex 1 Moist Heat Sterilization requirement are explained here. Presentation available in English and Hindi. Skip the English part if you wanted to listed in Hindi. Skip the Hindi part ant second half if you are English listeners. What is sterilization by moist heat? Sterilization by moist heat is also known as steam sterilization. Moist heat sterilization destroys microorganisms in a produ...
Sterility Assurance - Concept and fundamentals
มุมมอง 2.3K2 ปีที่แล้ว
Sterilization is an essential stage in the processing of any product destined for parenteral administration, or for contact with broken skin, mucosal surfaces, or internal organs, where the threat of infection exists. In addition, the sterilization of microbiological materials, soiled dressings and other contaminated items is necessary to minimize the health hazard associated with these article...
हिंदी में आइसोलेटर सीखें _Isolator Qualification with H2O2 Decontamination
มุมมอง 4.6K2 ปีที่แล้ว
आइसोलेटर के VHP डोन्टामिनाशन बारेमे सीखिये Isolator Qualification with H2O2 Decontamination This Video Presented By: Palash Chandra Das, M.Pharm (Pharmaceutical Chemistry) About Myself: I have completed my B.Pharm and M.Pharm in Pharmaceutical medicinal chemistry from WBUT. In the year 2010, I started my journey in the Pharmaceutical Industry. In my career I worked with the F & D, Production an...
Clean Utility Vs Raw utility use in Pharmaceutical Manufacturing Facility
มุมมอง 2.5K2 ปีที่แล้ว
Clean Utility Vs Raw utility use in Pharmaceutical Manufacturing Facility This Video Presented By: Palash Chandra Das, M.Pharm (Pharmaceutical Chemistry) About Myself: I have completed my B.Pharm and M.Pharm in Pharmaceutical medicinal chemistry from WBUT. In the year 2010, I started my journey in the Pharmaceutical Industry. In my career I worked with the F & D, Production and Quality Assuranc...
Sterile Injectable Manufacturing Process ( Part 2)
มุมมอง 2K2 ปีที่แล้ว
Sterile Injectable Manufacturing Process ( Part 2) Drug products that are delivered via the parenteral, ophthalmic, inhaled, or otic route present an increased risk of infection or harm because they bypass many of the body’s natural defenses. To ensure patient safety, the FDA requires that drug products delivered via these routes be supplied as sterile products. This designation includes many c...
Regulations (USFDA and EU) and guidance related to Biological indicator (BI) used in Sterilization
มุมมอง 6102 ปีที่แล้ว
Regulations (USFDA and EU) and guidance related to Biological indicator (BI) used in Sterilization This Video Presented By: Palash Chandra Das, M.Pharm (Pharmaceutical Chemistry) About Myself: I have completed my B.Pharm and M.Pharm in Pharmaceutical medicinal chemistry from WBUT. In the year 2010, I started my journey in the Pharmaceutical Industry. In my career I worked with the F & D, Produc...
Terminally Sterilized Products - Manufacturing Controls
มุมมอง 5862 ปีที่แล้ว
Terminally Sterilized Products - Manufacturing Controls
Easy Steps For Making and Editing Video Presentation
มุมมอง 812 ปีที่แล้ว
Easy Steps For Making and Editing Video Presentation
Terminal Moist Heat Sterilisation Process
มุมมอง 1.2K2 ปีที่แล้ว
Terminal Moist Heat Sterilisation Process
Definition and Comparison of Different Sterility Assurance Related Topics
มุมมอง 3412 ปีที่แล้ว
Definition and Comparison of Different Sterility Assurance Related Topics
Myth or Facts....Exposure of 3 min at 300°C necessary for Depyrogenation in Tunnel Dry heat PQ ?
มุมมอง 1.6K2 ปีที่แล้ว
Myth or Facts....Exposure of 3 min at 300°C necessary for Depyrogenation in Tunnel Dry heat PQ ?
483 observation analysis on Moist Heat Terminal Sterilization TS process
มุมมอง 6073 ปีที่แล้ว
483 observation analysis on Moist Heat Terminal Sterilization TS process
Investigate a faulty Investigation ! (Part 2 - What Good Investigation looks like)
มุมมอง 2203 ปีที่แล้ว
Investigate a faulty Investigation ! (Part 2 - What Good Investigation looks like)
Investigating Out of Specification (OOS) Test Results for Pharmaceutical Production
มุมมอง 1.2K3 ปีที่แล้ว
Investigating Out of Specification (OOS) Test Results for Pharmaceutical Production
483 or warning letter due to Inappropriate Investigation ? Lets Investigate a faulty Investigation !
มุมมอง 7533 ปีที่แล้ว
483 or warning letter due to Inappropriate Investigation ? Lets Investigate a faulty Investigation !
How to calculate depyrogenation tunnel belt speed
มุมมอง 5K3 ปีที่แล้ว
How to calculate depyrogenation tunnel belt speed
How to investigate a microbial failure in Aseptic injectable process ?
มุมมอง 1.4K3 ปีที่แล้ว
How to investigate a microbial failure in Aseptic injectable process ?
Part1-Sterility Assurance assessment considering EU Annex1(draft)
มุมมอง 3883 ปีที่แล้ว
Part1-Sterility Assurance assessment considering EU Annex1(draft)
Sterility Assurance assessment with EU Annex 1 Promotional clips
มุมมอง 1673 ปีที่แล้ว
Sterility Assurance assessment with EU Annex 1 Promotional clips
Concept of biological lethality and SAL calculation (applying moist heat sterilization process)
มุมมอง 7333 ปีที่แล้ว
Concept of biological lethality and SAL calculation (applying moist heat sterilization process)
Concept of thermal lethality applying steam sterilization process (D-Value, Z- Value, Fphy and F0)
มุมมอง 2.6K3 ปีที่แล้ว
Concept of thermal lethality applying steam sterilization process (D-Value, Z- Value, Fphy and F0)
Brief overview On Quality Risk Management
มุมมอง 5393 ปีที่แล้ว
Brief overview On Quality Risk Management
Freeze drying/ Lyophilization basics and fundamentals
มุมมอง 4.6K3 ปีที่แล้ว
Freeze drying/ Lyophilization basics and fundamentals
Pharmaceutical learning resources (Part 1) - Get free courses (i.e. USP, FDA) with certification
มุมมอง 2.4K3 ปีที่แล้ว
Pharmaceutical learning resources (Part 1) - Get free courses (i.e. USP, FDA) with certification
Sir kindly do the video on 1)actual practical basis disinfectant validation, process flow 2)actual microbial OOS flow. 3) trend analysis as per contamination recovery rate and incident rate... It will help a lot to people like me...
Sure , feel free to communicate if you want any specific topics based on your data or process. Our mail is mail2uscgmp@gmail.com
Nicely said sir
❤
Great job. Keep going.....
Very informative session
Good to learn basic Thanks for the Session
Great
Great 👍👍
dear can you plz provide a link USP out of specification ,which is not free in usp education side,but I do not have money to buy
Thoroughly explained. Are these same regulations used for nutraceuticals as well ?
All the Best.
Please explains change control risk assessment, impact assessment and action items for change in excipient, API vendor Change in equipment Change in area Change in location / site Introducing new product Change in batch size Change in software
Super
Sir, will you please answer my below question. Why ampoule products require sterilization and vial products for depyrogenation. Can we use depyrogenation tunnel for ampoule product
Yes, depyrogenation tunnel can be used for Vial and Ampoule both in case of aseptic manufacturing process.
@@cGMP what is the differences between aseptic & sterile process.
Have you made any vedio on injectable machines from engineering point of view of totally related to technical issues and maintenance.
Sir plz confirm that Dwell time and fd value is same in tunnel validation
Very helpful voor video
Thanks a lot
Can you share xls file download link
Thanks continue
Very department expansion good
Can you clarify this from EU Volume 4 annex 1 as I am confused how to include load dryness by visual inspection in SOP or part of line clearance? 8.56 The items to be sterilised, other than products in sealed containers, should be dry, packaged in a protective barrier system which allows removal of air and penetration of steam and prevents recontamination after sterilisation. All loaded items should be dry upon removal from the steriliser. Load dryness should be confirmed by visual inspection as a part of the sterilisation process acceptance.
very good understanding
Very informative..... well explained.....
Very informative content 👌 👏
Its informative
There is one more possibility of introducing H2O2 by turbulent flow through nozzle directly to the chamber, in IMA machine we had qualified.For your information
Knowledgeable 📸 video sir ji
Sir please explain about nitrosamine risk assessment
Tone is controlled very well. Try to show CC document also
As high pressure will be there in infeed zone of filling machine? Possible for air turbulence?
Is that air from hot zone can go to cool zone? Possibility for Contamination?
Great work done. Thanks for the presentation 👍
Nice presentation
Good
🤷 𝓹𝓻𝓸𝓶𝓸𝓼𝓶
The book "300 Questions About Drug Product Manufacturing" on A. did help me a lot!
Good explanation sir my dout compounding main checking points and critical observation Kya Kya hey mey ipqa mey job karahun
Thank you so much Palas, you videos are very informative
sir please explain about Risk assessment on new facility creation
Thank you
Neat n simple explanation... Thank you
dear palash , very good clarity on subject , good luck for your journey
Gracias, greetings from Perú
Sir please explain in Hindi also ..
Hindi me video banaye
Please Hindi so everyone can learn sir 🙏
Please tell about Fh value limit for depyrogenation at 320
Very helpful in short time video. Thanks sir