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Fluidized Bed Dryer
Principle of FBD
Construction of FBD
Working of FBD
Steps of Fluidization
Qualification of FBD
Design Qualification
Installation Qualification
Operational Qualification
Performance Qualification
References
Fluidized Bed Dryer
Principle of FBD
Construction of FBD
Working of FBD
Steps of Fluidization
Qualification of FBD
Design Qualification
Installation Qualification
Operational Qualification
Performance Qualification
References
“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.
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.
Raw material validation- process validationRavish Yadav
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“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.
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.
Raw material validation- process validationRavish Yadav
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Effective process validation contributes significantly to assuring drug quality. The basic
principle of quality assurance is that a drug should be produced that is fit for its intended use.
This principle incorporates the understanding that the following conditions exist:
• Quality, safety, and efficacy are designed or built into the product.
• Quality cannot be adequately assured merely by in-process and finished-product
inspection or testing
Process validation- This guidance incorporates principles and approaches that...Sanchit Dhankhar
This guidance incorporates principles and approaches that all manufacturers can use to validate manufacturing processes.
It is the process of establishing, through documented evidence, a high degree of assurance that a specific process will consistently produce a product that meets its predetermined specifications and quality characteristics.
It is the topic of Industrial pharmacy 2 from semester 7 of Bachelor of pharmacy.
It involved all information regarding Pharmaceuticals production scale up technique .role of managers, Engineer and scientists are explained properly .
ROLE OF MANAGER
1. Ensure a safe work environment for all pilot plant operations and compliance with all health and safety policies and procedures.
2.Provide technical leadership and operational oversight of Pilot Plant facility.
3.Partner with Process Development to optimize and implement new processes and technology at the pilot scale.
4.Train engineers and associates in the functional tasks necessary to successfully perform their duties.
5.Schedule activities of pilot plant personnel and ensure the tasks are completed in a timely manner.
6.Provide personnel career development, coaching, and feedback including performance management discussions with each direct report.
7.Train and oversee compliance with Quality Assurance policies and procedures that relate to the Pilot Plant.
8.Write and review standard operating procedures, batch records, process deviations reports, CAPAs, and change control requests.
Manage raw material receipt and release system.
9.Manage plant supplies and raw materials inventory.
Role of engineers:
1.Plant engineers oversee the electrical mechanical systems of a manufacturing plant, from installation to troubleshooting.
2. They are called upon to improve the plant's efficiency, upgrade to new technologies, repair equipment, increase production, and reduce manufacturing issues .
3.Try to process on a model of proposed plant before committing large sum of money on a production unit.
4.Examination of the formula to determine its ability to withstand batch scale & process modification.
5.Evaluation & Validation for process and equipment.
6.To identify the critical features of the process.
Guidelines for production & process controls.
7.To provide master manufacturing formula with instructions for manufacturing procedure.
8.To avoid the scale up problems.
Process of solid ,liquid dosage forms and their guidelines followed along with proper equipment study is provided and the major controls to maintain scale up consideration were mentioned.
Chemical Industry Case Study: Using Xanthan Gum in Chemical ApplicationsMatt Smith
Find the solution for one of the toughest mixing applications in the chemical industry, using xanthan gum in chemical applications such as adhesives, ceramic glazes, drilling muds, foundry compounds, latex emulsions, lubricants, paints and coatings, paper, pesticides & textiles. Read this case study on the Process, the Problem and the Solution.
Pharmaceutical Industry: Manufacturing Pharmaceutical Tablet CoatingsMatt Smith
Find the solution for one of the toughest mixing applications in the pharmaceutical industry, by reading this case study on manufacturing pharmaceutical tablet coatings. Read about the Process, the Problem and the Solution.
Food Industry Case Study: Hydration of Xanthan GumMatt Smith
Find the solution for one of the toughest mixing applications in the food industry, hydrating xanthan gum. Read this case study on the Process, the Problem and the Solution.
Food Industry Case Study: Hydrating Xanthan GumMatt Smith
Find the solution for one of the toughest mixing applications in the food industry, hydrating xanthan gum. Read this case study on the Process, the Problem and the Solution.
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Patient compliance with medical adviceRavish Yadav
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Infrared spectrum / infrared frequency and hydrocarbonsRavish Yadav
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Narcotic drugs and psychotropic substances act, 1985Ravish Yadav
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Medicinal and toilet preparations (excise duties) act, 1995 and rules, 1956Ravish Yadav
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Anti mycobacterial drugs (tuberculosis drugs)Ravish Yadav
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This slide is special for master students (MIBS & MIFB) in UUM. Also useful for readers who are interested in the topic of contemporary Islamic banking.
The simplified electron and muon model, Oscillating Spacetime: The Foundation...RitikBhardwaj56
Discover the Simplified Electron and Muon Model: A New Wave-Based Approach to Understanding Particles delves into a groundbreaking theory that presents electrons and muons as rotating soliton waves within oscillating spacetime. Geared towards students, researchers, and science buffs, this book breaks down complex ideas into simple explanations. It covers topics such as electron waves, temporal dynamics, and the implications of this model on particle physics. With clear illustrations and easy-to-follow explanations, readers will gain a new outlook on the universe's fundamental nature.
How to Add Chatter in the odoo 17 ERP ModuleCeline George
In Odoo, the chatter is like a chat tool that helps you work together on records. You can leave notes and track things, making it easier to talk with your team and partners. Inside chatter, all communication history, activity, and changes will be displayed.
Normal Labour/ Stages of Labour/ Mechanism of LabourWasim Ak
Normal labor is also termed spontaneous labor, defined as the natural physiological process through which the fetus, placenta, and membranes are expelled from the uterus through the birth canal at term (37 to 42 weeks
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!
Introduction to AI for Nonprofits with Tapp NetworkTechSoup
Dive into the world of AI! Experts Jon Hill and Tareq Monaur will guide you through AI's role in enhancing nonprofit websites and basic marketing strategies, making it easy to understand and apply.
Executive Directors Chat Leveraging AI for Diversity, Equity, and InclusionTechSoup
Let’s explore the intersection of technology and equity in the final session of our DEI series. Discover how AI tools, like ChatGPT, can be used to support and enhance your nonprofit's DEI initiatives. Participants will gain insights into practical AI applications and get tips for leveraging technology to advance their DEI goals.
Safalta Digital marketing institute in Noida, provide complete applications that encompass a huge range of virtual advertising and marketing additives, which includes search engine optimization, virtual communication advertising, pay-per-click on marketing, content material advertising, internet analytics, and greater. These university courses are designed for students who possess a comprehensive understanding of virtual marketing strategies and attributes.Safalta Digital Marketing Institute in Noida is a first choice for young individuals or students who are looking to start their careers in the field of digital advertising. The institute gives specialized courses designed and certification.
for beginners, providing thorough training in areas such as SEO, digital communication marketing, and PPC training in Noida. After finishing the program, students receive the certifications recognised by top different universitie, setting a strong foundation for a successful career in digital marketing.
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.
2. The Rapid Mixer Granulator is a multi-purpose processor
equally suitable for high speed dispersion of dry powders,
aqueous or solvent granulations, and effervescent products
and melt pelletization.
3. Blending and wet massing is accomplished by high
mechanical agitation by an impeller and chopper.
Mixing, densification, and agglomeration of wetted
materials are achieved through shearing and
compaction forces exerted by the impeller.
4. The primary function of chopper is to cuts lumps into smaller fragments
and aids the bowl or sprayed onto the powder to achieve a more
homogeneous liquid distribution.
5. VARIABLES :
PROCESS VARIABLES :
•Impeller rotation speed
•Chopper rotation speed
•Liquid flow rate
•Load of the mixer
•Liquid addition method
•Wet-massing time (subsequent of liquid addition time)
6. PRODUCT VARIABLES :
•Amount of liquid binder
•Characteristics of liquid binder
• Surface tension
• Viscosity
• Adhesiveness
•Characteristics of the feed materials
• Particle size and size distribution
• Particle specific surface area
• Solubility in the liquid binder
• Wettability
•Packing properties
12. Equipment installation site:
• Equipment is installed in the location as specified.
• Equipment is installed as per the supplier
instruction.
• Packing debris are removed
• As Built drawing is prepared and verified
13. Installation Qualification Procedure :
Test Equipment:
Spirit level For checking leveling of equipment
Multi meter For checking electrical supply
Molybdenum test kit To confirm material of
construction of the Stainless Steel 316 quality
14. Protocol Approval :
• Objective
• Critical Process control variables
• Test Program and Acceptance criteria
• Sampling points
• Qualification results
• Final Report
• Report Approval
15. OBJECTIVE:
• To verify that the utility, environment, equipment and
support system produces the required output by integrating
procedures, personnel, systems and materials.
• To verify the performance of the Rapid Mixer Granulator -
(RMG) for maximum occupancy capacity of 80%, minimum
occupancy capacity 30% and intermediate occupancy
capacity 55% based on 0.5 w/v bulk density, by adding
lactose and Ponceau 4R supra of 1% in RMG and estimate
the colour content uniformity in blend at different time
intervals.
• To verify the performance of Rapid Mixer Granulator -
(RMG) for a specific size by granulating lactose with HPMC
solution and observe amperage and granules consistency at
different time intervals.
16. S.
No
Operation stage Control variables Measured parameters
1 Dry Mixing Load size
Mixing time
Content uniformity
2 Wet Mixing Impeller speed, chopper speed
Granulation time
Amount of granulation fluid
Water content/LOD
Granules appearance
Amperage /torque
CRITICAL PROCESS CONTROL VARIABLES:
Process control variables of dry mixing, wet mixing
operations and measured parameters are identified as
follows
Performance of Rapid Mixer Granulator shall be verified at different
control variables such as load size, and mixing time.
17. Test program and acceptance criteria:
Objective:
• To verify the performance of the Rapid Mixer
Granulator (150 lts) for maximum, minimum and
intermediate occupancy capacities and at different
mixing intervals.
• Granulating performance for maximum capacity at
different control process parameters
18. Procedure (dry mixing):
• Add Lactose and Ponceau 4R supra (sifted through 40#) into
Rapid Mixer Granulator and mix the material for a period of 20
minutes.
• Collect samples in duplicate each equivalent to 2gms using unit
dose sampler from 5 different locations (shown in diagram and
transfer in to individual labeled glass vials.
• Collect the samples at different time intervals of 5, 10, 15 and
20 minutes
• Submit the samples for analysis of colour content. Analyse the
sample as per the analytical procedure. Record the results in
qualification result data sheets.
19. Sampling points in rapid mixer granulator
4
1 2
3
5
1.Top Left
2.Top Right
3.Middle
4.Bottom Front
5.Bottom Rear
20. Analysis procedure:
Sample preparation:
Weigh sample equivalent to 10 mg of Ponceau 4 R supra and
transfer into 200ml volumetric flask add 100ml of water and
sonicate for 5 minutes to dissolve completely, then dilute up to the
mark with water. Filter the solution and dilute 10ml of filtrate to
50 ml with water.
Procedure:
Measure the absorbance at 506nm using UV spectrophotometer.
Calculate the % of colour content using following formula.
Acceptance Criteria:
Colour content (assay) of all samples should be in between 90 -110
%
The average of assay results at each interval should be in between
95 -105 %
Content uniformity of 5 samples RSD should not be more than 4%
21. Procedure (wet mixing):
Add specified quantity of HPMC in purified water and dissolve
completely.
Take specified quantity of Lactose monohydrate (sifted through
#40) into RMG, add above HPMC solution and granulate at slow
speed till the required consistent granules formed.
Record the time of granulation at different intervals (after
5minutes and every after 2minutes till granulation completed)
during granulation till appearance of granules the required
consistent granules formed.
Record appearance of granules and LOD of wet mass after
granulation completed.
Acceptance Criteria:
RMG should be capable of producing desired granules.
Amperage reading should be increased as granulation time
progresses.
Functioning of RMG should be in normal, safe and secure
condition.
27. RSD
Mean
Batch size: Low
RSD
Mean
Batch size: Medium
RSD
Mean
Batch size: High
After 20 minutesAfter 15 minutesAfter 10 minutesAfter 5 minutes
Colour content in %
Final Report Summary
Dry mixing