Continuous manufacturing technology
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A basic concept of flow chemistry technology using continuous reactors in API manufacturing companies.
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Continuous Manufacturing - Issues and Answers
The document discusses continuous manufacturing in the pharmaceutical industry. It begins with an overview of continuous manufacturing and examples of companies that have adopted the technology. It then discusses some of the challenges that excipients may face with continuous manufacturing, such as quality constraints and ensuring content uniformity and flow. The document proposes some solutions for these challenges, including using mannitol as a multifunctional excipient and developing binary premixes and customized premixes of excipients ready for continuous manufacturing processes. It argues that mannitol and particle engineered grades like Parteck® M are well-suited as enabling excipients for continuous manufacturing due to their properties like compressibility, disintegration, and low hygroscopicity
Pilot plant scale up technique
A pilot plant allows investigation of a product and process on an intermediate scale before committing to full-scale production. It permits examination of formulae to determine ability to withstand scale-up and process modification. Pilot plant studies help identify critical process features, provide production guidelines and controls, and avoid scale-up problems. The document outlines steps for conducting pilot plant studies including laboratory work, preliminary larger studies, and defining rate-controlling steps before designing and constructing a pilot plant.
In process control, slide
In-process controls (IPC) involve checks carried out during the manufacturing process to monitor and adjust the process if needed to ensure the product meets specifications. IPC includes testing in-process materials for identity, strength, quality and purity, as well as monitoring process parameters and environmental conditions. Written IPC procedures describe tests like tablet weight variation, disintegration time, and content uniformity. The objectives of IPC are quality control and process control. IPC results are documented and evaluated by quality control as part of release procedures.
Good manufacturing practices (GMP)
GMP regulations are designed to minimize risks in pharmaceutical production. They provide a framework to assure safety, identity, strength, quality and potency of drug products. GMPs require controlled production and adherence to regulations under the Federal Food, Drug and Cosmetic Act. The US GMP regulations are divided into parts 210 and 211, addressing building and facilities, equipment, packaging, labeling, holding, returns, and more. GMPs help ensure drug products are manufactured and controlled using quality standards appropriate for their intended use and to prevent adulteration.
Process analytical techniques Esha shah
1. Process analytical technology (PAT) aims to improve understanding and control of pharmaceutical manufacturing processes through measurement of critical quality parameters during processing.
2. Conventional batch processing relies on final testing of samples, which risks discarding good batches if samples fail tests. PAT allows for continuous monitoring and adjustment to ensure consistent quality throughout production.
3. Key aspects of PAT include incorporating advanced sensors and instruments for online and inline measurements of critical attributes, linking these measurements to product quality through multivariate models, and using the enhanced process understanding to design control strategies and quality into the process from the start.
Form 483 Ranbaxy (Mohali Facility)
The presentation deals with the hot issues of regulatory violations made by the Ranbaxy in Mohali plant. It has the violations made and the observations of the FDA inspector, also gives a basic overview of what is form 483 and consent decree. The CAPA I will be uploading soon enough.
Technology transfer plan & exhibit
1. The presentation describes the steps for performing a successful technology transfer in the pharmaceutical industry, including feasibility studies, scale-up, exhibit batches, stability studies, and process validation batches.
2. A key part of the technology transfer is developing a technology transfer plan that describes the items and contents being transferred along with detailed procedures and a transfer schedule.
3. Successful technology transfers require effective communication, overcoming challenges through risk assessment, and commitment between the transferring and receiving parties.
THE ROLE OF QA IN PHARMACEUTICALS
The document provides a history of pharmaceutical quality and regulations, beginning with tragic events in the early 20th century that led to the first drug safety laws. It describes key milestones in GMP development and implementation, from the 1938 FD&C Act to modern ICH guidelines. The current pharmaceutical quality system aims to ensure safety, efficacy and conformity through elements like quality control, assurance programs, documentation standards, and change management processes across the product lifecycle.
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Continuous Manufacturing - Issues and Answers
The document discusses continuous manufacturing in the pharmaceutical industry. It begins with an overview of continuous manufacturing and examples of companies that have adopted the technology. It then discusses some of the challenges that excipients may face with continuous manufacturing, such as quality constraints and ensuring content uniformity and flow. The document proposes some solutions for these challenges, including using mannitol as a multifunctional excipient and developing binary premixes and customized premixes of excipients ready for continuous manufacturing processes. It argues that mannitol and particle engineered grades like Parteck® M are well-suited as enabling excipients for continuous manufacturing due to their properties like compressibility, disintegration, and low hygroscopicity
Pilot plant scale up technique
A pilot plant allows investigation of a product and process on an intermediate scale before committing to full-scale production. It permits examination of formulae to determine ability to withstand scale-up and process modification. Pilot plant studies help identify critical process features, provide production guidelines and controls, and avoid scale-up problems. The document outlines steps for conducting pilot plant studies including laboratory work, preliminary larger studies, and defining rate-controlling steps before designing and constructing a pilot plant.
In process control, slide
In-process controls (IPC) involve checks carried out during the manufacturing process to monitor and adjust the process if needed to ensure the product meets specifications. IPC includes testing in-process materials for identity, strength, quality and purity, as well as monitoring process parameters and environmental conditions. Written IPC procedures describe tests like tablet weight variation, disintegration time, and content uniformity. The objectives of IPC are quality control and process control. IPC results are documented and evaluated by quality control as part of release procedures.
Good manufacturing practices (GMP)
GMP regulations are designed to minimize risks in pharmaceutical production. They provide a framework to assure safety, identity, strength, quality and potency of drug products. GMPs require controlled production and adherence to regulations under the Federal Food, Drug and Cosmetic Act. The US GMP regulations are divided into parts 210 and 211, addressing building and facilities, equipment, packaging, labeling, holding, returns, and more. GMPs help ensure drug products are manufactured and controlled using quality standards appropriate for their intended use and to prevent adulteration.
Process analytical techniques Esha shah
1. Process analytical technology (PAT) aims to improve understanding and control of pharmaceutical manufacturing processes through measurement of critical quality parameters during processing.
2. Conventional batch processing relies on final testing of samples, which risks discarding good batches if samples fail tests. PAT allows for continuous monitoring and adjustment to ensure consistent quality throughout production.
3. Key aspects of PAT include incorporating advanced sensors and instruments for online and inline measurements of critical attributes, linking these measurements to product quality through multivariate models, and using the enhanced process understanding to design control strategies and quality into the process from the start.
Form 483 Ranbaxy (Mohali Facility)
The presentation deals with the hot issues of regulatory violations made by the Ranbaxy in Mohali plant. It has the violations made and the observations of the FDA inspector, also gives a basic overview of what is form 483 and consent decree. The CAPA I will be uploading soon enough.
Technology transfer plan & exhibit
1. The presentation describes the steps for performing a successful technology transfer in the pharmaceutical industry, including feasibility studies, scale-up, exhibit batches, stability studies, and process validation batches.
2. A key part of the technology transfer is developing a technology transfer plan that describes the items and contents being transferred along with detailed procedures and a transfer schedule.
3. Successful technology transfers require effective communication, overcoming challenges through risk assessment, and commitment between the transferring and receiving parties.
THE ROLE OF QA IN PHARMACEUTICALS
The document provides a history of pharmaceutical quality and regulations, beginning with tragic events in the early 20th century that led to the first drug safety laws. It describes key milestones in GMP development and implementation, from the 1938 FD&C Act to modern ICH guidelines. The current pharmaceutical quality system aims to ensure safety, efficacy and conformity through elements like quality control, assurance programs, documentation standards, and change management processes across the product lifecycle.
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The document discusses Good Manufacturing Practices (GMP) for distribution, distribution records, handling returned goods, and recovery/reprocessing of materials. It provides guidelines for distribution procedures including first expiration, first out (FEFO) and batch recall systems. It also outlines requirements for distribution records, handling returned products, and reprocessing materials to ensure quality is maintained.
Pharmaceutical documentation
This document describes a pharmaceutical documentation project submitted by Rahul Sharma for the degree of Bachelor of Pharmacy. It includes a certificate signed by his supervisor, Mr. Shailesh Kumar Singh, confirming Rahul conducted the project work. Rahul also includes a declaration that the work presented in the project entitled "Pharmaceutical Documentation" was carried out by him. The project acknowledges various individuals who helped Rahul complete the work. It then provides an abstract stating the project specifies GMP requirements for documentation within the pharmaceutical industry and describes key documents concerning manufacturing, testing, packaging and other aspects.
LC NMR HYPHENATED TECHNIQUES
The document discusses hyphenated techniques, specifically liquid chromatography-nuclear magnetic resonance (LC-NMR). It begins by introducing hyphenated techniques as the combination of two analytical methods, usually a separation technique coupled with a spectroscopic technique. It then describes LC-NMR in more detail, explaining how it works to separate components with liquid chromatography and then uses NMR for identification. Key aspects covered include instrumentation, modes of data acquisition (continuous flow, stopped flow, time sliced), and advantages such as automation, reproducibility, and simultaneous separation and quantification.
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Process validation is establishing documented evidence that a process will consistently produce a product meeting predetermined specifications. This presentation discusses process validation, including its definition, scope, objectives, types (prospective, retrospective, concurrent, revalidation), stages, responsibilities of different departments, protocols, sampling procedures, acceptance criteria, and reports. Key aspects of process validation include protocols, sampling plans, specifications, batch execution records, and data analysis to ensure a process is capable of reproducible commercial manufacturing of pharmaceutical products that meet quality standards.
Pharmaceutical industry and unit process
Pharmaceutical manufacturing involves the industrial scale synthesis and processing of drug products. Key steps include active pharmaceutical ingredient (API) synthesis, combining APIs and excipients, and processing the mixture into solid oral dosage forms like tablets through unit operations such as milling, blending, granulation, drying, compression, and coating. Quality is ensured through strict adherence to good manufacturing practices (GMP) regulations. Excipients are other ingredients included in drug products that aid processing and delivery of the active drug. Common processing routes for solid oral dosage forms are direct compression, dry granulation, and wet granulation which involve different sequences of unit operations.
Pilot plant scale up techniques
This document outlines the process and considerations for pilot plant scale-up of pharmaceutical manufacturing. It defines a pilot plant as transforming a lab-scale formula into a viable product through developing a reliable manufacturing procedure. The objectives of a pilot plant are to produce stable dosage forms, review equipment, establish production guidelines and controls, evaluate and validate processes and equipment, and determine a master manufacturing formula. Key steps involve reviewing the formula, approving raw materials, selecting appropriate sized equipment, determining production rates, developing standard operating procedures, and conducting stability testing. Personnel with both scientific and engineering knowledge are needed, and facilities must allow for physical testing, equipment, raw materials storage, and record keeping. Adherence to good manufacturing practices is also important for a
Process Analytical Technology (PAT)
The document discusses Process Analytical Technology (PAT), which is defined as a system for designing, analyzing, and controlling manufacturing processes through measurements of critical quality attributes during processing. PAT aims to ensure final product quality by building quality into products through enhanced process understanding and control. The key elements of a PAT framework include process understanding, principles and tools like multivariate analysis, process analyzers, process controls, continuous improvement, and risk-based approaches. PAT offers benefits like increased flexibility, reduced costs and improved yields.
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This document discusses chiral chromatography and ion-pair chromatography. It begins with definitions of stereoisomers including enantiomers, diastereomers, and racemates. It then covers the principles of chiral chromatography, which involves using a chiral stationary phase or chiral derivatization to separate enantiomers. Applications include resolving drug enantiomers. The document also discusses ion-pair chromatography, which uses ion-pairing reagents to separate charged analytes in HPLC. Key factors that affect ion-pair chromatography are also reviewed.
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The document discusses Good Manufacturing Practices (GMP) guidelines according to ICH Q7A. It states that both GMP and cGMP aim to prevent bad quality products from entering the market. GMP applies to pharmaceutical and healthcare products, while cGMP refers to using the most up-to-date production processes and technologies to comply with regulations, as defined by the FDA. Regulatory agencies that establish GMP standards are mentioned, along with the objectives of GMP and specific guidelines covering quality management, personnel, facilities, equipment, documentation, and production records.
Good lab practices (GLP)
The document discusses Good Laboratory Practices (GLP). It provides definitions and history of GLP. GLP refers to a quality management system for laboratories conducting non-clinical safety studies. It aims to ensure reliability and integrity of test data. Key aspects of GLP include organization, SOPs, facilities, equipment, test systems, study planning and reporting, archiving. Non-compliance can result in disqualification and rejection of study data by regulatory agencies.
Managing Process Scale-up and Tech Transfer
Are you involved with planning tech transfer of your drug product? Join this webinar to learn more about the regulations and considerations you need to consider and learnings from a case study.
According to ICH Q10, “The goal of technology transfer activities is to transfer product and process knowledge between development and manufacturing, and within or between manufacturing sites to achieve product realization. This knowledge forms the basis for the manufacturing process, control strategy, process validation approach, and ongoing continual improvement.”
As a result, there is an expectation for transfers to be performed in an organized, methodical manner with appropriate documentation. It is also expected that they happen between one Process Development group to another or to a Pilot Lab, from Process Development lab to clinical or commercial manufacturing, or from Process Development to external clinical manufacturing. Lastly, they may also happen between two company facilities at commercial scale, or between a company and an external contract manufacturing at commercial scale.
This presentation will cover points to consider for successful tech transfers with a focus on cGMP training requirements, and include lesson learned from real cases.
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The document discusses the international occupational health and safety management system specification OHSAS 18000. It originated in the 1990s as BS8800 and was later revised in 1999 as OHSAS 18001 and 18002 to be more compatible with ISO 14001. OHSAS 18000 comprises 17 elements that are designed similarly to ISO 14001 and allows for third-party certification. It provides guidelines for occupational health and safety management systems including hazard identification, legal requirements, objective setting, implementation, checking and corrective action, and management reviews.
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Presented by : Malarvannan.M (Department of pharmaceutical analysis).
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The document outlines the key steps in chemical process design:
1) Define design objectives and constraints based on market needs and feasibility studies.
2) Generate possible design concepts and evaluate each concept's ability to meet objectives.
3) Perform economic analysis and optimization to select the optimal design concept.
4) Develop detailed design of equipment and operating conditions.
5) Plan construction and start-up operations.
When developing a chemical plant design, engineers must consider factors like plant location, layout, utilities, safety, and cost. The design should meet economic, environmental and safety constraints. Where alternatives exist, concepts are evaluated based on capital and operating costs to determine the most profitable design.
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The document discusses Good Manufacturing Practices (GMP) for distribution, distribution records, handling returned goods, and recovery/reprocessing of materials. It provides guidelines for distribution procedures including first expiration, first out (FEFO) and batch recall systems. It also outlines requirements for distribution records, handling returned products, and reprocessing materials to ensure quality is maintained.
Pharmaceutical documentation
This document describes a pharmaceutical documentation project submitted by Rahul Sharma for the degree of Bachelor of Pharmacy. It includes a certificate signed by his supervisor, Mr. Shailesh Kumar Singh, confirming Rahul conducted the project work. Rahul also includes a declaration that the work presented in the project entitled "Pharmaceutical Documentation" was carried out by him. The project acknowledges various individuals who helped Rahul complete the work. It then provides an abstract stating the project specifies GMP requirements for documentation within the pharmaceutical industry and describes key documents concerning manufacturing, testing, packaging and other aspects.
LC NMR HYPHENATED TECHNIQUES
The document discusses hyphenated techniques, specifically liquid chromatography-nuclear magnetic resonance (LC-NMR). It begins by introducing hyphenated techniques as the combination of two analytical methods, usually a separation technique coupled with a spectroscopic technique. It then describes LC-NMR in more detail, explaining how it works to separate components with liquid chromatography and then uses NMR for identification. Key aspects covered include instrumentation, modes of data acquisition (continuous flow, stopped flow, time sliced), and advantages such as automation, reproducibility, and simultaneous separation and quantification.
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To convey the knowledge necessary to understand
issues related to different kinds of hazard and their management. Basic theoretical and practical discussions integrate the proficiency to handle the emergency situation in the pharmaceutical product development process.
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Pharmaceutical industry and unit process
Pharmaceutical manufacturing involves the industrial scale synthesis and processing of drug products. Key steps include active pharmaceutical ingredient (API) synthesis, combining APIs and excipients, and processing the mixture into solid oral dosage forms like tablets through unit operations such as milling, blending, granulation, drying, compression, and coating. Quality is ensured through strict adherence to good manufacturing practices (GMP) regulations. Excipients are other ingredients included in drug products that aid processing and delivery of the active drug. Common processing routes for solid oral dosage forms are direct compression, dry granulation, and wet granulation which involve different sequences of unit operations.
Pilot plant scale up techniques
This document outlines the process and considerations for pilot plant scale-up of pharmaceutical manufacturing. It defines a pilot plant as transforming a lab-scale formula into a viable product through developing a reliable manufacturing procedure. The objectives of a pilot plant are to produce stable dosage forms, review equipment, establish production guidelines and controls, evaluate and validate processes and equipment, and determine a master manufacturing formula. Key steps involve reviewing the formula, approving raw materials, selecting appropriate sized equipment, determining production rates, developing standard operating procedures, and conducting stability testing. Personnel with both scientific and engineering knowledge are needed, and facilities must allow for physical testing, equipment, raw materials storage, and record keeping. Adherence to good manufacturing practices is also important for a
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The document discusses Process Analytical Technology (PAT), which is defined as a system for designing, analyzing, and controlling manufacturing processes through measurements of critical quality attributes during processing. PAT aims to ensure final product quality by building quality into products through enhanced process understanding and control. The key elements of a PAT framework include process understanding, principles and tools like multivariate analysis, process analyzers, process controls, continuous improvement, and risk-based approaches. PAT offers benefits like increased flexibility, reduced costs and improved yields.
Chiral chromatography & ion pair chromatography
This document discusses chiral chromatography and ion-pair chromatography. It begins with definitions of stereoisomers including enantiomers, diastereomers, and racemates. It then covers the principles of chiral chromatography, which involves using a chiral stationary phase or chiral derivatization to separate enantiomers. Applications include resolving drug enantiomers. The document also discusses ion-pair chromatography, which uses ion-pairing reagents to separate charged analytes in HPLC. Key factors that affect ion-pair chromatography are also reviewed.
cGMP Vs GMP presentation
The document discusses Good Manufacturing Practices (GMP) guidelines according to ICH Q7A. It states that both GMP and cGMP aim to prevent bad quality products from entering the market. GMP applies to pharmaceutical and healthcare products, while cGMP refers to using the most up-to-date production processes and technologies to comply with regulations, as defined by the FDA. Regulatory agencies that establish GMP standards are mentioned, along with the objectives of GMP and specific guidelines covering quality management, personnel, facilities, equipment, documentation, and production records.
Good lab practices (GLP)
The document discusses Good Laboratory Practices (GLP). It provides definitions and history of GLP. GLP refers to a quality management system for laboratories conducting non-clinical safety studies. It aims to ensure reliability and integrity of test data. Key aspects of GLP include organization, SOPs, facilities, equipment, test systems, study planning and reporting, archiving. Non-compliance can result in disqualification and rejection of study data by regulatory agencies.
Managing Process Scale-up and Tech Transfer
Are you involved with planning tech transfer of your drug product? Join this webinar to learn more about the regulations and considerations you need to consider and learnings from a case study.
According to ICH Q10, “The goal of technology transfer activities is to transfer product and process knowledge between development and manufacturing, and within or between manufacturing sites to achieve product realization. This knowledge forms the basis for the manufacturing process, control strategy, process validation approach, and ongoing continual improvement.”
As a result, there is an expectation for transfers to be performed in an organized, methodical manner with appropriate documentation. It is also expected that they happen between one Process Development group to another or to a Pilot Lab, from Process Development lab to clinical or commercial manufacturing, or from Process Development to external clinical manufacturing. Lastly, they may also happen between two company facilities at commercial scale, or between a company and an external contract manufacturing at commercial scale.
This presentation will cover points to consider for successful tech transfers with a focus on cGMP training requirements, and include lesson learned from real cases.
Presented by Guillaume Plane on September 22, 2016
Oshas 18001
The document discusses the international occupational health and safety management system specification OHSAS 18000. It originated in the 1990s as BS8800 and was later revised in 1999 as OHSAS 18001 and 18002 to be more compatible with ISO 14001. OHSAS 18000 comprises 17 elements that are designed similarly to ISO 14001 and allows for third-party certification. It provides guidelines for occupational health and safety management systems including hazard identification, legal requirements, objective setting, implementation, checking and corrective action, and management reviews.
Cder
The Center for Drug Evaluation and Research (CDER) is responsible for regulating prescription and over-the-counter drugs. CDER oversees new drug development and approval, drug safety, and drug advertising and promotion. It reviews New Drug Applications, monitors drug safety after approval, develops regulations and guidance, and communicates with industry and the public about drugs and drug development.
Good Laboratory Practices Mubashir Maqbool
GLP (Good Laboratory Practice) is a quality system for managing non-clinical laboratory studies to ensure reliability and integrity of test data. It outlines requirements for facility organization, personnel responsibilities, quality assurance programs, standard operating procedures, and retention of records and reports. GLP aims to ensure studies are well-designed, conducted and documented according to all principles to allow for traceability and reproducibility of results.
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This document discusses product complaint handling procedures. It defines a complaint and provides reasons for having a complaint handling process. It describes the types of complaints that may occur and the steps involved in handling complaints which include receiving the complaint, investigating it technically and through documentation, determining if it is confirmed or not, taking corrective actions and feedback to customers, and performing monthly reporting and trend analysis. It also discusses regulatory guidelines around complaint handling and provides an example standard operating procedure on complaint handling.
Mass spectroscopy
Chemical Ionization
Field Ionization
Electrospray ionization
Matrix Assisted Laser Desorption (MALDI)
Fast-atom Bombardment (FAB)
Atmospheric Pressure Chemical Ionization (APCI)
Atmospheric Pressure Photoionization (APPI)
Manufacturing operation and control
This document summarizes key points about manufacturing operations and quality control from a seminar presentation. It discusses good manufacturing practices, identity, strength, safety and purity as important factors. It also covers sanitation, standard operating procedures, mix-ups and contamination prevention, in-process quality control, packaging operations, process deviations, drug product inspection, and expiration dating. Maintaining quality is essential at all stages of the manufacturing and packaging process.
Silica Gel | Aluminium Oxide Column chroamtography
Buy Silica Gel Powder for Silica Gel, Aluminium Oxide, Paper and Flash Column Chromatography us in Pharmaceutical Industries – Bulk Drugs & API, Nutraceuticals, Herbal Extracts products manufacturers, Research Laboratories, Laboratories Chemical Repackaging, Contract Research Laboratories. Column Chromatography is one of the most useful methods for purification & separation (Isolation) of individual desire compound from mixture of unwanted compounds.
HPLC-COLUMNS
In this slide contains types of HPLC Columns, Plate theory and Van Deemter Equation.
Presented by : Malarvannan.M (Department of pharmaceutical analysis).
RIPER,anantpur.
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Watch the interactive webinar now: https://bit.ly/2VplwQq
Resume
Mayank Mishra is seeking a position that utilizes his skills in mechanical engineering, project management, and maintenance. He has over 10 years of experience in roles at Siegwerk India, United Breweries Limited, and Cadbury India Limited. His experience includes overseeing plant projects, developing engineering skills, operating and maintaining various equipment, and completing projects involving boilers, chillers, water treatment systems, and more. He has a B.Tech in Mechanical Engineering and skills in areas like AutoCAD, SAP, and Solidworks.
kshitij_resume_Ln
Kshitij Pandey has over 15 years of experience in instrumentation engineering for the oil and gas industry. He currently works as a Reliability Engineer for SADAF Petrochemicals in Saudi Arabia, where he performs safety instrumented system studies, failure analysis, and implements reliability improvement strategies. Previously, he held roles as an Instrumentation Engineer for Agilent Technologies and Manager of Instrumentation for Reliance Industries, where he gained experience in maintenance management, reliability centered maintenance, and calibration. He also worked as a Service Engineer for Lab India Instruments.
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amcrasto@gmail.com
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Technology transfer by Zade Manasi S. M pharm 1st yr, Bharati vidyapeeth College of pharmacy, Kolhapur .
1. Introduction :-Technology transfer is the practice of transferring scientific findings from one organization to another for further development.
Which is mainly concerned with the transfer of technology from research areas to “Production and Quality Assurance” environment.
The process by which existing knowledge, facilities or capabilities developed under R & D are utilized to fulfil public and private need.
Technology transfer is the intersection between business, science, engineering, law and government.
Definition :-Transfer of technology is defined as “a logical procedure that controls the transfer of any process together with its documentation and professional expertise between development and manufacture or between manufacture sites” .
3. Objective :-To offer guidance & assistance to inventors & corporation.
-To provide a hands-on learning opportunity.
-To increase the general awareness.
-To accelerate scale-up and cost reduction.
4. Development of technology from Research & D to production :-R&D provides technology transfer dossier (TTD) document to product development laboratory, which contains all information of formulation and drug product as follows-
Master Formula Card (MFC)– Includes product name along with its strength, generic name, MFC number, page number, effective date, shelf life and market.
Master Packing Card– Gives information about packaging type, material used for packaging, stability profile and shelf life of packaging.
Master Formula–
5. Success of technology transfer :-It depends on :-
-Communication
-Open communication between all team members
-Direct communication between technical members
-Effective and timely communication with regulators
*Sending and Receiving Unit
- Technology transfer is not a “one way street”
The sending unit and receiving unit must be equally involved in the process to ensure success
-Team work at all time
6. Checklist for technology transfer :-It consists of:
Production master formula.
Manufacturing and Dispensing instructions.
Analytical methods.
Cleaning instructions and previous cleaning validation.
Active specifications and source.
Primary packaging material specifications and source.
Packaging instructions.
Process deviations file, Analytical deviations file.
Specimen manufacturing batch record.
7. Technology transfer team :- The technology transfer team consists of :
Process Technologist
QA Representative
Production Representative
Engineering representative
QC Representative
8. Steps in technology transfer process :-A] Development of technology by R&D( Reaserch Phase):
(a) Design of procedure and selection of excipients by R&D
(b) Identification of specifications and quality by R&D
B] Technology transfer from R&D to production (Development Phase):
(a)Master Formula Card (MFC)
(b) Master Packing Card
(c) Master Formula
(d) Specifications
ChE: 1st Principles Approach to Problem Solving
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Episode 27 : Project Management Costs
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Cost Method
1. If there is lack of information regarding the existing plant, investment cost can be estimated by using cost factor. It requires the existence of a process concept and the rough layout of the main equipment in order to determine the cost of the main processing unit.
Operating Cost
Consists of (a) Cost of raw material
Utility cost
Labour cost
Maintenance cost
Utility Cost
1. It is quantity based and consisted of electric power, steam and coolant consumption, heating media such as coal and other energy sources like hydrogen.
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Continuous manufacturing technology
- 1. Continuous Manufacturing Technology – A Changing Paradigm Nagaarjun Sridhar Process Engineer - API Research
- 2. Outline • API Development • Conventional Batch Process – In Brief • Introduction to Continuous Process • Process Engineering Aspects • Regulatory Considerations • Case studies of C.Mfg • Future Milestones
- 4. Conventional Batch Process • Batch process follows a step-by-step method of production and completed in ‘lots’ or ‘batches’. • It could be stopped and started according to our needs. Installation and running costs are affordable. • Longer cycle time, periodic services needed, increases skilled labors • Quality issues is a concern for every new batch
- 5. Introduction to C.Mfg Definition: Continuous production is a flow production method used to manufacture, produce, or process materials without interruption. Eg: Petroleum and allied industries Principle of flow technology: Flow rate of input = Flow rate of output • Assures consistency in product quality • Reduced/No major cycle time • Necessity for skilled labor is not needed • In-line PAT assessment • Can reach the markets at the earliest • Initial investment is high • Reactor designs are highly product specific
- 6. Comparison (Batch vs C.Mfg)
- 7. Economic Analysis (Batch v/s C.Mfg) Theory : Break Even Analysis – Its used to determine when your business will be able to cover all the expenses and begin to make a profit. Depends on Fixed Costs and Variable Costs.
- 8. Process Engineering Aspects Type of Reactors CSTR PFR Tubular Reactor Tubular Reactors: 1. Packed Bed Reactor 2. Fixed Bed Reactor 3. Baffled reactor 4. Trickle Bed Reactor Volume of reactor Volumetric Flow Rate Residence Time Important Design Parameters Reaction Technology = f(Mathematical models, Flow concepts, Basic kinetics, Design knowledge, Thermodynamics & H.T) + f(Lab experiments, Pilot experiments)
- 9. Lab Scale Reactors Pilot Scale Reactors Full Scale Reactor Scale up of PFR
- 10. Regulatory Considerations “FDA urges pharmaceutical giants to transform from batch to continuous” – ETT, 14th April 2016
- 11. Strategic Collaborations by Major Players 1. Novartis (Formulation Development using Continuous Mnf Tech) – MIT university (USA) 2. GSK – University of Strathclyde (UK) 3. Pfizer (Formulation Development) – GEA + Pfizer Global Engineering Team 4. AstraZeneca – University of Strathclyde (UK) 5. Bayer – University of Strathclyde (UK) 6. Eli Lilly Co – University of Strathclyde (UK) 7. J&J – University of Wisconsin, Madison (USA) 8. Takeda Pharmaceuticals – University of Strathclyde (UK) 9. Merck & Co – The Rutgers C-SOPS (USA) 10. Jansen – University of Puerto Rico
- 12. Case Study of Eli Lilly Co. API : Evacetrapib (A cholesterol ester transfer protein inhibitor) Steps 1 and 2a were done by batch process. Step 2b to final API , flow technology was used Reductive amination under high pressure
- 13. 1. 45 – 2 inch pipe in series connected using 0.25 inch jumpers 2. 316L SS MoC 3. Total Vol. of Reactor = 380L 4. Turndown Ratio is 3 5. Tube side pressure = 1200psig 6. Jacket side pressure =10psig 7. Temp rating (overall) 125 deg Note: 1. Pipe inspection was possible 2. Built per PED (ASME) Design considerations Simultaneous Activities: 1. Reactor monitoring 2. On-line Analytical Data Acquisition 3. Feed and Product Levels
- 14. Future Milestones • To identify loopholes and limitations of Continuous technology (on- going) • Getting inputs collectively from BD/R&D team on products/synthesis (yet to start) • To initiate talks with University of Strathclyde(or any Indian public universities) in order to get more clarity and support on developing it strategically (yet to start) • To design and evaluate feasibility of a lab or pilot scale reactor with the help of an experienced process design firm (Technograph Pvt. Ltd) • To identify a global premier engineering firm to establish full scale production plant (To get help from Technograph)
- 15. Thank You “Some goals are so worthy, its even glorious to fail “