The document outlines the stages involved in equipment development for a small-scale automated pasteurizer. It describes 9 stages: 1) idea generation, 2) concept development, 3) equipment development and testing, 4) marketing strategy development, 5) business analysis, 6) market testing, 7) commercialization, 8) consumer adoption. For the pasteurizer, the document focuses on the first 3 stages: generating the idea to address issues small processors face, developing the concept including specifications and design, and testing the developed equipment.
PILOT PLANT SCALE- UP TECHNIQUE
Plant, Pilot Plant, Scale-up, Objective, Significance, Steps in scale up, General considerations, Master Manufacturing Procedures, GMP consideration.
Pilot plant scale-up is a branch of the pharma companies in which a lab-scale formula is converted into a commercially viable product by creating a reliable manufacturing technique. The same techniques employed in dosage form Research and Development are adapted to multiple output volumes, frequently larger than those obtained during Research and Development. There is always a requirement for an intermediate batch scale describing techniques and imitating those in commercial manufacturing in any new or established pharmaceutical sector. This is accomplished by testing the formula’s ability to survive batch-scale and process changes.
PILOT PLANT SCALE- UP TECHNIQUE
Plant, Pilot Plant, Scale-up, Objective, Significance, Steps in scale up, General considerations, Master Manufacturing Procedures, GMP consideration.
Pilot plant scale-up is a branch of the pharma companies in which a lab-scale formula is converted into a commercially viable product by creating a reliable manufacturing technique. The same techniques employed in dosage form Research and Development are adapted to multiple output volumes, frequently larger than those obtained during Research and Development. There is always a requirement for an intermediate batch scale describing techniques and imitating those in commercial manufacturing in any new or established pharmaceutical sector. This is accomplished by testing the formula’s ability to survive batch-scale and process changes.
The all the content in this profile is completed by the teachers, students as well as other health care peoples.
thank you, all the respected peoples, for giving the information to complete this presentation.
this information is free to use by anyone.
Statistical solutions to help you with 5 FDA medical devices stagesMinitab, LLC
From bandages to pacemakers, medical devices have a single, primary purpose: to improve the quality of life. Medical devices companies must be responsible for the safety and effectiveness of their products throughout the entire product development cycle. In the U.S., the FDA recommends five stages for the device development process. These stages ensure the safety and efficacy of medical devices in the whole product development cycle, creating a need for rigorous pre-market trials and post-market surveillance activities to monitor the performance of medical devices.
In this webinar, we will explore the stage goals and the statistical techniques typically conducted within each stage through examples of different medical devices.
The uploaded Power point presentation is of Industrial Pharmacy-II Unit-I (Topic - Pilot Plant Scale up Techniques). ppt is very useful for student of B.pharmacy
A pilot plant is a facility in the pharmaceutical business that convert a lab scale formula in to a commercial product by developing a reliable and practical manufacturing technique.
Introduction, Objective; Significance; General consideration; Pilot plant scale up technique for solid, liquid and semi solids; SUPAC Guidelies; Introduction to platform technology
The all the content in this profile is completed by the teachers, students as well as other health care peoples.
thank you, all the respected peoples, for giving the information to complete this presentation.
this information is free to use by anyone.
Statistical solutions to help you with 5 FDA medical devices stagesMinitab, LLC
From bandages to pacemakers, medical devices have a single, primary purpose: to improve the quality of life. Medical devices companies must be responsible for the safety and effectiveness of their products throughout the entire product development cycle. In the U.S., the FDA recommends five stages for the device development process. These stages ensure the safety and efficacy of medical devices in the whole product development cycle, creating a need for rigorous pre-market trials and post-market surveillance activities to monitor the performance of medical devices.
In this webinar, we will explore the stage goals and the statistical techniques typically conducted within each stage through examples of different medical devices.
The uploaded Power point presentation is of Industrial Pharmacy-II Unit-I (Topic - Pilot Plant Scale up Techniques). ppt is very useful for student of B.pharmacy
A pilot plant is a facility in the pharmaceutical business that convert a lab scale formula in to a commercial product by developing a reliable and practical manufacturing technique.
Introduction, Objective; Significance; General consideration; Pilot plant scale up technique for solid, liquid and semi solids; SUPAC Guidelies; Introduction to platform technology
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2. Stages involved in Equipment
Development
There are nine stages in the new product development process:
1. Idea generation
2. Concept development
3. Equipment development and testing
4. Marketing strategy development
5. Business analysis
6. Market testing
7. Commercialization
8. Consumer adoption
3. Idea generation
• According to the research paper, thermal preservation of
liquid foods is a necessity during processing.
• Pasteurization is a key process in the liquids food processing
industry used for preservation of processed liquid foods.
• Conventional pasteurizing equipment is usually high capacity
and expensive hence many small scale processors resort to
heating liquid foods in open boilers to make it safe as well as
to extend its shelf life.
• This affect the nutritional quality of the liquid food and
increase the risk of post pasteurization contamination
during ensuing hand packaging or loose distribution.
4. Idea generation………………..cont’d
• However, the main problems faced by small-scale liquid
foods processors in developing countries like Uganda in
particular include:
high business start-up costs
lack of appropriately sized equipment
• Therefore, the aim of this study was to design, construct
and evaluate a small scale automated pasteurizer; an
important equipment in liquid foods industry.
5. Concept Developments
• This involves;
• Material selection basing the fact that the inner wall of the
jacket should minimize heat loss to the surrounding air mass
and maximize heat transfer to the test liquid and,
• Stainless steel was selected because it is much less reactive
than other metals, particularly with acidic foods.
6. Concept Developments
• Specifications development where
calculations of height and volume
were made to estimate the size of
pasteurizer to be made basing on
mathematical equations, the
estimated height of the user and
material properties.
• The design of the batch
pasteurizer drawing was done using
Solid Edge V16 as illustrated in the
figure.
7. Equipment Development and testing
This included the design of the batch pasteurizer components
involving
• Element design: cutting, welding, grinding of the different
component parts.
• Assembly: where the parts are then joined together that is
fabrication and assembled to be able to produce the batch
pasteurizer.
8. Equipment Development and testing
It also involves
• choosing of the heater to be used in the batch pasteurizer
basing on;
The volume of liquid that the batch pasteurizer can
accommodate,
The heat distribution through out the pasteurizer,
The lethality and the microbial analysis that is how
effective the heating system is to be able to destroy
different microorganisms.
9. Equipment Development and testing
The batch pasteurizer was tested for the following
specifications;
• Output basing on the time taken for a certain batch.
• Heat distribution using data logger model.
• Microbial analysis through checking a gradual decrease in
the number of microorganisms.
• Lethality (L) that was obtained through calculating the D
and Z values of the pasteurization.
• Pasteurization performance (E).
10. ……other stages of equipment
development
However from the paper though not indicated, after
equipment testing, it was supposed to undergo extra
step i.e;
• Marketing strategy development to plan of how who
and when to do the market testing, targeted groups
and consumer response.
• Business analysis to ascertain the feasibility of the
equipment in regard to the costs and benefits.
• Market testing to determine general acceptability
by the targeted group of consumers.
11. ……other stages of equipment
development
• Commercialization to ascertain whether the business
goal is achievable
• Consumer adoption for the continuity of production
or termination of the venture
12. Group Members
1. ASIIMWE GERALD MASEREKA
2. KAGO SIMON PETER
3. NAKYANZI DOREEN NOELINE
4. WASWA SHONIA MUTEEBI