The purpose of this document is to present a potential design to the client for manufacture of a DNA vaccine facility in the United Kingdom. Facility will have capacity to produce 1 kg/annum of two plasmid products.
Pivotal factors considered in design and layout of DNA vaccine facility were compliance to good manufacturing practices (cGMP), effective production, regulatory guidelines, contamination minimisation and effective cleanliness.
Handling of raw materials and final product both on and off site has been studied to outline features and add-ups that can be implemented to minimise environmental impact: such measures include process safety and instrumentation. Impact of airborne particles, temperature, pressure and relative humidity on purity, efficacy and safety have been reduced through design of class 100 cleanrooms equipped with controlled-air environment accessible via airlock, HVAC and high efficiency particulate air filters (HEPA).
Additionally, principles of process control and instrumentation have been applied throughout design stage of project with aim of creating a process that is ultimately safe, and one that complies with safety regulations, efficient and economically stable. Compliance to current good manufacturing practices (cGMP) and regulations are achieved through incorporation of key cGMP components such as validation master plan (VMP), quality control (QC), cleaning-in-place (CIP), sterilisation-in-place (SIP), trained personnel and waste treatment process.
Economic evaluation of project indicates viability, net profit of £557,000,000 is a very lucrative figure for a 10-year investment. Project payback time of 5 months and entire project timeline of 1 year and 10 months demonstrates that this project is highly feasible and has potential to attract numerous investors.
An investigation into the cause of loss of containment from the supply of min...Turlough Guerin GAICD FGIA
An Intermediate Bulk Container (IBC) was punctured during its handling, releasing oil onto soil at an environmentally-sensitive region of Australia. The telehandler did not pierce the plastic of the IBC directly (as was expected) but rather one of the tynes had caught on the underside of the metal base plate, despite numerous controls being in place at time of spill, revealing a previously unreported mechanism for a fluid spill from handling of petroleum hydrocarbons. The diverse investigation team used a root cause analysis (RCA) technique to identify the underlying cause: the inspection process was inadequate with contributing
factors of not using a spotter and design of IBC did not anticipate conditions. Engineering controls were put in place as part of the change management process to help prevent spills
from occurring from piercing from telehandler tynes on the current project site.
Presented to:
Kentucky Chemical Demilitarization Citizens’ Advisory Commission and
Chemical Destruction Community Advisory Board
Presented by:
Jeff Brubaker Doug Omichinski
Site Project Manager Project Manager
Charles dushek discusses “used cooking oil to bio dieselCharles Dushek
Developing countries use vast amounts of vegetable cooking oils for meals preparation. After the oils are fully used, they are typically thrown out and often cause local pollution of water supplies. Now, there is a simple system process for converting Used Cooking Oils into BioDiesel to power rural community generators, water pumps, agriculture machines and vehicles that burn diesel. Let’s learn about “BioFuels for Humanity.
Presented to:
Kentucky Chemical Demilitarization Citizens’ Advisory Commission and
Chemical Destruction Community Advisory Board
Presented by:
Jeff Brubaker
Site Project Manager
Crude-Oil Blend Scheduling Optimization: An Application with Multi-Million D...Alkis Vazacopoulos
The economic and operability benefits associated with better crude-oil blend scheduling are numerous and significant. The crude-oils that arrive at the oil-refinery to be processed into the various refined-oils must be carefully handled and mixed before they are charged to the atmospheric and vacuum distillation unit or pipestill. The intent of this article is to highlight the importance and details of optimizing the scheduling of an oil-refinery’s crude-oil feedstocks from the receipt to the charging of the pipestills.
This document is an important tool to understand what are the parameters of cleanroom environment for the production or manufacturing of vaccines. What type of cleanrooms required? Which type of ISO class is important to maintain for the vaccines?
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.
The purpose of this document is to present a potential design to the client for manufacture of a DNA vaccine facility in the United Kingdom. Facility will have capacity to produce 1 kg/annum of two plasmid products.
Pivotal factors considered in design and layout of DNA vaccine facility were compliance to good manufacturing practices (cGMP), effective production, regulatory guidelines, contamination minimisation and effective cleanliness.
Handling of raw materials and final product both on and off site has been studied to outline features and add-ups that can be implemented to minimise environmental impact: such measures include process safety and instrumentation. Impact of airborne particles, temperature, pressure and relative humidity on purity, efficacy and safety have been reduced through design of class 100 cleanrooms equipped with controlled-air environment accessible via airlock, HVAC and high efficiency particulate air filters (HEPA).
Additionally, principles of process control and instrumentation have been applied throughout design stage of project with aim of creating a process that is ultimately safe, and one that complies with safety regulations, efficient and economically stable. Compliance to current good manufacturing practices (cGMP) and regulations are achieved through incorporation of key cGMP components such as validation master plan (VMP), quality control (QC), cleaning-in-place (CIP), sterilisation-in-place (SIP), trained personnel and waste treatment process.
Economic evaluation of project indicates viability, net profit of £557,000,000 is a very lucrative figure for a 10-year investment. Project payback time of 5 months and entire project timeline of 1 year and 10 months demonstrates that this project is highly feasible and has potential to attract numerous investors.
An investigation into the cause of loss of containment from the supply of min...Turlough Guerin GAICD FGIA
An Intermediate Bulk Container (IBC) was punctured during its handling, releasing oil onto soil at an environmentally-sensitive region of Australia. The telehandler did not pierce the plastic of the IBC directly (as was expected) but rather one of the tynes had caught on the underside of the metal base plate, despite numerous controls being in place at time of spill, revealing a previously unreported mechanism for a fluid spill from handling of petroleum hydrocarbons. The diverse investigation team used a root cause analysis (RCA) technique to identify the underlying cause: the inspection process was inadequate with contributing
factors of not using a spotter and design of IBC did not anticipate conditions. Engineering controls were put in place as part of the change management process to help prevent spills
from occurring from piercing from telehandler tynes on the current project site.
Presented to:
Kentucky Chemical Demilitarization Citizens’ Advisory Commission and
Chemical Destruction Community Advisory Board
Presented by:
Jeff Brubaker Doug Omichinski
Site Project Manager Project Manager
Charles dushek discusses “used cooking oil to bio dieselCharles Dushek
Developing countries use vast amounts of vegetable cooking oils for meals preparation. After the oils are fully used, they are typically thrown out and often cause local pollution of water supplies. Now, there is a simple system process for converting Used Cooking Oils into BioDiesel to power rural community generators, water pumps, agriculture machines and vehicles that burn diesel. Let’s learn about “BioFuels for Humanity.
Presented to:
Kentucky Chemical Demilitarization Citizens’ Advisory Commission and
Chemical Destruction Community Advisory Board
Presented by:
Jeff Brubaker
Site Project Manager
Crude-Oil Blend Scheduling Optimization: An Application with Multi-Million D...Alkis Vazacopoulos
The economic and operability benefits associated with better crude-oil blend scheduling are numerous and significant. The crude-oils that arrive at the oil-refinery to be processed into the various refined-oils must be carefully handled and mixed before they are charged to the atmospheric and vacuum distillation unit or pipestill. The intent of this article is to highlight the importance and details of optimizing the scheduling of an oil-refinery’s crude-oil feedstocks from the receipt to the charging of the pipestills.
This document is an important tool to understand what are the parameters of cleanroom environment for the production or manufacturing of vaccines. What type of cleanrooms required? Which type of ISO class is important to maintain for the vaccines?
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.
Macroeconomics- Movie Location
This will be used as part of your Personal Professional Portfolio once graded.
Objective:
Prepare a presentation or a paper using research, basic comparative analysis, data organization and application of economic information. You will make an informed assessment of an economic climate outside of the United States to accomplish an entertainment industry objective.
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.
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Exploiting Artificial Intelligence for Empowering Researchers and Faculty,
International FDP on Fundamentals of Research in Social Sciences
at Integral University, Lucknow, 06.06.2024
By Dr. Vinod Kumar Kanvaria
June 3, 2024 Anti-Semitism Letter Sent to MIT President Kornbluth and MIT Cor...Levi Shapiro
Letter from the Congress of the United States regarding Anti-Semitism sent June 3rd to MIT President Sally Kornbluth, MIT Corp Chair, Mark Gorenberg
Dear Dr. Kornbluth and Mr. Gorenberg,
The US House of Representatives is deeply concerned by ongoing and pervasive acts of antisemitic
harassment and intimidation at the Massachusetts Institute of Technology (MIT). Failing to act decisively to ensure a safe learning environment for all students would be a grave dereliction of your responsibilities as President of MIT and Chair of the MIT Corporation.
This Congress will not stand idly by and allow an environment hostile to Jewish students to persist. The House believes that your institution is in violation of Title VI of the Civil Rights Act, and the inability or
unwillingness to rectify this violation through action requires accountability.
Postsecondary education is a unique opportunity for students to learn and have their ideas and beliefs challenged. However, universities receiving hundreds of millions of federal funds annually have denied
students that opportunity and have been hijacked to become venues for the promotion of terrorism, antisemitic harassment and intimidation, unlawful encampments, and in some cases, assaults and riots.
The House of Representatives will not countenance the use of federal funds to indoctrinate students into hateful, antisemitic, anti-American supporters of terrorism. Investigations into campus antisemitism by the Committee on Education and the Workforce and the Committee on Ways and Means have been expanded into a Congress-wide probe across all relevant jurisdictions to address this national crisis. The undersigned Committees will conduct oversight into the use of federal funds at MIT and its learning environment under authorities granted to each Committee.
• The Committee on Education and the Workforce has been investigating your institution since December 7, 2023. The Committee has broad jurisdiction over postsecondary education, including its compliance with Title VI of the Civil Rights Act, campus safety concerns over disruptions to the learning environment, and the awarding of federal student aid under the Higher Education Act.
• The Committee on Oversight and Accountability is investigating the sources of funding and other support flowing to groups espousing pro-Hamas propaganda and engaged in antisemitic harassment and intimidation of students. The Committee on Oversight and Accountability is the principal oversight committee of the US House of Representatives and has broad authority to investigate “any matter” at “any time” under House Rule X.
• The Committee on Ways and Means has been investigating several universities since November 15, 2023, when the Committee held a hearing entitled From Ivory Towers to Dark Corners: Investigating the Nexus Between Antisemitism, Tax-Exempt Universities, and Terror Financing. The Committee followed the hearing with letters to those institutions on January 10, 202
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.
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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!
2. Table of Contents
1) Executive Summary ………………………………………………………………………..Pg. 1
2) Introduction ……………………………………………………………………………………Pg. 2
3) Why install a bulk storage system? …………………………………………………Pg. 3-5
4) What are the Risks? ………………………………………………………………………..Pg. 6
5) Recommendation ……………………………………………………………………………Pg. 7
6) References ………………………………………………………………………………………Pg. 8
7) Appendix. ………………………………………………………………………………………..Pg. 9
3. Executive Summary
Rich’s Ice Cream will benefit from the installation of bulk storage tanks and improving chemical handling
equipment. The decreased safety risk, better organized chemical room, eases in ordering and cost
savings makes this project feasible.
Current status:
Chemicals are ordered weekly because of a shortage of storage space. This adds additional freight
charges. The chemical room is very congested as we have to stage 55-gallon drums in there until we are
ready to use them. On average 6 drums are maneuvered around weekly creating a risk of back strain as
the drums weigh in excess of 450 pounds.
Benefits:
Ordering of chemicals can be changed from weekly to monthly as we will have staging room.
The chemical room will have fewer drums to move and work around reducing the safety risk
associated.
There is a $.050 per gallon cost savings associated with ordering chemical on bulk versus drums.
Risks:
Will require training on new chemical transfer equipment.
The chemical room will be out of service for 2 days to complete the installation so this will have
to be coordinated on a weekend when production is down.
Recommendation:
1. Purchase 2 – 300 gallon poly storage tanks and associated plumbing.
2. Schedule Safe-Chem in on weekend to install equipment once delivered.
3. Schedule Sanitation lead to work with Safe-Chem on install to understand the flow and obtain
the training needed to train balance of crew.
Pg. 1
4. Introduction
The current ordering and storage of chemicals can be optimized. This optimization will pay dividends in
regards to safety and cost reduction. Currently chemicals are ordered weekly and delivered via 55-
gallon drums. The ordering has to be done weekly due to space constraints in the chemical storage
room. The drums weigh in excess of 450 lbs. each and are manually moved from pallet to drum dolly.
On average the plant consumes 5 drums of chemicals weekly. This is 5 drums that have to be moved
and opened weekly. I am proposing the installation of a bulk storage system for the commonly used
chemicals of Power Foam and Pipeline cleaner. Both of which are an alkaline caustic cleaner and very
corrosive.
While investigating this project I had the opportunity to speak with Randy Rich about the ordering
process and what his thoughts were related to the cost, space and time constraints. I discovered he was
not fully aware of the problems particularly related to space and time constraints. He was particularly
concerned with the cost of the chemicals used in the plant.
Pg. 2
5. Why install a bulk storage system?
According to the National Safety Council the average non disabling injury costs $23,400 per incident.
(NSC). Based on the frequency that these chemicals are handled this poses a substantial risk for injury
see figure 1.1 (Collins, 2010) From a safety standpoint reducing the amount of drum handled and
improving the chemical transfer system makes sense and provides a significant cost savings by reducing
the likeliness of having a safety incident.
Figure 1.1
An additional concern is the cost associated with the purchase of the chemicals as well as the freight
charges. Switching to a bulk delivery system would reduce the required ordering frequency and reduce
the frequency of deliveries. Safe -chem also provides a cost reduction of $0.50 per gallon on both Power
Pg. 3
6. Foam and Pipeline cleaner. The plant currently consumes an average of 100 gallons of each chemical
weekly. The cost savings is approximately $137.50 weekly or $7,100 annually in chemical and freight
charges.
The proposed changes to the chemical room the addition of 2 - 300 gallon poly tanks to hold the
chemicals, this will hold nearly a month supply of chemical reducing the amount of time needed to
inventory and order chemicals. The poly tanks will hold 3-4 weeks supply of chemical. Additionally new
product transfer pumps will be installed to ensure chemicals are dispensed more safely and efficiently.
The rearranging of the room will allow for better space utilization and clutter reduction. See figures 1.2
& 1.3 Cost of project is $3,975.00 with the savings in chemicals alone the return on investment is just
6.75 months.
Pg.4
3
8. Associated Risks:
There are few risks associated with the project.
The Primary one is the fact that the chemical room and systems will be out of service while
installation takes place. This will need to be scheduled on a weekend when production is down
and the system demands are at their lowest.
There will be a training curve as the system will be moved, new equipment installed and the
ordering process will be altered.
Pg. 6
9. Recommendations:
Safety being a paramount concern any opportunity that presents itself to reduce a hazard is one to take
seriously. The fact that an average back injury can cost $23,400 per incident and the fact that the
sanitation crew is forced to manually handle many drums weekly makes this project work.
Understanding the fact that it is hard to justify an expense against a possible expense makes the return
on investment questionable if relying only on the safety aspect. This project includes a substantial cost
savings in the price of the chemical and freight charges. This is a real and actual saving of $7,100
annually. The project will pay for itself in 6.75 months.
I propose moving forward with the project:
Order Poly tanks and necessary supplies
Schedule Safe-chem in over weekend to perform installation
Schedule Gary Watkins (Sanitation lead) in to work with Safe-Chem on installation to obtain the
training necessary for him to roll out training with rest of sanitation crew.
Pg. 7
10. References:
Collins, D. (2010, January 1). . . Retrieved May 1, 2014, from http://www.safetyrisk.net/risk-assessment-
form-templates/
Estimating the Costs of Unintentional Injuries, Fatal and Nonfatal Injuries. (n.d.). Estimating the Costs of
Unintentional Injuries, Fatal and Nonfatal Injuries. Retrieved May 1, 2014, from
http://www.nsc.org/news_resources/injury_and_death_statistics/Pages/EstimatingtheCostsofUnintenti
onalInjuries.aspx
Pg. 8
11. Appendix:
Transcript from conversation with Randy Rich – President Rich’s Ice Cream
Q. Do you know what is involved in the chemical ordering process?
A. Not completely, certainly understand what is needed to be done but not sure of frequency or levels.
Q. What are your concerns related to chemicals and chemical handling safety?
A. Safety is a huge concern, it is my hope that we are trining people to properly handle and dispense
chemicals.
Q. Would you be opposed to implementing some bulk storage systems assuming there is a return on the
investment?
A. As with any investment the quicker the return the easier it is to implement. As a general rule if you
can provide a return on investment in less than a year the project will be considered.
Pg. 9