This document discusses considerations for selecting liquid filling technologies. It describes types of fillers like overflow, servo pump, peristaltic, time gravity, and piston fillers. It focuses on compact line syrup filling machines, explaining their major units for filling, sealing, and labeling bottles at automated speeds up to 250 bottles per minute. Key aspects like filler type, sensors, number of nozzles and heads, and adjustments are covered.
This document describes the MoSCoW prioritization method for software project requirements. The MoSCoW method categorizes requirements into four levels: Must, Should, Could, and Won't. Must requirements are essential for project success. Should requirements are important but not critical. Could requirements would provide additional benefits but are not necessary. Won't requirements are lowest priority and unlikely to be included in the initial project. The method helps establish agreement on priority among stakeholders and scope the project appropriately.
This document discusses plant layout for pharmaceutical manufacturing facilities. It begins by defining plant layout and its importance for efficient production. There are two main types of layouts: process/functional layout which groups similar machines together and product/straight line layout which arranges machines in the order of operations. Key factors that influence layout include the production process, available space, operational convenience, and regulatory requirements. Special provisions for pharmaceutical facilities include preventing confusion or contamination. Storage areas for raw materials and finished goods are also discussed, including specific storage requirements. The document concludes by outlining the layout of sterile or aseptic manufacturing areas which separate different operations and control air flow and personnel movement to maintain sterility.
By following the best practices outlined in this presentation and avoiding the “don’ts” that go along with them, you can prevent unnecessary damage from occurring to your glass-lined equipment.
Kingdom of Bahrain | Single Use Plastic Products Licensing GuideRashed Isa
The document summarizes the plastic products licensing procedure in Bahrain, including:
- Applicants must submit an application form and documents like ISO 14001 certification and lab test reports to the Environmental Licensing Section at the Supreme Council for Environment.
- Plastic product licenses are valid for one year, and the council issues a serial number for each product.
- Manufacturers must affix the conformity marking on products and print the serial number with the marking at a clear, readable resolution according to standards.
The document then provides application forms, license templates, and appendices specifying requirements like marking dimensions, permitted heavy metal limits, and labeling information.
ISO 9000 is a family of standards related to quality management systems and procedures. It helps organizations ensure they meet customer and stakeholder needs while complying with legal requirements. The standards are based on eight quality management principles including customer focus, leadership, and continual improvement. ISO 9000 deals with quality management fundamentals, while ISO 9001 provides requirements for quality assurance in design and manufacturing. Implementing an ISO-certified quality management system helps organizations improve quality, meet regulations, and increase market credibility.
This document discusses quality assurance and quality control. Quality assurance refers to processes done before a project to ensure quality, such as process documentation and audits. Quality control refers to checks done on deliverables to ensure they meet standards. Both are interdependent. Accuracy and precision are important in analysis. Various charts can be used to monitor quality over time, including control charts. Validation of methods, equipment, and cleaning procedures helps ensure quality. Documentation, representative sampling, and use of standards are also discussed.
This document discusses parenteral products and water for injection (WFI). It provides details on:
1) What defines a parenteral product and reasons they are unique dosage forms.
2) The manufacturing process for parenteral products including procurement, processing, packaging, and quality control.
3) Key factors for WFI production including distillation units, storage and distribution, and validation to ensure quality standards.
This document discusses considerations for selecting liquid filling technologies. It describes types of fillers like overflow, servo pump, peristaltic, time gravity, and piston fillers. It focuses on compact line syrup filling machines, explaining their major units for filling, sealing, and labeling bottles at automated speeds up to 250 bottles per minute. Key aspects like filler type, sensors, number of nozzles and heads, and adjustments are covered.
This document describes the MoSCoW prioritization method for software project requirements. The MoSCoW method categorizes requirements into four levels: Must, Should, Could, and Won't. Must requirements are essential for project success. Should requirements are important but not critical. Could requirements would provide additional benefits but are not necessary. Won't requirements are lowest priority and unlikely to be included in the initial project. The method helps establish agreement on priority among stakeholders and scope the project appropriately.
This document discusses plant layout for pharmaceutical manufacturing facilities. It begins by defining plant layout and its importance for efficient production. There are two main types of layouts: process/functional layout which groups similar machines together and product/straight line layout which arranges machines in the order of operations. Key factors that influence layout include the production process, available space, operational convenience, and regulatory requirements. Special provisions for pharmaceutical facilities include preventing confusion or contamination. Storage areas for raw materials and finished goods are also discussed, including specific storage requirements. The document concludes by outlining the layout of sterile or aseptic manufacturing areas which separate different operations and control air flow and personnel movement to maintain sterility.
By following the best practices outlined in this presentation and avoiding the “don’ts” that go along with them, you can prevent unnecessary damage from occurring to your glass-lined equipment.
Kingdom of Bahrain | Single Use Plastic Products Licensing GuideRashed Isa
The document summarizes the plastic products licensing procedure in Bahrain, including:
- Applicants must submit an application form and documents like ISO 14001 certification and lab test reports to the Environmental Licensing Section at the Supreme Council for Environment.
- Plastic product licenses are valid for one year, and the council issues a serial number for each product.
- Manufacturers must affix the conformity marking on products and print the serial number with the marking at a clear, readable resolution according to standards.
The document then provides application forms, license templates, and appendices specifying requirements like marking dimensions, permitted heavy metal limits, and labeling information.
ISO 9000 is a family of standards related to quality management systems and procedures. It helps organizations ensure they meet customer and stakeholder needs while complying with legal requirements. The standards are based on eight quality management principles including customer focus, leadership, and continual improvement. ISO 9000 deals with quality management fundamentals, while ISO 9001 provides requirements for quality assurance in design and manufacturing. Implementing an ISO-certified quality management system helps organizations improve quality, meet regulations, and increase market credibility.
This document discusses quality assurance and quality control. Quality assurance refers to processes done before a project to ensure quality, such as process documentation and audits. Quality control refers to checks done on deliverables to ensure they meet standards. Both are interdependent. Accuracy and precision are important in analysis. Various charts can be used to monitor quality over time, including control charts. Validation of methods, equipment, and cleaning procedures helps ensure quality. Documentation, representative sampling, and use of standards are also discussed.
This document discusses parenteral products and water for injection (WFI). It provides details on:
1) What defines a parenteral product and reasons they are unique dosage forms.
2) The manufacturing process for parenteral products including procurement, processing, packaging, and quality control.
3) Key factors for WFI production including distillation units, storage and distribution, and validation to ensure quality standards.
In This PPT we are discussed about complete details of that product (Use,Operation, Technical details, Dimensions, Wiring, and etc..)
Please Support us and Follow our other Sites
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https://twitter.com/ControlsSystems
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https://controlsandsystems.business.site
www.controls.systemsdm@gmail.com
If you enjoyed this article, share it with your friends and colleagues
This document discusses water purification and engineering for pharmaceutical use. It examines requirements for water treatment systems, storage and distribution, sampling and testing, and sanitization. Key points include selecting suitable contact materials, maintaining turbulent flow and avoiding dead legs to control biocontamination, and using techniques like continuous circulation, UV radiation, and periodic sanitization to prevent microbial growth.
Active pharmaceutical ingredients (APIs) are the core components of drugs that provide the desired medicinal effects. APIs are manufactured through chemical and physical processes from raw materials by pharmaceutical companies. This involves converting materials into APIs through sophisticated chemical synthesis, extraction, or fermentation processes. The production of APIs must be done safely, cost-effectively, and in an environmentally friendly manner to tightly control particle sizes and achieve narrow distribution for consistent results.
The document discusses pharmaceutical water systems. It begins by defining various types of high purity water like purified water, sterile purified water, water for injection, and sterile water for injection. It then discusses how purified water and water for injection are produced, typically through processes like distillation, ion exchange, or reverse osmosis. The document also covers considerations for storing and distributing high purity water, such as using stainless steel materials, minimizing dead legs, and sanitizing distribution systems through heat, ozone, or chemicals. Finally, it presents different options for setting up hot and cold storage and distribution systems.
The document discusses the ISO 9000 and 14000 quality and environmental management standards, outlining their objectives to facilitate international trade, obtain competitiveness through quality, and promote total quality control systems. It provides definitions and principles of the ISO 9000 series, details their documentation requirements, and explains the implementation process and advantages of certification. The ISO 14000 series aims to standardize environmental management systems to help organizations minimize environmental impacts.
This document provides an introduction to water systems for pharmaceutical use. It discusses the importance of water quality for pharmaceutical processes and products. It outlines various water types like purified water, highly purified water, and water for injections. It emphasizes that water systems must be properly designed, installed, operated and maintained according to GMP to ensure consistent production of water meeting quality specifications. It also discusses common water contaminants and the need to monitor water sources and treat water appropriately based on its chemistry and contaminants.
The document discusses Total Quality Management (TQM) and Current Good Manufacturing Practice (cGMP). It defines TQM as a modern management approach that emphasizes quality to meet customer needs and expectations. TQM stresses quality management at all stages of production and customer interaction. cGMP refers to regulations that ensure products are consistently produced and controlled to quality standards. The document outlines key principles of TQM including customer satisfaction, continuous improvement, and quality-oriented management. It also discusses the importance of cGMP in ensuring product quality, reducing defects, and maintaining consistency in manufacturing. Historical events like the Elixir Sulfanilamide disaster led to the establishment of cGMP regulations to improve product safety.
HVAC systems are an integral part of environmental control and include air handling units. AHU are large metal boxes that condition and circulate air, containing components like blowers, filters, and controls for temperature and humidity. Proper filtration is important for pharmaceutical facilities, utilizing filters like HEPA that can remove 99.97% of particles over 0.3 microns through mechanisms like impingement, diffusion, and interception. Dust collectors are also used to control air pollution and maintain clean environments through various collection methods. Regular inspection and maintenance of air handling systems is crucial to ensure quality pharmaceutical production.
This document discusses the benefits of variable speed fire pump controllers compared to conventional controllers. Variable speed controllers can maintain a constant system pressure without the need for pressure reducing valves (PRVs) by adjusting the pump speed. This allows taller buildings to be designed without PRVs, saving significant costs. It also improves reliability by having redundant control circuits. While conventional controllers require PRVs for most floors in a 12-story building example, incurring high costs, a variable speed controller can maintain safe pressures on all floors without PRVs.
The document provides details about Neeraj Ojha's 7-day internship at Aadee Remedies pharmaceutical company. It describes his exposure to various departments including production, quality control, storage, and R&D. In production, he assisted with wet granulation and tablet compression processes. At quality control, he performed various tests on metronidazole and samples. He also learned about the duties of the storage and R&D departments. Overall, the internship provided him valuable practical learning experience about industrial pharmacy operations.
This document describes an automatic mixing and filling bottle system that uses a Siemens S7-1200 PLC as the controller. The system uses submersible pumps to transfer water and flavoring from containers into a mixing container. A mixing motor mixes the contents and a solenoid valve fills bottles on a conveyor belt. The PLC programming is done using ladder logic in TIA Portal software. The project aims to design an appropriate model and program the PLC to control the system components for automatic mixing and filling of bottles.
This document discusses quality audits in the pharmaceutical industry. It defines quality audits and differentiates them from periodic evaluations. The objectives of quality audits are to verify compliance with Good Manufacturing Practices (GMP) regulations and allow for timely correction of problems. The document describes different types of audits, including internal audits, external audits, and regulatory audits. It also outlines the key elements of a quality audit program, such as using checklists, training auditors, documenting findings in reports, and having management review and address any issues.
1. Salesforce's Red Account Program aims to identify and manage their most serious customer-impacting issues to drive effective resolution and ensure renewal and healthy relationships. It provides visibility across teams and leverages executive support.
2. The program has key elements like defined processes, cross-functional team support, roles and responsibilities, communication, analytics, and root cause analysis. It aims to create a culture where escalations are handled properly.
3. There are four types of Red Accounts: precautionary, core, Marketing Cloud, and incident outreach. The program looks to resolve issues threatening renewals, risking executive escalations, delaying go-lives, or needing multi-team involvement. Customer escalations
Vendor selection and certification is important for pharmaceutical companies to ensure quality control and regulatory compliance. It involves categorizing vendors based on risk level and monitoring them accordingly. The key steps are:
1) Evaluating vendors based on criteria like quality, delivery, facilities, financials, and compliance history.
2) Classifying them into categories from 1 to 4 based on risk, with category 1 needing minimal oversight and category 4 requiring intense monitoring.
3) Qualifying vendors through assessing processes, specifications, changes, and customer inspections to ensure quality standards are met.
4) Conducting periodic audits and follow-up visits to ensure continued compliance. This helps build confidence and trust in the vendor-customer relationship.
Layout of pharmaceutical building and servicesHimal Barakoti
The document discusses the layout of pharmaceutical buildings and services. It begins with an introduction to good manufacturing practices (GMP) and their importance. It then covers the basic requirements for building layout, including material and personnel flows, equipment layout, and ensuring proper process flow. Specific areas of the building are also addressed, including ancillary, storage, weighing, production, and quality control areas. Proper lighting, electricity, and environmental controls are emphasized throughout.
This document provides a checklist for creating a Project Initiation Document (PID). The PID checklist includes 4 sections that outline what the project is about, why it should proceed, who will work on it, and how and when it will be delivered. The checklist details items to include under each section, such as the project title, objectives, deliverables, roles and responsibilities, schedule, and quality control. Completing this comprehensive PID checklist helps ensure all necessary information is documented up front to plan and manage the project.
Document gives the lists of standards that have been developed by different international organizations. such as ISO, DIN, ASTM, AISI, and etc.inths document all the standards that have ever been introduced by any organization for engineering field are listed down
In This PPT we are discussed about complete details of that product (Use,Operation, Technical details, Dimensions, Wiring, and etc..)
Please Support us and Follow our other Sites
https://www.instagram.com/controlsandsystems.offical
https://twitter.com/ControlsSystems
https://automationtechplc2.blogspot.com
https://humidificationcontrol.blogspot.com
https://controlsandsystems.business.site
www.controls.systemsdm@gmail.com
If you enjoyed this article, share it with your friends and colleagues
This document discusses water purification and engineering for pharmaceutical use. It examines requirements for water treatment systems, storage and distribution, sampling and testing, and sanitization. Key points include selecting suitable contact materials, maintaining turbulent flow and avoiding dead legs to control biocontamination, and using techniques like continuous circulation, UV radiation, and periodic sanitization to prevent microbial growth.
Active pharmaceutical ingredients (APIs) are the core components of drugs that provide the desired medicinal effects. APIs are manufactured through chemical and physical processes from raw materials by pharmaceutical companies. This involves converting materials into APIs through sophisticated chemical synthesis, extraction, or fermentation processes. The production of APIs must be done safely, cost-effectively, and in an environmentally friendly manner to tightly control particle sizes and achieve narrow distribution for consistent results.
The document discusses pharmaceutical water systems. It begins by defining various types of high purity water like purified water, sterile purified water, water for injection, and sterile water for injection. It then discusses how purified water and water for injection are produced, typically through processes like distillation, ion exchange, or reverse osmosis. The document also covers considerations for storing and distributing high purity water, such as using stainless steel materials, minimizing dead legs, and sanitizing distribution systems through heat, ozone, or chemicals. Finally, it presents different options for setting up hot and cold storage and distribution systems.
The document discusses the ISO 9000 and 14000 quality and environmental management standards, outlining their objectives to facilitate international trade, obtain competitiveness through quality, and promote total quality control systems. It provides definitions and principles of the ISO 9000 series, details their documentation requirements, and explains the implementation process and advantages of certification. The ISO 14000 series aims to standardize environmental management systems to help organizations minimize environmental impacts.
This document provides an introduction to water systems for pharmaceutical use. It discusses the importance of water quality for pharmaceutical processes and products. It outlines various water types like purified water, highly purified water, and water for injections. It emphasizes that water systems must be properly designed, installed, operated and maintained according to GMP to ensure consistent production of water meeting quality specifications. It also discusses common water contaminants and the need to monitor water sources and treat water appropriately based on its chemistry and contaminants.
The document discusses Total Quality Management (TQM) and Current Good Manufacturing Practice (cGMP). It defines TQM as a modern management approach that emphasizes quality to meet customer needs and expectations. TQM stresses quality management at all stages of production and customer interaction. cGMP refers to regulations that ensure products are consistently produced and controlled to quality standards. The document outlines key principles of TQM including customer satisfaction, continuous improvement, and quality-oriented management. It also discusses the importance of cGMP in ensuring product quality, reducing defects, and maintaining consistency in manufacturing. Historical events like the Elixir Sulfanilamide disaster led to the establishment of cGMP regulations to improve product safety.
HVAC systems are an integral part of environmental control and include air handling units. AHU are large metal boxes that condition and circulate air, containing components like blowers, filters, and controls for temperature and humidity. Proper filtration is important for pharmaceutical facilities, utilizing filters like HEPA that can remove 99.97% of particles over 0.3 microns through mechanisms like impingement, diffusion, and interception. Dust collectors are also used to control air pollution and maintain clean environments through various collection methods. Regular inspection and maintenance of air handling systems is crucial to ensure quality pharmaceutical production.
This document discusses the benefits of variable speed fire pump controllers compared to conventional controllers. Variable speed controllers can maintain a constant system pressure without the need for pressure reducing valves (PRVs) by adjusting the pump speed. This allows taller buildings to be designed without PRVs, saving significant costs. It also improves reliability by having redundant control circuits. While conventional controllers require PRVs for most floors in a 12-story building example, incurring high costs, a variable speed controller can maintain safe pressures on all floors without PRVs.
The document provides details about Neeraj Ojha's 7-day internship at Aadee Remedies pharmaceutical company. It describes his exposure to various departments including production, quality control, storage, and R&D. In production, he assisted with wet granulation and tablet compression processes. At quality control, he performed various tests on metronidazole and samples. He also learned about the duties of the storage and R&D departments. Overall, the internship provided him valuable practical learning experience about industrial pharmacy operations.
This document describes an automatic mixing and filling bottle system that uses a Siemens S7-1200 PLC as the controller. The system uses submersible pumps to transfer water and flavoring from containers into a mixing container. A mixing motor mixes the contents and a solenoid valve fills bottles on a conveyor belt. The PLC programming is done using ladder logic in TIA Portal software. The project aims to design an appropriate model and program the PLC to control the system components for automatic mixing and filling of bottles.
This document discusses quality audits in the pharmaceutical industry. It defines quality audits and differentiates them from periodic evaluations. The objectives of quality audits are to verify compliance with Good Manufacturing Practices (GMP) regulations and allow for timely correction of problems. The document describes different types of audits, including internal audits, external audits, and regulatory audits. It also outlines the key elements of a quality audit program, such as using checklists, training auditors, documenting findings in reports, and having management review and address any issues.
1. Salesforce's Red Account Program aims to identify and manage their most serious customer-impacting issues to drive effective resolution and ensure renewal and healthy relationships. It provides visibility across teams and leverages executive support.
2. The program has key elements like defined processes, cross-functional team support, roles and responsibilities, communication, analytics, and root cause analysis. It aims to create a culture where escalations are handled properly.
3. There are four types of Red Accounts: precautionary, core, Marketing Cloud, and incident outreach. The program looks to resolve issues threatening renewals, risking executive escalations, delaying go-lives, or needing multi-team involvement. Customer escalations
Vendor selection and certification is important for pharmaceutical companies to ensure quality control and regulatory compliance. It involves categorizing vendors based on risk level and monitoring them accordingly. The key steps are:
1) Evaluating vendors based on criteria like quality, delivery, facilities, financials, and compliance history.
2) Classifying them into categories from 1 to 4 based on risk, with category 1 needing minimal oversight and category 4 requiring intense monitoring.
3) Qualifying vendors through assessing processes, specifications, changes, and customer inspections to ensure quality standards are met.
4) Conducting periodic audits and follow-up visits to ensure continued compliance. This helps build confidence and trust in the vendor-customer relationship.
Layout of pharmaceutical building and servicesHimal Barakoti
The document discusses the layout of pharmaceutical buildings and services. It begins with an introduction to good manufacturing practices (GMP) and their importance. It then covers the basic requirements for building layout, including material and personnel flows, equipment layout, and ensuring proper process flow. Specific areas of the building are also addressed, including ancillary, storage, weighing, production, and quality control areas. Proper lighting, electricity, and environmental controls are emphasized throughout.
This document provides a checklist for creating a Project Initiation Document (PID). The PID checklist includes 4 sections that outline what the project is about, why it should proceed, who will work on it, and how and when it will be delivered. The checklist details items to include under each section, such as the project title, objectives, deliverables, roles and responsibilities, schedule, and quality control. Completing this comprehensive PID checklist helps ensure all necessary information is documented up front to plan and manage the project.
Document gives the lists of standards that have been developed by different international organizations. such as ISO, DIN, ASTM, AISI, and etc.inths document all the standards that have ever been introduced by any organization for engineering field are listed down
The document introduces 10 Japanese game companies that will be presenting at Game Connection America 2012, including companies that develop social games, console games, and both experienced and first-time exhibitors seeking international partnerships. JETRO is promoting the companies and their games, which have proven success in Japan, in hopes of finding new business opportunities overseas. Visitors to Game Connection America 2012 are encouraged to meet with the companies to learn about their products and the Japanese gaming market.
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