Understanding types of ink migration in food, pharmaceutical, and health and beauty packaging. Overview of the 10 Good Manufacturing Practices (GMPs) to reduce risk.
This document discusses various ancillary materials required for packaging. It describes the functions of ancillary materials in providing product-package compatibility, preservation, protection, identification, convenience and consumer protection. The main ancillary materials discussed are adhesives, printing inks, labels, caps and closures, and reinforcement materials like tapes and straps. For each material, the document discusses different types, classifications, raw materials used, and applications in packaging.
Print quality is determined by several factors including color reproduction, detail reproduction, gloss, and defects. Color reproduction depends on paper properties, ink properties, dot gain, and trapping. Higher print densities and smoother paper surfaces allow for wider color gamuts. Ink demand is mainly controlled by paper roughness and porosity, with smoother papers requiring less ink. Dot gain increases halftone dot size and must be considered when choosing screen rulings. Trapping influences color gamut through secondary colors and depends on ink sequence and transfer properties. Gloss is influenced by paper coating and ink, though consumer perception of differences in gloss can vary.
Food Safety and Flexible Packaging MaterialEric Tu
This document discusses how packaging materials can affect food safety. It begins by establishing that packaging plays a critical role in food safety and outlines some key ways materials can impact it, such as through migration of residual chemicals from packaging or insufficient barrier properties. It then explores these topics in more detail. For example, it examines common sources of residual chemicals from additives and solvents and provides tips for selecting materials and processes to minimize them. The document also looks at the importance of barrier properties for tasks like maintaining freshness and preventing spoilage. Overall, the document analyzes how packaging design and material selection can help ensure food safety.
Ancillary packaging materials are secondary packaging items that add value to the primary package. They include caps and closures, adhesives, tapes, reinforcements, cushioning materials, clips, and labels. Ancillary materials improve performance by preventing contamination and damage during transport while providing information to consumers. Selection of the appropriate ancillary materials depends on the product and packaging type.
Smart and active packaging systems can incorporate sensors, indicators, and other technologies to monitor food quality and safety throughout the supply chain. Common functions of intelligent packaging include sensing oxygen, carbon dioxide, moisture, pathogens, and temperature to provide information on food freshness and detect potential issues. Key components include gas sensors, biosensors, time-temperature indicators, and RFID tags. Indicators produce a visible color change in response to chemical reactions to provide information on conditions inside the package. Active packaging technologies like oxygen scavengers and antimicrobial agents are designed to prolong shelf-life by absorbing or releasing specific gases.
The document discusses innovative food packaging technologies that can help reduce food waste. It begins by noting that 1/3 of the world's food production is wasted, costing $1000 billion annually. Packaging technologies like modified atmosphere packaging and controlled atmosphere packaging can help extend shelf life and freshness. The document then discusses active and intelligent packaging innovations, including oxygen scavengers, ethylene scavengers, antimicrobial agents, antioxidants, time-temperature indicators, seal and leak indicators, and freshness indicators. It provides examples of antimicrobial, antioxidant active films and nanoactive films. The document concludes by discussing the potential of these innovative packaging technologies to reduce food waste and carbon footprints.
This document discusses various ancillary materials required for packaging. It describes the functions of ancillary materials in providing product-package compatibility, preservation, protection, identification, convenience and consumer protection. The main ancillary materials discussed are adhesives, printing inks, labels, caps and closures, and reinforcement materials like tapes and straps. For each material, the document discusses different types, classifications, raw materials used, and applications in packaging.
Print quality is determined by several factors including color reproduction, detail reproduction, gloss, and defects. Color reproduction depends on paper properties, ink properties, dot gain, and trapping. Higher print densities and smoother paper surfaces allow for wider color gamuts. Ink demand is mainly controlled by paper roughness and porosity, with smoother papers requiring less ink. Dot gain increases halftone dot size and must be considered when choosing screen rulings. Trapping influences color gamut through secondary colors and depends on ink sequence and transfer properties. Gloss is influenced by paper coating and ink, though consumer perception of differences in gloss can vary.
Food Safety and Flexible Packaging MaterialEric Tu
This document discusses how packaging materials can affect food safety. It begins by establishing that packaging plays a critical role in food safety and outlines some key ways materials can impact it, such as through migration of residual chemicals from packaging or insufficient barrier properties. It then explores these topics in more detail. For example, it examines common sources of residual chemicals from additives and solvents and provides tips for selecting materials and processes to minimize them. The document also looks at the importance of barrier properties for tasks like maintaining freshness and preventing spoilage. Overall, the document analyzes how packaging design and material selection can help ensure food safety.
Ancillary packaging materials are secondary packaging items that add value to the primary package. They include caps and closures, adhesives, tapes, reinforcements, cushioning materials, clips, and labels. Ancillary materials improve performance by preventing contamination and damage during transport while providing information to consumers. Selection of the appropriate ancillary materials depends on the product and packaging type.
Smart and active packaging systems can incorporate sensors, indicators, and other technologies to monitor food quality and safety throughout the supply chain. Common functions of intelligent packaging include sensing oxygen, carbon dioxide, moisture, pathogens, and temperature to provide information on food freshness and detect potential issues. Key components include gas sensors, biosensors, time-temperature indicators, and RFID tags. Indicators produce a visible color change in response to chemical reactions to provide information on conditions inside the package. Active packaging technologies like oxygen scavengers and antimicrobial agents are designed to prolong shelf-life by absorbing or releasing specific gases.
The document discusses innovative food packaging technologies that can help reduce food waste. It begins by noting that 1/3 of the world's food production is wasted, costing $1000 billion annually. Packaging technologies like modified atmosphere packaging and controlled atmosphere packaging can help extend shelf life and freshness. The document then discusses active and intelligent packaging innovations, including oxygen scavengers, ethylene scavengers, antimicrobial agents, antioxidants, time-temperature indicators, seal and leak indicators, and freshness indicators. It provides examples of antimicrobial, antioxidant active films and nanoactive films. The document concludes by discussing the potential of these innovative packaging technologies to reduce food waste and carbon footprints.
Zwick has collaborated with the paper, board and corrugated board industries to develop a large range of test fixtures and accessories especially for their products. Multi-functional, highly flexible testing machines replace the single-purpose machines used previously, saving space and reducing investment costs.
Screen printing uses stencils to transfer images onto surfaces through a fabric screen. The stencil blocks ink from passing through in some areas while allowing it in others to create the image. Carousel screen printing uses multiple screens on a rotating mechanism to print with different colors more quickly and efficiently. Screen printing is commonly used to apply graphics and logos to products. Photocopying uses a dry toner instead of liquid ink in a non-contact printing process, allowing images to be reproduced in different sizes. Gravure printing employs an engraved plate to hold ink which is applied to paper to create high-quality art and photography books. Offset lithography uses oil and gum to divide a smooth plate surface into ink-accepting and ink
Printing and Writing Inks with Formulae and ProcessesAjjay Kumar Gupta
Ink is a liquid or paste that contains pigments or dyes and is used to colour a surface to produce an image, text, or design. Ink is used for drawing or writing with a pen, brush, or quill. Thicker inks, in paste form, are used extensively in letterpress and lithographic printing. Ink can be a complex medium, composed of solvents, pigments, dyes, resins, lubricants, solubilizers, surfactants, particulate matter, fluorescents, and other materials.
Tags
Printing and Writing Inks with Formulae, Printing and Writing Inks with Processes, A Guide to Popular Printing Techniques, best small and cottage scale industries, formulations of printing inks, Gravure Printing industry, Growth in the Writing inks, How Ink Is Made, How Ink is manufactured, How printing ink manufactured in factory, how to manufacture ink, How to Start a Printing and writing inks Production Business, How to start a successful Printing and writing inks business, How to Start Printing and writing inks Industry in India, Ink and Printability Testing, Inking Rollers, Inking Rollers uses, Manufacture of Inks and varnishes, manufacturing of varnish, Modern Printing Process, Most Profitable Printing and writing inks manufacturing Business Ideas, new small scale ideas in inks manufacturing industry, Newspaper Printing Ink, Packaging Inks Market - Covering the Printing Inks, Coatings and Allied Industries, Printing and writing inks Based Small Scale Industries Projects, Printing and writing inks Business, Printing and writing inks manufacturing Industry in India, Printing and writing inks, manufacturing Projects, printing ink formulation, printing ink manual, Printing Ink Manufacturing, printing ink manufacturing process, Printing Ink Technology and Manufacture, Printing Inks & Applications, Printing Processes and Printing Inks, Printing processes: Offset, Flexo, Digital, Gravure, Profitable Small Scale inks Manufacturing, Robust Growth in the Indian Exports of Printing Inks, screen printing process, Setting up and opening your Printing and writing inks Business, Setting up and opening your Printing Business, Setting up of Printing and writing inks manufacturing Units, Small scale Commercial Printing and writing inks production, Small Scale Printing and writing inks manufacturing Projects, Small Start-up Business Project, Start up India, Stand up India, Starting a Printing and writing inks manufacturing Business, Starting a Printing Business, Starting an Ink and Toner Cartridge Refilling Business, Starting an Offset Printing Press, Start-up Business Plan for Printing and writing inks, startup ideas, Startup Project, Startup Project for Printing and writing inks Business, startup project plan, The manufacturing process of a news ink, varnish making process, Varnish manufacturing, varnish manufacturing process, Web Offset Machines, What Equipment Do I Need to Start a Printing Business?, Writing ink manufacturing process
paharmaceutical packaging Medical device Packaging types of medical device p...RavichandraNadagouda
This document discusses pharmaceutical packaging and different types of packaging materials used. It begins by defining packaging and outlining its key functions of protection, preservation, presentation, and promotion. It then discusses ideal qualities for pharmaceutical packaging and types of packaging including primary, secondary, and tertiary packaging. The document focuses on primary packaging materials and medical device packaging, outlining different package types used and characteristics of materials like Tyvek, films, foils, and thermoformable plastics.
This document discusses various aspects of pharmaceutical packaging design and specifications. It begins with short introductions to packaging, objectives of packaging, and types of packaging. It then covers topics like packaging design considerations, component specifications, quality testing standards, and regulatory requirements. The key points are that packaging must protect products, provide information to customers and compliance, and quality control starts at the design stage. Component specifications involve drawings, artwork, material selection, and defining test standards.
This document summarizes guidelines for stability testing according to ICH guidelines. The key points are:
1) ICH guidelines are most commonly accepted and provide information on stability testing in the EU, Japan, and US. Stability testing aims to provide evidence of how quality varies over time under different conditions.
2) The objectives of ICH are more economical use of resources, eliminating delays in global development and availability of medicines, and maintaining safeguards for quality, safety, and efficacy.
3) Stability topics covered by ICH include testing, validation, impurities, specifications, and manufacturing. This summary focuses on stability testing guidelines for new drug substances and products.
The document discusses different types of printing inks used in various printing processes. It describes the key components of printing inks including solvents, binders, colorants and additives. It then classifies printing inks based on viscosity, drying method and chemical nature. Specific details are provided about letterpress, offset, silk screen, flexographic and gravure inks as well as recommended viscosity for different processes. Processing steps like adjusting viscosity and adding solvents/extenders are also summarized.
This document discusses water resistant paper packaging for food industries. It outlines different coating methods that can be used to make paper water resistant, including wax, biopolymers, fluorinated resins, foil, alginates, clays and more. The document then discusses how these coatings are applied in manufacturing and the standards and regulations for food-grade paper packaging. It also covers the pros and cons of water resistant packaging materials and their sustainability. The conclusion emphasizes that bio-based coatings can improve the barrier properties of paperboard for food packaging applications.
This document provides an overview of flexible packaging materials and their uses in common food products in India. It discusses the types of flexible packaging materials used for dairy products like milk, cheese and ice cream. It also discusses flexible packaging for confectionery items like chocolates, chewing gums and lollipops. Finally, it covers flexible packaging for sauces/condiments and dry food products like sugar and pasta. The document aims to analyze the packaging materials and labeling of these various food categories.
Bi-axially oriented Poly polypropylene films JayaVerma28
This presentation is about Bi-axially oriented poly - polypropylene films, it describes about its properties, processing parameters, methods, industrial manufacturing, Applications, advantages, disadvantages and references are added at the end.
The document discusses analytical quality by design (AQbD) and its implementation. It compares traditional analytical methods to AQbD methods. AQbD uses a systematic approach including risk assessment, design of experiments, and establishing a method operable design region. A case study demonstrates developing an HPLC method for assay using an AQbD approach including target measurement, design of experiment, method validation, and establishing a method operable design region. The conclusion states AQbD requires defining the right analytical target profile and using appropriate tools to ensure the right analytics are performed at the right time.
Red is associated with blood, fire, war, and passion. It was an important color in ancient Egypt and Greece and was sometimes associated with masculinity. The oldest red pigments were red ochre and madder lake. Vermilion, a bright red made from cinnabar, was prominent until the development of cadmium red in 1907. Green symbolizes nature, growth, and renewal. Important green pigments include malachite, verdigris, cobalt green, emerald green, and viridian. Emerald green was a brilliant blue-green pigment but was toxic and chemically unstable.
Digital inkjet printing allows designs to be printed directly onto fabrics from a computer without additional efforts like traditional printing. It has emerged as a flexible printing technique since the 1990s. Key benefits include quick design changes and mass customization capabilities. Various digital printing technologies exist, like DOD inkjet which only deposits ink where needed, and piezoelectric inkjet which uses electrostatic forces to spray micro ink droplets. Software programs help manage color and translate designs for printing. Digital printing is growing and offers opportunities in new applications and markets due to advantages in speed, cost, design flexibility and environmental friendliness over traditional textile printing.
The document discusses stability testing guidelines from the International Council for Harmonisation (ICH). The ICH brings together regulatory authorities and the pharmaceutical industry to harmonize technical requirements for drug development. The purpose of stability testing is to provide evidence of how a drug's quality changes over time under environmental factors and to establish shelf life and storage conditions. The document outlines ICH guidelines for stability testing and discusses variables that affect drug stability as well as potential effects of instability.
This document discusses packaging for pharmaceutical products. It defines packaging and outlines the selection criteria and characteristics of packaging materials. The main types of packaging are primary, secondary, and tertiary. Common materials include glass, metals, plastics, rubbers, fibrous materials, and films/foils. Blister packs and strip packs are described as primary packaging forms. The document provides details on specific materials like aluminum and discusses packaging symbols.
Cleaning validation is important to prove that equipment is consistently cleaned to acceptable levels to prevent contamination. There are three main goals of a cleaning validation program: 1) to prove equipment is consistently cleaned of product, detergent, and microbial residues; 2) to prevent possible contamination and cross-contamination; and 3) to demonstrate the cleaning process produces reproducible results. A cleaning validation program establishes standard cleaning procedures, validates the cleaning process, and provides documented evidence that the approved cleaning procedure is suitable for processing medicinal products.
Enteral Pharmaceutical Packaging- By Kaleem PetkarKaleem Petkar
Here you will learn about all the enteral packaging types.
This slide also includes certain packaging types with illustrative examples.
You can download my slide absolutely free.
Thanks & regards
Petkar kaleem.
SUSTAINABLE PACKAGING is integrating environmental criteria in the design process of a product-packaging combination. This means that besides the normal criteria, such as: marketing, functional, economic and technical criteria, also environmental criteria are taken into account.
This presentation is based on our experiences in the Network Sustainable Packaging. The Network organized from 2010-2013, ten workshops for different market segments and three general meetings about sustainable packaging in The Netherlands. More than 200 professionals from packaging industry attended this meetings and shared their views and insights.
Types of closures used for packaging of dosage forms include rubber closures, caps and overseals like screw caps and crown caps, and special types like tamper-evident, dispensing, and child-resistant closures. Rubber closures are commonly used and must pass fragmentation and self-sealability tests. Caps and overseals secure rubber closures and include screw caps, crown caps, snap on caps, and friction fit caps. Special closures provide features like tamper evidence, controlled dispensing, and child resistance. Proper closures are important to contain contents, provide barriers, allow resealing, and meet regulatory standards.
The importance of extractable/leachable testing in Pharmaceutical Dosage forms has grown considerably in the last few years.Recent USP general chapters <1663>, <1664> states the requirements for extractables and leachables in regulatory submissions. There were several criticalities associated in the container closure system assessment in identifying the probable leachables that could impact the
quality of the Drug product. Control extractions studies provide an insight based on the technical characteristics and logical conclusions made. Technology advancements and bundles of literature provided major insights in understanding the analytical evaluation limits,specifications and procedural things conducting extractable and leachable studies. This presentation provides a summary and overview of regulatory requirements for extractables and leachables with the current trend of FDA deficiencies for the drug products.
cGMP Guidelines According to Schedule MANKUSH JADHAV
This document provides an overview of cGMP guidelines according to Schedule M. It defines cGMP and outlines key areas that must be addressed including personnel, premises, equipment, standard operating procedures, raw materials, self inspections, master formula records, batch manufacturing records, warehousing, and validation. The guidelines ensure quality products are consistently produced and that quality is built into every step of the manufacturing process.
This document provides an overview of key elements and basic principles of Good Manufacturing Practices (GMP). It defines GMP and cGMP, outlines their importance in ensuring product quality and safety, and describes characteristics of GMP-compliant products. The document also summarizes key elements of GMP like personnel, premises, equipment, materials, and quality control. It emphasizes the importance of documentation, validation, recalls, self-inspection, storage and training in adhering to GMP. The objectives of GMP and guidelines from various regulatory bodies are also briefly mentioned.
Zwick has collaborated with the paper, board and corrugated board industries to develop a large range of test fixtures and accessories especially for their products. Multi-functional, highly flexible testing machines replace the single-purpose machines used previously, saving space and reducing investment costs.
Screen printing uses stencils to transfer images onto surfaces through a fabric screen. The stencil blocks ink from passing through in some areas while allowing it in others to create the image. Carousel screen printing uses multiple screens on a rotating mechanism to print with different colors more quickly and efficiently. Screen printing is commonly used to apply graphics and logos to products. Photocopying uses a dry toner instead of liquid ink in a non-contact printing process, allowing images to be reproduced in different sizes. Gravure printing employs an engraved plate to hold ink which is applied to paper to create high-quality art and photography books. Offset lithography uses oil and gum to divide a smooth plate surface into ink-accepting and ink
Printing and Writing Inks with Formulae and ProcessesAjjay Kumar Gupta
Ink is a liquid or paste that contains pigments or dyes and is used to colour a surface to produce an image, text, or design. Ink is used for drawing or writing with a pen, brush, or quill. Thicker inks, in paste form, are used extensively in letterpress and lithographic printing. Ink can be a complex medium, composed of solvents, pigments, dyes, resins, lubricants, solubilizers, surfactants, particulate matter, fluorescents, and other materials.
Tags
Printing and Writing Inks with Formulae, Printing and Writing Inks with Processes, A Guide to Popular Printing Techniques, best small and cottage scale industries, formulations of printing inks, Gravure Printing industry, Growth in the Writing inks, How Ink Is Made, How Ink is manufactured, How printing ink manufactured in factory, how to manufacture ink, How to Start a Printing and writing inks Production Business, How to start a successful Printing and writing inks business, How to Start Printing and writing inks Industry in India, Ink and Printability Testing, Inking Rollers, Inking Rollers uses, Manufacture of Inks and varnishes, manufacturing of varnish, Modern Printing Process, Most Profitable Printing and writing inks manufacturing Business Ideas, new small scale ideas in inks manufacturing industry, Newspaper Printing Ink, Packaging Inks Market - Covering the Printing Inks, Coatings and Allied Industries, Printing and writing inks Based Small Scale Industries Projects, Printing and writing inks Business, Printing and writing inks manufacturing Industry in India, Printing and writing inks, manufacturing Projects, printing ink formulation, printing ink manual, Printing Ink Manufacturing, printing ink manufacturing process, Printing Ink Technology and Manufacture, Printing Inks & Applications, Printing Processes and Printing Inks, Printing processes: Offset, Flexo, Digital, Gravure, Profitable Small Scale inks Manufacturing, Robust Growth in the Indian Exports of Printing Inks, screen printing process, Setting up and opening your Printing and writing inks Business, Setting up and opening your Printing Business, Setting up of Printing and writing inks manufacturing Units, Small scale Commercial Printing and writing inks production, Small Scale Printing and writing inks manufacturing Projects, Small Start-up Business Project, Start up India, Stand up India, Starting a Printing and writing inks manufacturing Business, Starting a Printing Business, Starting an Ink and Toner Cartridge Refilling Business, Starting an Offset Printing Press, Start-up Business Plan for Printing and writing inks, startup ideas, Startup Project, Startup Project for Printing and writing inks Business, startup project plan, The manufacturing process of a news ink, varnish making process, Varnish manufacturing, varnish manufacturing process, Web Offset Machines, What Equipment Do I Need to Start a Printing Business?, Writing ink manufacturing process
paharmaceutical packaging Medical device Packaging types of medical device p...RavichandraNadagouda
This document discusses pharmaceutical packaging and different types of packaging materials used. It begins by defining packaging and outlining its key functions of protection, preservation, presentation, and promotion. It then discusses ideal qualities for pharmaceutical packaging and types of packaging including primary, secondary, and tertiary packaging. The document focuses on primary packaging materials and medical device packaging, outlining different package types used and characteristics of materials like Tyvek, films, foils, and thermoformable plastics.
This document discusses various aspects of pharmaceutical packaging design and specifications. It begins with short introductions to packaging, objectives of packaging, and types of packaging. It then covers topics like packaging design considerations, component specifications, quality testing standards, and regulatory requirements. The key points are that packaging must protect products, provide information to customers and compliance, and quality control starts at the design stage. Component specifications involve drawings, artwork, material selection, and defining test standards.
This document summarizes guidelines for stability testing according to ICH guidelines. The key points are:
1) ICH guidelines are most commonly accepted and provide information on stability testing in the EU, Japan, and US. Stability testing aims to provide evidence of how quality varies over time under different conditions.
2) The objectives of ICH are more economical use of resources, eliminating delays in global development and availability of medicines, and maintaining safeguards for quality, safety, and efficacy.
3) Stability topics covered by ICH include testing, validation, impurities, specifications, and manufacturing. This summary focuses on stability testing guidelines for new drug substances and products.
The document discusses different types of printing inks used in various printing processes. It describes the key components of printing inks including solvents, binders, colorants and additives. It then classifies printing inks based on viscosity, drying method and chemical nature. Specific details are provided about letterpress, offset, silk screen, flexographic and gravure inks as well as recommended viscosity for different processes. Processing steps like adjusting viscosity and adding solvents/extenders are also summarized.
This document discusses water resistant paper packaging for food industries. It outlines different coating methods that can be used to make paper water resistant, including wax, biopolymers, fluorinated resins, foil, alginates, clays and more. The document then discusses how these coatings are applied in manufacturing and the standards and regulations for food-grade paper packaging. It also covers the pros and cons of water resistant packaging materials and their sustainability. The conclusion emphasizes that bio-based coatings can improve the barrier properties of paperboard for food packaging applications.
This document provides an overview of flexible packaging materials and their uses in common food products in India. It discusses the types of flexible packaging materials used for dairy products like milk, cheese and ice cream. It also discusses flexible packaging for confectionery items like chocolates, chewing gums and lollipops. Finally, it covers flexible packaging for sauces/condiments and dry food products like sugar and pasta. The document aims to analyze the packaging materials and labeling of these various food categories.
Bi-axially oriented Poly polypropylene films JayaVerma28
This presentation is about Bi-axially oriented poly - polypropylene films, it describes about its properties, processing parameters, methods, industrial manufacturing, Applications, advantages, disadvantages and references are added at the end.
The document discusses analytical quality by design (AQbD) and its implementation. It compares traditional analytical methods to AQbD methods. AQbD uses a systematic approach including risk assessment, design of experiments, and establishing a method operable design region. A case study demonstrates developing an HPLC method for assay using an AQbD approach including target measurement, design of experiment, method validation, and establishing a method operable design region. The conclusion states AQbD requires defining the right analytical target profile and using appropriate tools to ensure the right analytics are performed at the right time.
Red is associated with blood, fire, war, and passion. It was an important color in ancient Egypt and Greece and was sometimes associated with masculinity. The oldest red pigments were red ochre and madder lake. Vermilion, a bright red made from cinnabar, was prominent until the development of cadmium red in 1907. Green symbolizes nature, growth, and renewal. Important green pigments include malachite, verdigris, cobalt green, emerald green, and viridian. Emerald green was a brilliant blue-green pigment but was toxic and chemically unstable.
Digital inkjet printing allows designs to be printed directly onto fabrics from a computer without additional efforts like traditional printing. It has emerged as a flexible printing technique since the 1990s. Key benefits include quick design changes and mass customization capabilities. Various digital printing technologies exist, like DOD inkjet which only deposits ink where needed, and piezoelectric inkjet which uses electrostatic forces to spray micro ink droplets. Software programs help manage color and translate designs for printing. Digital printing is growing and offers opportunities in new applications and markets due to advantages in speed, cost, design flexibility and environmental friendliness over traditional textile printing.
The document discusses stability testing guidelines from the International Council for Harmonisation (ICH). The ICH brings together regulatory authorities and the pharmaceutical industry to harmonize technical requirements for drug development. The purpose of stability testing is to provide evidence of how a drug's quality changes over time under environmental factors and to establish shelf life and storage conditions. The document outlines ICH guidelines for stability testing and discusses variables that affect drug stability as well as potential effects of instability.
This document discusses packaging for pharmaceutical products. It defines packaging and outlines the selection criteria and characteristics of packaging materials. The main types of packaging are primary, secondary, and tertiary. Common materials include glass, metals, plastics, rubbers, fibrous materials, and films/foils. Blister packs and strip packs are described as primary packaging forms. The document provides details on specific materials like aluminum and discusses packaging symbols.
Cleaning validation is important to prove that equipment is consistently cleaned to acceptable levels to prevent contamination. There are three main goals of a cleaning validation program: 1) to prove equipment is consistently cleaned of product, detergent, and microbial residues; 2) to prevent possible contamination and cross-contamination; and 3) to demonstrate the cleaning process produces reproducible results. A cleaning validation program establishes standard cleaning procedures, validates the cleaning process, and provides documented evidence that the approved cleaning procedure is suitable for processing medicinal products.
Enteral Pharmaceutical Packaging- By Kaleem PetkarKaleem Petkar
Here you will learn about all the enteral packaging types.
This slide also includes certain packaging types with illustrative examples.
You can download my slide absolutely free.
Thanks & regards
Petkar kaleem.
SUSTAINABLE PACKAGING is integrating environmental criteria in the design process of a product-packaging combination. This means that besides the normal criteria, such as: marketing, functional, economic and technical criteria, also environmental criteria are taken into account.
This presentation is based on our experiences in the Network Sustainable Packaging. The Network organized from 2010-2013, ten workshops for different market segments and three general meetings about sustainable packaging in The Netherlands. More than 200 professionals from packaging industry attended this meetings and shared their views and insights.
Types of closures used for packaging of dosage forms include rubber closures, caps and overseals like screw caps and crown caps, and special types like tamper-evident, dispensing, and child-resistant closures. Rubber closures are commonly used and must pass fragmentation and self-sealability tests. Caps and overseals secure rubber closures and include screw caps, crown caps, snap on caps, and friction fit caps. Special closures provide features like tamper evidence, controlled dispensing, and child resistance. Proper closures are important to contain contents, provide barriers, allow resealing, and meet regulatory standards.
The importance of extractable/leachable testing in Pharmaceutical Dosage forms has grown considerably in the last few years.Recent USP general chapters <1663>, <1664> states the requirements for extractables and leachables in regulatory submissions. There were several criticalities associated in the container closure system assessment in identifying the probable leachables that could impact the
quality of the Drug product. Control extractions studies provide an insight based on the technical characteristics and logical conclusions made. Technology advancements and bundles of literature provided major insights in understanding the analytical evaluation limits,specifications and procedural things conducting extractable and leachable studies. This presentation provides a summary and overview of regulatory requirements for extractables and leachables with the current trend of FDA deficiencies for the drug products.
cGMP Guidelines According to Schedule MANKUSH JADHAV
This document provides an overview of cGMP guidelines according to Schedule M. It defines cGMP and outlines key areas that must be addressed including personnel, premises, equipment, standard operating procedures, raw materials, self inspections, master formula records, batch manufacturing records, warehousing, and validation. The guidelines ensure quality products are consistently produced and that quality is built into every step of the manufacturing process.
This document provides an overview of key elements and basic principles of Good Manufacturing Practices (GMP). It defines GMP and cGMP, outlines their importance in ensuring product quality and safety, and describes characteristics of GMP-compliant products. The document also summarizes key elements of GMP like personnel, premises, equipment, materials, and quality control. It emphasizes the importance of documentation, validation, recalls, self-inspection, storage and training in adhering to GMP. The objectives of GMP and guidelines from various regulatory bodies are also briefly mentioned.
The document discusses current good manufacturing practices (cGMPs) for biotechnology products. It explains that biotech products are produced from living cells and require strict production, storage, and manufacturing standards to remain effective and safe. The Food and Drug Administration approves biotech products and monitors manufacturers to ensure compliance with cGMPs. cGMPs establish industry-wide quality standards to protect consumers and help ensure consistent product quality. They address personnel, facilities, equipment, production processes, holding and distribution, and recordkeeping.
Good manufacturing practices (GMP) are regulations and guidelines for manufacturing safe quality products. GMP aims to minimize risks in pharmaceutical production that cannot be eliminated through testing. It covers facilities, equipment, personnel, sanitation, raw material testing, manufacturing controls, packaging, finished product testing, quality control, records, samples, stability testing, and sterile products. Following GMP helps guarantee high quality products free of contamination to protect consumer health.
This document summarizes a training presentation on Good Manufacturing Practices (GMP) for pharmaceutical executives. The presentation covers:
- What GMP is and why it is important for ensuring consistent, high-quality product and maintaining regulatory compliance, customer satisfaction, and company reputation.
- Key GMP requirements including proper facilities, equipment, documentation, staff training, quality control and quality assurance programs.
- Specific GMP guidelines for premises, equipment, storage areas, processes, and documentation. Vulnerable packaging and labeling operations are highlighted.
- Non-compliance with GMP can result in serious consequences like product rejects, recalls or regulatory actions. Questions from attendees are invited at the end.
C gmp’s for pharmaceutical manufacturingabhikanavaje
Current Good Manufacturing Practices (cGMP) are regulations aimed at ensuring consistent quality in manufacturing processes. cGMP guidelines have been established by various regulatory bodies worldwide including the US FDA, WHO, and India. Adhering to cGMP helps reduce errors and contamination, ensures safety and reproducibility, and prevents mislabeling. Key cGMP requirements include establishing quality systems, personnel training, facility and equipment validation, material handling procedures, production and packaging processes, quality testing, and record keeping. Proper documentation, process validation, and compliance with standard operating procedures are essential for meeting cGMP standards.
Unit 9 -Good manufacturing practice.pptxmarakiwmame
This document defines key concepts related to current good manufacturing practices (cGMP), including:
- cGMP ensures products are consistently produced and controlled to quality standards for intended use. It covers facilities, equipment, personnel, and manufacturing procedures.
- The primary goal of cGMP is to prevent errors, contamination, and mix-ups during manufacturing that could lead to unsafe or ineffective products.
- cGMP provides a framework to help ensure products are safe, effective, and high quality. It addresses premises, equipment, documentation, personnel, packaging/labeling, quality control, distribution, validation, and recall procedures.
Good Manufacturing Practices in Pharmaceutical IndustryMs. Kiran Divekar
GMP is a part of quality assurance which ensures that products are consistently produced and controlled to the quality standards approproiate to their intended use.
It is concerned with both production & quality control.
Product is considered adulterated if GMP is not followed
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.
This document outlines good manufacturing practices (GMP) and sanitation standard operating procedures (SSOP) across various areas of a food production facility. It discusses requirements and best practices for facilities, premises, production equipment, ingredients and raw materials, chemical control, personal hygiene, warehousing and distribution, traceability and recall, and cleanliness and sanitation. The goal is to prevent food contamination and adulteration at all stages of production and storage by maintaining high standards of hygiene, cleaning, and process control.
This document outlines good manufacturing practices (GMP) and sanitation standard operating procedures (SSOP) across various areas of a food production facility. It discusses requirements and best practices for facilities, premises, production equipment, ingredients and raw materials, chemical control, personal hygiene, warehousing and distribution, traceability and recall, and cleanliness and sanitation. Key points emphasized include facility design principles for hygienic food handling, establishing sanitation procedures and schedules, controlling chemicals, ensuring all personnel follow proper hygiene practices, implementing first in first out storage, and maintaining thorough distribution and lot identification records.
This document outlines good manufacturing practices (GMP) and sanitation standard operating procedures (SSOP) across various areas of a food production facility. It discusses requirements and best practices for facilities, premises, production equipment, ingredients and raw materials, chemical control, personal hygiene, warehousing and distribution, traceability and recall, and cleanliness and sanitation. The goal is to prevent food contamination and adulteration at all stages of production and storage by maintaining high standards of hygiene, cleaning, and process control.
This document outlines Good Manufacturing Practices (GMP) for food production. It discusses key principles of GMP including documentation, validation, sanitation, personnel training, auditing, and process and quality control. The goal of GMP is to consistently produce safe, pure, and effective products by establishing controls and standards at all stages of manufacturing.
GAP and GMP are practices to ensure safety and quality in agriculture and food manufacturing. GAP involves activities on farms like clean soil/water and worker hygiene. GMP involves following written procedures, documentation, facility maintenance, training and audits in manufacturing. Certification in GAP and GMP gives benefits like market access, consumer confidence and compliance with regulations.
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role of quality system and audit in pharmaceutical manufacturing environment....MridulBindra2
This document discusses quality systems and audits in pharmaceutical manufacturing. It covers cGMP regulations which provide minimum standards for manufacturing drugs to ensure safety, identity, strength and quality. It describes quality assurance functions like assuring quality at every stage of manufacturing and coordinating with quality control. It also discusses the quality system approach of having management commitment to quality and establishing responsibilities. Key resources like human resources, infrastructure and work environment are also outlined.
The document provides an overview of current good manufacturing practices (cGMP) as defined by the World Health Organization (WHO). It discusses key aspects of cGMP including personnel, facilities, equipment, material management, quality management, manufacturing operations, validation, sterile products, security, documentation, and records. The goal of cGMP is to consistently produce pharmaceutical products that meet quality standards for their intended use and legal requirements.
Good Manufacturing Practice (GMP) regulations ensure that pharmaceutical products are consistently produced and controlled according to quality standards. GMP has regulations for facilities, equipment, personnel, sanitation, testing of raw materials and finished products, manufacturing, packaging, quality control, records, and stability. Following GMP procedures guarantees high quality products for consumers by minimizing risks of contamination and ensuring correct labeling and potency. Key aspects of GMP include written procedures, process validation, environmental monitoring, and record keeping. Strict adherence to GMP is important for producing safe, effective medicines.
Good Manufacturing Practice is a set of regulations, codes, and guidelines for the manufacture of drug substances and drug products, medical devices, in vivo and in vitro diagnostic products, and foods.
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2. ● The printing on the outside
ends up in the product
INK
MIGRATION?
WHAT IS
3. What are the risks?
It puts consumer
health at risk
Changes the flavor and odor
of products
It violates regulations
It can damage the brand
reputation
7. ● Chemicals from the printed side
of one package or label transfer to
the reverse side, where it contacts
the food.
SET-OFF PHASE
8. SET-OFF MIGRATION
CAUSES
● Re-rolling or stacking printed
packaging materials
● Ink not completely cured or dried
PREVENTION
● Ensure complete curing before
stacking or re-rolling
● Keep total ink coverage below 300%
● Use inks tested for food contact
materials. (Based on third-party
testing)
9. ● Ink passes through the packaging
substrate to contact the food,
pharmaceutical, or beauty
product.
DIFFUSION
10. DIFFUSION MIGRATION
CAUSES
● Improper curing or drying
● Inferior substrate
PREVENTION
● Use absolute barrier - glass or metal
● Use inks tested for food contact
materials. (Based on third-party
testing.)
11. ● Volatile substances transfer in
the space between the
packaging and the product.
GAS PHASE
12. GAS PHASE MIGRATION
CAUSES
● Printing environment
● Incomplete curing
● Post-packaging environmental effects
● Using inks with VOCs
PREVENTION
● Match inks to the primary packaging
material, based on third-party testing
● Use mineral-oil-free ink for secondary
packaging
14. PROCEDURES
QUALITY CONTROL • GMPs ● Detailed written procedures
(easily understood)
● Track performance
● Verify calculations
● Tracing and tracking systems
1 10 GMPs
15. PLANT &
FACILITIES
QUALITY CONTROL • GMPs
● Free from contamination risk
● Operated in a suitable location
● Built to industry standards
● Designed to minimize risk
● Easy to clean and maintain
2 10 GMPs
16. DOCUMENTATION &
RECORD KEEPING
QUALITY CONTROL • GMPs
● Integrity of standard
operating procedures
● Design history file (DHF)
● Employee training
● Manage document changes
● Designed to minimize risk
● Easy to clean and maintain
3 10 GMPs
17. PERSONNEL
QUALITY CONTROL • GMPs ● Trained upon hiring
● Qualified for specific jobs
● Understanding of GMPs
● Ongoing annual training
● Traffic patterns for guests
and employees
4 10 GMPs
20. ALLERGEN
CONTROL
QUALITY CONTROL • GMPs
● Stages of prevention
● Complete ingredient lists
● Dedicated
storage/warehousing
● Dedicated equipment and
utensils
● Cleaning procedures
7 10 GMPs
21. EQUIPMENT,
UTENSILS &
MAINTENANCE
QUALITY CONTROL • GMPs
● Well-designed preventive
maintenance program
● Sanitation procedures
● Investigating, documenting
equipment failures
● Procedures for bringing new
equipment online
8 10 GMPs
22. RECEIVING,
WAREHOUSING,
SHIPPING
QUALITY CONTROL • GMPs ● Tracking from arrival to departure
● Storage in proper and sanitary
conditions
● Map of designated storage areas
● Supplier protocols
● Acceptance and rejections criteria
9 10 GMPs
23. RECALL & TRACKING
SYSTEMS
QUALITY CONTROL • GMPs
● System for tracking through
the supply chain
● Lot coding raw materials
● Established testing system
● Fast and efficient recall
processes
● Practice mock recalls
10 10 GMPs
25. WATER-BASED
INKS FOR FOOD PACKAGING
● Environmentally friendly with
no or low odors
● Standard formulations
available for paper and other
porous materials
● Nano pigment inks for flexible
packaging and thin film
* Third-party lab testing is necessary to ensure regulatory compliance.
26. LOW-MIGRATION
UV/LED CURABLE
INKS FOR FOOD PACKAGING
● High purity of ink components
● Specially formulated
photoinitiators
● High-quality results
● LED curing produces less heat
* Third-party lab testing is necessary to ensure regulatory compliance.
27. ELECTRON-BEAM
CURABLE
INKS FOR FOOD PACKAGING
● No photoinitiators used
● Low energy consumption
● No heat generated
● High visual appeal
● Instant curing
* Third-party lab testing is necessary to ensure regulatory compliance.
28. BIO-INK
MINERAL-OIL-FREE
INKS FOR FOOD PACKAGING ● No hazardous pollutants (HAP)
● Near-zero VOCs
● Rich, deep colors for single-pass
applications
● Easily scannable barcodes
● Compostable
* Third-party lab testing is necessary to ensure regulatory compliance.