The document defines packaging as enclosing and protecting products for distribution, storage, sale, and use. It discusses various types of packaging materials like glass, plastics, and rubber and their properties and uses. It also describes different types of containers, closures, and packaging systems like blister packs and describes factors to consider for selection of appropriate packaging materials and systems. Tests to evaluate properties of packaging materials like glass, plastics and rubber are also summarized.
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.
This document discusses quality control testing for various packaging materials used in the pharmaceutical industry, including glass, plastic, paper/cardboard, rubber, metals and foils. It provides details on specific tests for each material. For example, for glass it describes light transmission testing, hydrolytic resistance testing and powdered glass testing. For plastic, it outlines leakage testing, collapsibility testing and water vapor permeability testing. The document aims to guide testing to ensure that packaging materials meet quality standards.
PACKAGING OF TABLETS: TYPES, MATERIALS AND QC.Akshay Joshi
This document provides an overview of tablet packaging types, materials, and quality control. It discusses primary packaging formats like blister packs, bottles, and strip packs. Common materials include PVC, PVDC, aluminum, glass, and plastics. Quality is ensured through testing of water vapor transmission, oxygen transmission, and blister strength. A case study examines the stability of amoxicillin/clavulanic acid tablets under different packaging conditions.
This document discusses the selection and evaluation of pharmaceutical packaging materials. It begins by defining packaging and its purposes of providing protection, identification, convenience, and compliance for products. Key factors in selecting packaging materials include the type of container, product characteristics, and characteristics of the materials themselves like barrier properties and FDA approval. Common container materials like glass, plastic, and metal are described along with their advantages. The document also discusses evaluating packaging materials through tests like leakage tests, collapsibility tests, and permeability tests to ensure suitability for drug products.
Shrink wrap is a polymer plastic film and is a cost effective way to package products so
they can stand out when displayed. This presentation explains the different types of shrink wrap films and their packaging applications.
This document discusses aseptic processing and packaging. Aseptic processing involves sterilizing products, packaging materials, and facilities to prevent contamination. It results in shelf-stable products sealed in sterile packaging without refrigeration. The process includes UHT sterilization, filling in sterile environments, and hermetically sealed packages. Hyosung built Korea's first complete aseptic production facility with an annual capacity of 315 million bottles and state-of-the-art technology from preforms to filling. Aseptic packages provide benefits of portability, food safety from bacteria, and retaining more nutrients compared to canning.
This document discusses types of closures and closure liners used for containers. It describes five basic closure designs: screw on, crimp on, press on, roll on, and friction fit. It also discusses tamperproof, child resistant, and dispenser applicator variations. Common closure materials are plastic, metal, and laminates. Closure liners are used to create a seal and come in homogeneous one-piece or heterogeneous multi-layer designs. Selection factors for closures and liners include chemical inertness, permeability, stability, and economics. Regulations require packaging materials to preserve drug quality and safety.
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.
This document discusses quality control testing for various packaging materials used in the pharmaceutical industry, including glass, plastic, paper/cardboard, rubber, metals and foils. It provides details on specific tests for each material. For example, for glass it describes light transmission testing, hydrolytic resistance testing and powdered glass testing. For plastic, it outlines leakage testing, collapsibility testing and water vapor permeability testing. The document aims to guide testing to ensure that packaging materials meet quality standards.
PACKAGING OF TABLETS: TYPES, MATERIALS AND QC.Akshay Joshi
This document provides an overview of tablet packaging types, materials, and quality control. It discusses primary packaging formats like blister packs, bottles, and strip packs. Common materials include PVC, PVDC, aluminum, glass, and plastics. Quality is ensured through testing of water vapor transmission, oxygen transmission, and blister strength. A case study examines the stability of amoxicillin/clavulanic acid tablets under different packaging conditions.
This document discusses the selection and evaluation of pharmaceutical packaging materials. It begins by defining packaging and its purposes of providing protection, identification, convenience, and compliance for products. Key factors in selecting packaging materials include the type of container, product characteristics, and characteristics of the materials themselves like barrier properties and FDA approval. Common container materials like glass, plastic, and metal are described along with their advantages. The document also discusses evaluating packaging materials through tests like leakage tests, collapsibility tests, and permeability tests to ensure suitability for drug products.
Shrink wrap is a polymer plastic film and is a cost effective way to package products so
they can stand out when displayed. This presentation explains the different types of shrink wrap films and their packaging applications.
This document discusses aseptic processing and packaging. Aseptic processing involves sterilizing products, packaging materials, and facilities to prevent contamination. It results in shelf-stable products sealed in sterile packaging without refrigeration. The process includes UHT sterilization, filling in sterile environments, and hermetically sealed packages. Hyosung built Korea's first complete aseptic production facility with an annual capacity of 315 million bottles and state-of-the-art technology from preforms to filling. Aseptic packages provide benefits of portability, food safety from bacteria, and retaining more nutrients compared to canning.
This document discusses types of closures and closure liners used for containers. It describes five basic closure designs: screw on, crimp on, press on, roll on, and friction fit. It also discusses tamperproof, child resistant, and dispenser applicator variations. Common closure materials are plastic, metal, and laminates. Closure liners are used to create a seal and come in homogeneous one-piece or heterogeneous multi-layer designs. Selection factors for closures and liners include chemical inertness, permeability, stability, and economics. Regulations require packaging materials to preserve drug quality and safety.
This document discusses different types of closures used in pharmaceutical packaging. It defines closures and their functions, which include providing an adequate seal, easy access, tamper evidence, and protecting product compatibility. The document describes threaded closures like continuous threads, lug caps, and metal roll-ons. It also discusses friction-fit closures like bottle crowns, snap fits, and vial stoppers. The document outlines different materials used like metals, glass, plastics and elastomers. It provides details on liners, child-resistant and tamper-evident closures.
Plastic as a Packaging Material discusses the advantages and disadvantages of various plastic materials used for packaging. It describes common plastics like HDPE, LDPE, LLDPE, PP, PVC, nylon and polyester. The document outlines plastic processing methods like injection molding, blow molding and thermoforming. It also discusses plastic additives, defects, and their use in pharmaceutical packaging as containers, tubes, closures and blister packs.
This document discusses various tests that are conducted on food packaging materials and packages. Some key tests mentioned include thickness testing, which measures the thickness of materials like paper and film using a dial or digital gauge under a constant pressure. Pinhole testing checks for pinholes in aluminum foil laminates, which can impact barrier properties. Peel or delamination testing measures the bond strength between layers in laminates. Seal strength testing determines the force required to separate seals in flexible pouches and laminates. Permeation tests quantify the barrier properties of plastic films to moisture vapor and gases like oxygen.
This document discusses quality control tests for various pharmaceutical packaging materials. It provides details on tests for glass containers, including chemical resistance via powdered glass and water attack tests. It also describes tests for closures, such as sterility and fragmentation testing. Further tests are outlined for packaging materials like collapsible tubes, metallic tins, strips, blisters, paper and board. The document references additional sources for information on pharmaceutical packaging and quality control testing.
This document discusses secondary and tertiary packaging. Secondary packaging protects primary packaging and the product, often being visible to consumers. Examples include boxes, crates, and shrink wrapping. It is used for branding, logistics, and protecting individual units. Common secondary packaging materials include paper, corrugated fiberboard, and cartons/boxes. Tertiary packaging protects packaged goods for shipping and storage, usually being removed before retail sale. It protects secondary and primary packaging. Examples are cardboard boxes, wood pallets, and shrink wraps. The document discusses the purposes, materials, properties, and tests for secondary and tertiary packaging.
This document provides an overview of packaging technology, including its history, key materials, purposes, benefits, and difficulties. It discusses how packaging has evolved from early uses of natural materials to modern incorporation of plastics, paper, metals, and other materials. The main purposes of packaging are outlined as physical and barrier protection, containment, information transmission, marketing, security, and convenience. While packaging provides many benefits, it also presents difficulties such as increased costs, environmental impacts, and production footprints.
This document discusses pharmaceutical packaging. It begins by defining packaging and explaining that pharmaceutical packaging provides protection for drugs, devices, blood products, and other items. It then categorizes packaging into primary, secondary, and tertiary levels. The document outlines various purposes of pharmaceutical packaging, including protecting contents from environmental and mechanical hazards, preventing loss or addition of contents, and providing identification. It also discusses important properties of packaging materials and containers, factors that influence packaging choice, and common types of containers.
Packaging is best described as a coordinated system of
preparing goods for transport, distribution, storage,
retailing, and use of the goods. Contains, Types, Procedure of manufacturing the plastics, Advantages & Disadvantages.
Glass is a preferred packaging material for pharmaceuticals due to its protective qualities. It is inert, impervious to air and moisture, and allows inspection of contents. Glass containers come in various sizes and shapes. The manufacturing process involves melting ingredients at high temperatures, shaping the molten glass, annealing to slowly cool, and finishing. There are advantages like inertness and ease of cleaning, and disadvantages like fragility and high cost. Types of glass include Types I-IV which differ in chemical composition and properties suitable for various drug formulations.
This document provides information on various tests for food packaging, including the purpose and importance of packaging testing. It discusses how testing new packaging designs can save time and money by identifying potential issues. It then classifies packaging tests into material tests and package tests, and further into chemical and mechanical tests. Several specific mechanical tests are described in detail, including GSM (grammage), thickness, pinhole testing of aluminum foil, peel bonding (delamination), seal strength, permeability, coefficient of friction, ink rub/scuff testing, and compression/burst testing of pouches. Standards for conducting each test are provided. The document serves as an educational reference on packaging testing methods.
Closures are devices used to seal containers like bottles and jars. They must provide an effective hermetic seal while preventing contents from escaping and external substances from entering. Common closure types include screw caps, crown caps, roll-on closures, and press-on caps. Closure quality is ensured through testing of materials, dimensions, extractables and leachables, bioburden, and sterilization validation. Proper closure selection and quality control ensures container integrity and product safety.
Aseptic packaging involves sterilizing products and packaging materials under sterile conditions to prevent contamination and extend shelf life without refrigeration. It allows foods to be stored at ambient temperatures for months. The key aspects are pre-sterilizing the product using techniques like UHT and sterilizing packaging materials using methods like heat, chemicals, or radiation. Filled packages are then sealed quickly to maintain sterility. Common packaging types for aseptic storage include cartons, bags, bottles and cans. Aseptic packaging provides benefits like convenience, food safety, long shelf life and nutrient retention compared to canning.
This document provides an overview of various packaging machines used in the packaging process. It describes filling machines that fill bottles or pouches, including agitator filling machines, flow filling machines, and tablet fillers. It also discusses sealing machines that securely close packages, such as food packaging machines, vacuum packaging machines, and blister packaging machines. The document further describes labeling machines that apply labels to packages and end-of-line equipment like case sealers, sleeve wrappers, case erectors, case packers, and palletizers.
This topic comes under PRODUCT DEVELOPMENT AND TECHNOLOGY TRANSFER......
This is useful for M.Pharm (Pharmaceutical Quality Assurance) Students who studying in First year sem II and also for b.pharm and medical related students.
This Presentation Contain following...
#Introduction
#Objectives
#Process Flow
#Working of aseptic process
#Sterilization of Equipments
#Sterilization of Product
#Sterilization of container or packaging materials
#Aseptic packaging of Milk
#Packaging materials
#Aseptic packaging systems
#Benefits of aseptic packaging systems
#Storage
#References
This document discusses pharmaceutical packaging materials and their evaluation. It introduces the need for packaging in protecting pharmaceutical products and providing information. The main types of primary packaging materials discussed are glass, plastics, metals, films and foils, elastomeric closures. Secondary and tertiary packaging materials are also mentioned. Various tests for evaluating the different materials are summarized such as permeability and mechanical tests.
This document provides information on various metal packaging materials used for food, including steel, aluminum, tin, and chromium coatings. It discusses the manufacturing processes for these materials, including electrolytic tinplate production, electrolytic chromium coating of steel, and aluminum alloy production. The document also covers recycling of metal packaging and manufacturing processes for cans, including the different types of cans and their material compositions.
This document provides an overview of food packaging. It begins with brief introductions of the author and their background and qualifications. It then defines packaging and outlines its main functions. The document provides a brief history of important developments in food packaging. It discusses factors driving growth of the packaging industry in India and common packaging materials like glass, metal and plastic containers. It outlines requirements and types of food packaging and considerations for effective packaging. Finally, it discusses emerging packaging technologies.
This document discusses various packaging materials and their evaluation. It covers primary, secondary and tertiary packaging. Glass, plastics, rubber and metals are described as packaging materials along with their advantages and limitations. Tests to evaluate glass, plastics and rubber are outlined including physicochemical and biological tests. Closures, labels and tamper-resistant packaging are also covered.
Packaging is the art of science & technology of enclosing or protecting products for distribution , storage, sale & use.
Packaging is the process by which the pharmaceuticals are suitably placed so that they should retain their therapeutic effectiveness from the time of their packaging till they are consumed.
This document discusses different types of closures used in pharmaceutical packaging. It defines closures and their functions, which include providing an adequate seal, easy access, tamper evidence, and protecting product compatibility. The document describes threaded closures like continuous threads, lug caps, and metal roll-ons. It also discusses friction-fit closures like bottle crowns, snap fits, and vial stoppers. The document outlines different materials used like metals, glass, plastics and elastomers. It provides details on liners, child-resistant and tamper-evident closures.
Plastic as a Packaging Material discusses the advantages and disadvantages of various plastic materials used for packaging. It describes common plastics like HDPE, LDPE, LLDPE, PP, PVC, nylon and polyester. The document outlines plastic processing methods like injection molding, blow molding and thermoforming. It also discusses plastic additives, defects, and their use in pharmaceutical packaging as containers, tubes, closures and blister packs.
This document discusses various tests that are conducted on food packaging materials and packages. Some key tests mentioned include thickness testing, which measures the thickness of materials like paper and film using a dial or digital gauge under a constant pressure. Pinhole testing checks for pinholes in aluminum foil laminates, which can impact barrier properties. Peel or delamination testing measures the bond strength between layers in laminates. Seal strength testing determines the force required to separate seals in flexible pouches and laminates. Permeation tests quantify the barrier properties of plastic films to moisture vapor and gases like oxygen.
This document discusses quality control tests for various pharmaceutical packaging materials. It provides details on tests for glass containers, including chemical resistance via powdered glass and water attack tests. It also describes tests for closures, such as sterility and fragmentation testing. Further tests are outlined for packaging materials like collapsible tubes, metallic tins, strips, blisters, paper and board. The document references additional sources for information on pharmaceutical packaging and quality control testing.
This document discusses secondary and tertiary packaging. Secondary packaging protects primary packaging and the product, often being visible to consumers. Examples include boxes, crates, and shrink wrapping. It is used for branding, logistics, and protecting individual units. Common secondary packaging materials include paper, corrugated fiberboard, and cartons/boxes. Tertiary packaging protects packaged goods for shipping and storage, usually being removed before retail sale. It protects secondary and primary packaging. Examples are cardboard boxes, wood pallets, and shrink wraps. The document discusses the purposes, materials, properties, and tests for secondary and tertiary packaging.
This document provides an overview of packaging technology, including its history, key materials, purposes, benefits, and difficulties. It discusses how packaging has evolved from early uses of natural materials to modern incorporation of plastics, paper, metals, and other materials. The main purposes of packaging are outlined as physical and barrier protection, containment, information transmission, marketing, security, and convenience. While packaging provides many benefits, it also presents difficulties such as increased costs, environmental impacts, and production footprints.
This document discusses pharmaceutical packaging. It begins by defining packaging and explaining that pharmaceutical packaging provides protection for drugs, devices, blood products, and other items. It then categorizes packaging into primary, secondary, and tertiary levels. The document outlines various purposes of pharmaceutical packaging, including protecting contents from environmental and mechanical hazards, preventing loss or addition of contents, and providing identification. It also discusses important properties of packaging materials and containers, factors that influence packaging choice, and common types of containers.
Packaging is best described as a coordinated system of
preparing goods for transport, distribution, storage,
retailing, and use of the goods. Contains, Types, Procedure of manufacturing the plastics, Advantages & Disadvantages.
Glass is a preferred packaging material for pharmaceuticals due to its protective qualities. It is inert, impervious to air and moisture, and allows inspection of contents. Glass containers come in various sizes and shapes. The manufacturing process involves melting ingredients at high temperatures, shaping the molten glass, annealing to slowly cool, and finishing. There are advantages like inertness and ease of cleaning, and disadvantages like fragility and high cost. Types of glass include Types I-IV which differ in chemical composition and properties suitable for various drug formulations.
This document provides information on various tests for food packaging, including the purpose and importance of packaging testing. It discusses how testing new packaging designs can save time and money by identifying potential issues. It then classifies packaging tests into material tests and package tests, and further into chemical and mechanical tests. Several specific mechanical tests are described in detail, including GSM (grammage), thickness, pinhole testing of aluminum foil, peel bonding (delamination), seal strength, permeability, coefficient of friction, ink rub/scuff testing, and compression/burst testing of pouches. Standards for conducting each test are provided. The document serves as an educational reference on packaging testing methods.
Closures are devices used to seal containers like bottles and jars. They must provide an effective hermetic seal while preventing contents from escaping and external substances from entering. Common closure types include screw caps, crown caps, roll-on closures, and press-on caps. Closure quality is ensured through testing of materials, dimensions, extractables and leachables, bioburden, and sterilization validation. Proper closure selection and quality control ensures container integrity and product safety.
Aseptic packaging involves sterilizing products and packaging materials under sterile conditions to prevent contamination and extend shelf life without refrigeration. It allows foods to be stored at ambient temperatures for months. The key aspects are pre-sterilizing the product using techniques like UHT and sterilizing packaging materials using methods like heat, chemicals, or radiation. Filled packages are then sealed quickly to maintain sterility. Common packaging types for aseptic storage include cartons, bags, bottles and cans. Aseptic packaging provides benefits like convenience, food safety, long shelf life and nutrient retention compared to canning.
This document provides an overview of various packaging machines used in the packaging process. It describes filling machines that fill bottles or pouches, including agitator filling machines, flow filling machines, and tablet fillers. It also discusses sealing machines that securely close packages, such as food packaging machines, vacuum packaging machines, and blister packaging machines. The document further describes labeling machines that apply labels to packages and end-of-line equipment like case sealers, sleeve wrappers, case erectors, case packers, and palletizers.
This topic comes under PRODUCT DEVELOPMENT AND TECHNOLOGY TRANSFER......
This is useful for M.Pharm (Pharmaceutical Quality Assurance) Students who studying in First year sem II and also for b.pharm and medical related students.
This Presentation Contain following...
#Introduction
#Objectives
#Process Flow
#Working of aseptic process
#Sterilization of Equipments
#Sterilization of Product
#Sterilization of container or packaging materials
#Aseptic packaging of Milk
#Packaging materials
#Aseptic packaging systems
#Benefits of aseptic packaging systems
#Storage
#References
This document discusses pharmaceutical packaging materials and their evaluation. It introduces the need for packaging in protecting pharmaceutical products and providing information. The main types of primary packaging materials discussed are glass, plastics, metals, films and foils, elastomeric closures. Secondary and tertiary packaging materials are also mentioned. Various tests for evaluating the different materials are summarized such as permeability and mechanical tests.
This document provides information on various metal packaging materials used for food, including steel, aluminum, tin, and chromium coatings. It discusses the manufacturing processes for these materials, including electrolytic tinplate production, electrolytic chromium coating of steel, and aluminum alloy production. The document also covers recycling of metal packaging and manufacturing processes for cans, including the different types of cans and their material compositions.
This document provides an overview of food packaging. It begins with brief introductions of the author and their background and qualifications. It then defines packaging and outlines its main functions. The document provides a brief history of important developments in food packaging. It discusses factors driving growth of the packaging industry in India and common packaging materials like glass, metal and plastic containers. It outlines requirements and types of food packaging and considerations for effective packaging. Finally, it discusses emerging packaging technologies.
This document discusses various packaging materials and their evaluation. It covers primary, secondary and tertiary packaging. Glass, plastics, rubber and metals are described as packaging materials along with their advantages and limitations. Tests to evaluate glass, plastics and rubber are outlined including physicochemical and biological tests. Closures, labels and tamper-resistant packaging are also covered.
Packaging is the art of science & technology of enclosing or protecting products for distribution , storage, sale & use.
Packaging is the process by which the pharmaceuticals are suitably placed so that they should retain their therapeutic effectiveness from the time of their packaging till they are consumed.
Umang pharmaceutical packaging..b.k.mody goverment pharmacy college rajkotumang971991
This document discusses various aspects of pharmaceutical packaging including primary, secondary and tertiary packaging. It describes different types of materials used for packaging like glass, plastics, metals, rubber and closures. Glass containers discussed include types I, II, III and NP glass. Common plastics used are polyethylene, polyvinyl chloride, polymethyl methacrylate and polypropylene. Factors to consider for drug-plastic compatibility and different types of closures are also summarized.
P’ceutical packaging means the combination of components necessary to contain, preserve, protect and deliver a safe, efficacious drug products. Such that at any time point before expiration date of the drug product, a safe and efficacious dosage form is available.
Pharmaceutical packaging serves several important functions including product identification, protection, facilitating use, and promotion. There are three main types of packaging: primary, secondary, and tertiary. Packaging materials must be chosen based on the required protection, compatibility with the drug product, and sterilization method. Common materials include glass, plastic, rubber, paper, and metals. Packaging is tested through various tests and must meet tamper resistance requirements.
The document discusses various types of containers used for pharmaceutical products, including glass and plastic containers. It provides details on different types of glass containers based on their composition, such as lime soda glass, borosilicate glass, and neutral glass. It also discusses plastic containers such as thermoplastics and thermosettings. The document then covers various types of injection containers, including single dose small volume containers like ampoules and cartridges, and single dose large volume containers like transfusion bottles. It also discusses the differences between single dose and multiple dose containers.
University Institute of Pharmaceutical Sciences is a flag bearer of excellence in Pharmaceutical education and research in the country.
A presentation dealing with the types of containers and closure systems used in parenteral formulation.
The presentation has been submitted by 3rd year B.pharmacy students of University Institute of Pharmaceutical sciences, Panjab University, Chandigarh. The same is based on the new PCI syllabus for pharmacy.
this presentation deals with the type of material to be used as containers and closure systems of parenterals which have to have utmost level of stability and sterility and no complication.
Thank you for reading this presentation and we hope it helped you in all the ways you were looking for.
regards,
UIPS,PU
Pharmaceutical packaging serves several important functions:
1) It identifies pharmaceutical products, protects their contents, and facilitates their safe use.
2) Common packaging materials include glass, plastics, rubber, paper, and metals.
3) Packaging must provide tamper evidence to indicate if a product has been opened or compromised. Common tamper-resistant features include film wrappers, blister packs, bottle seals, and breakable caps.
Pharmaceutical packaging serves several important functions:
1) It identifies and protects pharmaceutical products, facilitating their safe use by consumers.
2) Common packaging materials include glass, plastics, rubber, metals, and paper which are chosen based on their ability to protect contents and compatibility with dosage forms.
3) Packaging is tested to ensure it can withstand impacts and stresses of distribution while maintaining product integrity.
The document discusses pharmaceutical packaging and describes various packaging materials and closure systems used. It covers characteristics of glass and plastic containers, types of closures, tamper resistance, and quality control tests for plastic packaging. The selection of packaging begins by determining the product's needs and marketing requirements to adequately preserve integrity.
Pharmaceutical Packaging is very important chapter for Packaging of Pharmaceutical product .
In this we learn about how to pack the Pharmaceutical dosage form like tablet ,capsule , and material use for pharmaceutical dosage form
This document discusses pharmaceutical packaging. It begins by defining pharmaceutical packaging and outlining its main functions, which include protective, storage, identification, and marketing functions. It then describes different types of packaging including primary, secondary, and tertiary packaging. The main materials used for pharmaceutical packaging are discussed, including glass, plastic, metal, paper, and cardboard. Common container types and closures are also outlined. The document provides details on specific packaging materials like glass composition and plastic types. It concludes by emphasizing the importance of packaging for product protection and stability as well as its role in marketing.
The document discusses pharmaceutical packaging. It covers primary, secondary and tertiary packaging used in pharmaceuticals. Common packaging materials like glass, plastics, metals and rubbers are described. The functions and types of packaging are summarized. Tamper resistant packaging methods like film wrappers, blister packs and bottle seals are also outlined.
Pharmaceutical packaging serves several important functions: product identification, protection, promotion, and facilitating use. There are three main types of packaging - primary, secondary, and tertiary. Common materials used include glass, plastics, rubber, paper/cardboard, and metals. The choice of material depends on the level of protection needed, compatibility with dosage form, customer convenience, and cost. Glass, plastic, and metal are widely used with glass providing good protection but being fragile while plastic is flexible and resistant to breakage. Proper packaging helps ensure the safety, efficacy and quality of pharmaceutical products.
This document discusses various materials used for pharmaceutical packaging and equipment construction. It describes common container types like well-closed, single and multi-dose, light-resistant, and aerosol containers. Primary, secondary and tertiary packaging are defined. Common materials like glass, plastic, rubber, metals and paper are outlined. Specific plastics like polyethylene, PVC, and polystyrene are detailed. Closures like screw caps, crowns and friction fits are summarized. Standards for glass containers are provided.
Pharmaceutical packaging serves several important functions:
1. It protects pharmaceutical products from external factors like moisture, light, and contamination.
2. Different types of packaging materials are used including glass, plastic, metal, paper, and closures to suit various drug forms.
3. Proper packaging helps ensure the stability, safety and efficacy of drugs by providing identification, information and tamper evidence on the product.
Packaging materials must protect sterile products, be non-reactive, and provide important product information to patients. There are primary, secondary, and associated packaging components. Primary components like vials and syringes contact the product directly, while secondary components provide additional protection. Glass, plastic, and rubber are common materials, each with advantages and limitations for packaging. Proper packaging selection is critical to avoid particulate, pyrogen, and stability issues.
This document discusses various aspects of packaging for sterile dosage forms. It begins by defining packaging and describing its purposes such as protecting products and preventing contamination. It then discusses different types of primary, secondary, and tertiary packaging as well as packaging materials like glass, plastic, rubber, and metals. Key characteristics and selection criteria for packaging materials are outlined. The document also covers packaging related topics such as quality assurance, sampling, testing, and validation.
PACKAGING ABLUM ON OIL SEEDS, NUTS AND RTC PRODUCTS
- DEFINE: - PACKAGING
- NEED OF PACKAGING
- TYPES OF PACKAGING
- Packaging Material use for Oil
- Packaging Material use for RTC Food
- Packaging Material use for RTE Foods
This document provides an overview of common instrumental analytical techniques used in chromatography and spectroscopy. It describes various chromatographic techniques including thin layer chromatography, column chromatography, gas chromatography, and high performance liquid chromatography. It also outlines several spectroscopic techniques such as atomic absorption spectroscopy, colorimetry, and UV-visible spectroscopy. The document explains the basic principles, components, and applications of these analytical methods for separating and analyzing mixtures.
The document discusses Investigational New Drug Applications (INDs), which are required for clinical trials of new drugs. It outlines the key components of an IND, including an introductory statement, investigator's brochure, protocols, chemistry/manufacturing information, and previous human experience. It also describes IND amendments, annual reports, and the roles of the sponsor and investigator. The overall purpose of an IND is to provide information to the FDA on a new drug's safety before it can be tested in humans.
Fractional factorial designs (FFDs) are used to efficiently study many factors using fewer experimental runs than a full factorial design. FFDs exploit redundancy in estimating interactions to select a subset of runs. Regular FFDs have desirable properties like balance and orthogonality. Resolution indicates how interactions are aliased, with higher resolutions preferred. FFDs are useful in screening experiments to identify important factors efficiently before further optimization. Software helps select appropriate FFDs based on desired resolution and aliasing.
This document discusses herbal medicines and their use in the pharmaceutical industry. It provides information on patient use of herbal remedies, why herbal products are in demand, approaches to developing herbal formulations, standardizing herbs, guidelines for using herbs safely, and interacting with other medications. The document addresses issues like herbal products not being well-tested, lacking quality control, and having imprecise potency, while also noting two sides to herbs in terms of benefits and risks.
Herbal medicine involves the use of whole plants to promote health and treat disease, drawing on a tradition of human use for over 60,000 years. It views disease more broadly by addressing underlying causes and individual expression rather than just symptoms. Herbal medicines are prescribed to restore homeostasis and promote optimal cellular nutrition and elimination. Around 1 in 5 people in the UK regularly use herbal medicine, and it is regulated through organizations like the National Institute of Medical Herbalists. Herbal medicines are prescribed individually based on a comprehensive medical history and clinical examination.
The document discusses Investigational New Drug Applications (INDs), which are required for clinical testing of new drugs. It describes the key components of an IND including an introductory statement, investigator's brochure, protocols, chemistry and manufacturing information, and annual reports. It also defines important terms like sponsor and investigator and outlines the regulatory requirements for INDs.
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.
Good Manufacturing Practices (GMPs) establish minimum standards for methods, facilities, and controls used in manufacturing drugs to ensure they are safe, have the appropriate identity and strength, and meet quality and purity standards. GMP violations can result in severe consequences for drug manufacturers such as product seizures, recalls, shutdown of facilities, and large financial penalties. Current trends in GMPs include a risk-based approach, international harmonization of quality standards, and proposed amendments regarding validation and cross-contamination prevention.
GMP (good manufacturing practices) and cGMP (current good manufacturing practices) are quality standards for the manufacture of pharmaceutical products and medical devices. They help ensure that products are consistently produced and controlled according to quality standards for safety and efficacy. Key aspects of GMP include establishing processes and procedures for production, cleaning, maintenance, personnel training, and quality testing of products. Following GMP guidelines helps manufacturers produce pharmaceuticals that meet the necessary quality standards.
The document discusses the FDA's Inactive Ingredient Guide (IIG), which lists inactive ingredients that are present in approved drug products. It provides information on obtaining the IIG and describes the contents and purpose of the guide. The IIG is intended to help identify inactive ingredients that may require less extensive review if they are already present in approved drug products for a particular route of administration. It lists ingredients alphabetically and provides information like routes of administration, CAS numbers, number of NDAs, and potency ranges.
The document discusses Drug Master Files (DMFs), which provide confidential detailed information to the FDA in support of applications. It defines 5 types of DMFs and outlines their typical contents. These include manufacturing processes and facilities, active pharmaceutical ingredients, packaging materials, excipients, and reference information. The summary provides guidelines on submitting DMFs, required content for each type, quality controls, stability testing, and the FDA review process. Holders must adhere to good manufacturing practices and be willing to allow inspections.
This document outlines the history of drug development and approval processes in the United States from 1820 to 1997. It describes key milestones and legislation that established regulations for new drug applications (NDAs). NDAs were first required in 1938 to show drug safety, and in 1962 were amended to require proof of efficacy. The FDA now reviews NDAs to ensure the benefits of new drugs outweigh the risks based on clinical trial data.
The EMEA (European Medicines Agency) is a decentralized body of the European Union headquartered in London. It was established in 1995 and coordinates the evaluation and supervision of medicines for human and veterinary use throughout the EU. It is composed of various committees including the CHMP (Committee for Medicinal Products for Human Use) and CVMP (Committee for Medicinal Products for Veterinary Use) which are responsible for assessment and authorization of medicines. The EMEA ensures that medicines are evaluated based on quality, safety and efficacy with the goal of protecting public health.
This document discusses key considerations for dosage form design and formulation. It explains that pharmaceutical formulation involves selecting excipients to solubilize, thicken, stabilize, flavor, and otherwise modify drug substances for patient delivery. Proper dosage form design requires considering the physical and chemical properties of drug substances and ensuring compatibility with excipients. Preformulation studies characterize the drug's properties including solubility, dissolution rate, and stability. Understanding these properties helps determine the appropriate dosage form and formulation to provide stable, effective delivery of the active drug to patients.
This document defines various microbiology terms related to sterilization and disinfection. It discusses sterilization techniques like heat, filtration, and radiation. It also covers chemical disinfectants including phenols, bisphenols, biguanides, halogens, and chlorine. Physical methods like heat, filtration, refrigeration, and radiation can kill microbes. Chemical disinfectants have varying mechanisms of action, with phenols and halogens damaging cell membranes and bisphenols inhibiting fatty acid synthesis. Proper evaluation of disinfectant efficacy involves tests against standard microbes.
This document provides an overview of computer validation and compliance with regulatory guidance. It discusses the need for computer validation and outlines key principles from guidance documents such as software validation, use of off-the-shelf software in medical devices, and validation of electronic records and signatures. Validation approaches for different systems and software are covered, including spreadsheets. The document provides references to FDA and international regulatory guidance on these topics.
This document discusses designing around patents from the perspectives of both patent holders and competitors. It notes that patent holders seek broad patent protection to maximize monopoly profits and minimize successful design around efforts, while competitors aim to create non-infringing alternative products without bearing the monopoly costs of the patent. The document outlines strategies for patent holders to draft claims to make designing around more difficult and for competitors to develop design around approaches in light of legal precedents like Festo v. Shoketsu, which impacted the doctrine of equivalents.
Clinical trials are conducted in phases to evaluate the safety and efficacy of new drugs. Phase 1 trials involve 10-20 healthy volunteers to determine toxicity and pharmacokinetics. Phase 2 trials involve 100-200 patients to identify effective doses and further evaluate safety. Phase 3 trials involve up to 1000 volunteers to study less common side effects, compare to standard treatments, and evaluate long-term safety and effectiveness. Phase 4 trials monitor drugs after approval in 5000-10,000 patients to identify rare or long-term issues.
Clinical trials progress through phases (preclinical, I-IV) to evaluate treatments safely in humans. Preclinical testing occurs in labs and animals. Phase I studies evaluate safety in 20-80 healthy volunteers. Phase II expands to 100-300 patient volunteers to assess efficacy. Phase III further tests efficacy in 1,000-3,000 patients. FDA approval requires compliance with Good Clinical Practice guidelines to protect subject rights and ensure credible data. Key elements include oversight by independent review boards, informed consent, qualified investigators and sponsors, adherence to protocols, and comprehensive record keeping.
Clinical research in India is growing rapidly due to several factors:
- India has a large population with a growing disease burden similar to developed countries. This provides opportunities for clinical trial recruitment.
- Regulatory reforms have made the approval process for clinical trials much faster, within 6-8 weeks for some applications.
- Costs for conducting clinical trials are around half of Western countries, providing significant cost savings for sponsors.
- There is an increasing pool of experienced investigators and staff familiar with Good Clinical Practice who can conduct trials to international standards.
- The pharmaceutical industry and contract research organizations see India as an important location for outsourcing various stages of drug development to take advantage of the opportunities.
2. Defn :-
Art & science of enclosing protecting
products for distn, storage, sale & use.
Package label- Written, electronic or graphic
on packaging or separate but associated label
Recognition of product
Packaging drug regulations
3. Physical protection eg. Shock, vibration
Barrier protection eg. O2, light
Containment eg. 10*10 packs
Information trasmission eg. Direction
Marketing potential
Security eg. Antithept seal,
Convenience eg. Distribution, handling, sale
Portion control eg. Single dosage pack
4. Packaging material that is in intimate
contact with product
First envelopes & holds product
Smallest unit of distribution
eg. Aerosol can, wrappers, bottle, envelope
It should be inert (no leaching, absorption or
adsorption, etc.)
Should withstand mfg. condition eg. Freezing
5. Packaging material outside the primary
packaging
Perhaps used to group primary packaging
eg. Boxes, cartons, shrink-wrap, etc.
Should protect from excessive
moisture, light, reactive
gases, microbes, etc.
Protection to flexible container
Ease in handling
6. Used for bulk handling and shipping eg.
Barrel, crate, Slip sheet, etc.
7. Container: refers to storage media in which
product is placed or enclosed. Glass, Plastic
Closure: tightly packs container to exclude
O2, CO2, moisture and micro-organisms &
prevent loss of water and volatile substances
from product. Rubber, aluminum
8. Carton: Outer covering which gives sec.
protection against mech. & environmental
hazards also display written information
Cardboard, molded wood pulp, expanded polystyrene
Box: Prim. defence against ext. hazards
provide containment, absorbs shocks.
Cardboard, wood
10. Prevents contents from escaping and allow no
substance to enter the container
Resiliency of liner, flatness of sealing surface &
tightness of seal
Closure designs:
Threaded screw cap- Engage threads in corresponding
threads molded on neck of bottle
Crimp on (crown)- Used for beverage bottles
Press on(snap)- Cap pressed to seal
Roll on- Seals securely, opened
easily, specific, available as reselable, nonresealable
& pliferproof
Friction design
11. Material inserted Selection factors
in a cap to effect Compatibility
a seal between Appearance
closure &container Gas Transmission
usually made of Heat resistance
resilient backing & Shelf life
facing material Economic
(soft & elastic)
Types
Homogenous
Heterogeneous
12. Well closed Container:
Protects from extraneous solids & loss of
article under ordinary or customary
conditions of handling, shipment, storage &
distribution
Tight Container:
Protects from contamination by
extraneous material, prevents loss of by
vaporization, efflorescence, deliquescence
under ordinary or customary conditions of
handling, shipment, storage & distribution
and capable of tight re-closure.
13. Hermetic Container:
Impervious to air or any other gas under
ordinary…
Light Resistant Containers…
14. Package having indicator or barrier to entry
which if breached or missing provides
evidence of tampering.
It may involve immediate container/closure
system or Sec. container/carton system
It was introduced to avoid adulteration of
product
Eg. Film wrappers, Blister packages, Strip
Package, Bubble packs, Shrink Seal, Aerosol
container
16. Film Wrapper
End folded wrapper-
Cellophane,PVDC, nitrocellulose
Fin seal- Crimping
Shrink Seal- PE, PP, PVC
Blister Package
Heat softened sheet of thermoplastic resin &
vacuum drawing of sheet in contoured moulds-
PVC, PVC/PE, PP, polystyrene,
Push through backing- Heat seal coated Al-foil
Peelable backing-polyester or paper
17. Strip Package
Formed by feeding 2 webs of heat sealable
flexible film thr’ heated crimping roller &
product is dropped into pocket formed prior to
forming final seal.
Cellophane, PE, PVC, etc.
Shrink Banding
Heat shrinkable polymer slightly larger in
diameter than cap and neck ring of bottle
Bottle is moved thr’ a heat tunnel which shrinks
tubing material tightly to engage cap & neck
18. Aerosol
HC propellant in its cooled liquid phase added to
drawn Al-container along with product and spray
nozzle contained in gasketted metal ferrule
crimmped over opening of container
Other Temper Resistant Packagings
Bubble pack
Breakable caps
Sealed Tubes
Sealed Cartons
19. Pilferproof packaging has a closure with
greater skirt length which extends below
threaded portion to form a bank.
It has several narrow metal “bridges”
When pilferproof closure is removed bridges
break and bank remains in place on the neck
of container
User can reseal closure but detached band
indicates package has been opened
Torque required to break bridge is nominal
20.
21. To avoid cases of poisoning
Reduce risk of accidental
ingestion medication
Safety cap provided for
prescription drug, OTC
medicine, pesticide, etc.
22.
23. Supercooled liquid of viscosity greater than
1013 poise which is composed of SiO2 (65-75%)
tetrahedron modified with oxides of metal
cations
Monovalent cations- M.P. of glass but also
reduce strength eg. Na, K, B
Divalent Cations- gives mech. strength and
chem. resistance eg. CaO, MgO
Trivalent Cations- chem. durability &
mech. Strength eg. B2O3, Al2O3
24. Advantages Disadvantages
Impermeable Leaching
Inert Fragility
Transparent Flaking
Inexpensive Heavy wt.
Withstand high Light trasmission
temp-pressure
Easy to clean
No absorption of
active
25. Glass
Type Description Use
I Highly resistant For aqueous solution
borosilicate (neutral glass)
II Surface treated soda lime For Aq. Soln, dry
glass powders, oily solutions
III Sodalime glass For dry powders, oily
(Regular) solutions
IV Nonparenteral glass (NP) NP use
Flint glass- Colorless glass
Amber colored glass/Nonactinic- Iron & MnO2
Siliconized glass- avoids sticking of oily formulation
26. Powdered Glass Test (Crushed Glass Test)
Digest borosilicate flask 121C for 60 min
Crush 6 Containers Sieving 10gm powder
40/50# + 50ml high
121 C
Decant & titrate 30 min purity water
solution with 0.02N H2SO4
Indicator Methyl red
Similarly blank
Limits:
Type I = 1.0ml, Type III = 8.5ml, NP= 15.0ml
27. Water Attack Test for Type II glass
3 containers filled 90% of overflow capacity
High
Purity
Water
Autoclaving at 121 C for 30 min
100 ml of combined extract titrated with
0.02N H2SO4
Capacity 100ml or less = 0.7 ml H2SO4
Capacity over 100ml = 0.2 ml H2SO4
28. Plastics are made of polymer and additives
like plasticizer, antioxidant, antistat
agent, fillers, lubricant, etc.
Additives are not chemically bound hence
can migrate into product
Material Use
PE, PP IV infusion container
HDPE, PP, PS Disposible syringes
Polypropylene IPP) Dialysis fluid &
irrigation solution
container
29. Advantages
Light Weight, Inexpensive, Nonbreakable
Disadvantages
Leaching of plastic additives
Sorption of API
Permeation of water vapours or gas
Loss of volatile components
Softening of plastic material during autoclaving
Chemical reactivity
30. Physicochemical Tests
Aq. Extract tested for nonvoalatile
residue, residue on ignition, heavy
metals, buffering capacity
Biological Reactivity Tests
In vitro Test- Extract placed in contact with
mammalian cells to check to toxicity
In Vivo Test-
Systemic Injection Test- Mice
Intracutaneous Inj. Test- Rabbit
Implantation Test & Eye Irritaion Test- Rabbit
31. Rubber is generally used as elastomeric
closure for vial infusion bottles & cartridges
Soft & elastic nature permits needle
insertion
Resilient- Seal integrity maintained
Autoclavable
32. Composed of
Polymer (elastomer)-
Vulcanising Agent- cross linking eg.sulphur
Accelerator- reduce sulphur requirement & time
for vulcanization eg. MBT
Activator- Activity of accelerator
Filler- carbon black, talc
Antioxidant- Prevents oxidatn of elastomer
Lubricant- Mould release eg.Talc
Softner- Plasticity eg. Mineral oil
34. Advantages Disadvantages
Softness allows Permeation
needle insertion Leaching
Resilence maintains Sorption
sterility Loss of volatile
Elasticity allows component
perfect fit
35. Physico Chemical Testing
Extract of Rubber is prepared and tested for
total extractable, heavy metals, pH
change, turbidity, reducing agents
Biological Testing
In Vitro Test: on mammalian cells direect contact
test
In Vivo Test:
Systemic Injection Test- Mice
Intracutaneous Inj. Test- Rabbits
36. Apperance
Closures must be free from
dust, fibres, pigments, oily pathces, etc.
Tackiness
Closures washed several times with
detergent and autoclaved at 121C in dist.
Water for 30 min. It should not become
tacky
37. Penetrability
Closure fixed to vial and force required to
penetrate it measured. It should not exceed in
house limits.
Self Sealability
Half filled vial with methylene blue, then 25
needle punctures made in 5mm circle
diameter
Vials then inverted in water there should not
be leakage of coloured solution
38. Fragmentation
20 closures selected randomly, 5 times
needle penetrated in specific area
Needle washed with water to collect
fragments
Fragments NMT 3 per closure
Permeability to water vapours
Anhydrous CaCl2 placed in vial, kept it in
high humidity conditions, measure wt. gain
39. Metals used as packaging material for
creams, aerosols, beverages, etc.
Metals can be moulded as collapsible
tubes, beverage cans, aerosol
containers, etc.
The mechanical strength provided by metal
containers is advantageous.
Leaching of metals into products may cause
catalytic oxidation of product
Its chemical reactivity may form
pharmacologically inert, less active or toxic
cpmpounds
40. Material Use
Tin Foods, pharmaceuticals,
Aerosol
Aluminium Collapsible tubes, foil packing,
Aerosol
Lead Non food products like inks
paints, lubricants
Stainless Aerosol containers
steel
41. Gen. Properties Disadvantages
Strong(Nonbrekabl) Leaching (Attcked
Opaque by acids & alkalis)
Mouldable to any Sorption
shape Corrosion
Withstand high
temp-pressure
Impermeable to
moisture, microbes,
gases, light, etc.