The document discusses packaging of parenterals. It defines packaging and describes the importance of packaging in protecting pharmaceutical products and maintaining quality. The ideal package should protect the contents from environmental, mechanical and other hazards, and not interact with or alter the contents. Primary packaging directly contains the product while secondary and tertiary packaging provide additional layers of protection. Common packaging materials include glass, plastic, metal and rubber. The document outlines the types and qualities of primary and secondary packaging as well as various closures used.
The document discusses labeling requirements and packaging for ophthalmic preparations. It states that labels must include the name of the drug, dosage, manufacturer, and expiration date. Labels can be printed directly on containers or applied separately. Eye drop packaging comes in glass bottles with droppers or plastic bottles with integrated droppers. Plastic is now more common. Packaging must be sterile and can be single-dose without preservatives or multi-dose which requires preservatives to maintain sterility between uses.
The document discusses the manufacturing process of parenteral preparations. It describes parenterals as sterile liquids or solids for injection or implantation. The manufacturing process involves planning, material management, production, quality control testing, filling, and packaging. Production areas are divided into strict zones based on cleanliness. Environmental controls and facility design aim to prevent contamination, with areas for filling, weighing, storage, and administration. Personnel flow and utility locations are also considered for efficiency.
Capsules are solid dosage forms that enclose one or more active ingredients within a soluble shell, typically made of gelatin. There are two main types: hard-shelled capsules containing dry powders, and soft-shelled capsules used for oils. Capsules are manufactured through a process involving dipping pins in gelatin solutions to form the shells, drying, stripping from the pins, trimming, joining the cap and body portions, and polishing. Various sizes of empty capsules are commercially available. Capsules offer benefits like ease of swallowing and unit dosing but require specialized filling equipment for industrial production.
The document discusses the requirements and layout for producing sterile parenterals. It describes the different sections needed - cleanup, compounding, aseptic, quarantine, and packing/labeling. Specific requirements for the aseptic area are outlined, including environmental controls like particle counting, slit to agar sampling, and Rodac plates to evaluate air quality. Floors, walls, and benches must be smooth, impervious, and easy to clean. Proper ventilation and filtration of air is essential to maintain sterility. Sources of contamination and prevention methods are also covered.
Containers are in intimate contact with the product. No container presently available is totally non reactive, particularly with aqueous solutions . Both the chemical and physical characteristics are given primary consideration in the selection of a protective container . Glass containers traditionally have been used for sterile products , many of which are closed with rubber stoppers. Interest in plastic containers for parenterals is increasing and such containers are being used for commercial ophthalmic preparations and IV solutions.
This document discusses the design and formulation of capsules. It begins by defining capsules and describing their history. There are two main types of capsules: hard gelatin capsules and soft gelatin capsules. Hard gelatin capsules have two pieces and typically contain powders, granules or pellets, while soft gelatin capsules are one piece and sealed and can contain liquids or suspensions. The document goes on to cover the advantages and disadvantages of capsules, as well as the formulation of the gelatin shell and capsule contents for both hard and soft gelatin capsules. Key components include gelatin, plasticizers, colorants, fillers and various other excipients.
This document provides an overview of parenterals (injectable drugs), including:
- Definitions and routes of administration for parenterals
- General requirements like vehicles, additives, and ensuring isotonicity
- Methods for sterilization, formulation, packaging, and quality control testing of parenterals
- Considerations for facilities and production areas to ensure sterility during manufacturing
It discusses key aspects of developing parenteral drugs like pre-formulation studies, adjustment of tonicity, and precautions for aseptic work. Common sterilization techniques and packaging materials are outlined. Quality control tests evaluated include leakage, clarity, sterility, and pyrogen testing. Overall, the document serves as an introduction
The document discusses packaging of parenterals. It defines packaging and describes the importance of packaging in protecting pharmaceutical products and maintaining quality. The ideal package should protect the contents from environmental, mechanical and other hazards, and not interact with or alter the contents. Primary packaging directly contains the product while secondary and tertiary packaging provide additional layers of protection. Common packaging materials include glass, plastic, metal and rubber. The document outlines the types and qualities of primary and secondary packaging as well as various closures used.
The document discusses labeling requirements and packaging for ophthalmic preparations. It states that labels must include the name of the drug, dosage, manufacturer, and expiration date. Labels can be printed directly on containers or applied separately. Eye drop packaging comes in glass bottles with droppers or plastic bottles with integrated droppers. Plastic is now more common. Packaging must be sterile and can be single-dose without preservatives or multi-dose which requires preservatives to maintain sterility between uses.
The document discusses the manufacturing process of parenteral preparations. It describes parenterals as sterile liquids or solids for injection or implantation. The manufacturing process involves planning, material management, production, quality control testing, filling, and packaging. Production areas are divided into strict zones based on cleanliness. Environmental controls and facility design aim to prevent contamination, with areas for filling, weighing, storage, and administration. Personnel flow and utility locations are also considered for efficiency.
Capsules are solid dosage forms that enclose one or more active ingredients within a soluble shell, typically made of gelatin. There are two main types: hard-shelled capsules containing dry powders, and soft-shelled capsules used for oils. Capsules are manufactured through a process involving dipping pins in gelatin solutions to form the shells, drying, stripping from the pins, trimming, joining the cap and body portions, and polishing. Various sizes of empty capsules are commercially available. Capsules offer benefits like ease of swallowing and unit dosing but require specialized filling equipment for industrial production.
The document discusses the requirements and layout for producing sterile parenterals. It describes the different sections needed - cleanup, compounding, aseptic, quarantine, and packing/labeling. Specific requirements for the aseptic area are outlined, including environmental controls like particle counting, slit to agar sampling, and Rodac plates to evaluate air quality. Floors, walls, and benches must be smooth, impervious, and easy to clean. Proper ventilation and filtration of air is essential to maintain sterility. Sources of contamination and prevention methods are also covered.
Containers are in intimate contact with the product. No container presently available is totally non reactive, particularly with aqueous solutions . Both the chemical and physical characteristics are given primary consideration in the selection of a protective container . Glass containers traditionally have been used for sterile products , many of which are closed with rubber stoppers. Interest in plastic containers for parenterals is increasing and such containers are being used for commercial ophthalmic preparations and IV solutions.
This document discusses the design and formulation of capsules. It begins by defining capsules and describing their history. There are two main types of capsules: hard gelatin capsules and soft gelatin capsules. Hard gelatin capsules have two pieces and typically contain powders, granules or pellets, while soft gelatin capsules are one piece and sealed and can contain liquids or suspensions. The document goes on to cover the advantages and disadvantages of capsules, as well as the formulation of the gelatin shell and capsule contents for both hard and soft gelatin capsules. Key components include gelatin, plasticizers, colorants, fillers and various other excipients.
This document provides an overview of parenterals (injectable drugs), including:
- Definitions and routes of administration for parenterals
- General requirements like vehicles, additives, and ensuring isotonicity
- Methods for sterilization, formulation, packaging, and quality control testing of parenterals
- Considerations for facilities and production areas to ensure sterility during manufacturing
It discusses key aspects of developing parenteral drugs like pre-formulation studies, adjustment of tonicity, and precautions for aseptic work. Common sterilization techniques and packaging materials are outlined. Quality control tests evaluated include leakage, clarity, sterility, and pyrogen testing. Overall, the document serves as an introduction
Pharmaceutical Packaging tablet and capsulesGirish Sahu
This document discusses packaging of tablets, capsules, and powders. It defines packaging and describes the roles and types of packaging. The key types discussed are blister packages, strip packages, aluminum foil packaging, and bottle packaging. It also covers materials used for different types of packaging, emphasizing properties like barrier effectiveness. The document provides details on formation of blister and strip packages and evaluates packaging for leakage. It discusses use of desiccants and packaging of powders in pouches and bottles.
Legal and official requirement of container, packaging Dheeraj Saini
Here we discuss, the following subject topics
1. Official and legal requirements of container
2. Types of packing
3. Material used in packing or container
4. Label
5. Labelling techniques
Pharmaceutical aerosols have been playing a crucial role in the health and wellbeing of millions of people throughout the world for many years. These products include pressurized metered dose inhalers (MDIs), dry powder inhalers (DPIs), nebulizers, sublingual’s, skin sprays (coolants, anaesthetics, etc.) and dental sprays. The technology’s continual advancement, the ease of use, and the more desirable pulmonary-rather-than-needle delivery for systemic drugs has increased the attraction for the pharmaceutical aerosol in recent years.
Many of the tests required for the evaluation of MDIs are similar to those used for other dosage forms. These include description, identification, and assay of the active ingredient; microbial limits; moisture content; net weight, degradation products and impurities (if any); extractable; and any other tests deemed appropriate for the active ingredient.
This document defines and discusses parenteral preparations and administration. Parenteral preparations are sterile preparations intended for administration by injection, infusion, or implantation rather than orally. They must be sterile, pyrogen-free, and packaged to ensure sterility. Common routes of parenteral administration include intravenous, intramuscular, subcutaneous, and intradermal injection. Requirements for parenteral preparations include sterility, freedom from pyrogens and particulates, isotonicity, stability, and compatibility.
Pharmaceutical aerosols can be filled using either a cold-fill or pressure-fill process depending on the nature of the product concentrate and propellant. The cold-fill process involves cooling the concentrate and propellant below their boiling points to liquefy them before filling the chilled container. The pressure-fill process places the concentrate in the container before forcing the hydrocarbon propellant in under pressure. Both processes involve sealing the valve and checking for leaks by heating the filled container in a water bath.
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.
This document discusses different types of solid drug forms including tablets, capsules, granules, powders, and pellets. Pellets are small, sterile tablets used for prolonged drug release and come in sizes between 0.5-1.5mm. Pellets can be manufactured using various methods including layering powders or liquids onto seed cores, spray drying, compaction processes like extrusion-spheronization, and globulation techniques. New production methods include hot melt extrusion and cryopelletization.
This document discusses parenteral suspensions and emulsions. It covers formulation considerations like choice of excipients, manufacturing methods, and evaluation. Suspensions require stabilization to prevent settling and caking. Emulsions are oil-water or water-oil dispersions used for total parenteral nutrition. Both require sterilization and maintenance of physical and chemical stability over shelf life.
Packaging material for various formulationsshindemk89
This document discusses various packaging materials used for solid, liquid, sterile, and transdermal drug delivery systems. It describes common packaging materials like glass bottles, plastic bottles, blister packs, strip packs, pouches, syringes, and aerosol containers. It provides details on the composition of different layers of various packaging like materials used for blister foils, semi-permeable membranes in transdermal patches, and layers in pouching composites. It also lists some common tests conducted on different drug packaging to check properties like leakage, permeability, and toxicity.
This document provides an overview of the formulation and development of parenteral products. It discusses the key components including containers, closures, processing, formulation, production facilities, and evaluation methods. The production area is divided into five sections - cleanup, preparation, aseptic, quarantine, and finishing/packaging areas. Parenteral formulations contain active drugs, vehicles, and adjuvants. Finished products undergo sterility, clarity, leakage, pyrogen, and assay testing to ensure quality control.
After the manufacturing of the drug, it is essential that these should be stored properly. The stability of drug during it’s storage depend on so many factor and proper packaging is one of them. The pharmaceutical products are in direct contact with the container and closures. So improper packaging and poor quality of container may lead to deterioration of the product.
The document discusses parenteral dosage forms. Parenterals are sterile solutions or suspensions of drugs administered directly into veins, muscles, or under the skin. They do not utilize the alimentary canal and must meet general requirements including stability, sterility, isotonicity, and being free of pyrogens, toxins, and foreign particles. Evaluation tests for parenterals include sterility, pyrogen, clarity, and leakage tests.
The document discusses parenterals, which are sterile preparations intended for administration through layers of skin or mucous membranes. It defines parenterals and outlines their advantages like 100% bioavailability and ability to administer to unconscious patients. The document also discusses the various routes of parenteral administration, types of parenterals like powders, solutions, and emulsions. It describes the formulation, layout, and quality control testing of parenterals. Specifically, it provides details on the areas involved in parenteral production, types of small and large volume parenterals, and common quality tests like leaker, clarity, pyrogenic, sterility, and content uniformity testing.
plastic and glass containers and its evaluation test, drug plastic considera...SUJIT DAS
This document discusses quality control tests that must be conducted on plastic containers used for pharmaceutical products. It outlines specific tests for non-parenteral and parenteral preparations, including leakage tests, clarity of extracts, and limits for substances like barium, heavy metals, and tin. It also discusses considerations for using plastic versus glass containers, noting potential issues like permeation of gases/liquids, leaching of substances from the plastic, and chemical reactions between drugs and container materials.
The document discusses various quality control tests that are performed on tablets during manufacturing, including tests for general appearance, hardness, friability, weight variation, content uniformity, disintegration and dissolution. It provides details on procedures and limits for these tests according to pharmacopoeial standards like the British Pharmacopoeia, Indian Pharmacopoeia and United States Pharmacopoeia. The tests are important to ensure tablets meet requirements for reproducibility, stability and accurate dosing of the active drug.
Tablets are solid oral dosage forms made by compressing powders containing active pharmaceutical ingredients and excipients. Tablets offer advantages like precise dosing, low cost, stability, and ease of production and administration. Tablet production involves blending powders, granulation to improve flow and compression properties, lubrication, and compression using tablet presses to form the final tablets. Tablet properties, types, ingredients, manufacturing processes, and equipment are described in detail in the document.
A detailed study on tablets, its classification, excipients, tablet granulation, methods of granulation, compression machines, equipment tooling and the problems that occur during the tablet manufacturing process. This presentation is based on the PCI syllabus for bpharm students of fifth semester.
This document discusses pharmaceutical packaging. It defines pharmaceutical packaging and describes the primary and secondary/tertiary packaging systems. The key requirements for pharmaceutical packaging are to protect the product, be non-reactive, prevent contamination, and be FDA approved. Important criteria for selecting packaging materials include stability, compatibility with contents, strength, moisture protection, and cost. Common packaging materials include glass, plastic, metal, paper, rubber, and closures. Guidelines for quality control of packaging materials require containers and closures to meet pharmacopeial standards and be properly washed and sterilized.
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.
Pharmaceutical Packaging tablet and capsulesGirish Sahu
This document discusses packaging of tablets, capsules, and powders. It defines packaging and describes the roles and types of packaging. The key types discussed are blister packages, strip packages, aluminum foil packaging, and bottle packaging. It also covers materials used for different types of packaging, emphasizing properties like barrier effectiveness. The document provides details on formation of blister and strip packages and evaluates packaging for leakage. It discusses use of desiccants and packaging of powders in pouches and bottles.
Legal and official requirement of container, packaging Dheeraj Saini
Here we discuss, the following subject topics
1. Official and legal requirements of container
2. Types of packing
3. Material used in packing or container
4. Label
5. Labelling techniques
Pharmaceutical aerosols have been playing a crucial role in the health and wellbeing of millions of people throughout the world for many years. These products include pressurized metered dose inhalers (MDIs), dry powder inhalers (DPIs), nebulizers, sublingual’s, skin sprays (coolants, anaesthetics, etc.) and dental sprays. The technology’s continual advancement, the ease of use, and the more desirable pulmonary-rather-than-needle delivery for systemic drugs has increased the attraction for the pharmaceutical aerosol in recent years.
Many of the tests required for the evaluation of MDIs are similar to those used for other dosage forms. These include description, identification, and assay of the active ingredient; microbial limits; moisture content; net weight, degradation products and impurities (if any); extractable; and any other tests deemed appropriate for the active ingredient.
This document defines and discusses parenteral preparations and administration. Parenteral preparations are sterile preparations intended for administration by injection, infusion, or implantation rather than orally. They must be sterile, pyrogen-free, and packaged to ensure sterility. Common routes of parenteral administration include intravenous, intramuscular, subcutaneous, and intradermal injection. Requirements for parenteral preparations include sterility, freedom from pyrogens and particulates, isotonicity, stability, and compatibility.
Pharmaceutical aerosols can be filled using either a cold-fill or pressure-fill process depending on the nature of the product concentrate and propellant. The cold-fill process involves cooling the concentrate and propellant below their boiling points to liquefy them before filling the chilled container. The pressure-fill process places the concentrate in the container before forcing the hydrocarbon propellant in under pressure. Both processes involve sealing the valve and checking for leaks by heating the filled container in a water bath.
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.
This document discusses different types of solid drug forms including tablets, capsules, granules, powders, and pellets. Pellets are small, sterile tablets used for prolonged drug release and come in sizes between 0.5-1.5mm. Pellets can be manufactured using various methods including layering powders or liquids onto seed cores, spray drying, compaction processes like extrusion-spheronization, and globulation techniques. New production methods include hot melt extrusion and cryopelletization.
This document discusses parenteral suspensions and emulsions. It covers formulation considerations like choice of excipients, manufacturing methods, and evaluation. Suspensions require stabilization to prevent settling and caking. Emulsions are oil-water or water-oil dispersions used for total parenteral nutrition. Both require sterilization and maintenance of physical and chemical stability over shelf life.
Packaging material for various formulationsshindemk89
This document discusses various packaging materials used for solid, liquid, sterile, and transdermal drug delivery systems. It describes common packaging materials like glass bottles, plastic bottles, blister packs, strip packs, pouches, syringes, and aerosol containers. It provides details on the composition of different layers of various packaging like materials used for blister foils, semi-permeable membranes in transdermal patches, and layers in pouching composites. It also lists some common tests conducted on different drug packaging to check properties like leakage, permeability, and toxicity.
This document provides an overview of the formulation and development of parenteral products. It discusses the key components including containers, closures, processing, formulation, production facilities, and evaluation methods. The production area is divided into five sections - cleanup, preparation, aseptic, quarantine, and finishing/packaging areas. Parenteral formulations contain active drugs, vehicles, and adjuvants. Finished products undergo sterility, clarity, leakage, pyrogen, and assay testing to ensure quality control.
After the manufacturing of the drug, it is essential that these should be stored properly. The stability of drug during it’s storage depend on so many factor and proper packaging is one of them. The pharmaceutical products are in direct contact with the container and closures. So improper packaging and poor quality of container may lead to deterioration of the product.
The document discusses parenteral dosage forms. Parenterals are sterile solutions or suspensions of drugs administered directly into veins, muscles, or under the skin. They do not utilize the alimentary canal and must meet general requirements including stability, sterility, isotonicity, and being free of pyrogens, toxins, and foreign particles. Evaluation tests for parenterals include sterility, pyrogen, clarity, and leakage tests.
The document discusses parenterals, which are sterile preparations intended for administration through layers of skin or mucous membranes. It defines parenterals and outlines their advantages like 100% bioavailability and ability to administer to unconscious patients. The document also discusses the various routes of parenteral administration, types of parenterals like powders, solutions, and emulsions. It describes the formulation, layout, and quality control testing of parenterals. Specifically, it provides details on the areas involved in parenteral production, types of small and large volume parenterals, and common quality tests like leaker, clarity, pyrogenic, sterility, and content uniformity testing.
plastic and glass containers and its evaluation test, drug plastic considera...SUJIT DAS
This document discusses quality control tests that must be conducted on plastic containers used for pharmaceutical products. It outlines specific tests for non-parenteral and parenteral preparations, including leakage tests, clarity of extracts, and limits for substances like barium, heavy metals, and tin. It also discusses considerations for using plastic versus glass containers, noting potential issues like permeation of gases/liquids, leaching of substances from the plastic, and chemical reactions between drugs and container materials.
The document discusses various quality control tests that are performed on tablets during manufacturing, including tests for general appearance, hardness, friability, weight variation, content uniformity, disintegration and dissolution. It provides details on procedures and limits for these tests according to pharmacopoeial standards like the British Pharmacopoeia, Indian Pharmacopoeia and United States Pharmacopoeia. The tests are important to ensure tablets meet requirements for reproducibility, stability and accurate dosing of the active drug.
Tablets are solid oral dosage forms made by compressing powders containing active pharmaceutical ingredients and excipients. Tablets offer advantages like precise dosing, low cost, stability, and ease of production and administration. Tablet production involves blending powders, granulation to improve flow and compression properties, lubrication, and compression using tablet presses to form the final tablets. Tablet properties, types, ingredients, manufacturing processes, and equipment are described in detail in the document.
A detailed study on tablets, its classification, excipients, tablet granulation, methods of granulation, compression machines, equipment tooling and the problems that occur during the tablet manufacturing process. This presentation is based on the PCI syllabus for bpharm students of fifth semester.
This document discusses pharmaceutical packaging. It defines pharmaceutical packaging and describes the primary and secondary/tertiary packaging systems. The key requirements for pharmaceutical packaging are to protect the product, be non-reactive, prevent contamination, and be FDA approved. Important criteria for selecting packaging materials include stability, compatibility with contents, strength, moisture protection, and cost. Common packaging materials include glass, plastic, metal, paper, rubber, and closures. Guidelines for quality control of packaging materials require containers and closures to meet pharmacopeial standards and be properly washed and sterilized.
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 pharmaceutical packaging. It begins by defining packaging and its purposes. It then discusses factors to consider when selecting packaging materials, desirable characteristics of materials, and barrier properties needed. The document outlines the primary uses of packaging and different types of packaging including primary, secondary and tertiary. It provides details on common packaging materials like glass, metals, plastics, rubbers and fibrous materials. For each material, it discusses advantages and disadvantages as well as examples of applications in pharmaceutical packaging.
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.
Pharmaceutical Packaging Material-Glassmonika maan
Pharmaceutical Packaging Material-Glass. It describes primary packaging, secondary packaging . Benefits of glass and its limitation in medicines or drugs while packaging. also discussed the problem related to glass material as pharmaceutical packaging.
This document discusses pharmaceutical packaging technology. It defines pharmaceutical packaging and outlines ideal packaging requirements. The key functions of packaging are then described, including product identification, protection, facilitating use, promotion, marketing, convenience, barrier protection and security. Various packaging materials are also discussed, including glass, metals, rubbers, plastics, fibrous materials and films. Specific plastic materials like polyethylene, polypropylene, polyvinyl chloride and polyvinylidene chloride are explained in terms of their properties and uses in pharmaceutical packaging.
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.
This document discusses pharmaceutical packaging. It begins by defining pharmaceutical packaging and describing its ideal requirements, such as protecting products from environmental conditions while not reacting with or imparting tastes/odors to the product. It then discusses the functions of packaging including product identification, protection, promotion, and convenience. Next, it covers selection of packaging materials and types of packaging materials including glass, plastics, metals and others. It concludes by describing some common plastic materials used in pharmaceutical packaging like polyethylene, polyvinyl chloride, and polystyrene.
This document discusses pharmaceutical packaging technology. It begins by defining pharmaceutical packaging and its purposes, which include protection, identification, containment, and stability of products. It outlines ideal packaging requirements and the functions of packaging. Next, it describes the selection of packaging materials, hazards packages may encounter, and types of packaging including primary, secondary and tertiary. Common packaging materials like glass, metals, plastics and their properties are explained. The document concludes by discussing tests for glass and some examples of commonly used plastic materials for pharmaceutical packaging.
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.
SELECTION AND EVALUATION OF PHARMACEUTICAL PACKAGING TECHNIQUE.pdfShankar Maind Patil
This document discusses the selection and evaluation of pharmaceutical packaging techniques. It begins with an introduction and then discusses the characteristics, roles, selection criteria, and ideal requirements of packaging materials. The main types of packaging materials discussed are glass, metal, plastic, and rubber. Specific packaging applications and the tests used to evaluate different packaging materials are also summarized. The key points covered include characteristics of ideal packaging materials, factors that influence packaging selection, common packaging types and the tests used to establish their suitability.
This document discusses pharmaceutical packing and packaging materials. It defines primary, secondary, and tertiary pharmaceutical packaging. Primary packaging has direct contact with the product and provides the first layer of protection. Secondary packaging protects primary packaging and displays product information. Tertiary packaging protects primary and secondary packaging during storage and transportation. Common primary packaging includes blister packs, vials, ampoules, and tubes. The document also discusses ideal qualities for pharmaceutical packaging materials and provides details on common materials like glass, plastic, paper, metal and their advantages and disadvantages for pharmaceutical use.
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.
This document provides an overview of pharmaceutical packaging. It discusses the functions of packaging including protection, storage, identification and information provision. It describes common packaging materials like glass, plastic, metal and rubber and how they are used. Different dosage forms like solids, liquids, and parenterals are outlined along with their typical packaging. Recent trends in the industry toward devices like prefilled syringes and regulations from the FDA are also summarized.
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.
The document discusses pharmaceutical packaging and describes the key functions and characteristics of packaging materials. It outlines that pharmaceutical packaging must protect the product, not react with or impart tastes/odors to it, be nontoxic, FDA approved, and meet tamper resistance requirements. It then provides details on common packaging materials like glass, plastics, metals, and closures. The materials must not leach or allow penetration of environmental factors that could compromise the drug.
Similar to LABELING AND PACKING OF PARENTRAL PREPARATIONS (20)
fetal movements of the baby is the best sign to acess the health condition of the fetes,During your pregnancy, feeling your baby move gives you reassurance of his or her well being.
If you notice your baby is moving less than usual or if you have noticed a change in the pattern of movements, it may be the first sign that your baby is unwell and therefore it is essential that you contact your midwife or local maternity unit immediately so that your baby’s wellbeing can be assessed.
evidence based practice is a important tool in clinical practice.everything we do in our life can also correlated to evidence based practice. PICO is used to frame a answerable question
hospital formulary is developed under the guidance of pharmacy and therapeutic commitee of the hospital.pharmacist working in a hospital should play an important role in the preparation of the hospital formulary
cluster headaches are also called as
Familial cluster headaches
Histamine cephalalgia
Vasogenic facial pain
Horton’s Syndrome
Cluster headache (CH) is a neurological disorder characterized by recurrent, severe headaches on one side of the head, typically around the eye.
A cluster headache commonly awakens paitent in the middle of the night with intense pain in or around one eye on one side of head.Cluster headache often accompanied with eye watering, nasal congestion, or swelling around the eye, on the affected side. These symptoms typically last 15 minutes to 3 hours.
The starting date and the duration of each cluster period might be consistent from period to period. For example, cluster periods can occur seasonally, such as every spring or every fall.
Most people have episodic cluster headaches. In episodic cluster headaches, the headaches occur for one week to a year, followed by a pain-free remission period that can last as long as 12 months before another cluster headache develops
Amyloidosis is the term used for a group of diseases characterized by extracellular deposition of insoluble protienaceous substance called “Amyloid”.Amyloidosis was first described by Rokintansy in 1842.
Virchow named it as amyloid under the mistaken belief that the material was starch like.
The medical term for tumor (or) cancer is Neoplasm, Which means a relatively autonomous growth (or) un corodinated cell proliferation of body tissue.The branch of medicine which deals with the excessive study of neoplasm (tumor) and its development diagnosis and treatment is called “Oncology.”
The term cancer was translated from a Latin word carcino i.e. Crab by celsus.
For the first time Hippocrates coined the Greek word Karkinos i.e. (crab/cray fish) for malignant breast cancer
Agents used to treat such abnormal cell productions are known as anti neoplastic agents.they are 1.Alkylating agents:-
Nitrogen mustards
Cyclophosphamide
Meclorethamine
2.Antimetabolites:-
purine antagonist:-6-mercaptopurine
Folic acid antagonist:-methotrexate
Pyrimidine antagonist:-5-flurouracil
3.Plant products:-
Vinca alkaloids
Vincrystine
vinblastine
4.Anti biotics:-
Doxorubicin
Actinomycin
5.Hormonal agents:
Tamoxifen
Glucocorticosteroids
6.Miscellaneous:-
Hydroxy urea
Asparginase
Public education campaigns are important in highlighting the dangers of smoking, because possibly as many as 30% of cancers are caused by smoking, excessive drinking, and hazardous solvents, as well as promoting healthy diets and lifestyles.
30% of cancers are diet related that’s why everybody should take healthy diets and lifestyles.
The benefits of eating high-fibre foods, fruit, and vegetables are clear.
Infact, there have been various research projects aimed at identifying the specific chemicals in these foods which are responsible for this protective property.
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2. CONTENTS
Labeling
labeling requirements for parental
recommendations for label design
materials used for labeling
Packing
types of packing
packing materials
containers and closures
2
3. LABELING
The term labeling designates all labels and other written, printed or graphic
matter on or in any package or wrapper in which it is enclosed.
The rules of the labelling made under the drugs and cosmetic act 1940.
No person cannot distribute (or)sell the any drug with out labelling
including patent (or)proprietary medicine.
Label states the name of the preparation, percentage content of drug of a
liquid preparation, the amount of active ingredient of a dry preparation, the
route of administration, a statement of storage conditions and expiry date.
also label must indicate the name of manufacturer or distributors and carry
an identifying lot numbers
FIG-2 3FIG-1
4. NAME OF THE PRODUCTname(s) and amount of the
active ingredient
NDC number
warning
Storage information
Batch information
Expiry
information
ROA
Manufacturer
information
Distrubuter
information
Logo information
Directionsforuse
Product
strength
Bar coding of product
4
5. RECOMMENDATIONS FOR PARENTAL LABEL DESIGN
ISSUE:Similar names can be easily mistaken for
each otherRECOMMENDATION: Highlight the
differences between the generic drug names.
Issues
• When the medicine name is
printed horizontally around the
vial or ampoule, similar names
can be more easily confused
with one another.
Issue Different representations ofconcentration can create confusion. Recommendations
Display concentration in total quantity/total volume, even if otherunits of concentration such
as percentage and ratios are also present.
Recommendation:
Print the medicine
name longitudinally,
along the length of the
ampoule.
5
FIG-3
FIG-4
FIG-5
6. MATERIALS USED IN LABELLING
The following types of labels are. Such as
Paper
Foil
Fabric
6
FIG -6 PAPER FIG -7 FOIL
FIG -8 FABRIC
7. PACKING
• Packing is a process that a bulk material must undergo to
become a finished product.
• packaging preserves the stability and quality of medicinal
products and protects them against all forms of spoilage and
tampering which ensure product safety through the
intended shelf life for the parentrals.
7
FIG -9
8. TYPES OF PACKING
PRIMARY PACKING:
primary packaging components are in direct
physical contact with the product(e.g.
bottles, vials, closures, blisters)
SECONDARY PACKING:
Secondary packing is not in
direct contact with the
product (e.g. aluminum
caps, cardboard boxes).
8
9. TYPES OF PACKING MATERIALS
GLASS:
Glass is one of the old and cheapest materials using for the packing of
various types of pharmaceutical formulations, especially for the
parenteral formulations.
Advantages DISADVANTAGES
Excellent barrier properties
High chemical resistance
High transparency
light protection with amber
glass
Reputation as high-grade
material
•Danger of breakage
•Part of free alkali oxide
•Traces of heavy metal
•costly manufacturing
9
10. TYPES OF PACKING MATERIALS
Classification of Glass:
The classes are based on the degree of chemical or hydrolytic resistance of
these glasses to water attack.
Type-I Highly resistant borosilicate glass: These can be used for
parenteral purpose.
Type-II Treated soda lime glass: These are also used parenteral liquids
as well as powders.
Type-III Soda lime glass: This type can also used for packing of
parenteral products.
Type-IV General purpose soda-lime glass: These are not used in
parenteral products packing.
10
FIG -10
11. TYPES OF PACKING MATERIALS
PLASTIC:
• Plastic containers are meant for using to packing of various types of sterile
dosage forms
• Plastic containers are made up with thermoplastic polymers of high
molecular weight.
The commonly useful polymers in parenteral packaging are
Polpropylene
Poly ethylene and poly ethylene teraphtalate
Poly vinyl chloride
ADVANTAGE DIS ADVANTAGE
Simple and
clean manufacturing process
Blow-Fill-Seal
Break resistant
Design flexibility
very strict dimensional
Cheap
•Low temperature resistance
•Minor transparency with some
polymers
•Barrier properties inferior to glass
•Interaction of material/additives
•Moulds necessary
11
12. TYPES OF PACKING MATERIALS
Rubber : The rubber closures are used to seal the openings
of cartridges, vials and bottles, providing a material soft and elastic
enough to permit entry and withdrawal of a hypodermic needle
without loss of integrity of the sealed container.
Aluminum: The material mainly used for seal the vials.
Paper: The paper cart boards are mainly used for final packing of
parenteral products. This packing is known as secondary packing.
12
FIG -11
FIG -12
FIG -13
13. CONTAINERS
Parenteral preparations are usually supplied in
• Glass ampoules
• Bottles
• Vials
• Plastic bottles or bags
• Prefilled syringes
13
FIG -13
FIG -14
FIG -15
14. CONTAINERS
• protect the contents from extraneous
matter or from loss of the substance
under normal conditions of handling
Well closed containers
• must protect the contents from extraneous
matter, from loss of the substance
Tightly closed
containers
• must protect the contents from extraneous
matter and from liquids, gasesHermetic containers
Containers used for packing parental are classified as
14
15. CLOSURES:
Closures for parenteral preparation containers are equipped with a
firm seal to prevent entry of microorganisms and other contaminants
while permitting the withdrawal of a part or the whole of the contents
without removal of the closure.
The closure, composed of
Plastic materials
Elastomers closures
FIG -17
15
FIG -16
16. CONCLUSION
It is vital for any pharma product that it remains in its original form and
maintains its quality until it reaches the hands of end users
The products manufactured to resolve health issues would be of no use
if they are not packed and labeled properly
16