1. The document discusses parenteral plant layout and blow-fill-seal (BFS) and form-fill-seal (FFS) technology for sterile product formulation.
2. BFS and FFS are automated techniques that form, fill, and seal sterile containers in a closed system to reduce contamination risk compared to manual methods.
3. The basic BFS/FFS process involves extruding a tube of plastic, molding it into a container within a mold, filling the container, sealing it, and then ejecting the finished product. This is done within a sterile environment to produce products like vials and ophthalmic solutions aseptically.
The document discusses the blow-fill-seal (BFS) technology used to aseptically produce sterile pharmaceutical products. It describes the BFS process which combines plastic container formation via blow/vacuum molding with aseptic filling. Strict controls and validations are required to minimize contamination risks, including clean room classification and environmental monitoring, cleaning and sterilization processes, personnel training and maintenance procedures. Broth fill tests are conducted to qualify the aseptic filling capability and demonstrate sterility assurance levels better than 10^-3 can be achieved.
This document provides information about coating technology. It discusses various coating principles, processes, equipment, and applications. Specifically, it describes sugar coating and film coating processes, common coating equipment like standard coating pans and fluidized bed coaters, and particle coating techniques like microencapsulation and spray drying. It aims to explain how coating is used to modify drug release profiles and protect pharmaceutical products.
The document discusses form fill and seal (FFS) or blow fill seal (BFS) technology used in pharmaceutical packaging. BFS is a process where plastic containers are formed, filled with sterile product, and sealed in a single integrated machine within a sterile environment. It has become a prevalent aseptic processing technique over the last 20 years. The basic BFS process involves extruding a plastic tube, molding it into a container within the mold, filling the container, sealing it, and discharging the finished package. It reduces personnel and validation requirements compared to traditional packaging. While it has advantages like reduced costs, it also has challenges like particulate and temperature control that require mitigation strategies.
This document provides information on aseptic processing technology and quality control testing for various sterile pharmaceutical dosage forms including ointments, suspensions, emulsions, and sterile solutions. It discusses cleanroom classifications, manufacturing processes, and in-process quality control tests for content uniformity, clarity, leakage, extractable volume, sterility, consistency, penetration, irritation potential, sedimentation, redispersibility, particle size, viscosity, and zeta potential.
This document discusses improved tablet production methods. It describes the rota granulation process which allows for the direct manufacturing of controlled release spheres from dry powder in a single step. The powder is added to a bowl and wetted with granulating liquid from one or more sprays to form granules. Rota granulation equipment comes in sizes from 45L to 450L capacity. The conclusion states that following a systematic approach to tablet production can minimize variables, contamination, and reduce production costs while improving quality and avoiding conflicts by adhering to good manufacturing practices.
Auditing of capsule, sterile production and packaging MittalRohit2
The document discusses vendor audits, supplier audits, and audits of sterile product manufacturing facilities. It provides information on:
- The purpose of vendor and supplier audits to assess compliance and reduce costs.
- Key areas evaluated in vendor audits like management responsibility and data integrity.
- Benefits of audits like cost savings, process improvements, and risk reduction.
- Elements of a supplier audit checklist like infrastructure, traceability, and regulatory compliance.
- Additional controls needed for sterile product manufacturing like clean rooms, air filtration, and environmental monitoring.
- Areas examined in audits of sterile facilities including equipment validation, personnel training, and media fill programs.
Qualification of Prefilled Syringe MachineAnwar Munjewar
This document provides an overview of prefilled syringes and the qualification process for a prefilled syringe filling machine. It describes that a prefilled syringe is a single-dose packet of medication that has a needle fixed by the manufacturer. The document outlines benefits of prefilled syringes such as reduced dosing errors and costs. It then details the objective to qualify a specific prefilled syringe filling and stoppering machine. The qualification approach and specifications for the PFS-A-10 filling machine are presented.
The document discusses the blow-fill-seal (BFS) technology used to aseptically produce sterile pharmaceutical products. It describes the BFS process which combines plastic container formation via blow/vacuum molding with aseptic filling. Strict controls and validations are required to minimize contamination risks, including clean room classification and environmental monitoring, cleaning and sterilization processes, personnel training and maintenance procedures. Broth fill tests are conducted to qualify the aseptic filling capability and demonstrate sterility assurance levels better than 10^-3 can be achieved.
This document provides information about coating technology. It discusses various coating principles, processes, equipment, and applications. Specifically, it describes sugar coating and film coating processes, common coating equipment like standard coating pans and fluidized bed coaters, and particle coating techniques like microencapsulation and spray drying. It aims to explain how coating is used to modify drug release profiles and protect pharmaceutical products.
The document discusses form fill and seal (FFS) or blow fill seal (BFS) technology used in pharmaceutical packaging. BFS is a process where plastic containers are formed, filled with sterile product, and sealed in a single integrated machine within a sterile environment. It has become a prevalent aseptic processing technique over the last 20 years. The basic BFS process involves extruding a plastic tube, molding it into a container within the mold, filling the container, sealing it, and discharging the finished package. It reduces personnel and validation requirements compared to traditional packaging. While it has advantages like reduced costs, it also has challenges like particulate and temperature control that require mitigation strategies.
This document provides information on aseptic processing technology and quality control testing for various sterile pharmaceutical dosage forms including ointments, suspensions, emulsions, and sterile solutions. It discusses cleanroom classifications, manufacturing processes, and in-process quality control tests for content uniformity, clarity, leakage, extractable volume, sterility, consistency, penetration, irritation potential, sedimentation, redispersibility, particle size, viscosity, and zeta potential.
This document discusses improved tablet production methods. It describes the rota granulation process which allows for the direct manufacturing of controlled release spheres from dry powder in a single step. The powder is added to a bowl and wetted with granulating liquid from one or more sprays to form granules. Rota granulation equipment comes in sizes from 45L to 450L capacity. The conclusion states that following a systematic approach to tablet production can minimize variables, contamination, and reduce production costs while improving quality and avoiding conflicts by adhering to good manufacturing practices.
Auditing of capsule, sterile production and packaging MittalRohit2
The document discusses vendor audits, supplier audits, and audits of sterile product manufacturing facilities. It provides information on:
- The purpose of vendor and supplier audits to assess compliance and reduce costs.
- Key areas evaluated in vendor audits like management responsibility and data integrity.
- Benefits of audits like cost savings, process improvements, and risk reduction.
- Elements of a supplier audit checklist like infrastructure, traceability, and regulatory compliance.
- Additional controls needed for sterile product manufacturing like clean rooms, air filtration, and environmental monitoring.
- Areas examined in audits of sterile facilities including equipment validation, personnel training, and media fill programs.
Qualification of Prefilled Syringe MachineAnwar Munjewar
This document provides an overview of prefilled syringes and the qualification process for a prefilled syringe filling machine. It describes that a prefilled syringe is a single-dose packet of medication that has a needle fixed by the manufacturer. The document outlines benefits of prefilled syringes such as reduced dosing errors and costs. It then details the objective to qualify a specific prefilled syringe filling and stoppering machine. The qualification approach and specifications for the PFS-A-10 filling machine are presented.
This document discusses key considerations for the aseptic manufacturing of sterile pharmaceutical products. It covers classification of clean areas, environmental monitoring, preparation and filtration of solutions, personnel requirements, equipment sterilization, and validation of aseptic processes. The main objectives are to prevent microbial contamination and maintain sterility throughout manufacturing.
This document provides an overview of facility design considerations for advanced sterile product manufacturing. It discusses key areas like area planning based on product type, facility classification, environmental control zones, wall and floor treatments, change rooms, personnel flow, and utility locations. Proper facility design with controlled environments and aseptic practices is necessary to ensure sterility of pharmaceutical products like APIs, antibiotics, and biological products during manufacturing.
In Process Quality Control Tests (IPQC) For Parenteral or Sterile Dosage FormsSagar Savale
These are the tests performed between QA and QC and provides for the authorization of approved raw materials for manufacturing based on actual laboratory testing generally called as IPQC such as physical, chemical, microbiologic and biologic tests.
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.
The document discusses the validation of liquid oral dosage forms. It defines validation and its objectives, which include ensuring consistency and reproducibility of the manufacturing process. The key stages of validation are described - pre-validation qualification, process validation, and validation maintenance. For liquid orals, the validation would include equipment, raw materials, the manufacturing process, microbiological quality, product specifications, stability, and packaging. Critical process parameters are identified and acceptance criteria defined. The validation report and requirements for revalidation with changes are also summarized.
The blow-fill-seal (BFS) technique is a specialized packaging method for producing small liquid-filled containers in a continuous, integrated process. Polymer granules are extruded into a tube, or parison, filled with liquid, and sealed without exposure to the non-sterile environment. Key steps include parison extrusion, container molding, aseptic filling without interruption, and container sealing. BFS provides advantages over conventional filling by integrating forming, filling and sealing in a continuous sterile process without pre-fabricated containers.
This document summarizes a seminar presentation on validation of packaging operations. It discusses the importance of packaging for pharmaceutical products and outlines key areas of packaging validation including packaging equipment qualification and packaging process validation. Specific examples of packaging processes like blister packaging and secondary packaging are described. Critical parameters and steps for these processes are identified. The presentation provides an overview of packaging validation requirements and procedures to ensure packaging processes consistently produce pharmaceutical packages that meet quality standards.
The document discusses aseptic processing, which involves bringing together sterile products, containers, and closures that have been separately sterilized and assembling them in a highly controlled environment using specialized personnel and equipment. Key elements of aseptic processing include facility design and control, equipment sterilization and material handling, the aseptic processing itself, personnel training, process verification through media fills and environmental monitoring, finished product testing, and comprehensive documentation.
Pharmaceutical packaging serves several important purposes: protection, identification, information, containment, integrity, and stability. Packaging design must consider factors like material selection, sterility, and regulations. There are three levels of pharmaceutical packaging: primary, secondary, and tertiary. Primary packaging has direct contact with the product, while secondary and tertiary packaging provide additional protection, grouping, and handling during storage and shipping. Proper packaging is essential for medical products to maintain quality and safety throughout distribution and use.
Blow Fill Seal technology is a specialized packaging technique that forms, fills, and seals containers in a continuous sterile process without human intervention. The process involves extruding plastic into a tube, molding containers, filling them with liquid, sealing the containers, and discharging the finished product. Key advantages are reduced human contact and economies of scale in packaging pharmaceutical liquids aseptically in small and large volumes for uses like injectables, respiratory products, and ophthalmic solutions.
Aseptic / sterile- “ A state of control attained by using an aseptic work area and performing activities in a manner that precludes microbiological contamination of the exposed sterile product”
This document provides an overview of non-sterile tablet manufacturing processes. It begins with definitions of non-sterile dosage forms including tablets, capsules, ointments, suspensions and emulsions. It then discusses various aspects of tablet manufacturing including formulation, equipment used, granulation techniques, compression, and quality control tests. The document focuses on tablet manufacturing processes and quality checks to ensure consistent and quality tablets are produced.
Ipqc tests for sterile formulations are as follows :
Leakage Test
Clarity Test
pH
Particulate Matter Injection
SterilityTest
Pyrogen Test
Content Uniformity & Weight
Volume Filled
The tests For Sterile products are as per IP, BP & USP
Aseptic process tech & advanced sterile product mfg rashmi nasareRASHMINasare
The document discusses aseptic processing and sterile manufacturing. It defines aseptic processing as bringing together sterilized product, container, and closure under controlled conditions to prevent contamination. Key elements of aseptic processing include personnel, facility, equipment, and process. The document also outlines various quality control tests performed during manufacturing like appearance, pH, sterility, and drug content tests. It discusses facility design considerations for aseptic areas including utility locations, engineering areas, and maintenance facilities.
The document discusses the importance of environmental control in the pharmaceutical industry. It states that controlling factors like particulate matter, microorganisms, temperature, humidity and airflow is crucial to protecting pharmaceutical products from contamination. A properly designed, validated and monitored HVAC system is necessary to ensure quality and safety. The HVAC system controls air movement and distribution of temperature and humidity in cleanrooms to maintain suitable manufacturing conditions.
Advance non – sterile solid product manufacturing technologyAbhishekJadhav189260
The pharmaceutical manufacturing process is typically made up of a
combination of specific unit processes chosen according to physical
and chemical characteristics of active pharmaceutical ingredients.
This document discusses in-process quality control (IPQC) tests for parenteral products. It describes several key IPQC tests including drug content assays, clarity testing to detect particulate matter using various methods, leakage testing of ampoules using dye bath or spark tests, sterility testing using membrane filtration or direct inoculation methods, and endotoxin/pyrogen testing. Maintaining strict quality controls during manufacturing is important for ensuring parenterals are sterile, pyrogen-free, and free of particulate matter when injected into the body.
This document provides an overview of process automation in the pharmaceutical industry. It discusses various pharmaceutical manufacturing processes like granulation, drying, milling, and compression. It also describes different types of pharmaceutical processing equipment used for unit operations like mixing, drying, milling etc. Finally, it discusses process automation and concepts like cleaning-in-place and sterilization-in-place which are important for ensuring sterility in pharmaceutical manufacturing.
This type of moulding is helpful to make containers ,jars ,water bottles and many more so please kindly go through this process .With the help of this type of moulding we can perform our experiment of our daily used water cans e.g: 5ltrs ,10ltrs ,20ltrs ,25ltrs ect.
This document discusses blow moulding, which uses compressed air to form hollow plastic products like bottles from thermoplastics. It describes the advantages of blow moulding over injection moulding, including its ability to produce irregular shapes with variable wall thickness at lower pressures. Extrusion blow moulding and injection blow moulding are the main types discussed, along with stretch blow moulding. The extrusion process and machinery are explained in detail. Common plastic materials used are also listed for small and large products.
This document discusses key considerations for the aseptic manufacturing of sterile pharmaceutical products. It covers classification of clean areas, environmental monitoring, preparation and filtration of solutions, personnel requirements, equipment sterilization, and validation of aseptic processes. The main objectives are to prevent microbial contamination and maintain sterility throughout manufacturing.
This document provides an overview of facility design considerations for advanced sterile product manufacturing. It discusses key areas like area planning based on product type, facility classification, environmental control zones, wall and floor treatments, change rooms, personnel flow, and utility locations. Proper facility design with controlled environments and aseptic practices is necessary to ensure sterility of pharmaceutical products like APIs, antibiotics, and biological products during manufacturing.
In Process Quality Control Tests (IPQC) For Parenteral or Sterile Dosage FormsSagar Savale
These are the tests performed between QA and QC and provides for the authorization of approved raw materials for manufacturing based on actual laboratory testing generally called as IPQC such as physical, chemical, microbiologic and biologic tests.
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.
The document discusses the validation of liquid oral dosage forms. It defines validation and its objectives, which include ensuring consistency and reproducibility of the manufacturing process. The key stages of validation are described - pre-validation qualification, process validation, and validation maintenance. For liquid orals, the validation would include equipment, raw materials, the manufacturing process, microbiological quality, product specifications, stability, and packaging. Critical process parameters are identified and acceptance criteria defined. The validation report and requirements for revalidation with changes are also summarized.
The blow-fill-seal (BFS) technique is a specialized packaging method for producing small liquid-filled containers in a continuous, integrated process. Polymer granules are extruded into a tube, or parison, filled with liquid, and sealed without exposure to the non-sterile environment. Key steps include parison extrusion, container molding, aseptic filling without interruption, and container sealing. BFS provides advantages over conventional filling by integrating forming, filling and sealing in a continuous sterile process without pre-fabricated containers.
This document summarizes a seminar presentation on validation of packaging operations. It discusses the importance of packaging for pharmaceutical products and outlines key areas of packaging validation including packaging equipment qualification and packaging process validation. Specific examples of packaging processes like blister packaging and secondary packaging are described. Critical parameters and steps for these processes are identified. The presentation provides an overview of packaging validation requirements and procedures to ensure packaging processes consistently produce pharmaceutical packages that meet quality standards.
The document discusses aseptic processing, which involves bringing together sterile products, containers, and closures that have been separately sterilized and assembling them in a highly controlled environment using specialized personnel and equipment. Key elements of aseptic processing include facility design and control, equipment sterilization and material handling, the aseptic processing itself, personnel training, process verification through media fills and environmental monitoring, finished product testing, and comprehensive documentation.
Pharmaceutical packaging serves several important purposes: protection, identification, information, containment, integrity, and stability. Packaging design must consider factors like material selection, sterility, and regulations. There are three levels of pharmaceutical packaging: primary, secondary, and tertiary. Primary packaging has direct contact with the product, while secondary and tertiary packaging provide additional protection, grouping, and handling during storage and shipping. Proper packaging is essential for medical products to maintain quality and safety throughout distribution and use.
Blow Fill Seal technology is a specialized packaging technique that forms, fills, and seals containers in a continuous sterile process without human intervention. The process involves extruding plastic into a tube, molding containers, filling them with liquid, sealing the containers, and discharging the finished product. Key advantages are reduced human contact and economies of scale in packaging pharmaceutical liquids aseptically in small and large volumes for uses like injectables, respiratory products, and ophthalmic solutions.
Aseptic / sterile- “ A state of control attained by using an aseptic work area and performing activities in a manner that precludes microbiological contamination of the exposed sterile product”
This document provides an overview of non-sterile tablet manufacturing processes. It begins with definitions of non-sterile dosage forms including tablets, capsules, ointments, suspensions and emulsions. It then discusses various aspects of tablet manufacturing including formulation, equipment used, granulation techniques, compression, and quality control tests. The document focuses on tablet manufacturing processes and quality checks to ensure consistent and quality tablets are produced.
Ipqc tests for sterile formulations are as follows :
Leakage Test
Clarity Test
pH
Particulate Matter Injection
SterilityTest
Pyrogen Test
Content Uniformity & Weight
Volume Filled
The tests For Sterile products are as per IP, BP & USP
Aseptic process tech & advanced sterile product mfg rashmi nasareRASHMINasare
The document discusses aseptic processing and sterile manufacturing. It defines aseptic processing as bringing together sterilized product, container, and closure under controlled conditions to prevent contamination. Key elements of aseptic processing include personnel, facility, equipment, and process. The document also outlines various quality control tests performed during manufacturing like appearance, pH, sterility, and drug content tests. It discusses facility design considerations for aseptic areas including utility locations, engineering areas, and maintenance facilities.
The document discusses the importance of environmental control in the pharmaceutical industry. It states that controlling factors like particulate matter, microorganisms, temperature, humidity and airflow is crucial to protecting pharmaceutical products from contamination. A properly designed, validated and monitored HVAC system is necessary to ensure quality and safety. The HVAC system controls air movement and distribution of temperature and humidity in cleanrooms to maintain suitable manufacturing conditions.
Advance non – sterile solid product manufacturing technologyAbhishekJadhav189260
The pharmaceutical manufacturing process is typically made up of a
combination of specific unit processes chosen according to physical
and chemical characteristics of active pharmaceutical ingredients.
This document discusses in-process quality control (IPQC) tests for parenteral products. It describes several key IPQC tests including drug content assays, clarity testing to detect particulate matter using various methods, leakage testing of ampoules using dye bath or spark tests, sterility testing using membrane filtration or direct inoculation methods, and endotoxin/pyrogen testing. Maintaining strict quality controls during manufacturing is important for ensuring parenterals are sterile, pyrogen-free, and free of particulate matter when injected into the body.
This document provides an overview of process automation in the pharmaceutical industry. It discusses various pharmaceutical manufacturing processes like granulation, drying, milling, and compression. It also describes different types of pharmaceutical processing equipment used for unit operations like mixing, drying, milling etc. Finally, it discusses process automation and concepts like cleaning-in-place and sterilization-in-place which are important for ensuring sterility in pharmaceutical manufacturing.
This type of moulding is helpful to make containers ,jars ,water bottles and many more so please kindly go through this process .With the help of this type of moulding we can perform our experiment of our daily used water cans e.g: 5ltrs ,10ltrs ,20ltrs ,25ltrs ect.
This document discusses blow moulding, which uses compressed air to form hollow plastic products like bottles from thermoplastics. It describes the advantages of blow moulding over injection moulding, including its ability to produce irregular shapes with variable wall thickness at lower pressures. Extrusion blow moulding and injection blow moulding are the main types discussed, along with stretch blow moulding. The extrusion process and machinery are explained in detail. Common plastic materials used are also listed for small and large products.
Blow Mould Tool Design and Manufacturing Process for 1litre Pet BottleIOSR Journals
the concepts of Blow molding is a process used to produce hollow objects from thermoplastic. The
basic blow molding process has two fundamental phases. First, a parson (or a perform) of hot plastic resin in a
somewhat tubular shape is created. Second, compressed air is used to expand the hot perform and press it
against mould cavities. The pressure is held until the plastic cools. Blow molding process is used for which has
thin wall sections.In this thesis, blow mould design is to be done for a bottle having 0.5mm thickness. This
thickness cannot be filled in pressure injection molding. So blow molding is considered for pet bottle design.
The mould is prepared by first modeling the part, extracting core & cavity and generating CNC program. Blow
mould tool design is done in Pro/Engineer according to HASCO standards. A prototype of the pet bottle using
blow mould design is also included.
Polymer processing involves converting plastic raw materials into finished products. There are primary, secondary, and tertiary processing methods. The selection of a processing method depends on factors like the product design, material properties, production quantity, and cost. Common primary methods include injection molding, extrusion, blow molding, and compression molding. The polymer properties like water absorption, physical form, thermal stability, and melt flow properties affect the suitable processing technique. Proper consideration of these factors ensures efficient processing and quality product manufacture.
This document summarizes bottle blow molding and finite element modeling (FEM) analysis of the process. It discusses how blow molding works by melting plastic into a parison shape, clamping the parison into a mold, and injecting air to push the plastic to the mold shape. FEM analysis can simulate the process to optimize parameters like pressure and temperature for uniform wall thickness. The document also outlines the different types of blow molding (extrusion, injection, stretch), commonly used materials like polyethylene, and applications like bottles. It concludes that FEM analysis can validate stress levels are within limits to ensure product quality and reduce costs and time compared to physical prototyping.
Polymer Processing( Manufacturing Of Polymer)Haseeb Ahmad
This document discusses various polymer processing techniques including extrusion, injection molding, blow molding, and compression molding. It provides definitions and descriptions of each process, diagrams to illustrate the basic steps, and discusses important terms and considerations for each technique. The key components and functioning of extruders and injection molding machines are explained. Examples of common applications for each type of processing are also provided.
This document provides an overview of plastic mould design and the injection moulding process. It discusses the importance of plastic parts in modern industries and advantages of plastics over metals. Key topics covered include design considerations for plastic parts, common plastic materials, types of moulds, injection mould components like the cavity and core, and the six main steps of the injection moulding process: mould closing and clamping, injection, dwelling, cooling, plasticizing resin, and mould opening and ejection. The document also provides a brief overview of injection moulding machines.
Blow Molding is defined appropriately and also the process compatible materials are listed. Blow Molding is broadly classified as - extrusion type, injection type, Multilayer type. All three processes are explained appropriately with diagrams and their application is also listed. Since every thing has advantages and disadvantages, so is the case with blow molding. References are also cited correctly. I hope you all find it useful
1. The document describes the design optimization and manufacturing plan for a plastic container using injection molding. It discusses selecting high density polyethylene as the material and designing the mold.
2. The key steps of injection molding are described, including feeding plastic pellets into a heated barrel, injecting the molten plastic into the mold, cooling and hardening in the mold shape, and then ejecting the part.
3. The document outlines designing the container dimensions at 40mm x 40mm x 2mm thick and selecting injection molding process parameters to minimize sink marks on the final part.
The document provides information about plastic injection moulding. It defines plastic as a polymeric substance that can be easily shaped and moulded. Plastics are used for their ability to be formed into complex shapes, their light weight, strength and availability in different colors. The main types of plastics are thermoset and thermoplastic. Injection moulding is described as the process of injecting melted plastic into a mould to form a part. Key aspects of the injection moulding process like the machine, mould, raw materials and defects are discussed. Injection moulding is concluded to be a very versatile process for producing a wide variety of plastic products.
The document discusses various polymer processing techniques. It begins by explaining that the main goal of polymer processing is to produce usable objects and lists the necessary parameters for processing including flow, heat transfer, mass transfer, and chemical reactions. It then focuses on extrusion, describing it as shaping material by forcing it through a die. Various extrusion techniques are discussed including single screw extrusion, twin screw extrusion, blown film extrusion, co-extrusion, and injection molding. Other processing methods summarized include thermoforming, vacuum forming, rotational molding, calendering, and spinning.
The document discusses different plastic processing methods used by group members Muazz Ali and Irfan Ali. Muazz Ali focuses on injection molding, blow molding, and injection blow molding. Irfan Ali discusses extrusion blow molding, stretch blow molding, and thermoforming. Both members provide details on the basic principles, processes, parameters, advantages, disadvantages and applications of each plastic processing technique.
Polymer processing involves shaping polymers into usable objects using techniques like extrusion, injection molding, blow molding, and thermoforming. Extrusion is commonly used to produce tubes, pipes, sheets, films and other continuous profiles by forcing molten plastic through a die. A single screw extruder has four main zones - feed, compression, metering, and die which plasticize and homogenize the polymer melt before extruding. Extrusion is widely used for compounding plastics and producing a variety of continuous profiles and films. Injection molding injects molten polymer into a closed, cooled mold to solidify into the desired shape.
The document discusses various polymer processing techniques. It begins by explaining that the main goal of polymer processing is to produce usable objects and discusses necessary parameters like rheology, heat transfer, mass transfer, and chemical reactions. It then focuses on extrusion, describing it as shaping material by forcing it through a die. Extrusion is used to produce tubes, pipes, sheets, films and other continuous profiles from thermoplastics and some thermosets. Single screw and twin screw extruders are discussed in detail along with their various zones and applications of extrusion processes. Other molding techniques like injection molding and blow molding are also summarized.
The document discusses the manufacturing process of plastic bags. It begins by introducing plastic bags and their common uses for containing and transporting goods. It then outlines the objective to investigate the materials and manufacturing process used. The main material is polyethylene due to its low cost and moldability as a thermoplastic. The predominant manufacturing process is film blowing, which uses air pressure to extrude molten plastic into a bubble that is cooled and flattened into a film. This process allows for high productivity and a variety of hollow products but relies heavily on non-renewable petroleum and produces plastic waste.
The document provides an introduction to plastics processing methods. It discusses that plastics processing involves converting plastic raw materials into semi-finished or finished products through techniques like deformation of polymer melts, rubbers, solutions, and more. The main processing methods include injection molding, extrusion, blow molding, compression molding, and thermoforming. The selection of the right processing method depends on factors like the product design, material properties, production quantities, quality requirements, and costs. The document provides an overview of various common processing methods and their basic workings.
The document provides an overview of plastics processing methods. It defines plastics processing as converting plastic raw materials into semi-finished or finished products. It then classifies common primary and secondary processing methods and discusses their basic principles and limitations. Key primary methods include injection molding, extrusion, blow molding, compression molding, and transfer molding. The document also covers how factors like material properties, part design, costs, and quality requirements influence the selection of the appropriate processing method.
The document provides an introduction to plastics processing methods. It discusses that plastics processing involves converting plastic raw materials into semi-finished or finished products through techniques like deformation of polymer melts, rubbers, solutions, and more. The main processing methods include injection molding, extrusion, blow molding, compression molding, and thermoforming. The selection of the right processing method depends on factors like the product design, material properties, production quantities, quality requirements, and costs. The document provides an overview of various common processing methods and their basic workings.
Similar to Blow fill-seal technology for parentral (20)
ISO/IEC 27001, ISO/IEC 42001, and GDPR: Best Practices for Implementation and...PECB
Denis is a dynamic and results-driven Chief Information Officer (CIO) with a distinguished career spanning information systems analysis and technical project management. With a proven track record of spearheading the design and delivery of cutting-edge Information Management solutions, he has consistently elevated business operations, streamlined reporting functions, and maximized process efficiency.
Certified as an ISO/IEC 27001: Information Security Management Systems (ISMS) Lead Implementer, Data Protection Officer, and Cyber Risks Analyst, Denis brings a heightened focus on data security, privacy, and cyber resilience to every endeavor.
His expertise extends across a diverse spectrum of reporting, database, and web development applications, underpinned by an exceptional grasp of data storage and virtualization technologies. His proficiency in application testing, database administration, and data cleansing ensures seamless execution of complex projects.
What sets Denis apart is his comprehensive understanding of Business and Systems Analysis technologies, honed through involvement in all phases of the Software Development Lifecycle (SDLC). From meticulous requirements gathering to precise analysis, innovative design, rigorous development, thorough testing, and successful implementation, he has consistently delivered exceptional results.
Throughout his career, he has taken on multifaceted roles, from leading technical project management teams to owning solutions that drive operational excellence. His conscientious and proactive approach is unwavering, whether he is working independently or collaboratively within a team. His ability to connect with colleagues on a personal level underscores his commitment to fostering a harmonious and productive workplace environment.
Date: May 29, 2024
Tags: Information Security, ISO/IEC 27001, ISO/IEC 42001, Artificial Intelligence, GDPR
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This slide is special for master students (MIBS & MIFB) in UUM. Also useful for readers who are interested in the topic of contemporary Islamic banking.
How to Make a Field Mandatory in Odoo 17Celine George
In Odoo, making a field required can be done through both Python code and XML views. When you set the required attribute to True in Python code, it makes the field required across all views where it's used. Conversely, when you set the required attribute in XML views, it makes the field required only in the context of that particular view.
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Odoo 17 CRM allows us to track why we lose sales opportunities with "Lost Reasons." This helps analyze our sales process and identify areas for improvement. Here's how to configure lost reasons in Odoo 17 CRM
Exploiting Artificial Intelligence for Empowering Researchers and Faculty, In...Dr. Vinod Kumar Kanvaria
Exploiting Artificial Intelligence for Empowering Researchers and Faculty,
International FDP on Fundamentals of Research in Social Sciences
at Integral University, Lucknow, 06.06.2024
By Dr. Vinod Kumar Kanvaria
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In Odoo, the chatter is like a chat tool that helps you work together on records. You can leave notes and track things, making it easier to talk with your team and partners. Inside chatter, all communication history, activity, and changes will be displayed.
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Blow fill-seal technology for parentral
1. Parenteral Plant Layout
BFS & FFS Technology
SUBJECT:- STERILE PRODUCTS FORMULATION & TECHNOLOGY
DEPARTMENT:- PHARMACEUTICS
M.PHARM (1ST SEM)
YEAR:- 2015-16
Presented By:
Mr. Pawara Dinesh C.
Roll No-6
supervised by
Mr. Jagdale Sachin K
MARATHWADA MITRA MANDAL COLLEGE OF PHARMACY
PUNE-33
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2. Basic plant requirement
Energy
Water
Air quality
Waste disposal
Non –technical factor
2
3. Type of production
Batch operations:
Continuous operations:
Container size
Environment control needs
Product characteristics
Space requirements
Personnel Movement
3
4. Function Area
Square meter percentage
Production 11,094 45.1
Warehouse 7,606 30.9
utility 1,716 4.1
Quality control 1,716 7.0
administration 1,018 4.1
Space requirements
4
5. Filling Line
Filling Area
Weighing, Mixing,t Transfer
Clean Area
General production Area
Ware House
Exterior
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6
5
3
2
1
4
1st. Zones as per the cGMP:-
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10. The room should undergo 15-20 air changes per hour.
A warning system should be provided to indicate failure in the air supply.
Adjacent rooms of different grades should have a pressure differential of 10 - 15
Pascals.
Counters in the clean room should be made of stainless steel or other non-porous,
easily cleaned material.
Walls and floors should be free from cracks or crevices and have rounded corners. If
the walls or floors are to be painted, epoxy paint is used.
Providing temp. & humidity controls appropriate to the product bein
10
12. Blow-Fill-Seal (BFS) technique used to produce small, (0.1-
99mL) and large volume, (100mL +) liquid-filled containers.
used to manufacture sterile pharmaceutical products as
parenteral (LVP & SVP), infusions, ophthalmic and inhalation
products.
These are automated techniques to prepare sterile products.
Europe in the 1930s, United States in the 1960s,
Blow-fill-seal is a specialised packaging technology using in-
line forming and sealing a polymeric material to a container of
choice.
12
13. 1. The basic concept of the FFS and BFS is to reduce the contamination by
forming the container, filling and sealing in a closed sterile chamber of the
machine.
2. There is no personnel intervention to reduce the chances of the
contamination during the manufacturing of sterile products.
3. It gives more production in very low operational cost with high assurance
of sterility
4. Thus this technology can be used to aseptically manufacture
sterile pharmaceutical liquid dosage forms.
5. BFS is used for the filling of vials for parenteral preparations
and infusions, eye drops, and inhalation products 13
14. Generally the plastic containers are made up of polyethylene and
polypropylene. Polypropylene is more commonly used to form
containers which are further sterilised by autoclaving as
polypropylene has greater parenteral
Blow fill seal technology is widely used and accepted by the
various pharmaceutical regulatory authorities as US-FDA and
MHRA.
System is reported to achieve contamination rate below 0.1%.
BFS and FFS techniques are more popular in United Kingdom
than United States.
14
15. The basic concept is formation, filling and sealing of plastic container in
aseptic environment. The BFS cycle can be divided into following main
steps:-
Step 1: Parison extrusion
Step 2: Container moulding
Step 3: Container filling
Step 4: Container sealing
Step 5: Discharge of container
15
16. first of all polypropylene
granules (pharmaceutical
plastic resin ) are vertically
heat (at 200 ±30°C) through a
circular throat to form the tube
shaped known as parison.
Parison reaches to the mould
forming the container by the
pressure of sterile compressed
air.
Step 1: Parison
16
17. container moulding the extruded tube is
then enclosed within a two part mould
and then the tube is cut above the mould.
Moulding of container
Blow molding (moulding) is a
manufacturing process by which hollow
plastic parts are formed.
• The blow molding process begins with melting down the plastic and forming
it into a parison or in the case of injection and injection stretch blow
moulding (ISB) a preform.
• The parison is a tube-like piece of plastic with a hole in one end through
which compressed air can pass.
17
18. The parison is then clamped into a mold and air is blown into
it.
The air pressure then pushes the plastic out to match the
mold. Once the plastic has cooled and hardened the mold
opens up and the part is ejected.
There are three main types of blow molding:
1. extrusion blow molding,
2. injection blow molding,
3. injection stretch blow molding.
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19. In Extrusion Blow Moulding
(EBM), plastic is melted and
extruded into a hollow tube (a
parison).
This parison is then captured by
closing it into a cooled metal
mold.
Air is then blown into the
parison, inflating it into the
shape of the hollow bottle,
container, or part.
1. Extrusion blow molding
19
20. After the plastic has cooled sufficiently, the mold is opened and the part is
ejected.
In Continuous Extrusion Blow Molding the parison is extruded continuously
and the individual parts are cut off by a suitable knife.
EBM processes may be either continuous (constant extrusion of the parison) or
intermittent.
Types of EBM equipment may be categorized as follows:
1. Continuous extrusion equipment
2. Intermittent extrusion machinery
Examples of container by EBM process include most polyethylene hollow
products, Milk bottles, shampoo bottles, watering cans and hollow industrial
parts such as drums. 20
21. Advantages :
low tool and die cost;
fast production rates;
ability to mold complex part;
Disadvantages :-
limited to hollow parts,
To make wide neck jars spin trimming is necessary
2. Injection blow molding
The process of injection blow molding (IBM) is used for the production of
hollow glass and plastic objects in large quantities.
In the IBM process, the polymer is injection molded onto a core pin; then the core
pin is rotated to a blow molding station to be inflated and cooled
21
22. The process is divided into three steps:
injection, blowing and ejection.
The injection blow molding machine is based on an extruder barrel and screw
assembly which melts the polymer.
The molten polymer is fed into a hot runner manifold where it is injected
through nozzles into a heated cavity and core pin.
The cavity mold forms the external shape and is clamped around a core rod
which forms the internal shape of the preform.
Advantages: It produces an injection moulded neck for accuracy.
Disadvantages: only suits small capacity bottles as it is difficult to control the
base centre during blowing.
No increase in barrier strength as the material is not biaxially stretched. Handles
can't be incorporated.
Injection blow molding cont…
22
23. This has two main different methods, namely
1) Single-stage 2)Two-stage process
Single-stage :
Single-stage process is again broken down into 3-station and 4-station machines
In the single-stage process both preform manufacture and bottle blowing are
performed in the same machine.
The older 4-station method of injection, reheat, stretch blow and ejection is more
costly than the 3-station machine which eliminates the reheat stage and uses latent
heat in the preform, thus saving costs of energy to reheat and 25% reduction in
tooling.
The process explained: Imagine the molecules are small round balls, when together
they have large air gaps and small surface contact, by first stretching the molecules
vertically then blowing to stretch
23
24. Advantages: Highly suitable for low volumes and short runs.
Disadvantages: - Restrictions on bottle design.
Two-stage process:-
In the two-stage injection stretch blow molding (ISB) process, the
plastic is first molded into a "preform" using the injection molding
process.
These preforms are produced with the necks of the bottles,
including threads (the "finish") on one end. These preforms are
packaged, and fed later (after cooling) into a reheat stretch blow
molding machine. 24
25. The preform is always stretched with a core rod as part of the
process.
Advantages:
Very high volumes are produced.
Little restriction on bottle design.
Is suitable for cylindrical, rectangular or oval bottles.
Disadvantages:
High capital cost.
Floor space required is high, although compact systems are
available since a few years.
Two-stage process:-
25
26. Step 4: Container Sealing
container sealing the mandrel is used to fill
the container with solution, following
filling, mandrels are removed and
secondary top mould seals the container.
Sealing of container
Step 3: Container filling
container filling the mould is transferred to
sterile filling zone where filling needles
called mandrels are lowered and used to
inflate the flat to form container within the
filling of container mold.
26
27. Step5:- container discharge
container discharge filled and
sealed containers are then
conveyed to labelling and
packing sections.
Container discharge rommelag’s
BFS bottle-pack 321 machine.
Produces around 3000 bottles
(1000ml) in one hour with six
moulds
27
28. Produce sterile products.
Reduced human intervention.
The code numbers and variable data such as batch number and
expiry date can be embedded on to the container itself.
Cleaning and sterilization of prefabricated containers and closures
is not required.
No need to purchase and stock a range of prefabricated containers
and their closures.
28
29. Respiratory preparations,
Oral solutions,
Disinfectant liquids Different types of ointments and gels,
Liquids for rectal or vaginal applications Packaging of certain
special food products such as soft drinks or milk products
Large volume Parenterals (normal saline, dextrose solution
etc) and small volume parenterals (eye drops, ear drops and
nasal drops).
29