logging in or signing up BFS Technology shilaranil Download Post to : URL : Related Presentations : Share Add to Flag Embed Email Send to Blogs and Networks Add to Channel Uploaded from authorPOINT lite Insert YouTube videos in PowerPont slides with aS Desktop Copy embed code: (To copy code, click on the text box) Embed: URL: Thumbnail: WordPress Embed Customize Embed The presentation is successfully added In Your Favorites. Views: 387 Category: Education License: All Rights Reserved Like it (4) Dislike it (1) Added: June 13, 2011 This Presentation is Public Favorites: 0 Presentation Description No description available. Comments Posting comment... By: mogalrajendra (3 week(s) ago) please send your PPT , ur prepared it superlbly. nice work. on my email mogalrajendra@yahoo.co.in Saving..... Post Reply Close Saving..... Edit Comment Close By: nileshtribhuvan (7 month(s) ago) plz send me on nileshtribhuvan63@yahoo.com Saving..... Post Reply Close Saving..... Edit Comment Close By: shrikant01 (8 month(s) ago) hi shilar i like ur presentetion can u please send it to me on my email id shri.rajput1@gmail.com Saving..... Post Reply Close Saving..... Edit Comment Close By: kbnarkhede (11 month(s) ago) thank you sir Saving..... Post Reply Close Saving..... Edit Comment Close By: kbnarkhede (11 month(s) ago) plz send me this great ppt Saving..... Post Reply Close Saving..... Edit Comment Close Premium member Presentation Transcript seminar on Blow-Fill-Seal Technology : For Parenteral Presented by Shilar Anil S. ( M.Pharm I st Sem ) SND College of Pharmacy Babhulgaon , Yeola . seminar on Blow-Fill-Seal Technology 1Content -: Introduction. Concept. Working. Requirement. Advantages. Application. 2 Content -Introduction -: Blow-Fill-Seal technology refers to the manufacturing technique used to produce small, (0.1mL) and large volume, (500mL +) liquid filled containers. Blow-fill-seal is a specialised packaging technology using in-line forming and sealing of a polymeric material to a container of choice. Introduction - 3History - : Blow-Fill-Seal technology was originally developed in Europe in the 1930s. It was introduced in the United States in the 1960s. But over the last 20 years it has become more prevalent within the pharmaceutical industry. History - 4Today -: It is now widely considered to be the superior form of aseptic processing by various medicine regulatory agencies. U.S. Food and Drug Administration (FDA) in the packaging of pharmaceutical and healthcare products. Today - 5Concept -: The basic concept of blow fill seal (BFS) is that a container is formed, filled, and sealed in a continuous process without or less human intervention, in a sterile enclosed area inside a machine. Thus this technology can be used to Aseptically Manufacture sterile pharmaceutical liquid dosage forms. Concept - 6How it is work ?: The BFS cycle can be divided into the following main steps - Step 1: Parison Extrusion. Step 2: Container molding. Step 3 : Container Filling. Step 4: Container Sealing. Step 5: Container Discharge. How it is work ? 7Step 1:Parison Extrusion - : Firstly pharmaceutical plastic resin is vertically heat extruded through a circular throat, to form a tube called the Parison . Step 1:Parison Extrusion - 8Slide 9: 9 9 9 Injection Extruder - Fig. Injection Extruder. Parison Tube: Parison Tube 10 Fig. Parison ExtrusionStep 2: Container molding - : This extruded tube is then enclosed within a two-part mould, and the tube is cut above the mould. Step 2: Container molding - 11 Mould: Mould 12 Fig. Container moldingStep 3 :Container Filling - : The mould is transferred to the filling zone, or sterile filling space where filling needle mandrels are lowered and used to inflate the plastic to form the container within the mould. Step 3 :Container Filling - 13 Mandrels: 14 Mandrels Fig. Container FillingStep 4: Container Sealing - : The mandrel is used to fill the container with liquid, following filling, the mandrels are remove and a secondary top mould seals the container. 15 Step 4: Container Sealing - Top mould: 16 Top mould Fig. Container SealingStep 5: Container Discharge - : Finally, the filled container is discharge from mould. 17 Step 5: Container Discharge - Fig. Container Discharge.BFS Cycle- : All actions take place inside a sterile chamber inside the machine. The product is then discharged to a non-sterile area for labelling, packaging and distribution. 18 BFS Cycle- 18 1 2 3 4 Discharge Fig. BFS cycleSlide 19: 19 Fig. ALP model 624 BFS Machine. Fig. Mould. Fig. BFS ContainerMaterial use for container -: 20 Material use for container - Material Polyethylene P olypropylene Polyvinyl chloride PolyesterRequirement for process -: Sterile-air is used. BFS machinery and its surrounding barriers should be designed to prevent the potential for extraneous contamination. Environment surrounding BFS machinery should generally meet Class 100,000 (ISO 8), or better, standards, depending on the design of the BFS machinery and the surrounding room. 21 Requirement for process -Slide 22: HEPA-filtered or sterile air provided should be used during the steps when sterile products or materials are exposed. (e.g. parison formation, container molding or filling steps). Air in the critical area should meet Class 100 (ISO 5) microbiological standards during operations. Only person who have been qualified and appropriately gowned should enter the classified environment surrounding the BFS machinery. 22Advantages -: This manufacturing technology includes economies in container closure processing. Reduced human intervention. Often used for filling and packaging ophthalmic. The same advantages that Blow/Fill/Seal brings to these products quality/sterility assurance, processing efficiencies, flexibility in container design. Make it a viable delivery option for injectable products Vs traditional glass or plastic vials. 23 Advantages -Slide 24: The code numbers and variable data such as batch number and expiry date can be moulded into the container itself rather than being added at a subsequent stage. Cleaning and sterilisation of prefabricated containers and closures is not required. There is no need to purchase and stock a range of prefabricated containers and their closures. 24Application -: Injectable products. For Ophthalmic Preparation. Respiratory Product. 25 Application -References -: Pharmaceutical Engineering Guides for New Renovated Facilities Volume3 Sterile Manufacturing Facilities,First Edition. International Society for Pharmaceutical Engineering. Pharmaceutical & Medicinal Packaging News, September 2009, Vol. 17, No. 9. Recent Technical Advancements in Blow-Fill-Seal Technology, report by. Charles H Reed ( Sales Manager, . Weiler Engineering, Inc). Aseptic Production of Pharmaceuticals in Boehringer Ingelheim Using Blow-Fill-Seal Technology a report by Boehringer Ingelheim. PHARMACEUTICAL MANUFACTURING HANDBOOK Production and Processes SHAYNE COX GAD, PH.D., D.A.B.T. Gad Consulting Services Cary, North Carolina. 26 References -Slide 27: 27 Blow-Fill-Seal Pharmaceutical Packaging – Towards Safe and Convenient Medical Containers, a report by Dr Anders Löfgren1 , Professor Arne Brodin and Eva Sjökvist-Saers. ISO 14644-1: Cleanrooms and Associated Controlled Environments, Classification of Air Cleanliness. Price, J., “Blow-Fill-Seal Technology: Part I, A Design for Particulate Control,” Pharmaceutical Technology, February, 1998. Thanks…Slide 28: ? Q. Task ? 28 You do not have the permission to view this presentation. In order to view it, please contact the author of the presentation.
BFS Technology shilaranil Download Post to : URL : Related Presentations : Share Add to Flag Embed Email Send to Blogs and Networks Add to Channel Uploaded from authorPOINT lite Insert YouTube videos in PowerPont slides with aS Desktop Copy embed code: (To copy code, click on the text box) Embed: URL: Thumbnail: WordPress Embed Customize Embed The presentation is successfully added In Your Favorites. Views: 387 Category: Education License: All Rights Reserved Like it (4) Dislike it (1) Added: June 13, 2011 This Presentation is Public Favorites: 0 Presentation Description No description available. Comments Posting comment... By: mogalrajendra (3 week(s) ago) please send your PPT , ur prepared it superlbly. nice work. on my email mogalrajendra@yahoo.co.in Saving..... Post Reply Close Saving..... Edit Comment Close By: nileshtribhuvan (7 month(s) ago) plz send me on nileshtribhuvan63@yahoo.com Saving..... Post Reply Close Saving..... Edit Comment Close By: shrikant01 (8 month(s) ago) hi shilar i like ur presentetion can u please send it to me on my email id shri.rajput1@gmail.com Saving..... Post Reply Close Saving..... Edit Comment Close By: kbnarkhede (11 month(s) ago) thank you sir Saving..... Post Reply Close Saving..... Edit Comment Close By: kbnarkhede (11 month(s) ago) plz send me this great ppt Saving..... Post Reply Close Saving..... Edit Comment Close Premium member Presentation Transcript seminar on Blow-Fill-Seal Technology : For Parenteral Presented by Shilar Anil S. ( M.Pharm I st Sem ) SND College of Pharmacy Babhulgaon , Yeola . seminar on Blow-Fill-Seal Technology 1Content -: Introduction. Concept. Working. Requirement. Advantages. Application. 2 Content -Introduction -: Blow-Fill-Seal technology refers to the manufacturing technique used to produce small, (0.1mL) and large volume, (500mL +) liquid filled containers. Blow-fill-seal is a specialised packaging technology using in-line forming and sealing of a polymeric material to a container of choice. Introduction - 3History - : Blow-Fill-Seal technology was originally developed in Europe in the 1930s. It was introduced in the United States in the 1960s. But over the last 20 years it has become more prevalent within the pharmaceutical industry. History - 4Today -: It is now widely considered to be the superior form of aseptic processing by various medicine regulatory agencies. U.S. Food and Drug Administration (FDA) in the packaging of pharmaceutical and healthcare products. Today - 5Concept -: The basic concept of blow fill seal (BFS) is that a container is formed, filled, and sealed in a continuous process without or less human intervention, in a sterile enclosed area inside a machine. Thus this technology can be used to Aseptically Manufacture sterile pharmaceutical liquid dosage forms. Concept - 6How it is work ?: The BFS cycle can be divided into the following main steps - Step 1: Parison Extrusion. Step 2: Container molding. Step 3 : Container Filling. Step 4: Container Sealing. Step 5: Container Discharge. How it is work ? 7Step 1:Parison Extrusion - : Firstly pharmaceutical plastic resin is vertically heat extruded through a circular throat, to form a tube called the Parison . Step 1:Parison Extrusion - 8Slide 9: 9 9 9 Injection Extruder - Fig. Injection Extruder. Parison Tube: Parison Tube 10 Fig. Parison ExtrusionStep 2: Container molding - : This extruded tube is then enclosed within a two-part mould, and the tube is cut above the mould. Step 2: Container molding - 11 Mould: Mould 12 Fig. Container moldingStep 3 :Container Filling - : The mould is transferred to the filling zone, or sterile filling space where filling needle mandrels are lowered and used to inflate the plastic to form the container within the mould. Step 3 :Container Filling - 13 Mandrels: 14 Mandrels Fig. Container FillingStep 4: Container Sealing - : The mandrel is used to fill the container with liquid, following filling, the mandrels are remove and a secondary top mould seals the container. 15 Step 4: Container Sealing - Top mould: 16 Top mould Fig. Container SealingStep 5: Container Discharge - : Finally, the filled container is discharge from mould. 17 Step 5: Container Discharge - Fig. Container Discharge.BFS Cycle- : All actions take place inside a sterile chamber inside the machine. The product is then discharged to a non-sterile area for labelling, packaging and distribution. 18 BFS Cycle- 18 1 2 3 4 Discharge Fig. BFS cycleSlide 19: 19 Fig. ALP model 624 BFS Machine. Fig. Mould. Fig. BFS ContainerMaterial use for container -: 20 Material use for container - Material Polyethylene P olypropylene Polyvinyl chloride PolyesterRequirement for process -: Sterile-air is used. BFS machinery and its surrounding barriers should be designed to prevent the potential for extraneous contamination. Environment surrounding BFS machinery should generally meet Class 100,000 (ISO 8), or better, standards, depending on the design of the BFS machinery and the surrounding room. 21 Requirement for process -Slide 22: HEPA-filtered or sterile air provided should be used during the steps when sterile products or materials are exposed. (e.g. parison formation, container molding or filling steps). Air in the critical area should meet Class 100 (ISO 5) microbiological standards during operations. Only person who have been qualified and appropriately gowned should enter the classified environment surrounding the BFS machinery. 22Advantages -: This manufacturing technology includes economies in container closure processing. Reduced human intervention. Often used for filling and packaging ophthalmic. The same advantages that Blow/Fill/Seal brings to these products quality/sterility assurance, processing efficiencies, flexibility in container design. Make it a viable delivery option for injectable products Vs traditional glass or plastic vials. 23 Advantages -Slide 24: The code numbers and variable data such as batch number and expiry date can be moulded into the container itself rather than being added at a subsequent stage. Cleaning and sterilisation of prefabricated containers and closures is not required. There is no need to purchase and stock a range of prefabricated containers and their closures. 24Application -: Injectable products. For Ophthalmic Preparation. Respiratory Product. 25 Application -References -: Pharmaceutical Engineering Guides for New Renovated Facilities Volume3 Sterile Manufacturing Facilities,First Edition. International Society for Pharmaceutical Engineering. Pharmaceutical & Medicinal Packaging News, September 2009, Vol. 17, No. 9. Recent Technical Advancements in Blow-Fill-Seal Technology, report by. Charles H Reed ( Sales Manager, . Weiler Engineering, Inc). Aseptic Production of Pharmaceuticals in Boehringer Ingelheim Using Blow-Fill-Seal Technology a report by Boehringer Ingelheim. PHARMACEUTICAL MANUFACTURING HANDBOOK Production and Processes SHAYNE COX GAD, PH.D., D.A.B.T. Gad Consulting Services Cary, North Carolina. 26 References -Slide 27: 27 Blow-Fill-Seal Pharmaceutical Packaging – Towards Safe and Convenient Medical Containers, a report by Dr Anders Löfgren1 , Professor Arne Brodin and Eva Sjökvist-Saers. ISO 14644-1: Cleanrooms and Associated Controlled Environments, Classification of Air Cleanliness. Price, J., “Blow-Fill-Seal Technology: Part I, A Design for Particulate Control,” Pharmaceutical Technology, February, 1998. Thanks…Slide 28: ? Q. Task ? 28