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See all Premium member Presentation Transcript Slide 1: Dr. Raju Jukanti Aseptic Processing Operation St. Peter’s Institute of Pharmaceutical Sciences Kakatiya University, Warangal-506 009, A.P Slide 2: Introduction Sterile manufacturing operations Terminal sterilization and Aseptic processing operations Terminal sterilization – product, container, and closure have a low bio-burden but are not sterile Aseptic processing - Sterile products, which cannot receive a post filling lethal treatment because the product, container cannot withstand terminal sterilization treatments. Aseptic processing the drug product, container, and closure are subjected to sterilization processes separately and then brought together in clean room environment to create the finished product. Slide 3: Minimizing the risk of microbiologic contamination during aseptic processing by employing clean room environments, sterilization validation programs, microbiologic environmental monitoring programs, simulations of sterile processing operations, and personnel training. Sources of microbial contamination in Aseptic processing Personnel borne contaminants Human error Non–routine operations during aseptic process Assembly of sterile equipment prior to use Mechanical failure Inadequate or improper sanitization Transfer of materials within APA Routine operations during aseptic process Airborne contaminants Surface contaminants Failure of sterilizing filter Failure of HEPA filter Inadequate or improper sterilization Slide 4: Contamination Control Airborne contamination Manufacturing systems and facilities that control or minimize exposure to airborne microorganisms can minimize the risk of microbiologic contamination during aseptic processing operations. Maintenance of a hygienic laboratory Frequent disinfection of floors and surfaces Minimizing the traffic in and out of the area Use of laminar air flow devices Use of water with excellent quality and free from microbial contamination. HEPA Filters Aseptic manipulations in laminar airflow units with HEPA filters. FDA recommends the use of HEPA filters at critical locations in aseptic manufacturing operations. Slide 5: Testing HEPA filtered Laminar airflow systems Leak test (DOP test) Air flow velocity (Hot wire anemometer) Airflow pattern (Titanium tetrachloride smoke sticks) Protective Garments Sanitization and facility design Personnel Training Sterilization Systems Slide 6: Types of Laminar Air Flow Cabinet Slide 7: Environmental Monitoring Methods Slide 11: Microbiologic Environmental Monitoring Microbiologic testing of Water Testing the microbiologic quality of the Air Identification of microorganisms Anaerobic culture conditions Air Particulate Monitoring Characterization of Aseptic processes Media fill test (Soybean casein digest broth) Microbiologic contamination rate in aseptic manufacturing operation - Concentration of airborne microorganisms. - Neck area opening of the container being filled. - Length of time the container remains open. Slide 12: Media commonly used for environmental control Slide 13: Quality and shelf life of any product depends on presence and nature of m.o contained in it. Under favourable conditions these m.o proliferate and result in loss of product quality. Microbiological monitoring is an essential part of Q.C. Bacteriological analysis of water is periodically done and the tests are performed. Standard plate count Detection of coliform bacteria Presumptive coliform count Differential coliform count Membrane filteration method Slide 14: Modern approach Dip slides : For detection of Bacteria, Yeast, Fungi Slide 15: Thank U You do not have the permission to view this presentation. In order to view it, please contact the author of the presentation.
Aseptic goutham.atla 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: 941 Category: Education License: All Rights Reserved Like it (1) Dislike it (1) Added: June 27, 2010 This Presentation is Public Favorites: 2 Presentation Description No description available. Comments Posting comment... By: NAGESHVANKADARA (1 month(s) ago) sir can i get this ppt nageshvankadara@gmail.com Saving..... Post Reply Close Saving..... Edit Comment Close By: 88soumya (7 month(s) ago) nice ppt .plz send it to my mail [soumyakantamohanty88@gmail.com] Saving..... Post Reply Close Saving..... Edit Comment Close By: mrudulasomisetty (12 month(s) ago) hiiiiiiiii sir the presentation was good and can u please tell me the books which you have reffered please do reply sir Saving..... Post Reply Close Saving..... Edit Comment Close By: abidaazam (12 month(s) ago) it was usefull presentation, requested to mail please at my id abida2020@yahoo.com Saving..... Post Reply Close Saving..... Edit Comment Close By: minhasiub (14 month(s) ago) nice presentation, please send to my e-mail; minhasiub@hotmail.com Saving..... Post Reply Close Saving..... Edit Comment Close loading.... See all Premium member Presentation Transcript Slide 1: Dr. Raju Jukanti Aseptic Processing Operation St. Peter’s Institute of Pharmaceutical Sciences Kakatiya University, Warangal-506 009, A.P Slide 2: Introduction Sterile manufacturing operations Terminal sterilization and Aseptic processing operations Terminal sterilization – product, container, and closure have a low bio-burden but are not sterile Aseptic processing - Sterile products, which cannot receive a post filling lethal treatment because the product, container cannot withstand terminal sterilization treatments. Aseptic processing the drug product, container, and closure are subjected to sterilization processes separately and then brought together in clean room environment to create the finished product. Slide 3: Minimizing the risk of microbiologic contamination during aseptic processing by employing clean room environments, sterilization validation programs, microbiologic environmental monitoring programs, simulations of sterile processing operations, and personnel training. Sources of microbial contamination in Aseptic processing Personnel borne contaminants Human error Non–routine operations during aseptic process Assembly of sterile equipment prior to use Mechanical failure Inadequate or improper sanitization Transfer of materials within APA Routine operations during aseptic process Airborne contaminants Surface contaminants Failure of sterilizing filter Failure of HEPA filter Inadequate or improper sterilization Slide 4: Contamination Control Airborne contamination Manufacturing systems and facilities that control or minimize exposure to airborne microorganisms can minimize the risk of microbiologic contamination during aseptic processing operations. Maintenance of a hygienic laboratory Frequent disinfection of floors and surfaces Minimizing the traffic in and out of the area Use of laminar air flow devices Use of water with excellent quality and free from microbial contamination. HEPA Filters Aseptic manipulations in laminar airflow units with HEPA filters. FDA recommends the use of HEPA filters at critical locations in aseptic manufacturing operations. Slide 5: Testing HEPA filtered Laminar airflow systems Leak test (DOP test) Air flow velocity (Hot wire anemometer) Airflow pattern (Titanium tetrachloride smoke sticks) Protective Garments Sanitization and facility design Personnel Training Sterilization Systems Slide 6: Types of Laminar Air Flow Cabinet Slide 7: Environmental Monitoring Methods Slide 11: Microbiologic Environmental Monitoring Microbiologic testing of Water Testing the microbiologic quality of the Air Identification of microorganisms Anaerobic culture conditions Air Particulate Monitoring Characterization of Aseptic processes Media fill test (Soybean casein digest broth) Microbiologic contamination rate in aseptic manufacturing operation - Concentration of airborne microorganisms. - Neck area opening of the container being filled. - Length of time the container remains open. Slide 12: Media commonly used for environmental control Slide 13: Quality and shelf life of any product depends on presence and nature of m.o contained in it. Under favourable conditions these m.o proliferate and result in loss of product quality. Microbiological monitoring is an essential part of Q.C. Bacteriological analysis of water is periodically done and the tests are performed. Standard plate count Detection of coliform bacteria Presumptive coliform count Differential coliform count Membrane filteration method Slide 14: Modern approach Dip slides : For detection of Bacteria, Yeast, Fungi Slide 15: Thank U