logging in or signing up final ppt NISHANT verma (M. PHARMA) 1010835 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: 1187 Category: Science & Tech.. License: All Rights Reserved Like it (0) Dislike it (0) Added: February 27, 2011 This Presentation is Public Favorites: 2 Presentation Description No description available. Comments Posting comment... By: aartishrivastava (11 month(s) ago) hi how r u...sir i if u have SOP material (industerial pharmacy) ...so plz send me i need must on shrivastava.shri116@gmail.com.....im aarti shrivastava ... Saving..... Post Reply Close Saving..... Edit Comment Close By: gupta23 (13 month(s) ago) this is very helpful and informative. the pictorial slides are also informative. one of the best presentation i have found Saving..... Post Reply Close Saving..... Edit Comment Close Premium member Presentation Transcript Slide 1: Factory layout of Parenteral Product Amity Institute of Pharmacy Guidance by: Mrs. Nimisha Presented by: Nishant Verma M. Pharm. 2 nd sem. PHARMACEUTICAL FACTORY LOCATION SELECTION : PHARMACEUTICAL FACTORY LOCATION SELECTION DEFINITION : DEFINITION Plant layout refers to the arrangement of physical facilities such as machinery, equipment, furniture etc. with in the factory building in such a manner so as to have quickest flow of material at the lowest cost and with the least amount of handling in processing the product from the receipt of material to the shipment of the finished product. According to Riggs, “the overall objective of plant layout is to design a physical arrangement that most economically meets the required output – quantity and quality.” According to J. L. Zundi, “Plant layout ideally involves allocation of space and arrangement of equipment in such a manner that overall operating costs are minimized. Plant Layout: Plant layout- is a co- ordinated effort to achieve the final objective to integrate machines, Materials, personnel for economic production. It is the organized properly planned Inter-department and Intra-department arrangements. Layout -can be described as location of different departments & arrangement of machinery in a each department. Principle factors to be considered are : Economic consideration-construction & operating cost. The process requirement Convenience of operation Safety Future expansion Modular construction 4 Plant Layout CONDITIONS FOR SELECTION OF SITES: Availability of raw material Nearness of the market Transport facilities Availability of power & fuel Nearness to Labour supply Nearness to capital supplies Existence of the related industries 5 CONDITIONS FOR SELECTION OF SITESCont’d…: Climatic conditions Financial & other aids Availability of water Absence of restrictions Availability of suitable Land Community attitudes Location Others 6 Cont’d…Slide 7: PARENTERALS * Parenteral products are products that are administered to the body by injection. Because this route of administration bypasses the normal body defence mechanisms. *It is essential that these products are prepared with a higher degree of care and skills than utilised in preparing conventional oral or topical products. *The finished product must be sterile, non- pyrogenic and free from extraneous insoluble materials. These products must satisfy a number of requirements for parenteral products.Slide 8: Parental Routes of Administration: Most Commo : 1 . Subcutaneous ( SC; SQ ;Sub Q ) 2 . Intramuscular (IM) 3. Intravenous (IV) Others: 4. Intra-arterial (IA) 5 . Intrathecal 6. Intraarticular 7. Intrapleural 8 . Intracardial 9. Intradermal (Diagnostic)Slide 9: Necessities of Parenteral preparations : Sterility (must) Pyrogen (must) Free from particulate matter (must) Clarity (must) Stability (must) Isotonicity (should) Solvents or vehicles used must meet special purity and other standards. Restrictions on buffers, stabilizers, antimicrobial preservative. Do not use coloring agents. Must be prepared under aseptic conditions. Specific and high quality packaging.Sterile Production: Objectives To review basic GMP requirements in the manufacture of sterile pharmaceutical products To review air classifications for activities related to the manufacture of sterile products To review the different types of sterilization methods To review quality assurance aspects in the manufacture and control of sterile products To consider current issues applicable in your country Sterile ProductionSterile Production: General Considerations Production in clean areas Filtered air supplied Airlocks for entry personnel and/or equipment materials Separate areas for operations component preparation (containers and closures) product preparation filling, sterilization, etc. Sterile ProductionSlide 12: Production facilities: Clean- up area Preparation area Aseptic area Quarantine area Finishing and packaging area Sterile areaSlide 13: S T O C K R O O M COMPOUNDING AREA CLEAN UP AREA ASEPTIC AREA QUARANTINE AREA STERILIZATION STORAGE AND TRANSPORT PACKING AND LABELLING LAY OUT OF PARENTERAL MANUFACTURING AREASlide 14: Clean- up area: Free from dust , fibres & micro-organisms. Constructed in such a way that should withstand moisture, steam & detergent. Ceiling & walls are coated with material to prevent accumulation of dust & micro-organisms. Exhaust fans are fitted to remove heat & humidity. The area should be kept clean sodium that to avoid contamination to aseptic area. The containers & closures are washed & dried in this area.Slide 15: Biogical clean rooms (BCR ) *There are three standards for industrial clean rooms (ICR) Class - ISO14644 US Federal Standard 209e Japanese Standard JIS B9920 ISO 8 (Class 100,000) (Class 100,000) ISO 7 (Class 10,000) (Class 10,000) ISO 6 (Class 1,000) (Class 1,000) ISO 5 (Class 100) (Class 100) ISO 4 (Class 10) (Class 10) ISO 3 (Class 1) * (Class 1)Slide 16: Class – 10,000 Class - 1000 CLEAN ROOM Class - 100Slide 17: Preparation area: The ingredients are mixed & preparation is prepared for filling Not essential that the area is aseptic Strict precaution is taken to prevent contamination from outside Cabinets & counters: SS Ceiling & walls : sealed & paintedSlide 18: Aseptic area: Filtration & filling into final containers & sealing is done The entry of outside person is strictly prohibited To maintain sterility, special trained persons are only allowed to enter & work Person who worked should wear sterile cloths Should be subjected for physical examination to ensure the fitness Minimum movement should be there in this area Ceiling & walls & floors : sealed & painted or treated with aseptic solution and there should not be any toxic effect of this treatmentSlide 19: Cabinets & counters AIR: Free from fibres, dust & micro organisms HEPA filters are used which removes particles upto 0.3 micron Fitted in laminar air flow system, in which air is free from dust & micro organisms flows with uniform velocity Air supplied is under positive pressure which prevents particulate contamination from sweeping UV lamps are fitted to maintain sterilitySlide 20: Quarantine area: After filling, sealing & sterilization the products or batch is kept in this area The random samples are chosen and given for analysis to QC dept. The batch is send to packing after issuing satisfactory reports of analysis from QC If any problem is observed in above analysis the decision is to be taken for reprocessing or others..Slide 21: Finishing and packaging area: After proper label, the product is given for packing Packing is done to protect the product from external environment The ideal Packing is that which protects the product during transportation, storage, shipping & handling. The labeled container should be packed in cardboard or plastic containers Ampoules should be packed in partitioned boxes.Sterile Production: Premises Design avoid unnecessary entry of supervisors and control personnel operations observed from outside In clean areas, all exposed surfaces smooth, impervious, unbroken minimize shedding and accumulation of particles, microorganisms permit cleaning and disinfection no uncleanable recesses, ledges, shelves, cupboards, equipment sliding doors undesirable false ceilings sealed Sterile ProductionSterile Production: Premises (continued) In clean areas, all exposed surfaces (2) proper installation of pipes and ducts, no recesses, no unsealed openings sinks and drains avoided, and excluded in Grade A and B areas where installed, design, location, maintenance effective cleanable traps air breaks preventing backflow floor channels open and easily cleanable Sterile ProductionSterile Production: Premises (continued) Changing rooms designed as airlocks effective flushing with filtered air separate rooms for entry and exit desirable hand washing facilities interlocking system for doors visual and/or audible warning system Pressure differential approximately 10 to 15 Pascals indicators – results regularly recorded Restricted access – e.g. use of barriers Sterile ProductionSterile Production: Premises (continued) Pathogenic, highly toxic, radioactive materials Pressure cascade may be different Decontamination procedures – air, equipment, garments Qualification including airflow patterns no risk to the product Warning system to indicate failure in air supply Sterile ProductionSlide 26: Precautions / necessities in mfg.: Free from foreign particles Free from micro organisms Isotonic with body fluids As they are in LVP no bacteriostatic agents are added Free from pyrogensSlide 27: Examples: Mannitol injection IP: Contains 5, 10 , 15, 20 % of mannitol Used as : Diagnostic aid Renal function determination As a diuretic Mannitol & Sodium chloride injection IP: Contains 5, 10 , 15, 20 % of mannitol & 0.45 % of Sodium chloride Used as : As a diureticPHARMACEUTICAL FECTORY LAYOUT AND PLANING: PHARMACEUTICAL FECTORY LAYOUT AND PLANING MAL = Material Air Lock, PAL = Personnel Air Lock Group Session – modified layoutSlide 29: Machine Room Lounge 2 3 Ampule Filling & Sealing 1 Filling Room 1 4 General office 2 Service Room 2 Sterile compounding 1 DISCH. ROOM Ampule testing General store room Wash Room 2 Sterile bulk mfg. Wash Room 3 Wash rm 4 S s Inspection & Packout Laboratory RM Shipping & Recieving NSSS COOLROOM Capping Area Sterile Corridor STERILE SOL.& POWDER STORE NON-STERILE MANUFACTURING ROOM Wash Room 1 Men's gown up Lobby Women's Locker Room Men's Locker room Non- Sterile Corridor US. FACTORY LAYOUT FOR PARENTERAL SECTIONSlide 31: Thank u You do not have the permission to view this presentation. In order to view it, please contact the author of the presentation.
final ppt NISHANT verma (M. PHARMA) 1010835 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: 1187 Category: Science & Tech.. License: All Rights Reserved Like it (0) Dislike it (0) Added: February 27, 2011 This Presentation is Public Favorites: 2 Presentation Description No description available. Comments Posting comment... By: aartishrivastava (11 month(s) ago) hi how r u...sir i if u have SOP material (industerial pharmacy) ...so plz send me i need must on shrivastava.shri116@gmail.com.....im aarti shrivastava ... Saving..... Post Reply Close Saving..... Edit Comment Close By: gupta23 (13 month(s) ago) this is very helpful and informative. the pictorial slides are also informative. one of the best presentation i have found Saving..... Post Reply Close Saving..... Edit Comment Close Premium member Presentation Transcript Slide 1: Factory layout of Parenteral Product Amity Institute of Pharmacy Guidance by: Mrs. Nimisha Presented by: Nishant Verma M. Pharm. 2 nd sem. PHARMACEUTICAL FACTORY LOCATION SELECTION : PHARMACEUTICAL FACTORY LOCATION SELECTION DEFINITION : DEFINITION Plant layout refers to the arrangement of physical facilities such as machinery, equipment, furniture etc. with in the factory building in such a manner so as to have quickest flow of material at the lowest cost and with the least amount of handling in processing the product from the receipt of material to the shipment of the finished product. According to Riggs, “the overall objective of plant layout is to design a physical arrangement that most economically meets the required output – quantity and quality.” According to J. L. Zundi, “Plant layout ideally involves allocation of space and arrangement of equipment in such a manner that overall operating costs are minimized. Plant Layout: Plant layout- is a co- ordinated effort to achieve the final objective to integrate machines, Materials, personnel for economic production. It is the organized properly planned Inter-department and Intra-department arrangements. Layout -can be described as location of different departments & arrangement of machinery in a each department. Principle factors to be considered are : Economic consideration-construction & operating cost. The process requirement Convenience of operation Safety Future expansion Modular construction 4 Plant Layout CONDITIONS FOR SELECTION OF SITES: Availability of raw material Nearness of the market Transport facilities Availability of power & fuel Nearness to Labour supply Nearness to capital supplies Existence of the related industries 5 CONDITIONS FOR SELECTION OF SITESCont’d…: Climatic conditions Financial & other aids Availability of water Absence of restrictions Availability of suitable Land Community attitudes Location Others 6 Cont’d…Slide 7: PARENTERALS * Parenteral products are products that are administered to the body by injection. Because this route of administration bypasses the normal body defence mechanisms. *It is essential that these products are prepared with a higher degree of care and skills than utilised in preparing conventional oral or topical products. *The finished product must be sterile, non- pyrogenic and free from extraneous insoluble materials. These products must satisfy a number of requirements for parenteral products.Slide 8: Parental Routes of Administration: Most Commo : 1 . Subcutaneous ( SC; SQ ;Sub Q ) 2 . Intramuscular (IM) 3. Intravenous (IV) Others: 4. Intra-arterial (IA) 5 . Intrathecal 6. Intraarticular 7. Intrapleural 8 . Intracardial 9. Intradermal (Diagnostic)Slide 9: Necessities of Parenteral preparations : Sterility (must) Pyrogen (must) Free from particulate matter (must) Clarity (must) Stability (must) Isotonicity (should) Solvents or vehicles used must meet special purity and other standards. Restrictions on buffers, stabilizers, antimicrobial preservative. Do not use coloring agents. Must be prepared under aseptic conditions. Specific and high quality packaging.Sterile Production: Objectives To review basic GMP requirements in the manufacture of sterile pharmaceutical products To review air classifications for activities related to the manufacture of sterile products To review the different types of sterilization methods To review quality assurance aspects in the manufacture and control of sterile products To consider current issues applicable in your country Sterile ProductionSterile Production: General Considerations Production in clean areas Filtered air supplied Airlocks for entry personnel and/or equipment materials Separate areas for operations component preparation (containers and closures) product preparation filling, sterilization, etc. Sterile ProductionSlide 12: Production facilities: Clean- up area Preparation area Aseptic area Quarantine area Finishing and packaging area Sterile areaSlide 13: S T O C K R O O M COMPOUNDING AREA CLEAN UP AREA ASEPTIC AREA QUARANTINE AREA STERILIZATION STORAGE AND TRANSPORT PACKING AND LABELLING LAY OUT OF PARENTERAL MANUFACTURING AREASlide 14: Clean- up area: Free from dust , fibres & micro-organisms. Constructed in such a way that should withstand moisture, steam & detergent. Ceiling & walls are coated with material to prevent accumulation of dust & micro-organisms. Exhaust fans are fitted to remove heat & humidity. The area should be kept clean sodium that to avoid contamination to aseptic area. The containers & closures are washed & dried in this area.Slide 15: Biogical clean rooms (BCR ) *There are three standards for industrial clean rooms (ICR) Class - ISO14644 US Federal Standard 209e Japanese Standard JIS B9920 ISO 8 (Class 100,000) (Class 100,000) ISO 7 (Class 10,000) (Class 10,000) ISO 6 (Class 1,000) (Class 1,000) ISO 5 (Class 100) (Class 100) ISO 4 (Class 10) (Class 10) ISO 3 (Class 1) * (Class 1)Slide 16: Class – 10,000 Class - 1000 CLEAN ROOM Class - 100Slide 17: Preparation area: The ingredients are mixed & preparation is prepared for filling Not essential that the area is aseptic Strict precaution is taken to prevent contamination from outside Cabinets & counters: SS Ceiling & walls : sealed & paintedSlide 18: Aseptic area: Filtration & filling into final containers & sealing is done The entry of outside person is strictly prohibited To maintain sterility, special trained persons are only allowed to enter & work Person who worked should wear sterile cloths Should be subjected for physical examination to ensure the fitness Minimum movement should be there in this area Ceiling & walls & floors : sealed & painted or treated with aseptic solution and there should not be any toxic effect of this treatmentSlide 19: Cabinets & counters AIR: Free from fibres, dust & micro organisms HEPA filters are used which removes particles upto 0.3 micron Fitted in laminar air flow system, in which air is free from dust & micro organisms flows with uniform velocity Air supplied is under positive pressure which prevents particulate contamination from sweeping UV lamps are fitted to maintain sterilitySlide 20: Quarantine area: After filling, sealing & sterilization the products or batch is kept in this area The random samples are chosen and given for analysis to QC dept. The batch is send to packing after issuing satisfactory reports of analysis from QC If any problem is observed in above analysis the decision is to be taken for reprocessing or others..Slide 21: Finishing and packaging area: After proper label, the product is given for packing Packing is done to protect the product from external environment The ideal Packing is that which protects the product during transportation, storage, shipping & handling. The labeled container should be packed in cardboard or plastic containers Ampoules should be packed in partitioned boxes.Sterile Production: Premises Design avoid unnecessary entry of supervisors and control personnel operations observed from outside In clean areas, all exposed surfaces smooth, impervious, unbroken minimize shedding and accumulation of particles, microorganisms permit cleaning and disinfection no uncleanable recesses, ledges, shelves, cupboards, equipment sliding doors undesirable false ceilings sealed Sterile ProductionSterile Production: Premises (continued) In clean areas, all exposed surfaces (2) proper installation of pipes and ducts, no recesses, no unsealed openings sinks and drains avoided, and excluded in Grade A and B areas where installed, design, location, maintenance effective cleanable traps air breaks preventing backflow floor channels open and easily cleanable Sterile ProductionSterile Production: Premises (continued) Changing rooms designed as airlocks effective flushing with filtered air separate rooms for entry and exit desirable hand washing facilities interlocking system for doors visual and/or audible warning system Pressure differential approximately 10 to 15 Pascals indicators – results regularly recorded Restricted access – e.g. use of barriers Sterile ProductionSterile Production: Premises (continued) Pathogenic, highly toxic, radioactive materials Pressure cascade may be different Decontamination procedures – air, equipment, garments Qualification including airflow patterns no risk to the product Warning system to indicate failure in air supply Sterile ProductionSlide 26: Precautions / necessities in mfg.: Free from foreign particles Free from micro organisms Isotonic with body fluids As they are in LVP no bacteriostatic agents are added Free from pyrogensSlide 27: Examples: Mannitol injection IP: Contains 5, 10 , 15, 20 % of mannitol Used as : Diagnostic aid Renal function determination As a diuretic Mannitol & Sodium chloride injection IP: Contains 5, 10 , 15, 20 % of mannitol & 0.45 % of Sodium chloride Used as : As a diureticPHARMACEUTICAL FECTORY LAYOUT AND PLANING: PHARMACEUTICAL FECTORY LAYOUT AND PLANING MAL = Material Air Lock, PAL = Personnel Air Lock Group Session – modified layoutSlide 29: Machine Room Lounge 2 3 Ampule Filling & Sealing 1 Filling Room 1 4 General office 2 Service Room 2 Sterile compounding 1 DISCH. ROOM Ampule testing General store room Wash Room 2 Sterile bulk mfg. Wash Room 3 Wash rm 4 S s Inspection & Packout Laboratory RM Shipping & Recieving NSSS COOLROOM Capping Area Sterile Corridor STERILE SOL.& POWDER STORE NON-STERILE MANUFACTURING ROOM Wash Room 1 Men's gown up Lobby Women's Locker Room Men's Locker room Non- Sterile Corridor US. FACTORY LAYOUT FOR PARENTERAL SECTIONSlide 31: Thank u