Design Considerations for Parenteral Production Facility

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Design Considerations for Parenteral Production Facility

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Presented by SEMINAR ON Parag V. Ingle M. Pharm – II nd sem. Department of Industrial Pharmacy, H. R. Patel Institute of Pharmaceutical Education and Research, Shirpur . Design Considerations for Parenteral Production Facility

CONTENTS:

CONTENTS Introduction Need of Design Consideration for Parenteral Environmental Control Zones Design Concepts HEPA Filter Laminar Air Flow (LAF) Systems Conclusion 4/19/2012 11:00 AM 2

Introduction1,3,11,15 :

Introduction 1,3,11,15 Parenteral : Two Greek Words Para: outside , Enteron : Intestine. “Sterile drug manufacturers should have a keen awareness of the public health implications of distributing a nonsterile product. Poor CGMP conditions at a manufacturing facility can ultimately pose a life-threatening health risk to a patient.” 4/19/2012 11:00 AM 3

Continue……… Aseptic process ::

Continue……… Aseptic process : Personnel training & monitoring Environmental monitoring Facilities design & HVAC system Process simulation (media fills) Controls for preventing contamination and cross contamination: Manufacturing area/equipment clearance and Labeling system. Flow of Product Waste Material and Personnel performance. Controlled sterilization of all product and added ingredients, container/closures, equipment, utensils, product-contract surfaces, routine dynamic environmental monitoring, equipment and environmental capabilities, sterility needs. 4/19/2012 11:00 AM 4

Need of Design Consideration for Parenteral Production1-3,13,14 :

Need of Design Consideration for Parenteral Production 1-3,13,14 For Air, Temperature, Humidity, Pressure, Control. For Product free from pyrogen , microorganisms, particulate matter. Suggest facility be designed to accommodate current and future needs. Suggest facility be designed to be as flexible as possible. For Effective monitoring of the conditions and Good Manufacturing Practices (GMP) and FDA requirements fulfill. Design Objectives: Temperature and relative humidity should be controlled and air pressure regulated. Contamination due to air borne particles should be controlled by an efficient filtration system. eg : HVAC System, HEPA Filter, Laminar Filter 4/19/2012 11:00 AM 5

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Environmental Control Zone Groupings 1,3,11 : Plant Exterior Warehousing General Production and Administrati -on Area Clean Area Weighing, Mixing, and Transfer Area Filling Area Filling Line 4/19/2012 11:00 AM 6

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Principels of Design Consideration for Parenteral Production : Only sterile items are used within the sterile field. Gowning are considered to be sterile. Persons who are sterile touch only sterile items areas. Anything that encloses sterile contents are considered to be sterile. Sterile areas are continuously kept in view and Sterile persons keep well within the sterile area. Design concepts 1,3-5,7,9,12,13 : 4/19/2012 11:00 AM 7

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Personnel Flow food facilities Quality Control Wall and Floor Treatment Glass Bead Sterilize Communication 4/19/2012 11:00 AM 8

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Change Rooms : Apparel Storage Cabinet Handwash Station : Shoes. 4/19/2012 11:00 AM 9 Continue………

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Air Shower velocity of 20-22m/s Air tight Door PVC Flap/Swing Doors Washer Selection Sampling Booth Pass Box 4/19/2012 11:00 AM 10 Continue………

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Building Design & Layout: 1. Sharp corners 2. Tile joints in the floor should be carefully sealed 3. Epoxy painting 4. Lighting layout 5. To prevent fungus growth and eliminate air leakage. Designing the Sterile Processing Department: Efficient infrastructure to support the processing of instruments. Limit the number of staff. Limit the movement of staff + Proper layout of surgical instruments. The number of washers and sterilizers will determine the number and type of steam-sterilizers, gas-sterilizers, plasma sterilizers and other equipment. Traditional control of temperature, humidity , suspended particulates, air flow velocity and air flow patterns, Cross contamination, noise, vibration . 4/19/2012 11:00 AM 11

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Definition of Clean room: PART 1: Specification for control environmental clean rooms,work stations and clean air devices. PART 2: Guide to construction and installation of clean rooms, work stations and clean air devices PART3: Guide to the operational procedure and disciplines applicable to clean rooms, work stations and clean air. Critical and General area of a clean room: The production where contamination can gain direct access to the process and area often protected by localized Laminar –Flow clean benches and workstations. The rest of the clean room where contamination will not gain direct entry into the product but should be kept clean because of the transfer of contamination into the critical area. 4/19/2012 11:00 AM 12

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HEPA/ULPA filters on ceiling Exhaust vents on floor Drains in aseptic processing areas are inappropriate Airlocks and interlocking doors to control air balance Seamless and rounded floor to wall junctions Readily accessible corners Floors, walls, and ceilings constructed of smooth hard surfaces that can be easily cleaned Limited equipment, fixtures and personnel Layout of equipment to optimize comfort and movement of operators General Cleanroom Design : 4/19/2012 11:00 AM 13

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Classification Of Clean Rooms : (1) Class 100,000 : (2) Class 10,000 : (3) Class 1,000 : (4) Class 100 : Class 10,000 cleanroom Class 100 cleanroom 4/19/2012 11:00 AM 14

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Facilities : Cleanroom Classification 4/19/2012 11:00 AM 15

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ENVIRONMENTAL CONTAMINATION CONTROL SYSTEM AND DESIGN: Heating Ventilation and Air Conditioning (HVAC) Systems: HVAC systems are an internal part of environmental control system design. to provide a specific set of environmental conditions required for the manufacturing process. 4/19/2012 11:00 AM 16

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Temperature and Humidity Control: Temperatures in the 68-74°F ( 19-23°C). 45-55% RH range. Normal humidity levels achieved with air conditioning systems. Aerosol Behavior: Gravitational forces-setting action due to gravity. Air Filtration: Main method for airborne contamination control in production areas. Ventilation: Determined by the number of people working in the environment. the number of air changes per hour. Entry and Exiting: 4/19/2012 11:00 AM 17 Continue………

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Air Handling System Design: Motors for supply air/return air fans should have two speeds. one for 10% to 20% and the second for 100% of fan capacity. Cooling and heating coil maintain air speeds. Air Flow Pattern : Air flow velocities of 0.36 m/s to 0.56 m/s (70 fpm to 110 fpm) are recommended as standard design for laminar flow clean room systems. 4/19/2012 11:00 AM 18 Continue………

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HEPA-Filter 1,3,8-10,14 : Filters out particles in the air by forcing them through microscopic pores. OPTIMUM PARAMETERS: Air changes per hour (fresh + re-circulating). Air filtration HEPA 99.97% efficiency. particles 0.3 micrometers (µm) Optimal temperature18 -25 o C and Optimal humidity 15-20%. Function: HEPA filter acts like a sieve. Designed to target much smaller pollutants and particles. Biomedical applications of HEPA filters : HEPA filters are critical in the prevention of the spread of airborne bacterial and viral organisms and infection . 4/19/2012 11:00 AM 19

Classifications of HEPA filters ::

Classifications of HEPA filters : Based on Use : Based on Type : HEPA Type A HEPA filters Type B HEPA filters Type C HEPA filters Type D HEPA filters Type E HEPA filters Type of HEPA Filter Horizontal Flow Vertical Flow 4/19/2012 11:00 AM 20

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LAMINAR AIR FLOW (LAF) SYSTEMS 1,3-6,12,15 : “ HEPA”filters + Lamination of Air flow. Laminar airflow system should provide a homogenous air speed of 0.45 m/s ±2.0% at the working position. Gives “AN ULTRA CLEAN AIR” Fig: Laminar flow cabinet. APPLICATIONS: Enhanced recovery of fastidious gram positive organism and Filtration of enzyme solutions. 4/19/2012 11:00 AM 21

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Laminar Flow Clean Air Benches: Specially designed for particulate and bacterial free sterile atmosphere to handle non hazardous non Pathogenic samples, cell & tissue cultures, alimentation controls in microbiology . Parameter Specification PREFILTER Efficiency - 99.9 % down to 5 microns . FINAL FILTER Efficiency - 99.997% down to 0.3 microns. FANS direct driven motor. FILTER GRILLS Made of anodized Perforated Al. Sheet SIDE PANELS Removable type ELECTRICAL Single phase 220 / 250 V AIR FLOW 90 ft.per min (0.45m / sec) NOISE LEVEL 40-50 db. VIBRATION LEVEL Less than 40 micro-inches (1 micron) LIGHTING Minimum 645 lux 4/19/2012 11:00 AM 22

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Horizontal airflow Vertical airflow Unidirectional airflow The operator should never come between the air source and the product . 4/19/2012 11:00 AM 23

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Classifications: 1) Vertical Laminar air Flow Class 100: The particle count of size 0.5 micron and larger and less than one hundred particle/ cubic feet, in the area of work. 2) Vertical Laminar Air Flow Class 10,000: The particle count of size 0.5 micron and larger and less than ten thousand particle per cubic feet . 3) Vertical Laminar Air Flow Class 1,00,000: The particle count of size 0.5 micron and larger and less than one lac particle per cubic feet. Applications (Vertical Laminar Air Flow) : Variety of applications such as Quality control labs of pharmaceutical Industries, microcircuit , electronic assembly, manufacturing applications and Deoxy Ribonucleic Acid Thermo cycling. 4/19/2012 11:00 AM 24

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Conclusion 1-3,5,7,11,14 Parenteral dosage form differ from other dosage form. Parenteral product directly enter into systemic circulation. So for that Parenteral preparation should be free from any type of pyrogen , micro-organisms and particulate matter. it is important to control the environment, proper design facility for quality, stability and safty of final product. 4/19/2012 11:00 AM 25

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Thank You For Your Attention 4/19/2012 11:00 AM 26