1.A Seminar On. PRESENTED BY:-Nimbalkar Pratik R. M.Pharm. (Sem-I) Quality Assurance Techniques Roll.No.- 08 1

2. ENVIRONMENT CONTROL SYSTEMHVAC system-Air filtration -Pressurization -Temperature -Humidity -Airborne cleanlinessArchitectural or isolation system-Walls -Flooring materials -Door & window -Glove box/isolator -Door interlocking devicePersonnel contamination control- Uniform - Mask - GlovesMonitoring and control systemCleaning and disinfection system -Material -Method -Equipment2 3. PURPOSE1)Provide a specific set of environment condition required for the manufacturing process.1) Heating and coolingFUNCTIONSUSES2) Humidifying and dehumidifying 3) Cleaning the air 4) Regulate air flow 5) Pressurization1) To prevent contamination 2) To provide comfortable working conditions3 4. Heating is significant in maintaining adequate room temperature especially during cold weather conditions.Process of "changing" or replacing air in any space to control temperature or remove any combinationAir conditioning and refrigeration are provided through the removal of heat 4 5. Objective Goal: To develop an automotive air-conditioning system that issmaller and lighter than with conventional technology. The Challenge: The system must be capable of keeping atemperature of 22C inside a room, with an outside temperature of 40C. Also, the system must be an efficient heating system, keeping an internal temperature of 15C with an outside temperature of 0C. 5 6. H.V.A.C H.V.A.C Heating, Ventilation and Air Conditioning system The HVAC regulates Room Temperature Humidity Air Quality Air Flow6 7. H.V.A.C COMPONENTS: Air conditioners AHUs Dehumidifiers/ Heater Filters (Pre & HEPA) Dust extractore Ducting (for delivery of controlled air) Supply fans Smoke detectores Damper Humidity/Temp./ Pressure sensor Heating & Cooling coils 7 8. DESIGN PARAMETERS Energy efficiency Cleanliness Cost Temperature uniformity Humidity control Chemical exhuast efficiency Noise control8 9. Air handling unit Blower/Fan Heating and cooling coils Humidifiers DehumidifiersAir distribution Network Duct network Insulators Dampers or valvesAir filters Pre-filter Intermediates or low efficiency filter Terminal filter (HEPA filter)9 10. HVAC SPECIFICATIONS Temperature18-23 o CRelative humidity45% 5% Dry powder = 30% 5% Moisture sensitive drug = 5%Air velocity80- 120 ft/minAir flowLaminar airflowPressure gradient15 PascalParticulate count (Critical area)5%NMT 100 particlesAir system failure alarm (ASFA) 10 11. A Particulate monitoring in airMonthly DailyB HEPA filter integrity testingYearlyC Air change rateMonthlyD Temperature and HumidityDailyE Air pressure differentialsDailyF Microbiological monitoringDaily ( In aseptic areas) Decreased frequency in other areas 11 12. Sources of contamination A. External Sources The external contamination is controlled primarily by 1. High efficiency filtration, 2. Space pressurization and 3. Sealing of space penetrations12 13. B. Internal Sources Control is primarily through airflow design. Construction finishes; personnel and garments; materials and equipments.Important control precautions include: 1. Walls, floors, ceiling tiles, doors, and windows. 2. People must wear garments. 3. Materials and equipment must be cleaned before entering the clean room. 4. Room entrances such as air locks . 5. Air showers are used to remove contaminants from personnel before entering .13 14. AIR FLOW PATTERNS Workbench (vertical)Cabin/ boothCeiling14 15. Air conditioners An air conditioner designed to change the air temperature and humidity within an area (used for cooling and sometimes heating depending on the air properties at a given time). The cooling is typically done using a simple refrigeration cycle, but sometimes evaporation is used,15 16. AHUs The air handling unit is an equipment consisting of fans, heating and cooling coils, air-control dampers, filters . It collect and mix outdoor air with that returning from the building space. The air mixture is then cooled or heated, after which it is discharged into the building space through a duct16 17. Dehumidifiers/ Heater In dehumidifier evaporator and condenser coils are placed in the same air path, and the entire unit is placed in the environment . Having the condenser coil in the same air path as the evaporator coil produces warm, dehumidified air The air next passes over the condenser coil, re-warming the now dehumidified air.17 18. Filters A particulate air filter is a device composed of fibrous materials which removes solid particulates such as dust, pollen grains, mold, and bacteria from the air A chemical air filter consists of an absorbent or catalyst for the removal of airborne molecular contaminants such as volatile organic compounds or ozone Air filters are used in applications where air quality is important.18 19. Dust extractore A dust collection system is an air quality improvement systemDust collection systems work on the basic formula of capture, convey and collect.19 20. Ducting (for delivery of controlled air) Ducts are used to deliver and remove air. A duct system is often called as ductwork.Materials 1. Polyurethane and Phenolic insulation panels (pre-insulated air ducts) 1. Fiberglass duct board (preinsulated nonmetallic ductwork 1. Flexible Ducting 20 21. Supply fans Flow rate controlled by inlet vanes or outlet dampers on the fan. The supply fan speed is controlled to maintain pressure in the supply duct.21 22. Smoke detectars A smoke detector is a device that detects smoke, typically as an indicator of fire. Commercial, industrial, and mass residential devices issue a signal to a fire alarm system22 23. Damper A plate or gate placed in a duct to control air flow by increasing friction in the duct. Smoke damper A damper or adjustable louver designed to augment the ventilation of a space during a fire.23 24. Humidity/Temp./ Pressure sensors This function board is used to measure humidity. Temperature sensors are devices used to measure the temperature.A pressure sensor measures pressure, typically of gases or liquids. 24 25. Heating & Cooling coils A heating coil is a piece of equipment built for efficient heat transfer from one medium to anotherA cooling coil cools air blown across it and into the building occupied space. 25 26. What can HVAC do? Control airborne particles, dust and micro-organisms Maintain room pressure (delta P) Maintain space moisture (Relative Humidity) Maintain space temperature26 27. What HVAC cant do? 1. HVAC can not clean up the surfaces of a contaminatedplaces, room or equipment 2. HVAC can not compensate for workers who do not followprocedures27 28. Animated representation of working of AHU/HVAC28 29. ROOM PRESSURIZATION The clean room is positively pressurized with respect to the adjacent areas. This is done by supplying more air and extracting less air from the room than is supplied to it The pressure differential should be of sufficient magnitude to ensure containment and prevention of flow reversal, but should not be so high as to create turbulence problems.Example :-Cascade airlock: high pressure on one side of the airlock and low pressure on the other. 29 30. TYPES OF CLEAN ROOMS Horizontal Clean Room Horizontal Laminar flow(HEPA filters in a wall force clean air from one side of the room to other.) Vertical Clean Room Vertical Laminar flow(HEPA filters on the ceiling push clean air down to the floor.)30 31. FOUR BASIC PRINCIPLES OF CLEAN ROOM Not To Bring Any DustNot To Accumulate Any DustNot To Generate Any DustTo Remove Any Dust Quickly31 32. Validation of AHU/HVAC System Temperature control testHumidity control testFilter integrity testAir velocity testAir flow pattern(Smoke test)Microbial test32 33. Objective:- To demonstrate the ability of the HVAC system to control temperature. Equipment- Thermometer Test procedure:Environment is divided by a grid Size of square- 60cm 60cm or more Sampling location- work height Result compare with specification60 60 cmAcceptance criteria:- Temp. 20 2C 33 34. Objective:- To demonstrate the ability of the HVAC system to control humidity. Equipment- Automatic humidity recorderTest procedure:Environment is divided by a grid Size of square- 60cm 60cm or more Sampling location- work height Result compare with specification Acceptance criteria:- Humidity: 45 5%60 60 cmFig.. Digital moisture meter34 35. Filter Integrity Test:Objective:- To provide evidence of the integrity of the HEPA filter Acceptance criteria:99.97 efficiency- 0.03% particles of 0.3 m 99.99 efficiency- 0.01% particles of 0.3 m100%0.03%HEPA filter35 36. DOP (Dioctyl phthalate) Test HOT DOPCOLD DOP Efficiency test Integrity test Vaporization Pressurization Mono-disperse aerosol Poly-disperse aerosol 0.3 m > 0.3 m < 0.3 m 0.3 m (20-30 %) 36 37. Air flow velocity and uniformity test:Test procedure:Environment is divided by grid Measure by Airflow meterFig.- Airflow meterAcceptance criteria:Vertical flows0.30 m/sec20%Horizontal flows0.45 m/sec20% Fig.- laminar air flow unitAction: Deviation indicates blockage of filter Solution : Alteration of fan speed HEPA filter replacement 37 38. Test procedure:- (smoke test) Generate visible smoke upstream from the work zone Establish the reference point Videotape the direction of the flow in both case Determine the direction 38 39. MICROBIOLOGICAL TESTS :Solid growth media Sampling conditions Sampling in the at rest condition may be continued at an agreed frequency to monitor baseline contamination levels. The operational conditions and the activities being performed at the time of testing should be recorded.Incubation conditionsIncubation of samples, inverted, at 20 25C for at least 5 days is suitable for the growth of mould and fungi. Incubation of samples, inverted, at 30 - 35C for at least 2 days is suitable for the growth of bacteria.39 40. 1. Health-Care Facilities Residences 2. Educational Facilities 3. Laboratories 4. Pharmaceutical Industries 5. Non Pharmaceutical Industries 6. Tall Buildings 7. Hotels 8. Places of Assembly 9. Nuclear Facilities 10. Commercial and Public Buildings 40 41. HVAU isHeartof Pharmaceutical Industries that purifythe outside air and circulate all over the areas.HVAC system provide specific set of environment condition which required to make quality product sotherefore it must be validated. 45 42. References : www.cedengineering.com. www05.abb.com A. Bhatia, B.E. PDH Online | PDH Center,5272 Meadow Estates Drive,Fairfax, VA 22030-6658. www.who.int www.pharmaguideline.com en.wikipedia.org www.pharmamanufacturing.com www.cleanairtech.com.au42 43. 43