Sahilhusen utility service

• 1.GUIDED BY: Dr. M. R. PATEL Principale & HOD in pharmaceuticsPRESENTEDE BY:SAHILHUSEN I . JETHARA M. PHARM I (2013-14) ROLL NO. - 02DEPARTMENT OF PHARMACEUTICS SHRI B. M. SHAH COLLEGE OF PHARMACEUTICAL EDUCATION 2/21/2014 1 AND REASERCH, MODASA-2013 SHRI B.M.C.P.E.R, MODASA

2. CONTENTS UTILITY SERVICES SERVICE FACILITIES HVACINRODUCTION ROLE IN PHARMACEUTICAL INDUSTRY LEVEL OF PROTECTION COMPONENTS FILTER CLASSES AIR FLOW PATTERNS VALIDATION AND QUALIFICATION PERSONNEL FACILITIES 2/21/2014SHRI B.M.C.P.E.R, MODASA2 3. UTILITY SERVICES 1. 2. 3. 4. 5. 6. 7.8.2/21/2014HVAC PLUMBING DRAINAGE SYSTEM GAS SYSTEM SANITATION WATER FOR PHARMACEUTICAL USE FIRE PROTECTION SYSTEM Services used by a factory include compressed gases, water, vacuum, electricity and room air conditioning SHRI B.M.C.P.E.R, MODASA3 4. 1.HVAC: (The Heating, Ventilating, and Air conditioning) 2.PLUMBING: Portable water shall be supplied under continuous positive pressure in a plumbing system free of defects that could contribute contamination to any drug product. The pipes and fittings must be of quality good enough to withstand the pressure and heat conditions Plumbing2/21/2014inIndustrySHRI B.M.C.P.E.R, MODASA4 5. Compatibility ofthe materials of construction with the characteristics of the waste water must be considered during the design of the facility. For example: Copper plumbing should not be used in drain line for acidic waste water . COLOUR CODEMATERIALSGREYRAW WATERORANGEDISTILED WATERGREENCOOLING WATERWHITE 2/21/2014SHRI B.M.C.P.E.R, MODASAAIR 5 6. 3.DRAINAGE SYSTEMS They remove effluent from spaces , systems, or process. Adequate size easy to clean For biological waste, it should be treated in a proper manner before disposal to not to harm the environment. Dissolved oxygen content in the waste to be disposed in lake or river must be within limits.2/21/2014SHRI B.M.C.P.E.R, MODASA6 7. Biological Waste System2/21/2014SHRI B.M.C.P.E.R, MODASA7 8. Sanitary waste system A separate sanitary waste drainage and vent system is provided to convey waste from toilets, lavatories, non-process service sinks and floor drains. Laboratory waste system A separate laboratory waste drainage and vent system is often provided in cases where acids or caustics used in laboratory processes must be sampled and potentially neutralized before disposal into the sanitary waste system. Hazardous Material Waste and Retention Provided in cases where hazardous materials such as solvents, toxins, radio actives, high concentrations etc. To maintain isolation of the hazardous material for other drainage systems. 2/21/2014 SHRI B.M.C.P.E.R, MODASA 8 9. Process Waste System A separate process waste drainage and vent system is often provided in cases where products used in the manufacturing process must either be contained separately or treated before disposal into the sanitary waste system Storm Drainage System A separate storm drainage system is provided to drain rainwater from all roof and area drains2/21/2014SHRI B.M.C.P.E.R, MODASA9 10. 4.GAS SYSTEMS All gases used in manufacturing and processing operations, including the sterilization process Compressed Air In general compressed air should be supplied by an oil- free type compressor and must be free of oil and oil vapour unless vented directly to a noncontrolled environment area. It should also be dehumidified to prevent condensation of water vapour. Breathing Air Breathing air is generally provided for use to personnel working in hazardous environment. Provided centrally through a breathing air distribution system or at the local level with backpack type breathing air units worn by each person. 2/21/2014SHRI B.M.C.P.E.R, MODASA10 11. Nitrogen Used for the purging of electrical equipment in volatile or explosive environments vacuum Vacuum is utilized in the encapsulation and tablet compression areas. Vacuum Cleaning For dry particulate and powder pickup2/21/2014SHRI B.M.C.P.E.R, MODASA11 12. 5. SANITATION IN THE MANUFACTURING PREMISES Objectives Removal of dirt and other waste material; Minimize the risk of cross contamination between different products in the same area; Reduce the number of micro-organisms in work area; Control pests so that these do not affect the quality of materials to be used in the manufacture of drugs. Cleaning procedure to be followed, including equipment and materials to be used for cleaning.CLEANING AGENTS AND DISINFECTANTS: Cleaning agents help to remove extraneous materials from surfaces. Disinfectants destroy pathogenic and other micro organisms and are used to reduce microbial count in manufacturing area. 12 2/21/2014SHRI B.M.C.P.E.R, MODASA 13. 6.WATER FOR PHARMACEUTICAL USE Water is most widely used material in pharmaceutical manufacturing. A greater volume of water is used in cleaning and rinsing processes than in formulation in most facilities. Regardless of the water volume used in actual drug formulation all pharmaceutical water is subject to cGMPs even when the water does not remain in the finished product. WATER QUALITY REQUIREMENTS The types of water defined in the pharmacopoeial monographs such asPurified Water and Water for Injection (WFI) are known as compendial waters. Other quality waters used in manufacturing, not defined by USP or other recognized compendia are known as non-compendial waters. 2/21/2014SHRI B.M.C.P.E.R, MODASA13 14. Rain waterriver Water purchased in bulkSources of waterDams, pondsMunicipal or civil water LakesWell water2/21/2014SHRI B.M.C.P.E.R, MODASA14 15. MONOGRAPH REQUIREMENTS The monographs require that the water purity is proven byconductivity and total organic carbon (TOC). conductivity test requires measurement of conductivity and water temperature. The conductivity limit varies from 0.6 S/cm at 0 C 3.1 S/cm at 100 C. 1.3 S/cm at 25 C and 2.7 S/cm at 80 C.2/21/2014SHRI B.M.C.P.E.R, MODASA15 16. 7.FIRE PROTECTION SYSTEMS Pharmaceutical manufacturing facilities are withtypically provided with automatic fire suppression and protection system throghout. The provision of specific suppresion and protection throughoutthe facility might be the requirement.2/21/2014SHRI B.M.C.P.E.R, MODASAconsequence of a strict code16 17. Sprinkler Systems Wet Sprinkler System Dry Pipe Sprinkler System Preaction Sprinkler System Antifreeze Sprinkler System Foam-Water Sprinkler System 2/21/2014SHRI B.M.C.P.E.R, MODASA17 18. Wet Sprinkler System2/21/2014SHRI B.M.C.P.E.R, MODASADry Pipe Sprinkler System18 19. Preaction Sprinkler System2/21/2014SHRI B.M.C.P.E.R, MODASAFoam-Water Sprinkler System19 20. SERVICE FACILITIES Medical ServicesCanteen FacilitiesWashing and Toilet FacilitiesProtective Clothing facilitiesChange Rooms FacilitiesEducational Programmes and Training facilitiesSafety Programmes will be covered in the personal facilities.2/21/2014SHRI B.M.C.P.E.R, MODASA20 21. HVAC The Heating, Ventilating, and Air conditioning -HVAC the technologyof indoor environmental comfort. HVAC system based on the principles of thermodynamic, fluid mechanics and heat transfer. HVAC system performs four basic functions: 1.Control airborne particles, dust and micro-organisms 2. Maintain room pressure. 3. Maintain space moisture. 4. Maintain space temperature. 2/21/2014SHRI B.M.C.P.E.R, MODASA21 22. 1. Heating There are different types of standard heating systems. Central heating It is used in cold climates to heat private houses and public buildings. contains a boiler, furnace, or heat pump to heat water, steam, or air, all in a central location such a furnace room in a home or a mechanical room in a large building.Boiler2/21/2014SHRI B.M.C.P.E.R, MODASA22 23. also contains either ductwork, for forced air systems, or piping todistribute a heated fluid .2. Ventilation It is the process of "changing" or replacing air in any space to controltemperature or remove moisture, odors, smoke, heat, dust and airborne particle. Ventilation includes both the exchange of air to the outside as well as circulation of air within the building. Methods for ventilating a building may be divided into mechanical/forced and natural types.Mechanical Ventilation Mechanical ventilation is the use of mechanical air handling systems commonly referred to as heating, ventilation, and air conditioning (HVAC) systemstoB.M.C.P.E.R, MODASA 2/21/2014 SHRI ventilate buildings. 23 24. 2/21/2014SHRI B.M.C.P.E.R, MODASA24 25. Natural Ventilation Natural ventilation is the use of differences in air pressure that exist between the inside of a building relative to the outside of it. These air pressure differences are created by natural forces such as wind and temperature. Air moves into and out of naturally ventilated buildings through windows, doors, vents and other openings incorporated into the building design.2/21/2014SHRI B.M.C.P.E.R, MODASA25 26. 3. Air conditioning Air conditioning and refrigeration are provided through theremoval of heat. Heat can be removed through the process of radiation, convection and cooling through a process called the refrigeration cycle. The system uses mediums such as water, air, ice, and chemicals referred to as refrigerants.2/21/2014SHRI B.M.C.P.E.R, MODASA26 27. WORKING OF HVAC2/21/2014SHRI B.M.C.P.E.R, MODASA27 28. Diagram Of HVAC System2/21/2014SHRI B.M.C.P.E.R, MODASA28 29. System Design Criteria Temperature and Moisture Air Cleanliness Pressurization Building Intake and Exhaust Heating Systems Humidification Systems Dehumidification Systems Supply Air Handling Systems Prime movers2/21/2014SHRI B.M.C.P.E.R, MODASA29 30. Temperature and Moisture Space and process temperature and moisture conditions are generally determined by the product or process performed. Air Cleanliness The level of acceptable airborne contamination within the space must be identified ,for product quality or employee safety. Environmental cleanliness is determined by several factors:The quality of air introduced into the space The quantity of air introduced into the space The effectiveness of air distribution through the space The effectiveness of the removal of the air contaminant2/21/2014SHRI B.M.C.P.E.R, MODASA30 31. Air flow sheets The airflow sheets should be developed on full size drawings and shouldshow air quantities supplied, returned, and exhausted from each space. They also must show air transferred into and out of spaces. The airflow sheet is a useful tool for transfer of information to the owner or user, for agency reviews, for transmission of information to HVAC designers, and for other engineering disciplines.Air Flow Pattern The air distribution has to be appropriate with the class of cleanroom. Air turbulance in the space can cause particulates which have settle onto the floor and work surfaces to become re-entrained in the air. Air turbulance is greatly influenced by the configuration of air supply and return grilles, people traffic and process equipment layout. 2/21/2014SHRI B.M.C.P.E.R, MODASA31 32. Pressurization Space relative pressurization will be determined primarily by requirementsof the product. Where product contamination control is required, the space relative pressurization must be designed to assure that the movement of exfiltred air is from the clean to the less clean areas.Building Intake and Exhaust Careful attention must be paid to the incoming system air quality. An industrial area may have a more corrosive or there are chemical in airquality. These issues must be carefully considered when selecting filtration systems so as to minimize the possibility of product contamination. Careful consideration must be made as to the impacts of building exhaust and relief systems, loading docks and other incidences of vehicle exhaust and electrical generator exhaust 2/21/2014SHRI B.M.C.P.E.R, MODASA32 33. Heating Systems Using steam or hot water as the heat source. Heating can also be provided by electric means that is easily controlled. Cooling System chilled water, condenser water, /anti-freeze solution or other heat exchange fluid may be utilized. Humidification Systems In most cases, air supplied to the space or process will require the addition of moisture to maintain relative humidity conditions. Moisture is generally provided utilizing steam injection and in some cases atomized water utilizing compressed air. Dehumidification Systems For moisture removal These mehtods includes; solid and liquid drying systems 2/21/2014 dry compressed air into the air stream. SHRI B.M.C.P.E.R, MODASA 33 34. Supply Air Handling Systems It assists in determining the temperature, moisture level, and cleanliness of that environment.2/21/2014SHRI B.M.C.P.E.R, MODASA34 35. Different Components of HVAC and their Function 1. FLOW RATE CONTROLLER Automated adjustment of volume of air. 2. HUMIDIFIER For humidification purposes, especially in clean areas, high purity water should be used, to avoid contamination.HUMIDIFIER2/21/2014SHRI B.M.C.P.E.R, MODASA35 36. 3. CONTROL DAMPER Dampers to control pressure differentials are important. They can be automated or fixed.4. DEHUMIDIFIRE In some cases, it is necessary to have very dry air. To generate dry air, the air supplied to the production is passed over an adsorbent, where the humidity is removed from the air. 5. DUCT To transport air. 2/21/2014SHRI B.M.C.P.E.R, MODASA36 37. 6. AIR DIFFUSOR (REGISTER) The air flows into the rooms via so-called registers (diffusor), which arebuilt and installed in such a way that the air is distributed evenly.2/21/2014SHRI B.M.C.P.E.R, MODASA37 38. 7. FILTERS To eliminate particles of predetermined dimensions and/or micro-organisms. Types of Filters Used in HVAC Primary Panel filters Secondary filters HEPA or tertiary filtersFILTER CLASSES ULPA- Ultra-Low Penetration Air filter HEPA- High Efficiency Particulate Air filter Leak tests (integrity tests), showing leakage of air through the filter itself or through its frame, therefore, have to be performed. Integrity tests are usually only carried out on the Aerosol filters. 2/21/2014SHRI B.M.C.P.E.R, MODASA38 39. HEPA Filter2/21/2014SHRI B.M.C.P.E.R, MODASA39 40. FILTER POSITION The filtered air entering a production room can be coming from: An air-handling unit, equipped with pre-filtration and the main (HEPA) filter, but at some distance from that room (AHU mounted final filter) for injectables and sterile forms, it is recommended that they be placed in terminal position.2/21/2014SHRI B.M.C.P.E.R, MODASA40 41. DIFFERENT AIR TYPES TO BE CONSIDERED WITHIN THE AIR HANDLING SYSTEM FRESH AIR If the plant is of the re-circulation type, it is necessary to replace some of the re-circulating air with fresh air, which is then called make-up air. SUPPLY AIR There are two ways to supply air to a room or a piece of equipment Turbulent air flow Uni-directional flow, often called laminar flow2/21/2014SHRI B.M.C.P.E.R, MODASA41 42. Role of HVAC in Pharmaceutical Industry PRODUCT PROTECTION PERSONNEL PROTECTION PROTECTION OF THE ENVIRONMENT2/21/2014SHRI B.M.C.P.E.R, MODASA42 43. 1. PRODUCT PROTECTION Contamination control Cross-contamination protectionThis can be achieved with the aid of the following methods. Adequate premises Good ventilation and dedusting system. Closed production systems: Validated cleaning procedures.2. PERSONNEL PROTECTION Protection from dust Unidirectional Airflow protection Air Showers Protective enclosures Operator comfort2/21/2014SHRI B.M.C.P.E.R, MODASA43 44. 3. PROTECTION OF THE ENVIRONMENT Exhaust air dust Exhaust air discharge points on pharmaceutical facilities, such as from fluid bed driers and tablet coating equipment, and exhaust air from dust extraction systems, carry heavy dust loads and should be provided with adequate filtration to prevent contamination. Effluent discharge Effluent control should be designed to ensure that system do not become source of possible risk or contamination. Fume removal Removal of fumes should be by means of wet scrubbers or dry chemical scrubbers (deep bed scrubbers). Wet scrubbers for fume removal should normally have various chemicals added to the water to increase the adsorption efficiency. Deep bed scrubbers should be designed with activated carbon filters, or chemical adsorption granular media. The chemical media for deep bed scrubbers should be specific to the effluent being treated. 2/21/2014SHRI B.M.C.P.E.R, MODASA44 45. GMP MANUFACTURING ENVIRONMENTPRODUCT PROTECTIONPERSONNEL PROTECTIONContamination (Product & Staff)ENVIRONMENT PROTECTIONPrevent contact with dustDust dischargeProtect from product crosscontaminationPrevent contact with fumesFume dischargeCorrect temperature & humidityAcceptable comfort ConditionsEffluent dischargeSYSTEMSSYSTEM VALIDATION 2/21/2014SHRI B.M.C.P.E.R, MODASA45 46. VALIDATION AND QUALIFICATION List of Parameters to be qualified room temperature (if there is an impact on product quality) room humidity (if there is an impact on product qualit return air or exhaust air quantities room air change rates room pressures room air flow patterns HEPA filter penetration tests room particle counts microbiological air and surface counts 2/21/2014SHRI B.M.C.P.E.R, MODASA46 47. PERSONNEL FACILITIES EATING AND DRINKING FACILITIES LAVATORIES & LOCKERS CLOTHING FIRST AID FACILITIES GOWNING ROOMS SAFETY PROGRAMS TRAINING FACILITES 2/21/2014SHRI B.M.C.P.E.R, MODASA47 48. 1. EATING AND DRINKING FACILITIES Eating & drinking permitted only in separate eating facilities. Permanent facilities for breaks & people bringing lunches required. Manufacturer should provide facility of canteen; it should be away fromoperating areas.2. LAVATORIES & LOCKERS Adequate in number for the number of personnel employed. Conveniently located to all areas. Complete cleaning with cleansing & disinfectant agents daily. Lavatory & locker areas separated from all sterile spaces by an air lock.3. CLOTHING Workers in special clean areas wearing only lint- & dust-free garments to prevent shedding. Where necessary the following articles are provided by the company:Hats & head covers for clean areas. Aprons Safety shoes Gloves, disposable in clean areas Safety glasses Masks Protective goggles2/21/2014SHRI B.M.C.P.E.R, MODASA48 49. 4. GOWNING ROOMS Gowning areas should be used when exposure to product could putpersonnel at risk & when necessary to prevent product contamination. Should be provided separate for male and female worker & With locker facilities Schedule-M prescribes an area of 8 sq. meters for change room. Gowning rooms should be adjacent to the washing area and before entry to the production area.2/21/2014SHRI B.M.C.P.E.R, MODASA49 50. 5. FIRST AID FACILITIES The manufacturer should provide adequate facilities for first aid andshould train some persons from every section in first aid. In order to minimize the risk of a serious medical hazard due to crosscontamination, dedicated and self-contained facilities must be available for the production of particular pharmaceutical products, such as highly sensitizing materials2/21/2014SHRI B.M.C.P.E.R, MODASA50 51. 6. RESTROOM FACILITIES Restroom facilities should be physically separated from lab & processingareas by a room, corridor or other intermediate space.7. SAFETY PROGRAMS Plant safety programs play an important role, since hazardous conditions diminish employee moral and performance. Posters displayed prominently & changed often. Safety equipment available free of cost to employee. Safety showers and eye baths in hazardous areas. Lectures, movies Safety bulletin boards listing recent plant accidents & methods of prevention. Safety inspection teams from several departments to audit work areas periodically2/21/2014SHRI B.M.C.P.E.R, MODASA51 52. 8. TRAINING FACILITES Management must provide training in accordance with written programfor all personnel whose duties taken them into manufacturing area or into control lab & for other Personnel working in areas where contamination is a hazard those should be given specific training. Consultant & contract staff should be qualified for services they provide. evidence of these should be included in training required.2/21/2014SHRI B.M.C.P.E.R, MODASA52 53. QUESTIONS Give role of HVAC in pharmaceutical industry. Draw a diagram of HVAC. Give name of different components, their functions. Give different type of air. Write a note on different types of filters, position of filters & filter classes with reference to HVAC? Write a note on system design criteria for HVAC? PERSONNEL FACILITIES What are the personnel facilities required in a pharmaceutical industry as per GMP?2/21/2014SHRI B.M.C.P.E.R, MODASA53 54. REFERENCES GOOD DESIGN PRACTICES FOR GMP PHARMACEUTICAL FACILITIES BY:- ANDREW. A.SIGNORE & TERRY JACOBS VOL-146, PAGE NOS:- 50,90-104,345 GOOD MANUFACTURING PRACTICES FOR PHARMACEUTICALS BY; - JAMES SWARBRICK VOL-2, PAGE NOS:- 20,21,22,23,36,37 www.wikipedia.com www.p2pays.org www.foreigntradeexchange.com www.industrialleaders.org Encyclopedia, vol. -7, page - 229 Encyclopaedia of pharmaceutical technology vol-16 water for pharmaceutical use 293-306 USP 25 Official Monograph pg. No. 1809-1810 2/21/2014SHRI B.M.C.P.E.R, MODASA54 55. Ph. No. :- +918460378336 Address:- 44, Assiyana Society; Dugarvada Road, Taluko & City : Modasa State: Gujarat Country: India Email: [email protected] OF LUCK TO ALL . . . . . . . . . . 2/21/2014SHRI B.M.C.P.E.R, MODASA55