Presentation on theme: "PHARMACEUTICAL INDUSTRY"— Presentation transcript:
1PHARMACEUTICAL INDUSTRY Prepared byA.Erenşah KayaHande KartalMerve MaçinZüleyha Atlay
2OUTLINE Description of Pharmaceutical Industry - Hıstory of Pharmaceutical Industry in Turkey- Acts and Standards
3Description of Industry The Pharmaceutical Industry provides medicines tobe used as medications for humans and animals.The Pharmaceutical Industry includes:ManufactureExtractionProcessingPurificationPackaging of chemicals to be used as medications.
5The Main Pharmeceutical Groups The main groups that are manufactured are:Proprietary ethical products ( prescription-only medicines POM)General ethical productsOver-the counter (OTC) products
6The Major Manufactured Groups The products are available as :tabletscapsulesliquidsointmentsaerosols
7The Major Manufactured Groups The groups include:Antibiotics such as penicillinOther synthetic drugsVitaminsSynthetic hormonsGlandular productsVaccines and seraDrugs of vegatable origin
8History of Pharmaceutical Industry In Turkey : Production of Pharmaceutical preparations done at laboratories1952: The start of fabrication period of the Turkish Pharmaceuticals industry: Investments of foreign capital companies increased. Foreign Capitals entered into Turkish MarketToday: There are 300 entities operating in Turkey. 43 manufacturing facilities, 14 of them are multinational firms.
9History of Pharmaceutical Industry In Turkey The most important international pharmaceutical companies are:Bayer (Germany)GlaxoSmithKline (UK)Aventis (US)Roche(Switzerland)Sanofi (France)Novartis( Switzerland)
10History of Pharmaceutical Industry In Turkey Turkish Manufacturers:EIS EczacıbaşıAbdi İbrahimFakoİlsan İltaşMustafa Nevzatİbrahim EthemBilim
11The Principal Manufacturing Step Steps are:Preparation of process intermediatesIntroduction of functional groupsCoupling and esterificationSeperation processes such as washing and strippingPurifications of the final product
12Additional Product Preparation Steps are:GranulationDryingTablet pressingPrintingCoatingFilling and packaging
13Industrial PollutionAccording to manufacturing steps, air emissions, liquid effluents ( wastewater) and solid wastes may be generated.To reduce the wastes, we should reuse and recycle. Remaning wastes should be treated according to characteristic.
14ACTS & STANDARDSThe Production and marketing of medicines must be authorized by The Health Ministry.Treated wastewater should be discharged; According to The Control of Water Pollution Management ( )
15ACTS & STANDARDS The Control of Water Pollution Management Discharge Standards For Pharmaceutical
21Processes In Pharmaceutical Industry Goods ReceivingLaboratoryPreparationFormulationFinishingPackagingWarehouse & Distrubituon
22Goods receiving pharmaceuticals are stored, either in the form of raw materials or packaging.It’s vital to optimally manage these materials, protect them from end to end,and systematically document them.
29Chemical Synthesis Most drugs production Chemical synthesis process manufacturing pharmaceuticals usingorganic andinorganic chemical reactions
30Typical manufacturing plant, one or more batch reactor vessels series of reaction,separation and purification steps desired end product
31In drug manufacturing plant, reaction vesselsEquipments arranged into separate
32Solvents to dissolveGaseousSolidViscous reactantsTo bring all the reactants close molecularalso serve to transmit heat to or from the reacting molecules.
33Some solvents also control the reaction temperature. common practice in a batch-type synthesis
34Natural Product Extraction Many materials as pharmaceuticalsderived from such natural sources;the roots,leaves of plants,animal glands,and parasitic fungi
35numerous and diverse pharmaceutical applications, ranging from Tranquilizers and allergy-relief medicationsInsulin andMorphineBlood fractionation plasma and its derivatives.
36Despite diversity,all extractive pharmaceuticals common characteristic:Too complex to synthesize commerciallyeither very large molecules to synthesize
37Extraction expensive manufacturing process requires collecting and processing largevolumes of specialized plantanimal matterto produce small quantities of products.
38FermentationMost antibiotics ,steroids and vitamin B fermentation process,two major steps:inoculum and seed preparationfermentation, followed by crude product recovery and purification
39Sterile inoculum preparation begins in the lab withcarefully maintained population of a microbial strain.A few cells this culture matured into a dense suspension through a series of test tubes, agar slants, and shaker flasks.
40For further propagation, the cells are then transferred to Seed tanklike a full scale fermenter and isDesigned for maximum cell growthFinal seed tank volume occupiesfrom 1 to 20% of the volume used in full scale production.
46Finishing The best way to reliably drug finishing efficiency, quality and transparencyis through consistent,end-to-end automation solutionscan seamlessly integratecomponents from a wide range of manufacturers.
49Warehouse & Distribution They’re efficient way stations on the road from manufacturer to consumer,using the most precise andup-to-date climate control,automation, andbuilding security.
50Typical Waste StreamsThe pharmaceutical industry is also highly diverse.With this diversity of processes comes a similarly diverse set of waste streams.
51spent fermentation broths, process liquors,solvents,equipment washwaters,spilled materials,off-spec products,used processing aids.
52Potential Environmental Issues Air emissionsWastewaterSolid and hazardous wastes
53Air emissions Volatile organic compounds(VOCs) Acid gases Particulates Greenhouse gas emissions (Combustion Source Emissions)Odorsemitted during manufacturing facilities
54Volatile Organic Compounds significant emissions of VOCs come from1) Mostly in chemical synthesis and extraction phases
552) In primary pharmaceutical manufacturing ; reactor ventsfiltering systems in the separation processSolvent vapors from purification tanks and dryers (including loading and unloading operations)fugitive emissions from valves, tanks, pumps, and other equipmentprefermentation and fermentation solventswastewater collection and treatment units.
563) In secondary pharmaceutical manufacturing; mixing, compounding, granulation, and formulationoperations involving the use of solvents (e.g. granulation)alcoholic solutions (e.g. tablet coating)aerosol manufacturing processes.
57How can we control the VOCs emissions? 1) Venting of emissions from sterilization chambers into control devices such ascarbon adsorptionORcatalytic converters;
582) Condensation and distillation of solvents emitted from reactors or distillation units. Possible installation of cryogenic condensersthat can reduce the gas stream temperaturebelow dew point to achieve higher VOCrecovery efficiencies.Cryogenic condensers have higher removalefficiency (up to 99 percent) but they havehigher energy requirements.
593) Installation of wet scrubbers (or gas absorbers), which may remove VOCs as well as other gaseous pollutants from a gas stream.Also, addition of hypochlorite to the scrubber inorder to reduce emissions of nuisance odors;WHAT IS SCRUBBER?Water, caustic, and acidic scrubbers are widely used for organic and inorganic gas emission reduction. Acid gas emissions are controlled through water and caustic scrubbing systems (often several scrubbersin series). Scrubbers create a wastewater stream requiring further treatment.
60Particulate MatterParticulates consisting of manufactured or in-process product can be emitted frombulk (e.g. fermentation)secondary manufacturing.The most common sources of particulatesinclude milling, mixing,compounding,formulation,tableting, and packaging.
61Recommended particulate matter management : Collection of particulates through air filtration units, typicallybaghouse / fabric filters.Depending on the volume of emissions and size of particulate matter,additional particulate emissions control methods should be considered,such asWet scrubbing and wet electrostatic precipitators, especiallyafter combustion / thermal oxidation treatments.
62Combustion Source Emissions Exhaust gas emissions produced by thecombustion of gas or diesel in turbines, boilers, compressors, pumps and other engines for power and heat generation, are a significant source of air emissions from pharmaceuticals manufacturing facilities.
63OdorsThe main source of odor emissions is typically associated with fermentation activities.Recommended odor management strategies include:Post-combustion of venting gases;Use of exhaust stack heights that are consistent withpractices as described in the regulations.Use of wet scrubbers to remove odors with a high affinity to water;
64Solid and Hazardous Wastes The principal solid wastes of concern includeprocess and effluent treatment sludges,raw materials packaging wastecontainer residuesused air filter mediaOffspec and expired productslaboratory wastes
65Approximately 200 kg wastes per ton of product of waste are generated.Hazardous and non-hazardous industrial wastes should be stored, transported, and managed as described in the regulations.
66Treatment of solid wastes Contaminated solid wastes are generally incinerated,and the flue gases are scrubbed.Combustion devices should be operated at temperaturesabove 1,000° C, with a residence time of at least 1 second,to achieve acceptable destruction efficiency(over 99.99%) of toxics.
67Water SupplyWater is generally needed both for the process (e.g., dilution) and for other uses including cooling water, deionized water, equipment and piping cleaning water, etc.Water for injection is used for manufacture of injectable products and in any process where sterile conditions are needed.
68Water purity is obtained by deionized water distillation or by double reverse osmosis. The storage tank is blanketed with pure nitrogen or air.Piping and storage are maintained at a temperature higher than 80°C, and water is continuously recycled to avoid contamination.
69Wastewater Industrial Process Wastewater Wastewater streams in pharmaceuticalsmanufacturing come from;chemical reactions streamsproduct wash waterspent acid and caustic streamscondensed steam from sterilization and strippersair pollution control scrubber releaseequipment and facility wash waterclean-in-place wastewater.
70The main pollutants of concern in these wastewater streams from primary manufacturing (e.g.fermentation, chemical synthesis,crystallization, purification, and biological / natural extraction)parameters arebiochemical oxygen demand (BOD)chemical oxygen demand(COD)total suspended solids (TSS)AmmoniaToxicityBiodegradabilitypH.
71Typical Wastewater Characteristic Typical amounts released with the wastewater are:25 kg/t (BOD)50 kg/t (COD)3 kg/t (TSS)0.8 kg/t phenol
72Wastewaters produced from pharmaceutical industry may contain : mercury, in a range of 0.1–4 (mg/l),cadmium (10–600 mg/l),isomers of hexachlorocyclohexane,1,2-dichloroethane,
73Typical wastewater treatment steps grease traps, skimmers, dissolved air floatation or oil water separators for separation of oils and floatable solids;filtration for separation of filterable solids;flow and load equalization;sedimentation for suspended solids reductionusing clarifiers; biological treatment, typically aerobic treatment for reduction of soluble organic matter (BOD)biological nutrient removal for reduction in nitrogen and phosphorus
74biological nutrient removal for reduction in nitrogen and phosphorus using clarifiers; biological treatment, typically aerobic treatment for reduction of soluble organic matter (BOD)chlorination of effluent when disinfection is requireddewatering and disposal of residuals in designated hazardous waste landfills.
75Additional engineering controls may be required for advanced metals removal using membrane filtration or other physical/chemical treatment technologiesremoval of recalcitrant organics and active ingredients using activated carbon or advanced chemical oxidationresidual color removal using adsorption or chemical oxidationreduction in effluent toxicity using appropriate technology (such as reverse osmosis, ion exchange, activated carbon, etc.)reduction in TDS in the effluent using reverse osmosis or evaporation
76Pollution Prevention and Control Recommended pollution prevention and control measures include:Waste reduction by material substitution (e.g. use of water based solvents),Process modifications (e.g. continuous rather than batch operations to reduce spillage and other material losses),
77Spent solvent recycling and reuse, through distillation,evaporation, decantation, centrifugation and filtration,Potentially pathogenic waste from biotechnology manufacturing should be inactivated through sterilization or chemical treatment before final disposal.
78Use automated filling to minimize spillage, Use “closed” feed systems into batch reactors,Use equipment washdown waters and other process waters (such as leakages from pump seals) as makeup solutions for subsequent batches,
79Recirculate cooling water, Use dedicated dust collectors to recycle recovered materials,Vent equipment through a vapor recoverysystem,Use loss-free vacuum pumps,
80Return toxic materials packaging to the supplier for reuse, or incinerate it in an environmentally acceptable manner,Minimize storage time of off-specification products through regular reprocessing,Find productive uses for off-specification products to avoid disposal problems,
81Use high-pressure hoses for equipment cleaning to reduce wastewater, Provide stormwater drainage and avoid contamination of stormwater from process areas,Label and store toxic and hazardous materials in secure, bunded areas. Spillage should be collected and reused.