Pharmaceutical Industry Sandoz& Bayer

1. Pharmaceutical IndustrySandoz& Bayer Erenşah KAYA Hande KARTAL Züleyha ATLAY Merve MAÇİN

2. Sandoz - is one of the largest manufacturer of generic pharmaceutical product in the world. - İs a member of Novartis Group - Sandoz is the champhion of exportation for last year

3. Manufacturing; -more than 200 products - More than 500 package sizes

4. Bayer is also the most famous manufacturer

5. Establishment date: 1955 Personel number: 429 Closed Area: 22.000 m² Residental Area: 16800m² BAYER TOPKAPI

6. Certificates

7. Major Groups of Pharmaceutical Manufacturing: -the production of active drug (Primary processing) -The conversion of the active drugs into products suitable for administration (Secondary Processing)

8. Secondary Processing Steps: Printing & Coating Granulation Drying Tablet pressing Filling & Packaging

9. PRODUCTS For Bayer • Tablet form - Liquid form • Pomade form For Sandoz -Pellet form - Tablet form

10. Industrial Pollution • According to manufacturing steps, air emissions, liquid effluents ( wastewater) and solid wastes may be generated. • To reduce the wastes, They reuse and recycle. Remaning wastes is treated according to characteristic.

11. Acts& Standards • Treated wastewater should be discharged; According to The Control of Water Pollution Management ( 04.09.1998) • Discharge Standards For Pharmaceutical

12. Acts& Standards • Hazardous wastes are removed accoding to Control of the Hazardous Wastes -APPENDIX 11-A - APPENDIX- 6

14. Weighing and mixing: • raw materials from the warehouse  to weighing part. • The weighing is made by the Automotic Container Weighing System. • mixed at the mixer for desired revolution and time. • The aim homogeneous mixing.

15. Granulation: • The aim homogeneous granules • Weighing is again • The solution is prepared ,added raw materials. • The demineralized water can be added if it is required. • The prepared granule is sifted (sieving). • Dried to reach a certain moisture value.

16. Tabletting: • The mix that is dust , is collected to press machine. • The pressing is applied. • Some portion of the sample is taken and sent In Process Control (IPC) after approval the ICP it is continued to tabletting.

17. Film Covering: • The tablets, are taken to the film covering boiler. • A solution is prepared homogeneously and sprayed to the tablets. • After that the tablets are dried at a certaion temperature in the same boiler.

18. Packing: • This part is seperated to 2 parts: • Primer and Seconder Parts. • In the primer part the blisteration process is made. • In the seconder part the boxing and packing is made.

19. Warehousing : • The boxes , that will be sent to pharmacies , are packed with polyethylene as groups of 5 or 10. At final they are packaged and warehoused.

23. Potential Environmental Issues • Air emissions • Wastewater • Solid and hazardous wastes

24. Air emissions • Volatile organic compounds(VOCs) • Acid gases • Particulates • Greenhouse gas emissions (Combustion Source Emissions)

25. Volatile Organic Compounds significant emissions of VOCs come from In secondary pharmaceutical manufacturing; • mixing, compounding, granulation, and formulation • operations involving the use of solvents (e.g. granulation) • alcoholic solutions (e.g. tablet coating)

26. How can control the VOCs emissions? Also odor problem. wet scrubbers

27. Wet Scrubbers • At total 5 wet scrubbers • Retention time = 4.6 to 6.5 sec • Velocity = 1.2 to 1.7 m/sec

28. Particulate Matter The most common sources of particulate include • milling • mixing • compounding • formulation • tableting • packaging

29. Air emissions Particulates Solution ; hepa filters

30. HOW CAN CONTROL PARTICULATE EMISSIONS? CYCLONE

31. Combustion Source Emissions • FROM DISTRIBUTION SERVICES TRUCKS CARS SOLUTION ; DIESEL MOTORS

32. Solid Wastes In both plant solid wastes include as • Spoiled packing material • Waste papers • Waste glass • Waste plastics • Household wastes • Electronic wastes

33. Treatment of solid wastes These wastes are collected and sent to the agredite organization that concern about these wastes .

34. Used scrubbers solutions Cyclone wastes Used hepa-filters Container residues Laboratory wastes İZAYDAŞ HAZARDOUS WASTES

35. Process and Effluent Treatment Sludges • NO SLUDGE PROBLEM • SENT TO İZAYDAŞ (10 tons in 2008.)

36. Wastewater Management at SANDOZ Wastewater Sources Municipal wastewater toilets refectory Process wastewater • wet granulation preparation • wet granulation sizing • tablet plating

37. Separate systems process wastewater wastewater treatment plant of facility organized industry locale WWTP municipal wastewater organized industry locale WWTP

38. SANDOZ Wastewater Treatment Plant HCl NaOH Coarse screen Aeration Tanks (4) Equalization Tank Neutralization Tank effluent Polymer Sludge CollectionTank Filter Press Main sewer line sludge

39. coarse screens : big particles captured • equalization tank : control fluctuations in ww characteristic • neutralization tank : adding HCl or NaOH

40. aeration tanks : biological treatment and sedimentation • sludge collection tank : sludge is pumped from aeration tanks to the collection tank • filter press : dewatering

41. Standards Local organized industry discharge limits SANDOZ wastewater treatment plant effluent COD : 600-650 mg/L TSS : 48 pH : 7.2 • COD : 4000 mg/L • TSS : 200 mg/L • pH : 6-9

42. Wastewater Management at BAYER Combined System process municipal wastewater wastewater wastewater treatment plant sea Main Sewer line

43. The first washing process wastewater with antibiotics is collected in a tank and sent to the İZAYDAŞ. 30-35 ton / year

44. BAYER Wastewater Treatment Plant Oil & grease separator HCl NaOH Aeration Tanks (2) Neutralization Tank Equalization Tank R A S Sedimentation Tanks (2) effluent main sewer line Gravity Belt thickener sludge Sludge cake

45. aeration tanks : air supplied from blowers, biological treatment • sedimentation tanks : solid settling, sludge production, recycle of sludge to the aeration tanks

46. Oil & grease seperator : removes oil&grease from the water • equalization tank: control fluctuation in ww • neutralization tank : pH adjustment

47. Gravity belt thickener: thickening of sludge High TOC in dewatered sludge, sent to the İZAYDAŞ.

48. BAYER influent parameters • pH : 6.8 • COD : 800 mg/L • TSS : 208 mg/L Oil&grease : 50 mg/L • Total N : 18.6 mg/L Total P : 2.4 mg/L

49. Acts & Standards İSKİ deep sea discharge after pre-treatment BAYER wastewater treatment plant effluent pH : 7.4 TSS : 53 mg/L Oil & grease : 4.7 mg/L COD : 175 mg/L total N : 8.5 mg/L total P : 1.4 mg/L • pH : 6-10 • TSS : 350 mg/L • oil & grease : 50 mg/L • COD : 600 mg/L • total N : 40 mg/L • total P : 10 mg/L

50. References • http://www.us.sandoz.com/site/en/company/profile/history/content.shtml • http://www.cygm.gov.tr/yonetmelik.htm • http://www.bayer.com.tr/ebbsc/cms/tr/BayerTurk/Locations.html • “Bayer ilaç fabrikaları A.Ş. ‘de endüstriyel atık yönetimi”, “Asiye BACIOGLU, Özlem DAGLI”, “Mayıs 2000”