Pharmaceutical Industry Sandoz& Bayer Erenşah KAYA Hande KARTAL Züleyha ATLAY Merve MAÇİN.

Pharmaceutical IndustrySandoz& Bayer

Erenşah KAYAHande KARTALZüleyha ATLAYMerve MAÇİN

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

Manufacturing;

-more than 200 products

- More than 500 package sizes

Bayer is also the most famous manufacturer

Subgroups of Bayer

BAYER HEALTHCARE

BAYER CROPSCIENCE

BAYER MATERIAL SCIENCE

BAYER TOPKAPI

Establishment date: 1955

Personel number: 429

Closed Area: 22.000 m²

Residental Area:

16800m²

Certificates

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)

Secondary Processing Steps:

Granulation DryingTablet

pressing

Printing & Coating

Filling & Packaging

PRODUCTS

For Bayer

- Tablet form- Liquid form- Pomade form

For Sandoz

-Pellet form- Tablet form

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.

Acts& Standards

Treated wastewater should be discharged; According to The Control of Water Pollution Management ( 04.09.1998)

Discharge Standards For Pharmaceutical

Acts& Standards

Hazardous wastes are removed accoding to

Control of the Hazardous Wastes

-APPENDIX 11-A

- APPENDIX- 6

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.

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.

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.

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.

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.

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.

Potential Environmental Issues

Air emissions Wastewater Solid and hazardous wastes

Air emissions

Volatile organic compounds(VOCs)

Acid gases

Particulates

Greenhouse gas emissions (Combustion Source Emissions)

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)

How can control the VOCs emissions? Also odor problem.

wet scrubbers

Wet Scrubbers

At total 5 wet scrubbers

Retention time = 4.6 to 6.5 sec Velocity = 1.2 to 1.7 m/sec

Particulate Matter

The most common sources of particulate include milling mixing compounding formulation tableting packaging

Air emissions

Particulates

Solution ; hepa filters

HOW CAN CONTROL PARTICULATE EMISSIONS?

CYCLONE

Combustion Source Emissions

FROM DISTRIBUTION SERVICES

TRUCKS

CARS

SOLUTION ; DIESEL MOTORS

Solid Wastes

In both plant solid wastes include as

Spoiled packing material Waste papers Waste glass Waste plastics Household wastes Electronic wastes

Treatment of solid wastes

These wastes are collected and sent to the

agredite organization that concern about these

wastes .

HAZARDOUS WASTES

Used scrubbers solutions Cyclone wastes Used hepa-filters Container residues Laboratory wastes

İZAYDAŞ

Process and Effluent Treatment Sludges

NO SLUDGE PROBLEM

SENT TO İZAYDAŞ

(10 tons in 2008.)

Wastewater Management at SANDOZ

Wastewater

Process wastewater

wet granulation preparation

wet granulation sizing

tablet plating

Sources

Municipal wastewater

toilets

refectory

Separate systems

process wastewater

wastewater treatment plant of facility

organized industry locale WWTP

municipal wastewater

organized industry locale WWTP

SANDOZ Wastewater Treatment Plant

Coarse screen

EqualizationTank

HClNaOH

Neutralization Tank

Aeration Tanks (4)

SludgeCollectionTank

Polymer

Filter Press Main sewer line

effluent

sludge

coarse screens : big particles captured

equalization tank : control fluctuations in ww characteristic

neutralization tank : adding HCl or NaOH

aeration tanks : biological treatment and sedimentation

sludge collection tank : sludge is pumped from aeration tanks to the collection tank

filter press : dewatering

Standards

Local organized industry discharge limits

COD : 4000 mg/L

TSS : 200 mg/L

pH : 6-9

SANDOZ wastewater treatment plant effluent

COD : 600-650 mg/L

TSS : 48

pH : 7.2

Wastewater Management at BAYER

Combined System

process municipal

wastewater wastewater

wastewater treatment plant

sea

Main Sewer

line

The first washing process wastewater with antibiotics is collected in a tank and sent to the İZAYDAŞ.

30-35 ton / year

BAYER Wastewater Treatment Plant

Oil & grease separator

Equalization Tank

Neutralization Tank

Aeration Tanks (2)

Sedimentation Tanks

(2)

sludge Gravity

Belt thickener

RAS

main sewerline

effluent

Sludge cake

HClNaOH

aeration tanks : air supplied from blowers, biological treatment

sedimentation tanks : solid settling, sludge production, recycle of sludge to the aeration tanks

Oil & grease seperator : removes oil&grease from the water

equalization tank: control fluctuation in ww

neutralization tank : pH adjustment

Gravity belt thickener: thickening of sludge

High TOC in dewatered sludge, sent to the İZAYDAŞ.

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

Acts & Standards

İSKİ deep sea discharge after pre-treatment

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

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

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”

http://www.iski.gov.tr/Web/UserFiles/File/mevzuat/pdf/Y_atiksularin_kanalizasyona_desarj_yonetmeligi.pdf