Environmental Issues in Pharmaceuticals

7/27/2019 Environmental Issues in Pharmaceuticals

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Prepared By:- ALTAF URREHMAN


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Key Points

Of the total amount of waste generated by health-careactivities, about 80% is general waste.The remaining 20% is considered hazardous materialthat may be infectious, toxic or radioactive.Every year an estimated 16 000 million injections areadministered worldwide, but not all of the needles andsyringes are properly disposed of afterwards.Health-care waste contains potentially harmfulmicroorganisms which can infect hospital patients,

health-care workers and the general public.


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1) RESEARCH AND DEVELOPMENT,

2) CHEMICAL SYNTHESIS,

3) QC AND MICROBIOLOGY LAB

4) FORMULATION & PROCESS.

5) CONTAMINATED GLOVES, FILTERS, CLOTHINGS, ETC6) EXPIRED & RETURNED PRODUCTS AND CHEMICALS


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Dosage Forms Properties Uses

aromatic waters volatile solids or oils, water flavoring agents, carminative action

liquors or solutions water, chemicals internally or externally formulating aids

spirits, essences alcohol, water, volatile substances flavor or medicinal

syrups sweetener, solvent, medicinal agent flavoring agent, medicinal

suspensions

powder suspended in water, alcohol, glycol,or an oil; viscosity builders, wetting agents,preservatives oral dosing, skin application

ointments

hydrocarbon (oily), absorptivewaterwashable, or water-soluble bases;emulsifying agents; glycols; medicatingagent external

bulk powdercornminuted or blended, dissolved in ormixed with water external, internal

capsulessmall-dose bulk powder enclosed in gelatinshell; active ingredient plus diluent internal

tabletsmall molded tablets intended for quickcomplete dissolution oral

emulsions, lotions oil-in-water (o/w), or water-in-oil (w/o) Oral or external


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Waste type Origin Composition

Process liquors Organic syntheses Contaminated solvents

Spent fermentation broth Fermentation processes Contaminated water

Spent natural product Natural product Leaves, tissues

raw materials extraction processes

Spent aqueous solutions Solvent extraction processes Contaminated water

Leftover raw material containers Unloading of materials into process equipmentSags, drums (fiber, plastic, metal), plasticbottles

Scrubber water from Dust or hazardous vapor Contaminated water

pollution control equipment generating processes Solvents

Volatile organic compounds Chemical storage tanks, drums

Off-spec or out-dated products Manufacturing operations Miscellaneous products

Spills Manufacturing and lab operations Miscellaneous chemicals

Waste water Equipment cleaning, extraction residues Contaminated water

Spent solvents Solvent extraction or wash practices Contaminated solvents

Used production materials Manufacturing operations Filters, tubing, diatomaceous earth

Used chemical reagents R & D operations Miscellaneous chemicals

Packaging materials Packaging operationsRejected materials (plastics, glass, aluminiumetc.)Carbon compounds, oxides of nitrogen and


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Waste Stream Minimization Method

Containers Return empties to supplier

Thoroughly empty and triple rinse with minimal water

Use containers with recyclable liners

Segregate solid waste

Collect and reuse plastic from in-house molding

Air Emissions Control bulk storage air emissions (e.g. internal floating roofs).

Use dedicated dust collectors and rework dust back into product

Optimize fossil fuel combustion

Use dedicated vent condensers and return condensate to source, wherepossible

Maintain N2 purge rates at minimum through vapor space of agitatedreactors


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Equipment Cleaning Wastes Maximize number of campaigns to reduce cleaning frequency

Use final rinse as prerinse on next cleaning cycle

Use wiper blades and squeegees and rework remainders into products

Use low volume, high efficiency cleaning (e.g. spray heads)

Spills and Area Washdown Use dedicated vacuum systems

Use dry cleaning methods

Use recycled water

Off-spec Products Rework off-spec material

Use automated processing systems

Solvents Substitute aqueous systems where possible

Reduce quantity of solvent used

Regenerate/recover spent solven

Production Materials Validate cleaning and reuse


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Material SubstitutionProcess ModificationGood operating Practices


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E.g: Aqueous-based cleaning solutionsinstead of solvent-based solutionsReplacement of chlorinated solvents withnon-chlorinated solvents.


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Control Fouling deposits throughProper agitator designoptimization of operating temperatures


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PlantManagement

Managementincentives

Employeetraining

Closer supervision

Productionscheduling

Additionaldocumentation


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Waste

Management:

Waste/environmentalaudits

Waste streamsegregation

Waste handling andstorage procedures


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MaterialsHandling:

Materialstracking and

inventory control

Spill preventionMaterial handling

and storage

procedures

Preventivemaintenance


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IncinerationLandfillDisposed off RecycleReprocess


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MUNICIPAL WASTE SEWER SYSTEM CHEMO WASTE- SHARPS

CHEMO WASTE- SOFT RED SHARPS

Packaging Empty glass bottles Empty plastic bottles Paper Plastic Food waste, etc.

IVs - D5W- NaCl- Other?

Controlledsubstances?

Antibiotics?

Vials - Empty (trace)- Partial (residue)

Syringes/Needles - Empty- Unused, partial

IVs - Empty- Unused, partial

Spill clean up?

Gowns Gloves Goggles Tubing Wipes Spill clean up?

Vials - Empty- Partial

Syringes/Needles - Empty- Unused, partial

IVs - Empty- Unused, partial

LANDFILL ORMUNICIPAL INCINERATOR

WATERTREATMENT PLANT

Leachate intoground water or air emissions

Discharge tosurface waters

Leachate

Contents of Current Pharmaceutical Waste Streams

AUTOCLAVE/MICROWAVE

Shredded (?)

NON-HAZARDOUS LANDFILL

Ash

MEDICAL WASTE INCINERATOR


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Conclusions of Presentation (continued )

Landfills are most popular final disposaltechnique

Proper design of incinerators and landfills isimportant to fulfil the regulatory requirements

Proper planning, design, and operation are

the key points involved in the disposal of suchwaste


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Conclusions of Presentation

Treatment of pharmaceutical solid/gaseouswaste is important from health and safetyrelated properties

There is not much treatment of solidpharmaceutical waste. Most of the time solidwaste is disposed of

Disposal of solid pharmaceutical waste andelimination of the emissions from incinerator operations are very important to protect theland, water bodies and atmosphericenvironment

Environmental Issues in Pharmaceuticals

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