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QUALITY MANAGEMENT OF WASTE AND SCRAP DISPOSAL

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About Authors:
Sahil Jasuja1*, Mahesh Kumar Kataria1
1 Department of Quality Assurance,
Seth G.L. Bihani S.D. College of Technical education (Institute of Pharmaceutical Sciences & Drug Research),
Sri Ganganagar, (Raj.), India.
*sahiljasuja@rediffmail.com

ABSTRACT
Regulatory involvement and environmental concerns are causing pharmacists to take a closer look at how their organizations are managing pharmaceutical waste. Each organization should evaluate its current waste management practices in comparison with state regulatory guidelines. Organizations must then develop a comprehensive plan for full compliance through segregation of waste into the appropriate waste streams. The discovery of a variety of pharmaceuticals in surface, ground, and drinking waters around the country is raising concerns about the potentially adverse environmental consequences of these contaminants. Pharmaceutical waste is not one single waste stream, but many distinct waste streams that reflect the complexity and diversity of the chemicals that comprise pharmaceuticals. Pharmaceutical waste is potentially generated through a wide variety of activities in a health care facility, including but not limited to intravenous (IV) preparation, general compounding, spills/breakage, partially used vials, syringes, and IVs, discontinued, unused preparations, unused unit dose repacks, patients’ personal medications and outdated pharmaceuticals. The consistent increase in the use of potent pharmaceuticals, driven by both drug development and our aging population, is creating a corresponding increase in the amount of pharmaceutical waste generated.

Reference Id: PHARMATUTOR-ART-1491

INTRODUCTION
In pharmaceutical unit there could be solid, liquid or gaseous waste. Out of these three physical forms of waste liquid waste is the most common in pharmaceutical industry. According to GMP there should be proper handling and subsequent safe disposal of waste and scrap materials. Industrialization is posing problem of pollution. This can affect public health adversely. It is therefore, necessary that waste and scrap materials should be disposed in safe manner and if required these may be treated before disposal.[1]

There are three aspects of pharmaceutical waste management:-
*  Management of regulated hazardous pharmaceutical waste;
*  Management of non-regulated hazardous pharmaceutical waste applying best management practices; and,
*  Minimization of pharmaceutical waste.[10]

Table 1: Limits of Pollutants for bulk drugs

COMPULSORY PARAMETERS

mg/l except pH

1)   pH

6.5-8.5

2)   OIL AND GREASE

10.00

3)   BOD (3 days at 27oC)

100.00

4)   TOTAL SUSPENDED SOLIDS

100.00

5)   BIOASSY TEST

90% survival after 96 hrs in 100 % effluent.

ADDITIONAL  PARAMETERS


6)   MERCURY

0.001

7)   ARSENIC

0.20

8)   CHROMIUM

0.10

9)   LEAD

0.10

10)         CYANIDE

0.10

11)         PHENOLICS

1.00

12)         SULPHIDES

2.00

13)         PHOSPHATES

5.00

HANDLING OF WASTE & SCRAP:
Objective

Handling of rejects from production assumes great significance in the pharmaceutical industry, since the use of incorrect destruction procedures have serious adverse consequences for the manufacturing unit, particularly if such material finds its way into the wrong hands, therefore, it is of utmost importance that the inherent dangers of mishandling of rejects/scraps is understood by all the persons concerned with production operations.

Scope
This part provides an overview regarding the generation of rejects/scrap, its collection and accounting, and recommends guidelines for dealing with rejects/scrap and their disposal.

Responsibility
The main responsibility for dealing with rejects/scrap shall rest with the employees directly responsible and accountable for production activities, however, other employees, such as representatives of quality assurance and the housekeeping staff who normally clear the rejects/scrap are equally responsible to ensure that the rejects/scrap are properly handled, right up to its final disposal, in such a manner that they can neither be misused nor can cause any accidents or injuries.

WASTE & SCRAP GENERATION
The following rejects are generated at various stages of manufacture of pharmaceutical products and should be systematically collected, accounted for, destroyed and disposed off in a manner suitable to prevent their misuse.
·         Product residues or rejects generated during sifting, milling, weighing, filtering, and transfer operations.
·         Product residues extracted into dust extraction system at the various stages of manufacture or leftovers in various processing equipment and machinery. Rejects generated during compression, encapsulation,, coating, filling, inspection, and packaging stages.[11]
·         Rejects generated from in-process checks such as weight variation, volume checks, vacuum testing of strips and other such processes.
·         Non-utilizable residues arising out of batches containing utilizable residues.
·         Excess or rejects printed packaging materials coded or non-coded, like labels, cartons, leaflets, foils, tubes leftover at the end of packaging operation.
·         Date-expired or damaged goods returned to the factory or depots.
·         Excess samples remaining with the quality control, after the testing is completed.
·         Control samples in the custody of quality control, after the mandatory storage period.
·         Product samples from R&D laboratories at any stage or development.
·         So called “Empty Containers” carrying residual material such as acids, alkalis, solvents, oxidizing or reducing agents.[11]

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DESTRUCTION OF WASTE & SCRAP

General principles
·         There shall be written authorized procedure (S) for:
1. Differentiating recoverable rejects from non-recoverable rejects
2. Scrap which can be disposed/sold on commercial basis, and precautions to be taken thereof e.g.; defacing of labels on empty bulk.
·         There shall be written authorized procedure (S) for the handling, destruction, and disposal of all the rejects generated during the production/handling of pharmaceutical products and printed packaging components.
·         All rejects should be collected in suitable closed containers, appropriately labeled, and held in secured segregated space until taken for destruction.
·         Destruction must be carried out by the authorized personnel under the supervision of a responsible person.
·         Rejected printed packaging material shall not be returned to the supplier.
·         Appropriate precautions with respect to environment, health and safety must be taken while carrying out destruction.
·         Final disposal of the residual solids/liquids shall be consistent with the local regulatory requirements including the effect on the environment.[11]

Mode of destruction
The following methods are recommended for carrying out the destruction of rejects generated during the manufacture and handling of pharmaceutical products.[3]

Table 2: Mode of destruction

S.NO.

TYPE OF REJECTS

METHOD OF DESTRUCTION

1

Empty containers of bulk materials from stores.

Ensure that the containers are empty. If necessary, rinse with water. Deface the labels before disposal.

2

Granules, powders, tablets, capsules.

Slurry or make a solution in water or any special solvent, send slurry to effluent treatment system.

3

Syrups, liquids including injectable preparations.

Drain into the effluents treatment system with or without any special treatment (to destroy any toxic waste)

4

Injectables in ampoules

Manual or mechanical crushing to be done after which the residue must be drained into the effluent treatment system.

5

Granules/tablets/liquid in bottles.

Unseal the pack destroy the contents indicated in pts. 3 & 4, destroy the seal by crushing.

6

Strips/ blister packs including empty packs

Tablets/capsules to be recovered, if permitted by SOP, by defoiling. Rejected tablets/capsules to be destroyed per point no.3

8

Labeled bottles

Remove the label and destroy by shredding. Destroy the bottles by crushing.

9

Printed packaging components (Labels, cartons, foils, leaflets)

Destroy by incineration or by shredding

BIO- MEDICAL WASTE MANAGEMENT AND HANDLING
Microbiological and animal testing generates biomedical waste. Drug and Cosmetics Rules provides that all biological waste should be disposed off as per the provisions of Biomedical Waste (Management and Handling) Rules, 1998.

Treatment and Disposal
·         Bio-medical waste shall be treated and disposed of in accordance with Schedule I, and in compliance with the standards prescribed in Schedule V.
·         Segregation of bio-medical waste should be done so that it shall not be mixed with other waste. It should be packed, transport and stored separately in containers or bags.

Segregation, packaging, transportation and storage
·         Bio-medical waste shall not be mixed with other waste.
·         It should be segregated into separate containers or bags at the point of generation in accordance with Schedule II prior to its storage, transportation, treatment and disposal.
·         The containers should carry labels with information prescribed in Schedule III and IV.
·         No untreated bio-medical waste shall be kept or stored beyond a period of 48 hrs.

Maintenance of records
·         Every authorized person shall maintain records related to the generation, collection, reception, storage, transportation, treatment, disposal of bio-medical waste in accordance with rules and guidelines issued.
·         All records shall be subjected to inspection and verification by prescribed authority at any time.

Annual report
Every occupier or operator submit an annual report to the prescribed authority in the form II by 31st January every year, to include the information about the categories and quantities of bio-medical waste handled during proceeding year.[1]

Table 3: Categories of bio-medical waste[1]

OPTION

WASTE CATEGORY

TREATMENT AND DISPOSAL

Category no. 1

Human anatomical waste (human tissues, organs, etc.)

Incineration or deep burial

Category no. 2

Animal waste (animal tissues, organs, body parts)

Incineration or deep burial

Category no. 3

Microbiological waste and biotechnological waste

Local autoclaving or microwaving or incineration

Category no. 4

Waste sharps (needles, blades, syringes, etc.)

Disinfection ( chemical treatment or autoclaving or microwaving)

Category no. 5

Discarded  medicine and cytotoxic drugs

Incineration  or Destruction

Category no. 6

Solid waste (cotton dressing, plaster casts, lines etc.)

Incineration,  autoclaving  or microwaving

Category no. 7

Solid waste (such as tubings, catheters, intravenous sets etc.)

Disinfection ( chemical treatment or autoclaving or microwaving)

Category no. 8

Liquid waste ( washing, cleaning, house-keeping and disinfecting activities)

Disinfection by chemical treatment and discharge into drains

Category no. 9

Incineration ash ( from bio-medical waste)

Disposal in municipal landfill)

Category no. 10

Chemical waste (production of  biologicals)

Chemical  treatment  and discharge into drains

Table 4: COLOUR CODING AND TYPE OF CONTAINERS FOR BIO-MEDICAL WASTE[1]

COLOUR CODING

TYPE OF CONTAINER

WASTE CATEGORY

Yellow

Plastic bags

Cat.1, Cat.2, Cat.3, Cat.6

Red

Disinfected container or plastic bags

Cat.3, Cat.6, Cat.7

Blue/white translucent

Plastic bag or puncture proof container

Cat.4, Cat.7

Black landfill

Plastic bag

Cat.5, Cat.9, Cat.10

RECORDS OF DISPOSAL OF WASTE AND SCRAP MATERIAL
Records of disposal of waste and scrap material should be maintained. A written recommendation should be issued by quality control for destruction and disposal of waste and scrap material. A certificate of disposal should be issued after disposal by in-charge of quality control department. This certificate should be a part of batch documentation. [1]

Particulars that should be recorded in these records include:-
·         Name of the product or disposable material
·         Batch or lot number
·         Type of material or Dosage form
·         Quantity issue
·         Date of issue
·         Origin of waste or scrap
·         Storage conditions
·         Sign of issuing person
·         Sign of person assigned for disposal
·         Type of disposal methods
·         Special instructions if any
·         Date, time and place of disposal

GUIDELINESOF M.H.R.AFOR REJECTED AND WASTE MATERIAL:
·         Segregated areas should be provided for the storage of rejected, recalled or returned materials or products.
·         Rejected materials and products should be clearly marked as such and stored separately in restricted areas. They should either be returned to the suppliers or, where appropriate, reprocessed or destroyed. Whatever reaction is taken should be approved and recorded by authorized personnel.
·         The reprocessing of rejected products should be exceptional. It is only per- mitted if the quality of the ?nal product is not affected, if the speci?cations are met and if it is done in accordance with a de?ned and authorized procedure after evaluation of the risks involved. Record should be kept of the reprocessing.
·          Containment premises should be easily disinfected and should have the following characteristics:
1. The absence of direct venting to the outside.

2. Ventilation with air at negative pressure. Air should be extracted through HEPA ?lters and not be re circulated except to the same area.
·         Changing rooms designed and used as air locks, and equipped with washing and showering facilities if appropriate. Air pressure differentials should be such that there is no ?ow of air between the work area and the external environmental risk of contamination of outer clothing worn outside the area.
·         An air locks system for the passage of equipment, which is constructed so that there is no ?ow of contaminated air between the work area and the external environment or risk of contamination of equipment within the lock.
·         Disinfection and/or wastes and effluents disposal may be particularly important in the case of manufacture of immunological products.
·         Liquid or solid wastes such as the debris after harvesting eggs, disposable culture bottles, unwanted cultures or biological agents, are best sterilized or disinfected before transfer from a contained area. However, alternatives such as sealed containers or piping may be appropriate in some cases.[3]

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GUIDELINES OF W.H.OFOR SAFE DISPOSAL
Constraints in funding for disposal of waste pharmaceuticals necessitate cost-effective management and methods. The main way to achieve this is to sort the material to minimize the need for expensive or complicated disposal methods.

The various disposal methods are briefly described here:-
1. Return to donor or manufacturer
Wherever practical the possibility of returning unusable drugs for safe disposal by the manufacturer should be explored; particularly drugs which present disposal problems, such as antineoplastics. For unwanted, unrequested donations, especially those that arrive past or unreasonably near their expiry date it may be possible to return them to the donor for disposal. 

2. Landfill
To landfill means to place waste directly into a land disposal site without prior treatment or preparation. Landfill is the oldest and the most widely practiced method of disposing of solid waste.

Three types are recognized:-
a. Open uncontrolled non-engineered dump- A non-engineered dump is probably the most common land disposal   method in developing countries. Untreated waste discharged into an uncontrolled, non-engineered open dump does not protect the local environment and should not be used.

b. Engineered landfill - Such a landfill has some features to protect from loss of chemicals into the aquifer. Direct deposit of pharmaceuticals is second best to discharging immobilized pharmaceutical waste into such a landfill. 

c. Highly engineered sanitary landfill
Properly constructed and operated landfill sites offer a relatively safe disposal route for municipal solid wastes, including waste pharmaceuticals.

3. Waste immobilization: encapsulation
Encapsulation involves immobilizing the pharmaceuticals in a solid block within a plastic or steel drum. Drums should be cleaned prior to use and should not have contained explosive or hazardous materials previously.

4. Waste immobilization: inertization
Inertization is a variant of encapsulation and involves removing the packaging materials, paper, cardboard and plastic, from the pharmaceuticals. Pills need to be removed from their blister packs. The pharmaceuticals are then ground and a mix of water, cement and lime added to form a homogenous paste. Worker protection in the form of protective clothing and masks is required as there may be a dust hazard. The paste is then transported in the liquid state by concrete mixer truck to a landfill and decanted into the normal urban waste. The paste then sets as a solid mass dispersed within the municipal solid waste.

5. Sewer
Some liquid pharmaceuticals, e.g. syrups and intravenous (IV) fluids, can be diluted with water and flushed into the sewers in small quantities over a period of time without serious public health or environmental affect. Fast flowing watercourses may likewise be used to flush small quantities of well-diluted liquid pharmaceuticals or antiseptics.

6. Medium temperature incineration
In many countries there are no high temperature, two-chamber incinerators designed to handle more than 1% halogenated compounds. Such incinerators meet strict emission control standards, such as those published by the European Union. However, it is likely that only medium temperature furnaces and incinerators will be available. In emergency situations the responsible authorities may consider it acceptable to treat expired solid form pharmaceuticals using a two-chamber incinerator that operates at the minimum temperature of 850°C, with a combustion retention time of at least two seconds in the second chamber.

7. Chemical decomposition
If an appropriate incinerator is not available, the option of chemical decomposition can be used in accordance with the manufacturer's recommendations, followed by landfill.[8]

Table 5: Summary of disposal methods in and after emergencies[8]

Disposal methods

Types of pharmaceutical

RETURNTO MANUFACTURER FOR DISPOSAL

All bulk waste pharmaceuticals, particularly antineoplastics.

HIGH TEMPERATURE INCINERATION (1200oC)

Solids, semisolids, powders, antineoplastics, controlled substances.

MEDIUM TEMPERATURE INCINERATION  (850°C)

In the absence of high temperature incinerators, solids, semi-solids, powders.

IMMOBILIZATION

Inertization

Solids, semi-solids, powders, antineoplastics, controlled substances

LANDFILL

Highly engineered sanitary

Landfill

Limited quantities of untreated solids, semi-solids and powders. Disposal of waste pharmaceuticals after immobilization preferable. PVC plastics.

Open uncontrolled non-

engineered dump

As last resort untreated solids, semi- solids, powders - must be covered immediately with municipal waste. Immobilization of solids, semi-solids, powders is preferable.

SEWER

Diluted liquids, syrups, intravenous fluids, small quantities of diluted disinfectants.

BURNING IN OPEN CONTAINERS

As last resort, packaging, paper, cardboard.

CHEMICAL DECOMPOSITION

Not recommended unless special chemical expertise and materials available.

Table 6: Disposal methods by sorting category[8]

Category

Disposal methods

Comments

Solids

 Landfill

No more than 1% of the daily municipal waste should be disposed of daily in an untreated form (non-immobilized) to a landfill.

Semi-solids

Waste encapsulation


Powders

Waste inertization



Medium and high temperature incineration

(cement kiln incinerator)


Liquids

Sewer

Antineoplastics not to sewer

Ampoules

Crush ampoules and flush diluted fluid to Sewer

Antineoplastics not to sewer

Anti-infective drugs

Waste encapsulation

Liquid antibiotics may be diluted with water, left to stand for several weeks and discharged to a sewer


Waste inertizat



Medium and high temperature incineration

(cement kiln incinerator)


Antineoplastics

Return to donor or manufacturer

Not to landfill unless encapsulated


Waste encapsulation

Not to sewer.


Waste inertization

No medium temperature incineration.


Medium and high temperature incineration

(cement kiln incinerator) (chemical decomposition)


Controlled drugs

Waste encapsulation

Not to landfill unless encapsulated


Waste inertization



Medium and high temperature incineration

(cement kiln incinerator)


Aerosol canisters

Landfill Waste encapsulation

Not to be burnt: may explode

Disinfectants

Use

To sewer or fast-flowing watercourse: small quantities of diluted disinfectants

No undiluted disinfectants to sewers or water courses

Maximum 50 litres per day diluted to sewer flowing watercourse.



PVC plastic, glass

Landfill

Not for burning in open containers

Paper, cardboard

Recycle, burn, landfill


GUIDELINES OFW.H.O FOR REJECTED PRODUCTS[7]
·         Rejected products and those returned to a distributor should be appropriately identified and handled in accordance with a procedure which involves at least the physical segregation of such pharmaceutical products in quarantine in a dedicated area, or other equivalent (e.g. electronic) segregation, in order to avoid confusion and prevent distribution until a decision has been taken with regard to their disposition.
·         The storage conditions applicable to a pharmaceutical product which are rejected or returned should be maintained during storage and transit until such time as a decision has been made regarding the product in question.
·         The necessary assessment and decision regarding the disposition of such products must be taken by a designated person.
·          The nature of the product returned to the distributor, any special storage conditions required, its condition and history and the time elapsed since it was issued, should all be taken into account in this assessment.
·         Where any doubt arises over the quality of a pharmaceutical product it should not be considered suitable for reissue or reuse.
·         Provision should be made for the proper and safe transport of returned products in accordance with the relevant storage and other requirements.
·         Provision should be made for the proper and safe transport of rejected and waste materials prior to their disposal.
·         Pharmaceutical products should be destroyed where necessary in accordance with international, national and local requirements regarding disposal of such products, and with due consideration to protection of the environment.
·         Records of all returned, rejected and/or destroyed pharmaceutical products should be kept.

CONCLUSION
Pharmaceutical waste management program, it is vitally important to ensure that all medications are disposed of in the proper waste stream. The handling, storage and disposal of waste and scrap products should be exceptional. It is only per- mitted if the quality of the ?nal product is not affected, if the speci?cations are met and if it is done in accordance with a de?ned and authorised procedure after evaluation of the risks involved. Record should be kept of the reprocessing.All residuals from empty containers and cleaning of reactors must be stored, well labeled, and disposed of by specialized waste disposal companies. Incineration is normally suggested as the best method of disposal. The amount of waste must be controlled and kept to a minimum.

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