Thursday, 26 February 2015

Waste Disposal Process

Standard Operating Procedure
Procedure for Waste Disposal
(General)




GP010

Version No.:                                    

Effective Date:                                

Review Date:                                  

Supersedes:                       

Author(s):                            


Technical Approver
Authorized By
Name



Designation
Head of Function / DI
Director / DI
 QA QA
Signature





Date






1.            Purpose
To describe a procedure for disposal of all general and hazardous waste and to ensure that the waste is disposed off in accordance with global and legal requirements.

2.            Scope
This procedure is applicable for disposal of waste generated at various functions of Fem Analytika, India.

3.            Abbreviations / Definitions
CHIP: Chemical Hazards Information and Packaging Regulations
OTC: Over the Counter
WLOC: Waste Liquid Organic Compound
WLG: Waste Laboratory Glassware
           
4.            Procedure
Classification of Waste:
Essentially all waste materials can be segregated into one of the following waste types: non-hazardous, hazardous, laboratory glass and plastics, sharps and general. Each one of these types requires disposal in a specific manner. Therefore, care must be taken to ensure different wastes are not mixed together.
Non-hazardous Waste
Aqueous solutions that consist mainly of mineral acids/bases those are not highly toxic. These may be poured down the sink after dilution with water or neutralization. These include such acids/bases as sulfuric, hydrochloric, hydrobromic, hydroiodic, nitric, and acetic acids; sodium and potassium hydroxide, sodium and potassium carbonate and bicarbonate.

Non-toxic salts may be diluted and washed down the drain. This includes such materials as the sodium and potassium halides, magnesium and sodium sulfate, calcium carbonate. Solutions disposed of down the drain must first be neutralized to a pH between 5.5 and 9.5.

Raw Materials, Samples, Product
Non-hazardous raw materials (food ingredients, starches, cellulose, etc.) can be disposed of in very limited quantities in the conventional waste dumpsters.  Materials that contain a drug ingredient cannot be discarded in the regular trash. Flavourings <100ml are to be disposed of down the sink with copious quantities of water. Flavourings >100ml are to be decanted into a dedicated container kept locked in a flammables cupboard for collection by waste management.

Finished product
Samples or Product in identifiable containers cannot be discarded in the regular trash.  The containers must be defaced or destroyed so that the material is unusable.  Quantities less than 500 liters can be flushed down the sink/drain with copious quantities of water. Larger quantities must be segregated for collection by waste management.

Powders
Powders that do not carry a CHIP hazards label must be segregated for collection by site waste management.

Antifoam
Antifoam must not be disposed of down the sink or drain in any quantity. Segregate for collection by waste management.

Excipients
Excipients such as starch, talc, magnesium stearate, carbopol, MCC, propylene glycol food colors and pigments can be disposed off as routine laboratory waste

Acetone (used for a final rinse for clean lab glassware) must not be disposed of to drain.

Hazardous Waste
A waste is hazardous if it exhibits any one of the four characteristics of a hazardous waste:
1. Ignitable
Flammable Liquids- Flashpoint <140° F: Examples: Alcohols, Toluene, Acetonitrile, etc
Oxidizers: Examples: Nitrates, Perchlorates, Bromates, Permanganates, Peroxides, etc
Organic Peroxides: Examples: Benzoyl Peroxide, etc.

2. Corrosive – Aqueous liquids with pH ≤ 2 or pH ≥ 12.5
Inorganic Acids: Examples: Hydrochloric Acid, Sulfuric Acid, Nitric Acid, Phosphoric Acid
Organic Acids: Examples: Formic Acid, Lactic Acid, Acetic Acid
Bases: Examples: Hydroxide solutions, Amines
3. Reactive - materials which can react violently with water, create toxic and /or flammable gases when mixed with water, ignite or react upon exposure to air, or are capable of detonation at standard temperature and pressure. Examples: Peroxide formers, Alkali metals - Sodium, Potassium, Lithium, Perchloric Acid, etc.

4. Toxic – Toxic heavy metals (e.g., arsenic, barium, cadmium, lead, mercury, silver) and organic chemicals (e.g., chloroform, cresols, carbon tetrachloride).

Acids and bases containing heavy metals. These are usually toxic or dangerous oxidants and should not be disposed of down the sink, but should be bottled separately from other wastes and labeled appropriately. These include perchloric, periodic, perbromic, arsenous, stannous, chromic, and similar acids. If in doubt, do not put down the sink, but bottle separately and ask.

Toxic metal salts should not be put down the sink. These should be bottled separately from other wastes. These include salts of mercury, thallium, barium oxide, and transition metals of any sort such as chromium trioxide and other chromium salts, selenium, etc.

Non-halogenated waste. All organic materials that are liquid, that do not contain halogens or sulfur, will dissolve in organic solution, and do not contain water may be combined in a common waste container (the "NONHALOGENATED WASTE" container). This includes such common substances as THF, alcohols, acetone, ether, hexanes, DMF, benzene, toluene, used pump oil, etc. There does not have to be a separate container for carcinogenic waste or washings, but it may be appropriate to bottle these separately and label them (e.g., benzidine, nitrosomethylurea) for safety in handling by EHS personnel.

Halogenated waste. All sulfur and halogen containing organic materials should be combined in a common waste container (the "HALOGENATED WASTE" container). These include tetrahydrothiophene, dichloromethane, chloroform, carbon tetrachloride, chlorobenzene, dimethyl sulfide, thiophene, thiols, etc. These should not be mixed under any circumstances with the NONHALOGENATED WASTE!! It is thus most reasonable to rinse flasks containing halogenated waste with a SMALL amount of dichloromethane and pour it into the halogenated waste.

Corrosive / Reactive waste. Do not simply pour corrosive and/or reactive molecules into any waste bottle. Neutralize carefully to a less nasty form wherever reasonably possible. Example: all acyl chloride waste should be cautiously neutralized with a small amount of waste recycled methanol (result - an ester!) and placed in the HALOGENATED WASTE bottle.

Waste Liquid Organic Compound (WLOC)
From HPLC. These are collected directly from the instruments in suitable plastic/glass containers (containers must be compatible with the waste chemicals), clearly labeled with the correct WLOC category (see below) and hazard(s) signs.

From other analytical procedures. WLOC’s derived from other analytical processes must be removed to the fume hood for transfer to a suitable plastic / glass container clearly labeled with the correct WLOC category and hazard(s) signs (see below). Container lids must closed and secure (i.e., screw type lid) at all times waste is not being added to them.  Stoppered bottles or use of paraffin wax to seal containers is not acceptable.  When full (to the shoulder) transfer container to the designated chemical waste satellite accumulation area. Utilize secondary containment in the Chemical Waste Satellite Accumulation Area to hold potential spills from containers and to segregate incompatible wastes (e.g. oxidizers from flammables).

The current categories are listed below:
a)     Iodinated Waste - materials with iodine, such as Karl Fischer waste (unless it contains pyridine, in which case it goes with Basic/Nitrogenous waste).
b)    Halogenated Waste - Organic compounds containing chlorine and bromine.
c)     Acetonitrile Waste - Primarily HPLC related eluents and solvents containing this compound.
d)    Basic/Nitrogenous waste - Waste with pH7 or above plus nitrogenous waste compound, which do not fall into any other category and excluding Karl Fischer waste.
e)     Oxygenated Waste - Organic acids, alcohols, ketones, esters, ethers, aldehydes, sulphoxides, anhydrides and phthalates.
f)     Hydrocarbon Waste - Compounds containing hydrogen and carbon only.
g)    Acid waste - Waste with pH 6 or below.

Expired Chemicals
Periodically inspect chemical inventory and dispose of any chemicals that meet the descriptions below. The following are signs of chemicals in inventory which may require disposal.
a)     Change of color, or clarity
b)    Change of state (e.g., solid to liquid or liquid to solid)
c)     Expiration date on container label is exceeded
d)    Inventory or opening dates are several years old
e)     Accretion of sweating, crusts, or crystals around caps and container surfaces
f)     Hydrated compounds lost their water of hydration 
g)    Corrosion, rust, cracked caps on containers
h)     Tattered, discolored, illegible or missing container labels
Expired chemicals / chemicals matching the above description should be left in their original containers, stored in the “Expired Chemicals” cabinet under the fume hoods for collection by waste management.

Unknown Chemicals
If the identity of a chemical cannot be ascertained, this chemical must be handled by EHS as an unknown.  Unknown chemicals are considered to be extremely dangerous, because of the lack of information available regarding reactivity, physical stability and decomposition by-products.  Since some chemicals can develop reactive moieties around caps or ground glass stoppers, never open an unknown chemical container. To remove the unknown chemical, provide EHS personnel with any information you may have regarding the material.

OTC medicines/stability testing products
All products containing solid tablets such as paracetamol and placebo’s etc must be segregated from liquid OTC products and all will be treated as hazardous waste.

Hazardous Biological Waste
Waste containing or contaminated with an infectious or potentially infectious agent, a biological toxin, an animal carcass, a genetically modified organism, recombinant DNA, etc.

Clean laboratory glass/plastic waste
Laboratory Glassware is any item that could puncture regular trash bags and potentially cause injuries to someone handling the trash bag.  Laboratory Glassware includes: clean and empty broken glassware, bottles, flasks, vials and glass pasteur pipettes not used for chemical, bio-hazardous or infectious materials.  Broken laboratory glassware, as well as intact glassware that could potentially break during waste handling activities, is referred to as Waste Laboratory Glassware (WLG). Broken plastic ware may also be disposed as WLG if it has potential to cause injury during handling.  In general, plastic pipette tips do not have potential to cause injury and may be disposed of directly into the regular trash.  It is acceptable to use a plastic bucket with a lid in lieu of the trash bag-lined cardboard box.  Regardless of the type of container used, always ensure you place a “Broken Glass Only” label on the outside.  This label communicates the potential hazard to anyone who may handle the container.  WLG may be disposed of as regular trash after it has been safely packaged and labeled.
Acceptable Glass or Plastic Materials for Disposal: Laboratory glass must be appropriately decontaminated, where necessary, prior to disposal. Remove/empty all materials from the container by using the methods commonly employed to empty the container (pumping, pouring, etc.). Empty containers, that contained aqueous based liquids or solid materials (i.e. acids or bases), are to be rinsed out (3 times). If the container previously held a hazardous chemical, the rinsate must be collected as hazardous waste. Empty glassware, that contained volatile liquids (i.e. solvents), may be placed into an operating empty fume hood overnight (without the cap) to allow the vapors to disperse.
When containers are contaminated with residues that would be classified as a hazardous waste and the residues cannot be removed, the entire container with residues must be disposed of as a hazardous waste.
Sharps waste
Sharps are defined as any object having acute corners, edges or protuberances capable of cutting or piercing, e.g. syringe needles, razor blades, etc. These items cannot be disposed of in the normal lab trash. Needles must not be separated from syringes prior to discard. All needles and syringes must be disposed as units. Sharps must be stored in puncture-proof containers marked “Chemical Sharps”. Containers must be placed near the area of sharps waste generation in the work area or laboratory. They must be segregated for collection by site waste management when no more than 3/4 full and must not be overfilled.
General Waste Materials
The disposal of general waste materials generated from, for example, food preparation or office waste may be disposed of in standard waste paper baskets. ALL cardboard packaging will have to be flattened prior to disposal in general waste bin. This waste must not contain any radioactive, chemical, or biomedical materials. No liquids of any kind (sterile water, saline, etc.), nor grease or motor oil may be placed into the general refuse.

Disposal of Waste:
Solid non-hazardous waste – Disposed in Black Bag – handed over to agency
Solid hazardous waste – Disposed in Red Bag – handed over to agency
Liquid hazardous waste – Disposed in compatible container – handed over to agency
Sharp waste – Disposed in Blue container – handed over to agency
General refuse type wastes are removed by the cleaners.

Storage of Waste
Waste that has to be stored before collection and final disposal should not accumulate in corridors, wards or places that are accessible to the general public. The location and size of any storage area depends upon the quantity, quality and type of waste produced and how frequent collections are made.
Waste disposal is carried out via a two- tiered waste accumulation and storage system: satellite accumulation and main accumulation.

Satellite Accumulation Areas (SAA)
Satellite Accumulation Areas are designated storage locations for hazardous waste while the material is accumulated. Specific rules apply to these areas:
a)     SAA must be in close proximity to the place of waste generation. Waste from one lab cannot be stored in another lab, a prep room, or in a room across a hallway
b)    The waste containers must be closed at all times except when waste is being added. Tight-fitting, non-leaking lids must be used
c)     All containers must be clearly labeled with the words “hazardous waste” as soon as any waste is placed in the container. The complete chemical name must be on the label
d)    Segregate containers by hazard class and compatibility. (e.g. acids away from bases and flammables). Secondary containers can be used to accomplish this
e)     Waste containers must be in good condition and compatible with the wastes being stored
f)     A generator may accumulate up to a total of 55 gallons of hazardous waste
g)    Once the container is full, the date must be written on the label. The waste must be transferred to the 30-day storage area within three days of this date.
h)     Partially full containers cannot be stored in satellite accumulation areas for more than one year from the date when satellite accumulation began in that container. The waste container must be moved to the 30-day storage area at or before the end of that year.

Before transferring the waste to the 30-day storage area the employee must fill the chemical waste log sheets (refer Appendix A) kept with the security. Complete the details accurately especially regarding the chemical substances, the quantity, and the exact location of the waste. Make sure to properly log every waste entering into a waste container.

30 Day Storage Area
Hazardous waste is taken to and stored in the 30-day storage area until a transporter picks up the material. Since we are a small quantity generator we must ship out the hazardous waste within 30 days of the date on each container. Typically a waste shipment will occur approximately twelve times per year.  
The following rules for wastes stored here are:
a)     Chemicals must be separated based on compatibility
b)    Labels must identify its contents, marked with the words such as  “hazardous waste”, and should be easy to read
c)     Containers should be filled to a safe level (must not be filled over 90%)
d)    All containers should be placed in a contained area
e)     Containers must be in good condition
f)     Adequate aisle space must be maintained
g)    Container must be compatible with the waste
h)     Container must be kept closed
i)      The room gets inspected weekly to ensure compliance with the above

Procedure for Waste Collection by Chemical Contractor
Waste will be picked up by the contractors (Vulcan Bio-Medical Waste Management Company) at regular intervals as defined in the agreement.

5.            Responsibilities
Managers and Supervisors must ensure that:
a)     All staff are trained in all aspects of this SOP or are deemed to be competent in its applications
b)    Hazardous waste is identified and segregated into the appropriate waste streams;
c)     Hazardous waste stored, labeled and transported appropriately; staff receive appropriate training that includes waste segregation, storage requirements, transportation requirements, labeling, emergency procedures, spill control and awareness of all associated hazards
d)    The waste storage areas have signs designating the purpose of the area and the hazards present
e)     Contracts with the waste pick-up contractors are renewed in time
It is the responsibility of the lab in-charge to ensure that the lab is in compliance with this procedure.
Personnel working under different functions are responsible for following this procedure.

6.            References
SP – 017
SP – 028 Waste Liquid Organic Compound Stores

7.            Appendices
Appendix A: Chemical waste log sheets

8.            Revision History

SOP No.
Supersedes No. & Date
Changes made (in brief)
GP010-01