Laboratory waste disposal procedure at a GMP site
- Kazi
- Last modified: July 27, 2024
Purpose
This waste disposal procedure outlines the necessary steps to effectively dispose of laboratory waste and provides guidelines for maintaining an acceptable level of good manufacturing practice (GMP).
Scope of the procedure
This procedure covers the disposal of wastes typically generated in pharmaceutical quality control laboratories.
Sorting of waste
Efficient laboratory waste disposal is an important and fundamental requirement for ensuring the safety of laboratory analysts and protecting the environment.
It is the responsibility of all colleagues intending to dispose of waste to ensure that the following precautions and procedures are complied with.
It is important to properly segregate laboratory waste because different types of waste have different treatment standards.
Waste generators must follow strict EPA regulations, Corporate Policy, and the guidelines set forth by individual transporters and treatment, storage, and disposal facilities.
Responsibility for waste disposal
All personnel should follow this procedure and ensure their visitors and contractors do the same. Laboratory Supervisors shall ensure that all personnel are trained, understand, and comply with this procedure.
The Area Manager is authorized to check and approve any proposed changes to this procedure.
240 SOPs, 197 GMP Manuals, 64 Templates, 30 Training modules, 167 Forms. Additional documents included each month. All written and updated by GMP experts. Checkout sample previews. Access to exclusive content for an affordable fee.
Laboratory waste disposal procedure
Tools required
– Waste disposal containers
– Waste container trolley
– Key to the destruct cage
– PPE (Gloves, lab coat, safety glasses, safety shoes, etc)
– Waste container labels
– Zeofresh spill kit and absorbent mats
Solid waste disposal procedure
Paper, plastic, glass, and finished goods must be segregated into the appropriate colored waste disposal bins. Recyclable waste must be free of any chemical contaminants or residues.
Chemical waste disposal procedure
All chemical waste should be categorized before disposal. Specific disposal methods are discussed in the following Sections.
In general, waste material should be classified according to the main hazardous constituent of the waste material and will follow the local Dangerous Goods Code.
However, in some situations, the waste material should be classified according to its main hazard. For example, organic mercury waste should be disposed of with other mercury wastes.
Determining the hazardous nature of a waste material is a key step in the disposal process. This can be done by consulting Material Safety Data Sheets (MSDS), manufacturer and supplier information, and other laboratory reference material.
Remember, the Laboratory Manager can provide further details if needed.
The following generic waste categories are applicable:
– Flammable Liquid, Toxic (Non-Halogenated Organic Waste)
– Toxic Liquid, Organic and Inorganic (Halogenated and Heavy metals Waste)
– Corrosive Liquid, Acidic (Acids)
– Corrosive Liquid, Basic. (Bases)
– Mercury Compounds, Liquid (Mercury Compounds)
– Oxidising Liquid (Oxidisers).
Details on these categories are provided in the following sections.
1. Disposal of flammable toxic liquid
All liquid chemical wastes containing non-halogenated organic liquids should be included in this waste.
Although the final waste material is not expected to be flammable or acutely toxic, it will typically contain significant amounts of flammable organic solvents (e.g., acetonitrile) or toxic (e.g., methanol) in their pure state.
Therefore, as a precaution and to comply with the Dangerous Goods Code, this waste category will be classified and labeled as flammable with a subsidiary risk of toxicity.
Small quantities (<1L) of water-miscible organic solvents (e.g., ethanol used for glassware cleaning) may also be included in this waste category.
However, it is also acceptable to flush these down the sink with a large quantity of water.
Labeling
– Class: 3 (Flammable)
– Subsidiary Risk: 6.1 (Toxic)
– UN Number: 1992
– Hazchem Code: 3WE
– Packaging Group: II
Storage
Quality control laboratory flammable store.
Examples
All HPLC waste contains organic solvents (e.g., acetonitrile, methanol, ethanol, acetone).
2. Disposal of toxic liquid – organic and inorganic
All liquid chemical wastes containing halogenated organic liquids, concentrated aqueous solutions (>2M) of halogenated compounds, and large quantities (>2L) of dilute aqueous solutions of halogenated compounds should be included in this waste category.
Arsenic, barium, boron, cadmium, copper, lead, manganese, nickel, selenium, and silver are regulated toxic metals that require special disposal precautions.
This category should include concentrated solutions (>2M) and large quantities (>2L) of dilute aqueous solutions of these metals.
Small quantities of dilute solutions may also be included in this waste category.
However, it is also acceptable to flush these down the sink with a large quantity of water (at least ten times the waste volume in water should be used).
Labeling
– Class: 6.1 (Toxic)
– Subsidiary Risk: Nil
– UN Number: 2810
– Hazchem Code: 2X
– Packaging Group: II
Storage
Quality control laboratory toxic cabinet.
Examples
Halogenated compounds, halogenated organic liquids (e.g., chloroform, dichloromethane), Iodine and bromine solutions (including Hydranal waste), Lead and Arsenic standard solutions.
Precautions
Some halogenated compounds (particularly fluoro compounds) should be protected from moisture, as hazardous decomposition products may form (e.g., Hydrofluoric Acid).
Check labels and MSDSs to ensure the waste’s reactive nature (e.g., protection from moisture) prior to disposal.
If in doubt, consult EHS for advice.
240 SOPs, 197 GMP Manuals, 64 Templates, 30 Training modules, 167 Forms. Additional documents included each month. All written and updated by GMP experts. Checkout sample previews. Access to exclusive content for an affordable fee.
3. Disposal of corrosive liquid – acidic
In general, corrosive substances (pH less than 6.0 or higher than 9.0) are specified as prohibited discharges to plant sewer systems.
Such waste can interfere with the operation of either in-house or offsite treatment facilities or adversely impact surface waters or public health and safety.
Therefore, this waste category should include concentrated acids (>4M). All concentrated acids must be diluted with a large quantity of water before addition to the waste mixture.
Dilute acids may also be included in this waste category. However, it is also acceptable to flush these down the sink with a large quantity of water.
Labeling
– Class: 8 (Corrosive)
– Subsidiary Risk: Nil
– UN Number: 3264/3265
– Hazchem Code: 2X
– Packaging Group: II
Storage
Quality control laboratory acid corrosive cabinet.
Examples
Inorganic acids (e.g., perchloric, sulphuric, hydrochloric, nitric). Organic acids (e.g., acetic, formic acid).
Precautions
All concentrated acids must be diluted with water before disposal.
Please don’t add water to the acid.
Instead, add the acid waste to water and then dispose of it.
4. Disposal of corrosive liquid – basic (alkaline)
Corrosive substances (pH less than 6.0 or higher than 9.0) are generally prohibited from being discharged to plant sewer systems.
Such waste can interfere with the operation of either in-house or offsite treatment facilities or adversely impact surface waters or public health and safety.
Therefore, this waste category should include concentrated bases (>4M). All concentrated bases must be diluted with a large quantity of water before addition to the waste mixture.
Dilute bases may also be included in this waste category. However, it is also acceptable to flush these down the sink with a large quantity of water.
Labeling
– Class: 8 (Corrosive)
– Subsidiary Risk: Nil
– UN Number: 3266
– Hazchem Code: 2X
– Packaging Group: II
Storage
Quality control laboratory alkali corrosive cabinet.
Examples
Sodium hydroxide, Potassium hydroxide.
240 SOPs, 197 GMP Manuals, 64 Templates, 30 Training modules, 167 Forms. Additional documents included each month. All written and updated by GMP experts. Checkout sample previews. Access to exclusive content for an affordable fee.
5. Disposal of liquid mercury compounds
Mercury or mercury compounds should be kept separate from other liquid waste whenever possible.
This is primarily a safety concern, but it also facilitates the reuse or recycling of the material.
Mercury is so toxic that the element and its compounds should not be allowed to contaminate air or water.
Mercury compounds are bio-accumulative.
Labeling
– Class: 6.1 (Toxic)
– Subsidiary Risk: Nil
– UN Number: 2024
– Hazchem Code: 2X
– Packaging Group: II
Storage
Quality control Laboratory toxic cabinet.
Examples
Mercury and mercury compounds, Solutions containing mercury oxide, mercury acetate, etc.
6. Disposal of ethers
Ethers are very volatile, hygroscopic, colorless liquids with a characteristic odor.
It is not appropriate to use hoods in fume cupboards to intentionally evaporate significant quantities of chemicals such as ethers.
The laboratory fume cupboards do not have adequate air pollution control equipment. Ether vapors contribute to photochemical smog and air pollution.
Labeling
– Class: 3 (Flammable)
– Subsidiary Risk: Nil
– UN Number: 3271
– Hazchem Code: 3YE
– Packaging Group: II
Storage
Quality control laboratory flammable store.
Examples
Diethyl ether, Tetrahydrofuran Precautions.
Ether waste should not be stored in containers over 2 liters to ensure safe handling.
Containers must be tightly closed and kept in a cool, well-ventilated area away from heat and sunlight.
Under the influence of light and air, ethers can form explosive peroxides.
Ether waste should be handled with the same care and regard as pure diethyl ether reagent.
New containers shall be dated upon filling commencement. If, after one month, any ether waste container has not been filled, it will be necessary to dispose of that lot and introduce a new empty container.
Before moving the ether waste container, check if any crystals are visible in the chemical solution or if crystals are on or in the container.
Please look over the container near the cap to see if there are crystals.
Some peroxide crystals in solution have a very fine, spun glass-wool appearance.
If peroxides are detected, do not open the container. Instead, notify the Environmental Manager, who will arrange for our chemical waste contractors to remove the waste.
240 SOPs, 197 GMP Manuals, 64 Templates, 30 Training modules, 167 Forms. Additional documents included each month. All written and updated by GMP experts. Checkout sample previews. Access to exclusive content for an affordable fee.
Storage for chemical wastes
Chemical waste must be stored appropriately so as not to create a hazard to colleagues, visitors, and/or the Company’s property.
The laboratory’s liquid chemical wastes are stored in the flammable solvent room, the fume cupboard area, the acid and alkali corrosive cabinets, and the toxic cabinets, as specified in the section above.
These areas do not allow spills, fires, etc., so it is important to keep the different categories well separated.
All liquid chemical wastes are to be stored in 5-litre white HDPE plastic containers commonly referred to as carboys) except for ether and mercury wastes (use 2-litre containers instead).
Such containers are approved for the transport of Dangerous Goods.
All the waste containers should be tightly closed, leak-free, and clearly and permanently labeled.
At the time of usage, the waste containers should be opened in the fume cupboard.
Liquid waste containers should only be filled to 80-90% capacity to allow for vapor expansion and minimize the potential for spills from overfilled containers.
Frequency of disposals
Chemical waste must not be accumulated for disposal. You’ll need to arrange regular disposal.
Laboratory waste should be disposed of at least once a week or as the laboratories require. It must be taken to the designated area in the waste depot.
Daily inspections of the waste depot will indicate the need for offsite collection and disposal by an approved chemical waste contractor.
240 SOPs, 197 GMP Manuals, 64 Templates, 30 Training modules, 167 Forms. Additional documents included each month. All written and updated by GMP experts. Checkout sample previews. Access to exclusive content for an affordable fee.
Work instruction example for laboratory waste disposal
Wear all necessary personal protective equipment (PPE), such as gloves, safety shoes, a lab coat, and safety glasses. Respirators may be required for wastes that emit toxic vapors.
Collect all wastes and sort them according to their recognized characteristics before disposal into the appropriate waste container (to facilitate segregation, refer to MSDS, reagent bottle labels, laboratory manuals, etc.).
Identification shall be based on waste category, type, UN No., Class, and Hazchem Code.
Prepare the waste for disposal by storing it in an appropriate container.
The container must be sound and leak-tight and appropriate for the type of waste to be disposed of. No harmful quantity of chemical waste shall adhere to the outside of the container.
Chemical waste must only be mixed with other chemical waste for accumulation if it is of the same type.
If in doubt, avoid mixing chemical wastes, as unexpected reactions may occur. The waste generators ensure that incompatible chemicals are not stored in the same container.
Each container shall be labeled with a waste category label and an orange reject label, as below.
Fill in the reject label as follows:
Product name = WASTE,
Date = as appropriate,
N/A all other sections.
– Stick the labels on all the containers and ensure that all containers are properly sealed/secured.
– Obtain the trolley specifically designated for the transport of waste containers. The trolley should have rails along all sides to prevent containers from falling off.
– Lock the wheels before loading the waste containers. The maximum number of containers allowed to be loaded on the trolley is 24 x 5 liters.
– Care should be taken while transporting the waste containers to the trolley and moving it to the lift area.
– Spill kits and appropriately trained colleagues must accompany waste. Wastes must always be supervised.
– Notify EH&S that waste needs to be disposed of so they can accompany it to the waste areas with keys, etc.
– Use the lift in the HVSD area to level 1
– Carefully transport the waste containers to the reject cage.
– Remove the waste containers from the trolley and leave them in the dangerous goods storage cabinets in the reject cage. Wherever possible, keep non-compatible wastes apart in the cabinets.
– Flammable wastes are to be stored in the segregated depot.
– Contact EH&S for advice on the arrangements for collection by an approved Waste Collection agent.
– The Waste Management colleagues will monitor the accumulation of waste containers and coordinate the collection process.
Making new labels for the empty waste containers:
– Select the file(s) applicable to the waste type(s) that requires labeling. NB Each waste category defined in the section above has a unique label.
– Obtain the required number of blank white self-adhesive vinyl labels.
– Print off the required number of labels using a color laser printer. (If a color laser printer is not used, the Dangerous Good labels must also be applied to the printed label, e.g., flammable, toxic.)
– Peel off the backing and carefully place the labels onto the containers. Please make sure the labels are attached.
– Any unused extra labels should be stored in the flammable storage area.
1. Flammable, toxic liquid (Non-halogenated Organic waste)
Organic-based chemical waste is treated via thermal destruction. Organic chemical wastes are blended into a usable fuel source.
The incinerators operate at extremely high temperatures with long retention periods, ensuring the most complex organic compounds are destroyed.
The flame temperature is typically above 2,000°C with gas residence times over five seconds at 1,000°C.
Waste gases given off are passed through a secondary burner (afterburner) to ensure total breakdown.
The gas is then passed through a separate scrubber, where the emissions are neutralized in accordance with EPA standards.
2. Organic toxic liquid (Halogenated waste)
Halogenated wastes are biologically treated to strip the halogens from the waste solvent.
A filter press separates an inert salt slurry for security landfill burial from the liquid component.
The high percentage yield of organic liquid and aqueous waste is fractionated by distilling to produce a clean hydrocarbon solvent used to fuel plant reactors such as heat exchange columns.
The aqueous waste with little calorific value is transferred and utilized in the acidification plant.
3. Inorganic toxic liquid (Heavy metals)
Concentrated heavy metal wastes are recycled where possible.
Otherwise, they are treated via solids fixation, whereby the waste is encapsulated and then buried in a security landfill.
Low-level heavy metal solutions are treated in the liquid waste treatment plant.
4. Corrosive Liquid – Acidic
Acidic wastes are utilized to manage other wastes at the treatment plant by neutralizing appropriate alkalis and dosing particular treatment operations (such as breaking down oily emulsions in Dissolved Air Flotation reactors).
5. Basic corrosive liquid (Bases)
Basic wastes are utilised in the management of other wastes at the treatment plant by neutralising appropriate acids and alkali dosing particular treatment operations.
6. Liquid mercury compounds
Mercury is recovered from the waste wherever possible. Otherwise, it is encapsulated in a concrete matrix and then buried in a secure landfill.
7. Ethers waste
Ether waste is treated at an approved liquid waste treatment facility.
Conclusion
In conclusion, the laboratory waste disposal procedure is important for maintaining safety and compliance with GMP standards in pharmaceutical quality control laboratories.
Proper segregation, handling, and disposal of various waste types, including solid, chemical, and hazardous materials, are essential to protect laboratory analysts and the environment.
Responsibilities are clearly defined for all personnel, ensuring adherence to EPA regulations and corporate policies.
Regular training and thorough documentation support the effective implementation of this procedure, ensuring a safe and compliant laboratory environment.
Author: Kazi Hasan
Kazi is a seasoned pharmaceutical industry professional with over 20 years of experience specializing in production operations, quality management, and process validation.
Kazi has worked with several global pharmaceutical companies to streamline production processes, ensure product quality, and validate operations complying with international regulatory standards and best practices.
Kazi holds several pharmaceutical industry certifications including post-graduate degrees in Engineering Management and Business Administration.
Thanks for the information provided! I can’t express how much I appreciate the effort put into creating this resource. Truly exceptional.