Waste Management; Purpose
The purpose of this SOP is to describe the laboratory waste management procedure for disposal of test samples (raw materials, in-process, bulk/ finished product left over samples); expired retention samples (raw materials, finished product); broken glassware and glass container; packaging materials; all Laboratory chemicals & reagents used within the quality control laboratory.
Waste Management; Scope
This procedure is applicable to all laboratory operations associated with the disposal activity in the quality control and microbiology laboratory for general block at XX Pharmaceuticals Limited.
Definitions / Abbreviation
- SOP: Standard Operating Procedure
- QC: Quality Control
- ETP: Effluent Treatment Plant
- MSDS: Material Safety Data Sheet
Responsibilities
The roles and responsibilities are as follows
Senior Executive/Executive, QC & Microbiology
- To ensure that this procedure is followed.
- To identify correct sample for disposal.
Asst. Manager, Quality Control
- To ensure that this procedure is kept up to date.
- To confirm that the SOP reflects the required working practices.
- Arrange training on the SOP to all concerned personnel.
- To ensure implementation of the SOP into routine use after training.
- To ensure availability of adequate facilities, systems and resources to carry out this process and approve the SOP.
Head of Quality Assurance
- Take initiative to Approval of this SOP
- To ensure the overall implementation of the SOP
Procedure
- Wear rubber gloves, mask, safety glass and footwear during disposal work.
- Carry out the disposal work at the designated place.
- Wash hands thoroughly with soap and water, at the end of the operation.
- Always keep the waste bin covered with lids.
- Destroy any label/carton/ foil before dumping into the bin for disposal.
- Cross mark all label on the container with marker pen or destroy the label of container before disposal.
- Use separate container for collecting the broken glass and transfer to the salvage yard-marking container as “BROKEN GLASSWARE”.
- Do not return left over samples of raw materials, in-process material, bulk/ filled products to the container or work points from which it has been taken.
- Keep all the waste in designated bin.
- Carefully identify the name and check the status label of the sample to be disposed off.
- Check the MSDS of raw materials for the hazardous identification and proper method of disposal.
- Check the container properly for any left out material before disposition of the containers.
- Use the sink of fume cupboard to drain out flammable, toxic, corrosive water-soluble solvent and all mobile phase.
- Never light any type of flames & always place sign “No Flames” to warn others about the presence of Ether. Accumulate water immiscible solvents [like Chloroform, Dichloromethane, Carbon Tetrachloride, etc.) into one bottle & ether (Diethyl Ether waste) in another bottle & evaporate them separately using beaker by placing in fume cupboard.
- Place hazardous solid waste (e.g. tissue paper, filter paper, cotton, contaminated gloves etc.) in dedicated bin/container.
- Dispose liquid samples in sink by using large amount of tap water.
- After completion of test, retain left over samples of raw materials, in-process material, bulk/ finished products with proper identification labeled as “UNDER TEST SAMPLE” in specified place the batch is approved.
- After approval of the batch, transfer the excess samples (tablets, raw materials, capsules) of approved batch to a place labeled as “SAMPLE FOR DISPOSAL” record the disposal details in the Sample Disposal Register (Annexure-I).
- Once in a month or when required, collect and destroy all samples for disposal following the above steps.
- In case of raw materials, in-process material, and bulk/ finished products, empty out the sample from the poly bag into a container containing water, destroy the sample label of poly bag by shredding into “WASTE BIN FOR PAPER” & destroy the ploy bag in to the bin, labeled as “HAZARDOUS SOLID WASTE “.
- Shake dispersion of sample in container with the help of a glass & allow disintegrating. After the complete disintegration, drain out slowly into designated place & clean the drain with adequate water flushing.
- For stability sample after approval of report, analyst shall destroy the samples by dispersing them into a container having sufficient water and destroy the film, foil, de-blistered strips/blisters into a designated bin, labeled as “FILM/ FOILS FOR DISPOSAL”;
- The secondary packaging materials (carton, leaflets, labels, shipper carton, master carton) into “WASTE BIN FOR PAPER” and other packaging materials (i.e. polyethylene bag, cap, plastic stopper, dropper etc.) into another bin, labeled as “PACKAGING MATERIAL FOR DISPOSAL”.
- Shake the dispersion of sample in container with the help of a glass rod and allow to disintegrate. After complete disintegration, drain out slowly into designated place and clean the drain with adequate water flushing.
- In case of ampoules, vials and bottles; break open the glass ampoule, open the vials and bottles, empty the contents in water and discard the broken ampoule and vial into a bin, labeled as “BROKEN GLASSWARE”. Shake the dispersion of sample in container with the help of a glass rod and allow to disintegrate. After the complete disintegration, drain out slowly into designated place and clean the drain with adequate water flushing.
- Collect all types of waste from the respective bins into the different polythene bag by attaching “TO BE DISPOSED” label, weigh the waste content, and send waste to the salvage yard with a waste transfer note.
Download Annexure Here: Waste Management
Annexure I Sample Disposal Register