You dont have javascript enabled! Please enable it! LAB-110 Safety Procedure in Laboratory Pharmaceuticals quality assurance & validation procedures GMPSOP

LAB-110 Safety Procedure in Laboratory

DepartmentLaboratoryDocument noLAB-110
TitleLaboratory Housekeeping and Glassware Cleaning
Prepared by: Date: Supersedes: 
Checked by: Date: Date Issued: 
Approved by: Date: Review Date:

1.0 DOCUMENT OWNER

Laboratory/Quality Manager

2.0 PURPOSE

This document outlines the procedure to be followed to provide a safe working environment in the Quality Control Laboratory.

3.0 SCOPE

This procedure applies to all personnel entering the QC Laboratory including both internal employees and external visitors.

4.0 RESPONSIBILITY \ BUSINESS RULES

4.1 All Laboratory Personnel are responsible and must:

4.1.1 Be aware of safety regulations and prohibitions.

4.1.2 Use appropriate safety equipment and all personal protective equipment (PPE) provided.

4.1.3 Ensure that all areas and equipment are cleaned and decontaminated after use.

4.1.4 Be aware of the hazards of chemicals before use by referring to the relevant Material Safety Data Sheet (MSDS) or other relevant materials and follow safety rules and regulations.

4.1.5 Prior to working with any new chemical, ensure that a risk assessment is conducted and appropriate safety precautions are followed.

4.1.6 Report all accidents and near misses to the appropriate Team Leader, Laboratory Manager or designee.

4.1.7 Advise maintenance and service personnel of special chemical hazards in the laboratory as appropriate.

4.2 The Team Leader, Laboratory Manager or designee should:

4.2.1 Ensure that the required safety training is provided for all Laboratory personnel (both contract and permanent) at the time of initial orientation and on a continual basis.

4.2.2 Ensure that all employees have access to MSDS and PPE.

4.2.3 Ensure that prior to conducting a new task laboratory personnel have been trained in relevant safety procedures.

4.2.4 Ensure that all staff working with any new chemical complete a risk assessment for that chemical, which identifies safety precautions that must be implemented prior to working with the chemical.

4.2.5 Ensure action is taken to prevent injuries from occurring as a result of job related activities.

4.2.6 Ensure that visitors and service providers working in the laboratory comply with this safety procedure.

5.0 PROCEDURE

5.1 General Safe Laboratory Practices

5.1.1 All personnel must be acquainted with the location of safety equipment and emergency procedures in cases of fire, etc.  Refer to Site Emergency Response Plan SOP for emergency procedures.

5.1.2 All laboratory personnel should ensure that the work area is decontaminated before work commences and after the work has been completed and that the work area is free from objects not relevant to the work being undertaken.

5.1.3 In order to maintain a safe working environment, laboratory personnel must follow good housekeeping practices and carry out housekeeping duties as outlined in SOP LAB-105Laboratory Housekeeping and Glassware Cleaning.

5.1.4 All laboratory personnel should not lift heavy objects without the aid of an additional person or the use of a lifting aid.

5.1.5 A ‘Wet Floor’ sign must be displayed when liquid is on the floor to prevent injuries occurring.

5.1.6 Hands must be washed thoroughly before leaving the Laboratories.

5.1.7 Long hair may constitute both a fire risk and risk of contamination; therefore it must be tied back with a hair band.

5.2 Personal Protective Equipment

5.2.1 All personnel entering the laboratory must follow SOP Personal Protective Equipment Policy and wear appropriate PPE to reduce the risk of exposure to hazards.

5.2.2 Safety glasses must be worn at all times within the Quality Control Laboratory.

5.2.3 All GMP site personnel, visitors and contractors should ensure that their PPE is properly fitted and maintained in a clean and serviceable condition.

5.2.4 Protective shoes with covered toes and a non-slippery sole must be worn within the laboratories.

5.2.5 Protective clothing must be removed before leaving the building.

5.3 Storage, Labelling and Handling of Chemicals

5.3.1 A risk assessment must be carried out for all chemicals in the laboratory.  All chemical containers and decanting vessels must be appropriately labelled.

5.3.2 Consult the relevant Material Safety Data Sheet (MSDS) to find information relating to the material such as its properties, proper handling and storage, first aid treatment and others, and to ensure safe handling and disposal.  MSDS should be available in folders on mezzanine level, also in EHS website.

5.3.3 Hazardous chemicals must be stored in their dedicated cabinets.  Incompatible chemicals should not be stored together unless segregated.

Note: Inorganic cyanides, mercury, arsenic and barium compounds are stored in the poisonous cabinet.  The keys to this cabinet are kept by the Laboratory Team Leader or Manager.

5.3.4 Peroxides and peroxide forming chemicals are to be checked periodically for stability.

5.3.5 For detailed information storage, labelling and handling of laboratory chemicals refer to SOP LAB-115 Use and Control of Laboratory Chemical Materials.

5.4 Laboratory Equipment

5.4.1 All laboratory equipment must be kept clean and be well maintained throughout its life.

5.4.2 All laboratory personnel must not attempt to start, energise or use a piece of equipment with a sign of “DO NOT USE”.

5.5 Disposal of Waste

All laboratory personnel must dispose of waste as stated in SOP LAB-040 Laboratory Waste Management.

5.6 Hazardous Spills

5.6.1 All laboratory personnel must be aware of and adhere to the direction outlined in the standard procedure Laboratory Spill Response for any chemical spills.

5.6.2 In case of a mercury spill, all laboratory personnel must quickly and completely clean up the spill as following:

5.6.2.1 Obtain the Roth Mercurisorb Kit located in the Spill Response Kit cabinet next to the Analytical Services Laboratory.

5.6.2.2 Put on disposable gloves.

5.6.2.3 Using the disposable pipette, push the mercury together, suck the mercury up and place it in the labelled Mercury Waste bottle.

5.6.2.4 Cover the remaining mercury completely with Mercurisorb reagent, and allow it to react for 15 – 30 minutes.

5.6.2.5 Brush the powder up and collect it in the Mercury Waste bottle.

5.6.2.6 Clean up the residue with a cloth and place in the Mercury Waste bottle, and dispose of the mercury waste as per SOP LAB-040 Laboratory Waste Management.

5.7 Accidents

5.7.1 Safety or environmental incidents (accident or hazard near miss) must be reported by laboratory personnel as prescribed in SOP Hazard Identification and Incident / Accident Investigation Report.

5.7.2 For the location of fire alarm, safety showers, fire blankets, first aid kit, fire hose reel, eye wash stations and safety glasses refer to SOP Site Emergency Evacuation Plan,  which is displayed on the Laboratory notice board.

5.7.3 Operation of Safety Shower

5.7.3.1 Stand the affected person under the showerhead; pull the loop handle down to start the flow of water. The required time for washing depends on the nature of the irritant.

5.7.3.2 Push the loop handle up to stop the flow of water.

5.7.3.3 Contact the First Aid Officer for further instructions.

5.7.3.4 Mop up any remaining water under and around the area of the safety shower.

5.7.4 Operation of Eye Wash Fountain

5.7.4.1 Stand the affected person in front of and leaning over the sink.

5.7.4.2 Pull the eye wash fountain out of its receptacle.

5.7.4.3 With the fountainhead face up, gently squeeze the handle towards the hosting to create a flow of water.

5.7.4.4 Position the fountain so that the flow of water gently flushes the eye. The required time for flushing eyes depending on the nature of the irritant.

5.7.4.5 Release the pressure on the fountain to stop the flow of water.  Holding the fountain head allow the eye wash fountain to retract into its receptacle.

5.7.4.6 Contact the First Aid Officer for further instructions.

5.8 Compressed Gasses

Note: The compressed gas cylinders (Nitrogen and Helium) are housed in the Boiler Room, situated on the side of the Manufacturing Building facing the Building 1 executive sheltered car park.  The Laboratory Attendant is responsible for the keys to this room.

Note: Compressed gas cylinders (Helium, Nitrogen and Air) are also located outside the Quality Control Laboratory in an enclosed cage to supply the GC.

5.8.1 The designated person entering the Boiler Room must wear appropriate PPE such as ear protection, safety glasses and safety shoes.

5.8.2 When a gas cylinder runs low, the outlet valve on the cylinder must be turned off, and disconnected from the pressure regulator.

5.8.3 The empty gas cylinder is then taken away, using the cylinder trolley with cylinder securely fitted in, and stored in the designated area for empty gas cylinders.

5.8.4 A new gas cylinder is then taken into the Boiler Room, the blue cap seal on the mouth of the cylinder removed, and connected to the pressure regulator.

5.8.5 The outlet valve of the new cylinder should be turned on and the connection of the new cylinder must be checked for leaks using Snoop Liquid Leak Detector or equivalent.

6.0 DEFINITIONS / ACRONYMS

None

7.0 REFERENCES

SOP LAB-040 Laboratory Waste Management

8.0 SUMMARY OF CHANGES

Version #Revision History
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