1.0 Purpose
1.1 This SOP describes the procedure to follow “Safety Precaution in Laboratory”.
2.0 Scope
2.1 “Safety Precaution in Laboratory” is a GMP requirement to assure the safety in laboratory. This is
why “Safety Precaution in Laboratory” is very important for laboratory to confirm the safety of laboratory and
the personal who are working in the laboratory. This SOP is applicable for quality control laboratory at
"NAME" Pharmaceuticals Ltd.
3.0 Responsibility
3.1 It is the responsibility of trained Quality Control personnel to perform the “Safety Precaution in
Laboratory”.
3.2 Head
of Quality Control is responsible to monitor of the procedure for “Safety
Precaution in Laboratory”
3.3 Head of Quality Assurance is responsible for compliance of the SOP.
4.0 Abbreviations and Definitions
4.1 SOP : Standard Operating Procedure
5.0 Materials and Equipment
5.1 Not Appreciable
6.0 Precaution / Health and Safety Considerations
6.1 Provide adequate training on “Safety Precaution in Laboratory” to the laboratory personals to
understand the SOP. So that no confusion arise during the routine laboratory work.
7.0 Procedure
7.1 Laboratory Clothing:
Wear shoes that fully cover the feet. Shoes provide a great deal of initial protection in the case of dropped
containers, spilled chemicals, and unseen hazards on the floor. Use old clothes, which are not too loose,
especially at the sleeves. Laboratory coats or aprons must be worn over clothes. Fasteners are preferable to
buttons for quicker removal in case of an emergency. Tie back long hair so that it will not fall into flames or
chemicals. Avoid shorts in the lab. Exposed body skins give added risk to irritation and burns by corrosive
chemicals and gases.
7.2 Safety Glasses:
Wear safety glasses at all times in the laboratory. Goggles are required to be worn at each lab period
and should also be worn over prescription glasses. Contact lenses should not be used during the lab.
7.3 Working Alone in the laboratory:
All work must be performed under the supervision of a laboratory Manager. The instructor should be aware of
the exact nature of all work being done in the laboratory.
7.4 Unauthorized Experiments:
Do only the experiment which has been assigned by the laboratory Manager. Never do any unauthorized
experiment in place of the one assigned by the instructor. Do not change the designated procedure without
the advice of the instructor.
7.5 Read up experiment procedure:
Know exactly what you are to do. Occasionally incomplete directions or a misunderstanding of instruction
causes accidents. Whenever you are in doubt, ask Manager. Think about what you are doing and why you
are doing it at all times. Do not start any experiment involving the use of an experimental set-up (apparatus)
until it has been checked and approved by your laboratory Manager unless otherwise instructed.
7.6 Food:
Do not eat, drink or smoke in the laboratory. For safety purposes, assume all chemicals to be poisonous
either by themselves or because of impurities. Also avoid direct contact with organic chemicals. Many are
absorbed directly through the skin.
7.7 Cleanliness:
Keep the lab bench cleans at all times. If a solution, a solid or liquid chemical is spilled on the bench or on
the laboratory floor, clean up the spill immediately. Any chemical spilled on your skin or your clothing, should
be washed immediately and thoroughly. Notify the laboratory manager of the spill. When leaving the
laboratory, wipe the bench top thoroughly. Make sure that your work area is clean and free of spilled
chemicals or scraps of paper. Wash your hands with detergent or soap and water.
7.8 Waste Disposal:
Dispose of waste and excess materials in the proper manner. Used matches, paper, broken glass, or
porcelain ware should be placed in the appropriate containers but not in the sinks. If you have any questions
concerning the waste disposal, ask Manager for the proper procedure.
7.9 Fume Hood:
Use fume hood when necessary. Use the fume hood when you are so directed by the laboratory instructor, or
when it is indicated to do soon the experimental procedure. Fume hoods remove toxic vapors and irritating
odors from the laboratory. The removal of these materials is essential for protecting the health and safety of
those people working in the laboratory.
7.10 Burners:
Light burners only when needed. Properly extinguish any flame not being used. Any open flame may ignite
reagents being used by you or others near you. Many organic liquids are highly flammable and these liquids
should be heated only on hot plates or heating mantles.
7.11 Reactions:
Never look directly into the mouth of an open flask or test tube if it contains a reaction mixture.
7.12 Hot Objects:
Avoid touching hot objects. When heating a chemical in a container, the clamp holding the container and the
burner will also become hot. Place the object on a piece of asbestos board or on wire gauze, which is not
directly touching the bench top. Glass objects take a long time to cool, so allow plenty of time to cool before
touching them.
7.13 Glassware:
Use only equipment which is in good condition. Defective equipment is an important source of accidents.
Some defects to watch for include:
7.13.1 Chipped tips on burettes, pipettes and funnels.
7.13.2 Chipped or broken rims on beakers,
flasks, funnels, graduated cylinders and test tubes.
7.13.3 Cracks in beakers, flasks, graduated
cylinders, test tubes and crucibles.
7.13.4 Star-shaped breaks in the bottom of
test tubes or near the bottom edges of beakers and flasks.
7.13.5 Severe scratches in the bottom of
beakers, flasks, and test tubes.
7.13.6 Sharp edges on glass tubing and
glass rods. These defects may be minimized by replaced them.
7.13.7 Inflexibility in rubber stoppers -
(replace)
7.13.8 Separations in the mercury column of
thermometers - (replace)
7.13.9 Non-working parts of screw clamps, buret clamps or rings. - (replace)
7.14 Gloves:
When working with extremely corrosive material, wear thick gloves. Contaminated disposable gloves should
be discarded in designated containers (e.g., radioactive or bio-hazardous waste containers). Wash hands as
soon as possible after removing protective gloves.
7.15 Handling Liquid Chemicals:
7.15.1 Reagent in dropper bottle:
If the general supply bottle is equipped with a dropper, use it, but be sure that the dropper never touches your
container or the contents in it. Never put it down on the bench top, but return it immediately the right reagent
bottle.
7.15.2 Reagent in a stopper bottle:
If the general supply bottle is equipped with a stopper, the stopper should either be held during the transfer or
placed on its flat top. Pour chemicals from the general supply bottle into your container. Be sure that the
proper stopper is returned to the supply bottle; do not interchange stoppers.
7.15.3 Mixing:
If liquid chemicals are to be mixed with water, always add the concentrated chemical to water rather than
water to chemical. This keeps the new solution dilute at all times and avoids many accidents. Usually addition
should be done slowly, using small quantities. It is especially important to add acid to water because of the
heat generated.
7.15.4 Pipetting:
Liquids are drawn into the pipet by applying a slight vacuum at the top, using a small rubber suction bulb but
NEVER THE MOUTH. Use pipette fillers.
7.15.5 Heating:
Liquids in beakers and flasks can be heated by placing them on a ring or tripod stand on wire gauze with the
container preferably supported by a clamp. Liquid should never be heated in a graduated.
7.15.6 Disposal:
Check with your laboratory Manager before disposing of any chemicals down the drain. If the liquid chemical
can be disposed of in the sink, dispose of it by rinsing it down the sink with large quantities of water.
7.16 Handling Solid Chemicals:
Take an appropriate container to the reagent shelf where the general supply is kept. Solids are somewhat
more difficult to transfer than are liquids, so a wide-mouthed container such as a beaker is preferable. During
the transfer, hold the stopper or lay it on the bench without contaminating the stopper. If you use your own
spatula, be sure that it is absolutely clean. Return the proper stopper to the general supply bottle; do not
interchange stoppers.
7.16.1 Mixing:
If the solid is to be mixed with a liquid, add the solid to the liquid. Additions should be made in small quantities
except in special circumstances.
7.16.2 Disposal:
If the laboratory instructor directs you to dispose of any solid chemicals in the sink, flush it down the drain with
copious amounts of running water. All other solids should be disposed of in special containers provided for
this purpose.
7.17 Chemical Spills In the Laboratory:
Wear the appropriate personal protective equipment (e.g., gloves, goggles) when cleaning up spills.
7.17.1 Non volatile and non flammable materials:
If the material is not particularly volatile, nor toxic, and poses no fire hazard the liquid can be cleaned up by
using an absorbent material which neutralizes them, for example, sodium bicarbonate solution or powder for
acids, or sodium thiosulfate solution for bromine. Rubber or plastic gloves should be worn while using
absorbent materials. A dustpan and brush should be used to remove the absorbent material. Then, the
contaminated area should be cleaned with detergent and water and the area mopped dry.
7.17.2 Volatile, flammable and toxic spill materials:
Alert everyone in the laboratory to extinguish flames, disconnect spark-producing equipment, shut down all
experiments, and evacuate the laboratory. The laboratory manager and safety personnel will handle the clean
up.
7.17.3 Acid Spills:
Apply neutralizer (or sodium bicarbonate) to perimeter of spill. Mix thoroughly until fizzing and evolution of gas
ceases. NOTE: It may be necessary to add water to the mixture to complete the reaction. Neutralizer has a
tendency to absorb acid before fully neutralizing it. Check mixture with pH indicator paper to assure that the
acid has been neutralized. Transfer the mixture to a plastic bag, tie shut, fill out a waste label, and place in the
fume hood. Notify supervisor.
7.17.4 Caustic Spills:
Apply neutralizer to perimeter of spill. Mix thoroughly until fizzing and evolution of gas ceases. Check mixture
with pH indicator paper to assure that the material has been completely neutralized. Transfer the mixture to a
plastic bag, tie shut, fill out a waste label, and place in the fume hood. Notify supervisor.
7.17.5 Solvent Spills:
Apply activated charcoal to the perimeter of the spill. Mix thoroughly until material is dry and no evidence of
liquid solvent remains. Transfer absorbed solvent to a plastic bag (if compatible), tie shut, fill out and attach a
waste label, and place in the fume hood. Notify supervisor.
7.18 Chemical Spills on a Person:
7.18.1 Over the body:
Within seconds, quickly remove all contaminated clothing while person is under safety shower. Flood the
affected body area with cold water for at least fifteen minutes. If pain continues or resumes, flood with more
water. Wash off chemicals with a mild detergent solution. Do not apply any materials such as neutralizing
agents or salves, to the area. Obtain medical assistance immediately.
7.18.2 On small area of body:
Immediately flush area thoroughly with cold water. Wash with a mild detergent solution. If there is no visible
burn, wash out the area with warm water and soap.
7.18.3 In the eyes:
You will need to assist the person who has chemicals spattered in the eyes. Immediately drench the eyes at
the nearest emergency eyewash station. Force the eye or eyes open to get water into them. The speed of
your response to this emergency is extremely important. Notify the laboratory Manager of the accident
immediately.
7.19 Swallowing Chemicals:
The laboratory Manager should determine what specific substance is ingested. The individual should be
forced to drink copious amounts of water and seek medical assistance.
7.20 Burns:
For burns by hot objects, flames or chemical, flush the affected area with cold water for several minutes.
Notify the laboratory Manager of the burn and he will arrange transportation to the infirmary if necessary.
7.21 Fire:
Get a fire extinguisher and direct its spray toward the base of the fire. If the fire is too big to extinguish, the
laboratory manager should call the fire department and sound the fire alarm. When the fire is out, be sure all
extinguishers used are tagged as empty and are replaced.
7.22 Injury or Illness:
For minor cuts, wash them thoroughly; apply a good antiseptic, and a band-aid. For major cuts, severe
bleeding or serious illness, send someone for help and administer first aid. Only a physician is trained to treat
serious injury or illness. Notify the Manager immediately.
7.23 Emergency Response:
7.23.1 It is your responsibility to read safety and fire alarm posters and follow the instructions during an
emergency.
7.23.2 Know the location of the fire extinguisher, eye wash, and safety shower in your lab and know how to
use them.
7.23.3 Notify Head of Quality Control immediately after any injury, fire or explosion, or spill.
7.23.4 Know the building evacuation procedures.
7.24 Common Sense:
Good common sense is needed for safety in a laboratory. It is expected that each Officer will work in a
responsible manner and exercise good judgement and common sense. If at any time you are not sure how to
handle a particular situation, ask your Head of Quality Control for advice. DO NOT TOUCH ANYTHING WITH
WHICH YOU ARE NOT COMPLETELY FAMILIAR!!! It is always better to ask questions than to risk harm to
yourself or damage to the equipment.
7.25 Electrical safety:
7.25.1 Obtain permission before operating any high voltage equipment.
7.25.2 Maintain an unobstructed access to all electrical panels.
7.25.3 Wiring or other electrical modifications must be referred to the Engineering Coordinator.
7.25.4 Never, ever modify, attach or otherwise change any high voltage equipment.
7.25.5 Always make sure all capacitors are discharged (using a grounded cable with an insulating handle)
before touching high voltage leads or the "inside" of any equipment even after it has been turned off.
Capacitors can hold charge for many hours after the equipment has been turned off.
7.25.6 When you are adjusting any high voltage equipment or a laser which is powered with a high voltage
supply, USE ONLY ONE HAND. Your other hand is best placed in a pocket or behind your back. This
procedure eliminates the possibility of an accident where high voltage current flows up one arm, through your
chest, and down the other arm.
7.26 Personal and General laboratory safety:
7.26.1 Never eat, drink, or smoke while working in the laboratory.
7.26.2 Read labels carefully.
7.26.3 Do not use any equipment unless you are trained and approved as a user by your supervisor.
7.26.4 Wear safety glasses or face shields when working with hazardous materials and/or equipment.
7.26.5 Wear gloves when using any hazardous or toxic agent.
7.26.6 Clothing: When handling dangerous substances, wear gloves, laboratory coats, and safety shield or
glasses. Shorts and sandals should not be worn in the lab at any time. Shoes are required when working in
the machine shops.
7.26.7 If you have long hair or loose clothes, make sure it is tied back or confined.
7.26.8 Keep the work area clear of all materials except those needed for your work. Coats should be hung
in the locker. Extra books, purses, etc. should be kept away from equipment that requires air flow or
ventilation to prevent overheating.
7.26.9 Disposal - Officers are responsible for the proper disposal of used material if any in appropriate
containers.
7.26.10 Equipment Failure - If a piece of equipment fails while being used, report it immediately to your Head
of Quality Control. Never try to fix the problem yourself because you could harm yourself and others.
7.26.11 If leaving a lab unattended, turn off all ignition sources and lock the doors.
7.26.12 Never pipette anything by mouth.
7.26.13 Always inform your Manager if you break a thermometer. Do not clean mercury yourself!!
7.26.14 Clean up your work area before leaving.
7.26.15 Wash hands before leaving the lab.
8.0 Reference Document
8.1 WHO Guidelines, volume 2, second edition.
9.0 Annexure
9.1 Not Appreciable
10.0 Revision History
Revision No. | Brief reason for the revision | Effective Date | Remarks |
01 | New |
|
|
11.0 Training
11.1 Head of Quality Control or his/her nominee shall give the SOP training before effective date.
