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Personal protective equipment (PPE) is equipment worn to reduce exposure to hazards that cause serious workplace injuries and illnesses. Chemical, radiological, physical, electrical, mechanical, or other workplace hazards may cause these injuries and illnesses. Gloves, safety glasses, and shoes, earplugs or muffs, hard hats, respirators, or coveralls, vests, and full body suits are examples of personal protective equipment.

Usage of Personal protective equipment (PPE)

1.0   PURPOSE

• • The objective of this Standard Operating Procedure (SOP) is to establish the guidelines for use of Personal Protective Equipment (PPE).

2.0   SCOPE

• • This SOP shall be applicable to all the drug product manufacturing and API sites.

3.0   RESPONSIBILITY – USAGE OF PERSONAL PROTECTIVE EQUIPMENT (PPE)

• • Concern Department shall be responsible for;

• • Usage of Personal protective equipment (PPE) whenever & wherever required.

• • Maintaining Personal protective equipment (PPE) in working condition.

• • Preparation list of requirement and availability of Personal protective equipment (PPE) in department.

• • Department Head shall be responsible for;

• • Ensuring that appropriate Personal protective equipment (PPE) are available, maintained and being used in the right way whenever & wherever required.

• • Work permit system is being followed wherever required.

• • Prescribed precautions are being taken while performing a job involving use of PPE

• • Officer/Executive- Environment, Heath and Safety (EHS) Head shall be responsible for;

• • Training of Personnel on usage of Personal protective equipment (PPE).

• • Safety audit of departments under consultation of Quality Assurance (QA).

4.0   PROCEDURE FOR USAGE OF PERSONAL PROTECTIVE EQUIPMENT (PPE)

• • General Instructions for usage of Personal protective equipment (PPE):

  • It is essential that a right type of personal protective equipment (PPE) shall be used for each job, and this applies particularly to equipment for respiratory protection because equipment of wrong type may prove dangerous to the user.

• • Use of wrong type of personal protective equipment (PPE) may give false sense of Safety to user.

• • Any doubt regarding the selection and use of a personal protective equipment shall be got clarified in consultation with EHS Department.

• • It shall be ensured that required personal protective equipment (PPE) is available in good condition and provided to employee for use.  Also Supervisors shall be thoroughly trained in the use of PPE.

• • The employee shall realize that personal protective equipment (PPE) are for their safety and shall for the regular habit of using them on all jobs requiring their use.

• • It is the duty of all personnel working in the plants to know the locations of the personal protective equipment (PPE) in their plants so that they can be found quickly in emergency or even under black out conditions. 

• • personal protective equipment (PPE) must not be removed from their defined locations unless required for use or for stand by purpose as in the maintenance operations.

• • The removal of personal protective equipment from its defined location, without proper authority, will be considered as an offence against discipline.

• • The Store/Purchase Department will be maintaining the stock of personal protective equipment for issuing to All Concern Department of plants in.

• • The record of personal protective equipment issued for the use in All Concern Department of plants will maintain service records of respiratory equipments.

• • All respiratory protective equipments issued for the use or reserve in Safety Section will be inspected and tested periodically by Safety personnel and record maintained.

  • Hand protection Personal Protective Equipment (PPE):

• • To handle hot surfaces or objects

• • When temperature is moderate, leather hand gloves shall be used.

• • For high temperature applications, cotton lined asbestos hand gloves or gloves made of heat resistant, low conductivity synthetic materials shall be used.

• • To handle sharp, hard & pointed objects

• • Plain canvas, canvas with leather padding, full leather, thin steel or plastic strip protection for fingers, etc. shall be used.

• • To handle corrosive & toxic liquid substances

• • Rubber/Poly Vinyl Chloride (PVC) or plastic hand gloves shall be used.

• • If full protection is required, then fore arm shall be completely covered.

• • Hand gloves shall be inspected for their intactness prior to using them.

• • The contaminated or dirtied full PVC or full rubber hand gloves shall be washed dried & dusted with boric acid powder before storing.

• • Contaminated leather or combination gloves shall not be washed & shall be discarded.

• • Canvas hand gloves shall be discarded.

• • To save from electric shock:

• • Before using these hand gloves, the voltage for which it is designed shall be checked.

• • These gloves shall be thoroughly checked for their integrity before use.

• • These gloves shall be dry during use.

• • Foot protection Personal Protective Equipment (PPE)

• • Falling or dropping material on foot:

• • Leather shoes with steel toe-cap shall be used.

• • Protruding nails or sharp objects lying on the floor:

• • Leather shoes with hard rubber sole or thin metal flexible inner sole shall be used.

• • Hot surfaces / material lying on the floor:

• • Leather soled shoes shall be used.

• •  Heat radiation:

• • Hard rubber soles along with leather shine covers shall be used.

• • Corrosive material or liquid lying on the floor:

• • Rubber or plastic gum boots with inner cotton lining shall be used.

• • For complete protection, shoe shall cover leg up to knee.

• • Leather safety shoes with molded rubber, PVC or polyurethane soles (without stitching or nails) shall be used.

• • Electric shock:

• • Leather shoes with rubber soles & without any metal nails shall be used.

• • Handling Inflammable material:

• • Leather safety shoes with soles made of rubber or synthetic material (PVC, polyurethane, etc.) without nails shall be used.

• • Head protection Personal Protective Equipment (PPE)

• • The fittings to the individual shall be comfortable.

• • The helmet shall fit closely on the head.

• • Eye protection PPEs:

• • Protection against dust:

• • Safety goggles shall be used.

• • Lenses used shall be of clear glass or plastic having impact resistance capacity.

• • Fine mesh shall be fitted on its side for ventilation to avoid perspiration & to avoid fogging on the glasses.

• • Protection against chemical liquid splashes:

• • Safety goggles made from soft acid & alkali resistant material shall be used.

• • The safety goggles shall closely fit over the eyes.

• • On the sides, baffled slots shall be provided for ventilation.

• • Protection against glares & injurious light glare:

• • The goggle lenses shall be colored or tinted as per the requirement.

• • In hot operations, these goggles shall be worn along with helmet.

• • For welding operation, special goggles or shield fitted with special dark glass shall be used.

• • Face protection equipments (PPEs):

• • Face shield made of rubber, high density plastic, fiberglass etc shall be used.

• • A window fitted with a transparent glass or hard plastic shall be provided for viewing.

• • Corrective vision spectacles shall be worn along with face shield.

• • The face shield shall be cleaned & disinfected after use.

• • Face shield shall be closely fitted to avoid lateral movement while working.

• • Skin & body protection equipments (PPEs)

• • Apron shall be sufficient for laboratory technician.

• • Full sleeved boiler suit shall be worn by boiler operator.

• • The type & material used for equipment shall depend upon hazard   from which protection is required. The material shall be cotton, rubber, plastic, asbestos, Teflon, etc.

• • The protective equipment shall be cleaned & maintained by the user.

• • Design of PPE shall be such that, when used for long period, it shall not cause excessive sweating or restrict movement.

• • Protection against fall – Personal Protective Equipment (PPE):

• • Safety belt shall be provided to a person, while working at heights & on the rooftop to save from possible injury.

• • Safety belt shall be used while working on height more than 6 feet.

• • The safety equipment shall consist of two components of which one is a string harness or a strap & the other is rope or lifeline.

• • Strap shall be of 60mm width & shall be made of leather or strong woven fabric.

• • The harness shall run over both shellers & waist.

• • The sheller straps & rope shall be connected to the strap running around the waist.

• • Buckles shall be provided to fasten the belt around the waist.

• • The length of the harness around the waist shall be adjustable for good fit.

• • The buckle shall be correctly fitted, as holding strength of belt depends upon its proper fitting.

• • Lifeline shall be made of 12-mm nylon rope or 20-mm Manila hemp rope.

• • The rope shall be attached to the belt through a ‘D’ shaped ring or a special hook. For this, loop shall be made at one end of rope by splicing. Knotting of rope shall be avoided since it reduces strength.

• • The free end of the rope shall be anchored at a fixed point. The length of rope or anchorage of lifeline shall be 1.6m.

• • Prior to its use, the rope & belt shall be visually inspected for damage.

• • Cuts on belt or worn out rope will reduce strength of equipment & shall not be used.

• • Capability of anchorage point and rope or harness line shall be ascertained to sustain anticipated shock load.

• • Hearing conservation or protection against noise:

• • Earmuff:

• • Outer face of cup shall be cushion lined for good sealing to keep noise out.

• • The cup shall fit on the ear from outside thus sealing ears.

• • Inner part of muff is filled with sound absorbing material like plastic foam.

• • These shall be in pair, joined in elastic headband or they shall be fitted on a specially designed safety helmet.

• • The cups shall be held in position over the ear with pressure (adequate for proper sealing) by a headband.

• • After use, ear-muffs shall be cleaned & disinfected.

• • Earmuffs shall be allotted to each individual & shall not be used by others.

• • Ear plugs:

• • Ear plugs shall be made from soft & expandable polyurethane or other similar foam or cotton.

• • The ear plugs shall closely fit directly in the ear canal & as such shall not hinder the use of safety goggles & helmet.

• • While using ear plug, hands & fingers shall be clean.

• • Care shall be taken for storing of ear-plugs in between use.

• • Earplugs can be washed & reused.

• • Ear plugs shall not be used by person having ear infection.

• • The effective noise reduction level shall be as below:

Effective Reduction in Noise Levels
Equipment	Noise Reduction in dB
Ear Plugs (well fitted)	10 – 20
Earmuffs	15 – 35

• • Respiratory protection – Personal Protective Equipment (PPE):

• • Respirators (breathing air is passed through filters for purification): 2 types

• • Dust filters

• • Dust filters shall be used in dusty atmosphere.

• • Dust filter shall be made from cotton, wool, synthetic fiber or woven cloth in the form of a simple strip or cup shape piece with the filtering media & shall fit around nose & mouth.

• • When the filter element gets dirty, it shall be replaced with new ones.

• • Contaminated gases & toxic vapor filters.

• • Shall be used for filtering contaminated gases or toxic vapors.

• • Apparatus consists of face piece & filtering cartridge.

• • The filtering media shall be a suitable chemical compound filled in cartridges capable of purifying certain specific type of gas.

• • Face piece shall either be full mask covering full face or half face mask covering face partially.

• • These respirators shall not be used where concentration of harmful gases is high.

• • The oxygen content in the atmosphere shall be adequate.

• • The stay in the contaminated air shall not be long.

• • The gases in the contaminated air shall be known & selection of respirator shall be suitable to the gas.

• • Breathing apparatus: again of two types:

• • External air supply type:

• • Supplies fresh & clean air from an outside source.

• • Apparatus consists of a facemask, an air supply tube of sufficient length & a blower.

• • The blower shall be kept outside the contaminated area & clean air shall be supplied to person via air tube.

• • Self contained breathing apparatus:

• • Consists of a face mask, metallic cylinder & a connecting air supply tube.

• • Before entering contaminated atmosphere, the cylinder shall be on back & mask shall be closely fitted on the face.

• • During its use, with the consumption of air, the pressure inside the cylinder reduces & at a certain set value, the low pressure warning system comes in operation giving a whistle.

• • Thereafter, air supply will last for about time specified in the manual, within which, the person shall come out of contaminated atmosphere.

• • The face-piece shall be cleaned & disinfected after each use.

• • After cleaning & disinfection, the face-piece shall be wrapped in a clean plastic bag.

• • Air cylinder shall be recharged after use.

Annexure – 1

Table for Usage of Personal Protective Equipment (PPE)        

Sr. No.	Body Part/Area	Type of Hazard	PPE
1.	Hand	Hot surface	For Moderate Temperature – Leather Gloves For High Temperature – Asbestos Hand Gloves
		Sharp object	Canvas with leather padding along with thin steel
		Corrosive or toxic liquid substance	Rubber/PVC or plastic gloves
		Electric Shock	Rubber Hand Gloves
2.	Foot	Fall or drop on foot	Leather shoes with metal toe-cap
		Sharp object	Leather shoes with hard rubber sole
		Hot surface	Leather Shoes with rubber sole
		Heat radiation	Leather shoes with hard rubber sole
		Corrosive Material	Rubber/Plastic gum boots
		Electric shock	Leather shoes with rubber sole without any metal parts
		Inflammable Material	Leather shoes with rubber sole
3.	Head	Fall or drop	Helmet
4.	Eye	Dust	Safety goggles
		Liquid Chemical splashes	Safety Goggles made from alkali and acid resistance material.
		Glares and Injurious lights	Coloured/tinted glass

5.	Face	Dust	Face shield made of high density plastic or fiber glass.
		Chemical Splashes
6.	Skin and Body	Chemical	Apron
7.	Protection Against Fall	Working on height	Safety rope
8.	Ear/Hearing	High volume	Ear muff/Ear Plug
9.	Respiratory	Dust	Mask with dust filter
		Gas – Normal	Mask with filter cartridge
		Gas – Toxic	Breathing apparatus
10.	Fire		Fire safety Suit.
			Fire extinguisher
			Fire Hydrant system

 

REFERENCES

• • Factories Act 1948
  • IS (Indian Standards) :9623: Classification of hazards & selection of respiratory PPE
  • IS: 10245 (Part-I)   – 1982 : for Compressed Air Closed Circuit type, IS: 10245 (Part-II) –   1982 : for Compressed Air Open Circuit type, IS: 10245 (Part-III) –  1982 : for Air Line Respirator, IS: 8523 – 1977:        for color coding for Air Purifying canisters & cartridges, IS: 8522 – 1977:        for Chemical Cartridge Respirators, IS: 9473 – 1980 :       for Mechanical Filter Respirators, IS: 2925 – 1975 :       for head protection (Helmets), IS: 8520 – 1977 :       for eye, face & ear protection, IS: 2523 – 1971 :       for safety glass, IS: 8807 – 1978 :       for hand & arm protection
  • In-house