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The Standard Operating Procedure (SOP) to describe the various aspect of Industrial Hygiene in pharmaceutical drug manufacturing plants.

Industrial Hygiene – The science devoted to the anticipation, recognition, evaluation, prevention, and control of those occupational factors or stresses arising in or from the workplace which may cause sickness, impaired health and well being, or significant discomfort among workers.

Various Aspects of Industrial Hygiene

1.0   PURPOSE:

• • This procedure describes the various aspects of an Industrial Hygiene Program at the pharmaceutical drug manufacturing plant.

2.0   SCOPE:

• • This procedure applies to the formulation manufacturing unit at the pharmaceutical drug manufacturing industry.

3.0   RESPONSIBILITIES – Industrial Hygiene:

• • User Department Head / Area in-charge:

• • Arrange the initial survey in his department.

• • Ensure monitoring of Workplace conducted.

• • Ensure the implementation and sustain of effective control measures.

• • Head EHS / Designee:

• • Train all relevant staff.

• • Review our system relating to Industrial Hygiene.

• • Co-ordinate with relevant section heads and support the Industrial Hygiene Program.

• • Conduct an Industrial Hygiene survey and implement the program.

• • Quality Assurance Department:

• • Check the SOP and maintain the master copy of SOP for all departments.

• • Issue controlled copy of SOP & maintain issuance copy record.

• • Retrieve the controlled copy of SOP when it is superseded and to control & monitor the review process of the SOP.

• • Ensure the compliance of the procedure by all departments.

• • To ensure the implementation of SOP.

4.0   ABBREVIATIONS – Industrial Hygiene:

• • EHS: Environment, Health & Safety

• • HOD: Head of the Department

• • IH: Industrial Hygiene

• • mg/m3: Milligrams of substance per cubic meter

• • NFPA: National Fire Protection Association

• • OEL: Occupational Exposure Limit

• • PEL: Permissible Exposure Limit

• • PPE: Personal Protective Equipment

• • PPM: Parts Per Million

• • TLV: Threshold Limit Value

• • TWA: Time Weighted Average

5.0   DEFINITION:

• • Industrial Hygiene:

• • The science devoted to anticipation, recognition, evaluation, prevention, and control of those occupational factors or stresses arising in or from the workplace which may cause sickness, impaired health and well being, or significant discomfort among workers.

• • Air Sampling:

• • The collection of samples of air followed by laboratory analysis to measure the presence and concentration of the chemical, physical or biological pollutants in the air.

• • Area Air Samplings:

• • The collection of samples from a fixed location in a work

• • Chemical hazard:

• • A chemical hazard is a type of occupational hazard caused by exposure to chemicals in the workplace.

• • There are many hazardous chemicals such as acids, bases, solvents, carcinogens, etc.

• • High-Efficiency Particulate Air (HEPA) Filter:

• • A filter capable of removing from the air at least 99.97 percent of dust, pollen, mold, bacteria, and any airborne particulates with a size of 0.3 micrometers or larger.

• • Industrial Hygiene Monitoring:

• • Workplace survey for hazardous materials and contaminants, often including area and personal sampling.

• • Hazard Control Ventilation:

• • An industrial exhaust system that captures and removes contaminants emitted from local sources before dilution into ambient workplace air can occur.

• • This includes chemical fume hood, extractor arms glove boxes and biological safety hoods and cabinets.

• • Occupational Exposure Limit (OEL):

• • An exposure limit that is lower of the Permissible Exposure Limit or Threshold limit value.

• • Permissible Exposure Limit (PEL):

• • An exposure limit published and enforced by OSHA.

• • PEL may be either a Time Weighted Average (TWA) exposure limit (8 hour/day, 40hour/week), a 15 min.

• • Short term exposure limit (STEL, that cannot be repeated more than 4 times per day with at least 60 minutes between exposure periods), ceiling ( C, absolute exposure limit that should not be exceeded at any time.)

• • Physical hazards: Hazards from physical agents like noise, non-ionizing radiation, and magnetic fields.

• • Personal Air Sampling: The collection of air samples at the worker’s breathing zone to reflect the level of a worker’s exposure to a contaminant throughout a workday.

• • Threshold Limit Value:

• • Recommended guidelines for occupational exposure to airborne contaminants and TLV represents the average concentration for an 8 hr. workday and a 40-hour workweek to which nearly all workers may be repeatedly exposed without any adverse effects.

6.0   PROCEDURE FOR INDUSTRIAL HYGIENE:

• • Industrial Hygiene program supports a safe and healthy environment by:

• • • Anticipating, Recognizing, and Evaluating potential workplace hazards before they exist (during the design and development stage)

• • • Surveying work areas to identify hazards such as toxic agents, ventilation problems, noise, etc. and taking appropriate measures to control them.

• • • Potential hazards can include air contaminants, chemical, physical, biological, and ergonomic hazards.

• • Air contaminants are commonly classified as either particular or gas and vapor contaminants.

• • The most common include dust, fumes, mist, aerosols, and fibers.

• • Chemicals hazards are the harmful chemical compounds in the form of-

• • • Solids,

• • • Liquids,

• • • Gases,

• • • Mist,

• • • Dust,

• • • Fumes, and

• • Vapors exert toxic effects by inhalation (breathing), absorption (through direct contact with the skin), or ingestion (eating or drinking), Airborne Chemical hazards exist as concentrations of mists, vapors, gases, fumes, or contact; some can be toxic by absorption through the skin or through inhalation and some are corrosive to living tissue.

• • Biological hazard includes bacteria, virus, fungi, and other living organisms that can cause acute and chronic infections by entering the body either directly or through breaks in the skin.

• • Ergonomics hazard is a physical factor within the environment that harms the musculoskeletal system.

• • Ergonomic hazards include themes such as repetitive movements, manual handling, workplace/job/task design, uncomfortable workstation height, and poor body positioning.

• • Ergonomic hazards are avoided primarily by the effective design of a job or job site and by better-designed tools or equipment that meet workers’ needs in terms of the physical environment and job tasks.

• • Implementing the recommended engineering controls.

• • Implementing administrative controls when engineering controls are not feasible.

• • Risk Assessors to recognize hazards and to take appropriate safety measures when working under potentially hazardous conditions.

• • Appropriate PPE selection.

• • Identifying medical surveillance for the relevant people who are exposed to the hazard.

• • Exposure Assessment is done to assess the potential health risks to the worker.

• • It helps to differentiate between acceptable and unacceptable exposure levels.

• • Qualitative exposure assessment includes an evaluation of potential exposures via inhalation, ingestion, skin contact, and ergonomic factors.

• • While doing this type of assessment following factors shall be considered and documented;

• • • Frequency,

• • • Magnitude, and variability of exposure and tasks;

• • • Route of exposure;

• • • Potentials for short-duration tasks and

• • • Exposure (acute) and long term or frequently repeated tasks and exposures (chronic); and

• • • Adequately and potential for failure of engineering and work practice controls.

• • Qualitative exposure assessment shall be completed for all processes and operations that present a potential exposure to a chemical or physical agent.

• • These assessments are completed by using the:

• • • Industrial Hygiene Risk Assessment (IHRA)

• • • Industrial Hygiene Walkthrough Survey.

• • • A qualified person or team conducts qualitative exposure assessments.

• • • Developing IHRA’s – EHS Leader

• • • Review of IHRA’s – EHS Head / Designee

• • The initial workplace assessment shall be conducted using the Industrial Hygiene risk assessment or job exposure assessment worksheet.

• • A review of the past exposure data shall be performed to evaluate the effectiveness of the existing control measures.

• • The assessment is prioritized based on the risk of the task, past injury/illness history, and regulatory requirements.

• • An annual review of the assessment shall be conducted to verify no new hazards have been introduced into the work environment.

• • Qualitative exposure assessment includes air or wipes sampling, to measure the amount or concentration of hazards.

• • This assessment shall be performed for all processes or operations which are identified as potentially posing risk of overexposure to hazards.

• • Perform the assessment by the following methods-

• • • Personal air monitoring measures personal exposure to airborne contaminants.

• • • The sampling is done for 8 hrs or the full work shift.

• • • Some Samples are also taken on activity-based to determine the exposure for a particular activity.

• • • This is a representative sample of the individuals breathing zone.

• • • Area air sampling/work zone monitoring is to be done to define the extent of contamination or to measure the effectiveness of engineering controls.

• • • The air sampler is placed in a fixed location in the work area or near the potential source of hazard.

• • • Wipe sampling helps to measure the surface contamination for selected hazardous material.

• • • This type of sampling helps us to validate the effectiveness of the decontamination process.

• • • Exposure monitoring is conducted on employees across all shifts & seasons to most accurately evaluate the potential for personal exposure in the work environment.

• • • If personal monitoring is not feasible, area monitoring in the work area is used as a representative of personal exposure.

• • Exposure monitoring is conducted using recognized sampling methodologies and quality control techniques (e.g., blanks, etc.), which results in time-weighted average and peak exposure determinations.

• • Analysis of industrial hygiene samples is performed by an independently accredited quality control program certified laboratory.

• • The results of exposure monitoring are compared to the lowest (most protective) value of the OEL, TLV, or local regulatory limit.

• • The departmental HOD should responsible for preparing the list of permissible limits of exposure as per Annexure – 3 with the help of EHS Team / Qualified individual.

• • Assign the revision No. as YYYY/XXX

• • • Where

• • • YYYY denotes the Current Year.

• • • XXX denotes sequential numbers like – 001, 002 etc.

• • Exposure monitoring shall conduct by qualified individuals:

• • • An Industrial Hygienist

• • • Departmental HOD / EHS Leader with training in exposure assessment as per Annexure – 2

• • • Consultant approved by the organization.

• • The results of the industrial hygiene monitoring are summarized in written reports and reviewed by industrial hygiene or equally qualified professionals.

• • The reports will identify the following:

• • • Actual & acceptable exposure levels.

• • • Monitoring methods.

• • • Control measures (e.g., elimination, substitution, engineering, work practices and administrative controls, and personal protective equipment (PPE)

• • • Provisions for implementation, follow up, and closure.

• • • Updates to quantitative assessment schedules based on operational changes.

• • Engineering and administration shall Identify, evaluate, and control hazards by engineering/administrative controls.

• • Engineering controls include glove box, isolators, acoustic enclosures, etc.

• • Administrative controls include job rotation, training, safe work practices, good housekeeping, regular preventive and predictive maintenance of equipment.

• • When these controls are not feasible or when they are in the process of installation or implementation, appropriate PPE’s like safety glasses, positive pressure suits, helmets, safety shoes, earplugs, gloves, and respirators.

7.0   DISTRIBUTION OF SOP FOR INDUSTRIAL HYGIENE:

• • Maintenance

• • Environment, Health & Safety

• • Quality Assurance

• • Quality Control

• • Production

• • Personnel and Administration

• • Information Technology

8.0   ANNEXURES – INDUSTRIAL HYGIENE :

Annexure 1: Industrial Hygiene

We study various workplace hazards & learn about Industrial Hygiene (IH) which protects us on the job site by –

• Investigating
• Recommending
• Researching
• Anticipating and controlling
• Training
• Advising
• Enforcing

KEY POINTS TO REMEMBER

• Industrial Hygiene plays an important role in your health & safety.
• We can help prevent injuries and illnesses.
• Do your part by reporting hazards and following safety rules.

Annexure-2: Industrial Hygiene Walkthrough Survey

Date :

Time :

 

LOCATION	:
DEPARTMENT	:
HOD NAME	:
PROCESS	:

 

Sr. No.	ACTIVITY	HAZARDS	CURRENT CONTROL MEASURES	RECOMMENDATION

*NOTE: Hazards can be Air Contaminants, Physical, Chemical, Biological, and Ergonomics.

Analyzed By: (Sign. & Date)

Approved By : (Sign. & Date)

Annexure-3: Permissible Levels of Certain Chemical substances in the work environment (Template)

Revision No.:-                                                                         Effective Date:-                             

Sr.No.	Name of the Substances	Permissible Limits of Exposure
		Time-Weighted Average- Concentration (TWA) (8 hrs.)		Short-term exposure Limit STEL (15 min)
		ppm	mg/m3**	ppm	mg/m3**

Remarks:

• Revise as when required by the inclusion/deletion to the item if any
• Lint-free dust as measured by the vertical elutriator cotton dust sampler.
• Ins. by Act 20 of 1987, S.45 (w. e .f. 1.12.1987)
• Subs. by S.O.342 (E) dt.19.4.2001 (w. e. f.) 19.4.2001, Gaz. of India Ext.247, Dt. 19.4.2001. Pt. II, Sec.3(ii).

Revision History:

Revision No.	Effective Date	Revision Details