JSA for Safe Operation of Tablet Metal Detector

1. Purpose

The purpose of this JSA is to identify and mitigate potential hazards associated with the operation of the Tablet Metal Detector. This equipment is used in pharmaceutical manufacturing to detect and remove metal contaminants from tablets, ensuring product quality and patient safety. Proper handling and operation are essential to prevent safety risks, contamination, and mechanical hazards.

2. Scope

This JSA applies to all operators, supervisors, and maintenance personnel involved in using, cleaning, and maintaining the Tablet Metal Detector in the Oral Dosage department. Ensuring compliance with safety measures is necessary to minimize risks associated with electromagnetic exposure, mechanical movement, and calibration errors.

3. Responsibilities

Operators:

• Follow the standard operating procedure (SOP) while operating the Tablet Metal Detector.
• Ensure the machine is properly set up and calibrated before use.
• Wear appropriate Personal Protective Equipment (PPE) when handling rejected tablets.
• Monitor the machine operation and ensure proper rejection of contaminated tablets.
• Regularly inspect and clean the reject collection bin.
• Perform post-operation cleaning and maintenance as per SOP.

Supervisors:

• Ensure compliance with GMP and workplace safety regulations.
• Monitor machine efficiency and ensure calibration is performed as scheduled.
• Conduct routine inspections of metal detector equipment and maintenance logs.

Safety Officers:

• Perform risk assessments and ensure compliance with occupational safety standards.
• Ensure proper shielding is in place to reduce electromagnetic exposure.
• Verify that operators are trained in handling rejected tablets safely.

4. Definitions & Abbreviations

• PPE: Personal Protective Equipment (e.g., gloves, safety glasses).
• GMP: Good Manufacturing Practices – Guidelines ensuring product quality and worker safety.
• LOTO: Lockout/Tagout – A procedure to isolate hazardous energy sources.

5. Procedure

6. Risk Assessment

7. Emergency Procedures

1. In case of machine malfunction, shut down the unit and report to maintenance.
2. For incorrect rejection, recalibrate and conduct test runs before restarting.
3. In case of electrical failure, ensure the unit is powered off before performing troubleshooting.
4. All incidents must be reported and logged for investigation.

8. Required PPE & Safety Controls

• Gloves: Prevents contamination when handling rejected tablets.
• Safety glasses: Shields eyes from dust and particles.
• Protective clothing: Prevents tablet contamination from operators.
• Grounding system: Ensures safe operation and reduces static electricity.
• Calibration tablets: Used to verify correct operation of the detector.

9. References

• OSHA 1910.97 – Non-Ionizing Radiation Standards.
• ISO 45001 – Occupational Health & Safety Management.
• GMP guidelines for tablet quality inspection.

10. Approval Section

JSA for Safe Operation of Tablet Deduster

1. Purpose

The purpose of this JSA is to identify and mitigate potential hazards associated with the operation of the Tablet Deduster. This equipment is used in pharmaceutical manufacturing to remove excess dust from compressed tablets, ensuring a clean final product before packaging. Proper handling and operation are essential to prevent dust exposure, contamination, and mechanical hazards.

2. Scope

This JSA applies to all operators, maintenance personnel, and supervisors involved in using, cleaning, and maintaining the Tablet Deduster in the Oral Dosage department. Ensuring compliance with safety measures is necessary to minimize risks associated with dust exposure, mechanical movements, and electrical components.

3. Responsibilities

Operators:

• Follow the standard operating procedure (SOP) while operating the Tablet Deduster.
• Ensure the machine is properly set up and calibrated before use.
• Wear appropriate Personal Protective Equipment (PPE) to prevent inhalation risks.
• Monitor machine operation, tablet movement, and dedusting efficiency.
• Regularly check and empty dust collection units to maintain efficiency.
• Perform cleaning after each batch to prevent cross-contamination.

Supervisors:

• Ensure compliance with GMP and workplace safety regulations.
• Monitor dust levels and tablet quality post-dedusting.
• Conduct routine inspections of dedusting equipment and maintenance schedules.

Safety Officers:

• Perform risk assessments and ensure compliance with occupational safety standards.
• Ensure proper functioning of ventilation and dust extraction systems.
• Verify that PPE, such as respirators and protective clothing, are used correctly.

4. Definitions & Abbreviations

• PPE: Personal Protective Equipment (e.g., gloves, respirators, goggles).
• GMP: Good Manufacturing Practices – Guidelines ensuring product quality and worker safety.
• LOTO: Lockout/Tagout – A procedure to isolate hazardous energy sources.

5. Procedure

6. Risk Assessment

7. Emergency Procedures

1. In case of excessive dust exposure, move to fresh air and seek medical help.
2. For fire hazards, use a Class D fire extinguisher and evacuate if necessary.
3. In the event of an equipment failure, follow emergency shutdown procedures.
4. All incidents must be reported and logged for investigation.

8. Required PPE & Safety Controls

• Respiratory mask: Prevents inhalation of airborne dust particles.
• Goggles: Shields eyes from fine dust exposure.
• Protective clothing: Prevents dust adherence to skin and garments.
• Grounding system: Reduces the risk of static electricity ignition.
• HEPA filters: Ensure high-efficiency dust extraction.

9. References

• OSHA 1910.94 – Ventilation Standards.
• ISO 45001 – Occupational Health & Safety Management.
• GMP guidelines for dust control in pharmaceutical production.

10. Approval Section

JSA for Safe Operation of Dust Extractor

1. Purpose

The purpose of this JSA is to identify and mitigate potential hazards associated with the operation of the Dust Extractor. This equipment is used in pharmaceutical manufacturing to remove airborne dust particles, ensuring a clean and safe work environment. Proper operation and handling are essential to prevent inhalation hazards, fire risks, and mechanical malfunctions.

2. Scope

This JSA applies to all operators, maintenance personnel, and supervisors involved in using, cleaning, and maintaining the Dust Extractor in the Oral Dosage department. Following safety measures minimizes risks associated with dust collection, filter cleaning, and machine operation.

3. Responsibilities

Operators:

• Follow the standard operating procedure (SOP) while operating the Dust Extractor.
• Ensure the dust extractor is turned on before starting any powder-related operations.
• Wear appropriate Personal Protective Equipment (PPE) to prevent inhalation risks.
• Monitor filter conditions and empty dust collection bins regularly.
• Ensure the dust extraction system is functioning efficiently during operations.
• Perform routine cleaning of filters and dust bins as per manufacturer guidelines.

Supervisors:

• Ensure compliance with GMP and workplace safety regulations.
• Monitor dust levels in production areas and ensure extractors are in working condition.
• Conduct routine inspections of dust extraction units and ensure prompt maintenance.

Safety Officers:

• Perform risk assessments and ensure compliance with occupational safety standards.
• Ensure proper functioning of the dust collection and ventilation systems.
• Verify that PPE, such as respirators and protective clothing, are used correctly.

4. Definitions & Abbreviations

• PPE: Personal Protective Equipment (e.g., gloves, respirators, goggles).
• GMP: Good Manufacturing Practices – Guidelines ensuring product quality and worker safety.
• LOTO: Lockout/Tagout – A procedure to isolate hazardous energy sources.

5. Procedure

6. Risk Assessment

7. Emergency Procedures

1. In case of excessive dust exposure, move to fresh air and seek medical help.
2. For fire hazards, use a Class D fire extinguisher and evacuate if necessary.
3. In the event of an equipment failure, follow emergency shutdown procedures.
4. All incidents must be reported and logged for investigation.

8. Required PPE & Safety Controls

• Respiratory mask: Prevents inhalation of airborne dust particles.
• Goggles: Shields eyes from fine dust exposure.
• Protective clothing: Prevents dust adherence to skin and garments.
• Grounding system: Reduces the risk of static electricity ignition.
• HEPA filters: Ensure high-efficiency dust extraction.

9. References

• OSHA 1910.94 – Ventilation Standards.
• ISO 45001 – Occupational Health & Safety Management.
• GMP guidelines for dust control in pharmaceutical production.

10. Approval Section

JSA for Safe Operation of Soft Gelatine Capsule Encapsulation Machine

1. Purpose

The purpose of this JSA is to identify and mitigate potential hazards associated with the operation of the Soft Gelatine Capsule Encapsulation Machine. This equipment is used in pharmaceutical manufacturing to produce soft gelatin capsules by encapsulating liquids, suspensions, or pastes. Proper handling and operation are critical to preventing safety risks, contamination, and mechanical hazards.

2. Scope

This JSA applies to all operators, supervisors, and maintenance personnel involved in using, cleaning, and maintaining the Soft Gelatine Capsule Encapsulation Machine in the Oral Dosage department. Ensuring compliance with safety measures is necessary to minimize risks associated with gelatin handling, temperature control, moving machine parts, and lubrication systems.

3. Responsibilities

Operators:

• Follow the standard operating procedure (SOP) while operating the Soft Gelatine Capsule Encapsulation Machine.
• Ensure proper calibration and temperature settings before initiating operations.
• Wear appropriate Personal Protective Equipment (PPE) before handling gelatin and fill materials.
• Monitor machine settings, capsule integrity, and reject capsule counts.
• Handle gelatin sheets and fill materials carefully to avoid contamination.
• Perform post-operation cleaning to maintain hygiene and prevent gelatin residue buildup.

Supervisors:

• Ensure compliance with GMP and safety regulations.
• Monitor work areas for gelatin handling and reject rates.
• Conduct routine inspections of the machine and its safety features.

Safety Officers:

• Perform risk assessments and ensure compliance with workplace safety guidelines.
• Ensure that dust collection systems and ventilation are functioning correctly.
• Verify that machine guards and lubrication systems are in place and operational.

4. Definitions & Abbreviations

• PPE: Personal Protective Equipment (e.g., gloves, respirators, goggles).
• GMP: Good Manufacturing Practices – Guidelines ensuring product quality and worker safety.
• LOTO: Lockout/Tagout – A procedure to isolate hazardous energy sources.

5. Procedure

6. Risk Assessment

7. Emergency Procedures

1. In case of hand entrapment, immediately activate the emergency stop and seek medical help.
2. If an electrical issue arises, shut down the machine and report to maintenance.
3. For gelatin spills, clean the area immediately to prevent slip hazards.
4. All incidents must be reported and logged for investigation.

8. Required PPE & Safety Controls

• Gloves: Protect hands from contamination and mechanical risks.
• Respiratory mask: Prevents inhalation of airborne particles.
• Goggles: Shields eyes from gelatin splashes.
• Protective clothing: Prevents contamination and lubricant exposure.
• Machine guard: Ensures safety from moving parts.

9. References

• OSHA 1910.212 – Machine Guarding Standards.
• ISO 45001 – Occupational Health & Safety Management.
• GMP guidelines for soft gelatin capsule manufacturing.

10. Approval Section

JSA for Safe Operation of Hard Gelatine Capsule Filling Machine

1. Purpose

The purpose of this JSA is to identify and mitigate potential hazards associated with the operation of the Hard Gelatine Capsule Filling Machine. This equipment is used in pharmaceutical manufacturing to accurately fill hard gelatin capsules with powders, granules, or pellets, ensuring uniform dosage and high production efficiency. Proper handling and operation are critical to preventing safety risks, contamination, and mechanical hazards.

2. Scope

This JSA applies to all operators, supervisors, and maintenance personnel involved in using, cleaning, and maintaining the Hard Gelatine Capsule Filling Machine in the Oral Dosage department. Ensuring compliance with safety measures is necessary to minimize risks associated with moving machine parts, powder dispersion, material handling, and electrical components.

3. Responsibilities

Operators:

• Follow the standard operating procedure (SOP) while operating the Hard Gelatine Capsule Filling Machine.
• Ensure proper calibration and machine setup before initiating operations.
• Wear appropriate Personal Protective Equipment (PPE) before handling raw materials.
• Monitor machine settings, filling accuracy, and reject capsule counts.
• Handle gelatin capsules and filling materials carefully to avoid contamination.
• Perform post-operation cleaning to maintain hygiene and prevent material buildup.

Supervisors:

• Ensure compliance with GMP and safety regulations.
• Monitor work areas for capsule integrity and reject rates.
• Conduct routine inspections of the machine and its safety features.

Safety Officers:

• Perform risk assessments and ensure compliance with workplace safety guidelines.
• Ensure that dust collection systems are functioning correctly to minimize airborne contamination.
• Verify that machine guards and interlocks are in place and operational.

4. Definitions & Abbreviations

• PPE: Personal Protective Equipment (e.g., gloves, respirators, goggles).
• GMP: Good Manufacturing Practices – Guidelines ensuring product quality and worker safety.
• LOTO: Lockout/Tagout – A procedure to isolate hazardous energy sources.

5. Procedure

6. Risk Assessment

7. Emergency Procedures

1. In case of hand entrapment, immediately activate the emergency stop and seek medical help.
2. If an electrical issue arises, shut down the machine and report to maintenance.
3. For powder exposure, move to fresh air and seek medical attention.
4. All incidents must be reported and logged for investigation.

8. Required PPE & Safety Controls

• Gloves: Protect hands from powder contact and mechanical risks.
• Respiratory mask: Prevents inhalation of airborne powder particles.
• Goggles: Shields eyes from dust and particles.
• Protective clothing: Prevents contamination and powder adhesion.
• Machine guard: Ensures safety from moving parts.

9. References

• OSHA 1910.212 – Machine Guarding Standards.
• ISO 45001 – Occupational Health & Safety Management.
• GMP guidelines for capsule filling operations.

10. Approval Section

JSA for Safe Operation of Fluidized Bed Coater

1. Purpose

The purpose of this JSA is to identify and mitigate potential hazards associated with the operation of the Fluidized Bed Coater. This equipment is used in pharmaceutical manufacturing to apply coatings to granules, pellets, or powders to enhance stability, taste, and controlled release properties. Proper handling and operation are critical to preventing safety risks, contamination, and equipment malfunctions.

2. Scope

This JSA applies to all operators, supervisors, and maintenance personnel involved in using, cleaning, and maintaining the Fluidized Bed Coater in the Oral Dosage department. Ensuring compliance with safety measures is necessary to minimize risks associated with high airflow, solvent exposure, electrostatic hazards, and heat-related risks.

3. Responsibilities

Operators:

• Follow the standard operating procedure (SOP) while operating the Fluidized Bed Coater.
• Ensure proper calibration and settings before starting the coating process.
• Wear the appropriate Personal Protective Equipment (PPE) before handling coating solutions.
• Monitor machine settings, airflow rates, drying temperature, and spray nozzle settings.
• Handle coating solutions carefully to avoid spills and contamination.
• Perform post-operation cleaning to prevent residual buildup and contamination.

Supervisors:

• Ensure compliance with GMP and safety regulations.
• Monitor work areas for solvent exposure and ensure proper ventilation.
• Conduct routine inspections of the machine and its safety features.

Safety Officers:

• Perform risk assessments and ensure compliance with workplace safety guidelines.
• Ensure that solvent vapor exposure remains within permissible limits.
• Verify that fume extraction and ventilation systems are functioning correctly.

4. Definitions & Abbreviations

• PPE: Personal Protective Equipment (e.g., gloves, respirators, goggles).
• GMP: Good Manufacturing Practices – Guidelines ensuring product quality and worker safety.
• LOTO: Lockout/Tagout – A procedure to isolate hazardous energy sources.

5. Procedure

6. Risk Assessment

7. Emergency Procedures

1. In case of chemical exposure, rinse affected areas immediately and seek medical help.
2. For fires, use a Class B fire extinguisher and evacuate if necessary.
3. In the event of an equipment failure, follow emergency shutdown procedures.
4. All incidents must be reported and logged for investigation.

8. Required PPE & Safety Controls

• Gloves: Protects hands from chemical exposure.
• Respiratory mask: Prevents inhalation of solvent fumes.
• Goggles: Shields eyes from splashes and airborne particles.
• Protective clothing: Prevents contamination and chemical exposure.
• Ventilation system: Ensures the safe removal of solvent vapors.

9. References

• OSHA 1910.106 – Flammable and Combustible Liquids Standards.
• ISO 45001 – Occupational Health & Safety Management.
• GMP guidelines for fluidized bed coating in pharmaceutical production.

10. Approval Section

JSA for Safe Operation of Spray Coating System

1. Purpose

The purpose of this JSA is to identify and mitigate potential hazards associated with the operation of the Spray Coating System. This equipment is used in pharmaceutical manufacturing to apply a uniform film coating onto tablets or capsules, improving their stability, taste, and controlled release. Proper handling and operation are essential to prevent safety risks, contamination, and equipment malfunctions.

2. Scope

This JSA applies to all operators, supervisors, and maintenance personnel involved in using, cleaning, and maintaining the Spray Coating System in the Oral Dosage department. Ensuring compliance with safety measures is necessary to minimize risks associated with solvent exposure, airborne particles, high-pressure spray nozzles, and potential fire hazards.

3. Responsibilities

Operators:

• Follow the standard operating procedure (SOP) while operating the Spray Coating System.
• Ensure proper calibration and settings before starting the spray coating process.
• Wear the appropriate Personal Protective Equipment (PPE) before handling coating solutions.
• Monitor machine settings, spray pressure, airflow, and solvent flow rates.
• Handle coating solutions carefully to avoid spillage and contamination.
• Perform post-operation cleaning to maintain hygiene and prevent nozzle blockages.

Supervisors:

• Ensure strict compliance with GMP and safety regulations.
• Monitor work areas for potential solvent exposure and ensure proper ventilation.
• Conduct routine inspections of the machine and its safety features.

Safety Officers:

• Perform risk assessments and ensure compliance with workplace safety guidelines.
• Ensure that solvent vapor exposure remains within permissible limits.
• Verify that fume extraction and ventilation systems are functioning correctly.

4. Definitions & Abbreviations

• PPE: Personal Protective Equipment (e.g., gloves, respirators, goggles).
• GMP: Good Manufacturing Practices – Guidelines ensuring product quality and worker safety.
• LOTO: Lockout/Tagout – A procedure to isolate hazardous energy sources.

5. Procedure

6. Risk Assessment

7. Emergency Procedures

1. In case of chemical exposure, rinse affected areas immediately and seek medical help.
2. For fires, use a Class B fire extinguisher and evacuate if necessary.
3. In the event of an equipment failure, follow emergency shutdown procedures.
4. All incidents must be reported and logged for investigation.

8. Required PPE & Safety Controls

• Gloves: Protects hands from chemical exposure.
• Respiratory mask: Prevents inhalation of solvent fumes.
• Goggles: Shields eyes from splashes and airborne particles.
• Protective clothing: Prevents contamination and chemical exposure.
• Ventilation system: Ensures the safe removal of solvent vapors.

9. References

• OSHA 1910.106 – Flammable and Combustible Liquids Standards.
• ISO 45001 – Occupational Health & Safety Management.
• GMP guidelines for spray coating in pharmaceutical production.

10. Approval Section

11. Revision History

JSA for Safe Operation of Sugar Coating Machine

1. Purpose

The purpose of this JSA is to identify and mitigate potential hazards associated with the operation of the Sugar Coating Machine. This equipment is used in pharmaceutical manufacturing to apply a sugar-based protective coating to tablets, improving taste, appearance, and stability. Safe operation is essential to prevent injuries, chemical exposure, and mechanical hazards.

2. Scope

This JSA applies to all operators, maintenance personnel, and supervisors involved in using, cleaning, and maintaining the Sugar Coating Machine in the Oral Dosage department. Proper safety measures must be followed to minimize risks associated with high-speed rotation, hot air drying, handling of sugar solutions, and potential slip hazards.

3. Responsibilities

Operators:

• Operate the Sugar Coating Machine according to the standard operating procedure (SOP).
• Wear the appropriate Personal Protective Equipment (PPE) before handling coating materials.
• Ensure uniform loading of tablets into the machine.
• Monitor temperature, airflow, and sugar solution spray settings.
• Handle sugar solutions carefully to prevent spills and contamination.
• Conduct routine cleaning of the machine to prevent sugar build-up.

Supervisors:

• Ensure strict compliance with GMP and safety guidelines.
• Monitor operations for potential hazards and ensure corrective actions are taken.
• Conduct inspections of machine components and ensure regular maintenance.

Safety Officers:

• Perform risk assessments and ensure compliance with safety regulations.
• Ensure the proper functioning of ventilation and exhaust systems.
• Verify that operators are trained in handling hot sugar solutions safely.

4. Definitions & Abbreviations

• PPE: Personal Protective Equipment (e.g., gloves, goggles, protective clothing).
• GMP: Good Manufacturing Practices – Guidelines ensuring product quality and safety.
• LOTO: Lockout/Tagout – A safety procedure to isolate hazardous energy sources.

5. Procedure

6. Risk Assessment

7. Emergency Procedures

1. In case of burns, immediately rinse the affected area with cool water and seek medical help.
2. For respiratory exposure, move to fresh air and seek medical attention.
3. If an equipment failure occurs, initiate an emergency shutdown and report to maintenance.
4. All incidents must be recorded and reported to the safety officer for investigation.

8. Required PPE & Safety Controls

• Heat-resistant gloves: Protect hands from burns due to hot sugar solutions.
• Respiratory mask: Prevents inhalation of sugar aerosols.
• Goggles: Shields eyes from splashes and airborne particles.
• Protective clothing: Prevents contamination and exposure to sticky residues.
• Non-slip footwear: Reduces the risk of slips and falls.

9. References

• OSHA 1910.120 – Hazardous Materials Handling.
• ISO 45001 – Occupational Health & Safety Management.
• GMP guidelines for sugar coating in pharmaceutical production.

10. Approval Section

11. Revision History

JSA for Safe Operation of Film Coating Pan

1. Purpose

The purpose of this JSA is to identify and mitigate potential hazards associated with the operation of the Film Coating Pan. This equipment is essential in pharmaceutical manufacturing to apply a uniform film coating to tablets, enhancing their appearance, stability, and controlled release. Proper operation and adherence to safety protocols are critical to preventing exposure to coating solutions, mechanical hazards, and contamination risks.

2. Scope

This JSA applies to all operators, supervisors, and maintenance personnel involved in the operation, cleaning, and maintenance of the Film Coating Pan in the Oral Dosage department. Ensuring compliance with safety measures is essential to minimize risks associated with coating solvents, moving mechanical parts, and high-temperature drying systems.

3. Responsibilities

Operators:

• Operate the Film Coating Pan as per the standard operating procedure (SOP).
• Wear appropriate Personal Protective Equipment (PPE) before handling coating solutions.
• Ensure the proper loading of tablets into the coating pan.
• Monitor machine parameters, airflow, and spray system during operation.
• Follow safety measures for handling and disposing of solvents.
• Thoroughly clean the coating pan after each batch to prevent cross-contamination.

Supervisors:

• Ensure compliance with safety protocols and GMP guidelines.
• Monitor the work environment for solvent exposure and adequate ventilation.
• Conduct routine inspections of the machine, safety features, and operational practices.

Safety Officers:

• Perform risk assessments and ensure compliance with occupational safety regulations.
• Verify solvent exposure levels remain within permissible limits.
• Ensure proper functioning of fume extraction and ventilation systems.

4. Definitions & Abbreviations

• PPE: Personal Protective Equipment (e.g., gloves, goggles, respirators).
• GMP: Good Manufacturing Practices – Guidelines ensuring quality and safety in pharmaceutical production.
• LOTO: Lockout/Tagout – A procedure for isolating hazardous energy sources.

5. Procedure

6. Risk Assessment

7. Emergency Procedures

1. In case of chemical exposure, rinse affected areas immediately and seek medical help.
2. For fires, use a Class B fire extinguisher and evacuate if necessary.
3. In the event of an equipment failure, follow emergency shutdown procedures.
4. All incidents must be reported and logged for further investigation.

8. Required PPE & Safety Controls

• Gloves: Protect hands from solvent exposure.
• Respiratory mask: Prevents inhalation of solvent fumes.
• Goggles: Shields eyes from splashes.
• Protective clothing: Prevents contamination and chemical exposure.
• Ventilation system: Ensures safe removal of solvent vapors.

9. References

• OSHA 1910.106 – Flammable and Combustible Liquids Standards.
• ISO 45001 – Occupational Health & Safety Management.
• GMP guidelines for pharmaceutical tablet coating.

10. Approval Section

11. Revision History

JSA for Safe Operation of Tablet Coating Machine

1. Purpose

The purpose of this JSA is to identify and mitigate potential hazards associated with the operation of the Tablet Coating Machine. The coating process enhances the stability, appearance, and controlled release of pharmaceutical tablets. Proper operation and adherence to safety protocols are necessary to prevent contamination, exposure to chemicals, and mechanical hazards.

2. Scope

This JSA applies to all operators, maintenance personnel, and supervisors involved in using, cleaning, and maintaining the Tablet Coating Machine in the Oral Dosage department. Ensuring compliance with safety measures is necessary to minimize risks associated with coating solutions, mechanical components, and high-temperature operations.

3. Responsibilities

Operators:

• Ensure the machine is operated according to the standard operating procedure (SOP).
• Wear appropriate Personal Protective Equipment (PPE) before handling coating solutions.
• Monitor machine settings, airflow, and coating parameters.
• Follow safe handling practices for solvents and other coating materials.
• Conduct routine cleaning to prevent cross-contamination.

Supervisors:

• Ensure compliance with GMP and safety guidelines.
• Monitor the work environment for solvent exposure and ventilation efficiency.
• Conduct routine inspections of the machine and safety features.

Safety Officers:

• Perform risk assessments and ensure compliance with occupational safety regulations.
• Ensure that solvent exposure limits are within permissible levels.
• Verify that PPE and fume extraction systems are functioning properly.

4. Definitions & Abbreviations

• PPE: Personal Protective Equipment (e.g., gloves, goggles, respirators).
• GMP: Good Manufacturing Practices – Regulations ensuring consistent product quality.
• LOTO: Lockout/Tagout – A procedure for isolating hazardous energy sources.

5. Procedure

6. Risk Assessment

7. Emergency Procedures

1. In case of chemical exposure, rinse affected areas immediately and seek medical help.
2. For fires, use a Class B fire extinguisher and evacuate if necessary.
3. In the event of an equipment failure, follow emergency shutdown procedures.
4. All incidents must be reported and logged for investigation.

8. Required PPE & Safety Controls

• Gloves: Protects hands from solvent exposure.
• Respiratory mask: Prevents inhalation of solvent fumes.
• Goggles: Shields eyes from splashes.
• Protective clothing: Prevents contamination and chemical exposure.
• Ventilation system: Essential to remove solvent vapors.

9. References

• OSHA 1910.106 – Flammable and Combustible Liquids Standards.
• ISO 45001 – Occupational Health & Safety Management.
• GMP guidelines for pharmaceutical tablet coating.

10. Approval Section

11. Revision History