Pharmaceutical Safety Measures – SOP Guide for Pharma

Job Safety Analysis for Automatic Tablet Packager

Sat, 15 Mar 2025 08:16:00 +0000

Job Safety Analysis for Automatic Tablet Packager

JSA for Safe Operation of Automatic Tablet Packager

JSA Number	JSA/OralDosage/050/2025	Department	Oral Dosage
Revision Number	V 1.0	Issue Date	01/02/2025
Effective Date	05/02/2025	Review Date	05/02/2026

1. Purpose

The purpose of this JSA is to identify and mitigate potential hazards associated with the operation of the Automatic Tablet Packager. This equipment is used in pharmaceutical manufacturing to automate the packaging of tablets into blister packs, bottles, or pouches. Proper handling and operation are essential to ensure packaging accuracy, prevent contamination, and maintain workplace safety.

2. Scope

This JSA applies to all operators, supervisors, and maintenance personnel involved in using, cleaning, and maintaining the Automatic Tablet Packager in the Oral Dosage department. Ensuring compliance with safety measures minimizes risks associated with moving parts, packaging material handling, and improper machine settings.

3. Responsibilities

Operators:

Follow the standard operating procedure (SOP) while operating the Automatic Tablet Packager.
Ensure the machine is properly calibrated before use.
Wear appropriate Personal Protective Equipment (PPE) to prevent contamination.
Monitor tablet feeding and ensure correct packaging alignment.
Ensure proper cleaning and avoid cross-contamination between batches.
Report any machine malfunctions immediately to the supervisor.

Supervisors:

Ensure compliance with GMP and workplace safety regulations.
Monitor machine efficiency and ensure calibration is performed as scheduled.
Conduct routine inspections of the Automatic Tablet Packager and maintenance logs.

Safety Officers:

Perform risk assessments and ensure compliance with occupational safety standards.
Ensure that proper ventilation and packaging waste disposal procedures are followed.
Verify that PPE, such as gloves, safety glasses, and protective clothing, are used correctly.

4. Definitions & Abbreviations

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

5. Procedure

Step	Task Description	Potential Hazard	Risk Level (L/M/H)	Control Measures
1	Machine setup and calibration	Electrical hazards, incorrect calibration	Medium	Ensure proper grounding and calibration before operation.
2	Loading tablets into the feeding system	Manual handling strain, tablet contamination	Medium	Use clean handling tools; wear gloves.
3	Adjusting packaging material feed	Misalignment, incorrect sealing	High	Follow SOP guidelines for setting film or bottle alignment.
4	Tablet packaging process	Moving parts hazards, tablet breakage	High	Ensure safety guards are in place; do not reach into moving parts.
5	Unloading and inspecting packaged tablets	Cross-contamination, packaging errors	Medium	Follow GMP cleaning procedures and use designated collection containers.
6	Cleaning and maintenance	Residual packaging material exposure, electrical shock	High	Follow LOTO procedures before servicing; wear PPE during cleaning.

6. Risk Assessment

Likelihood	Consequence	Risk Level
Rare	Minor tablet misalignment	Low
Possible	Tablet rejection due to incorrect packaging	Medium
Likely	Entrapment due to moving parts	High

7. Emergency Procedures

In case of packaging material jam, stop the machine and notify the supervisor.
If the system malfunctions, shut it down and report to maintenance.
For equipment entrapment, activate the emergency stop and seek immediate assistance.
All incidents must be reported and logged for investigation.

8. Required PPE & Safety Controls

Respiratory mask: Prevents inhalation of airborne dust from packaging materials.
Safety glasses: Shields eyes from packaging debris.
Protective gloves: Prevents direct contact with tablets.
Machine guards: Ensures safety from moving parts.
Packaging waste disposal bins: Ensures proper handling of defective packaging.

9. References

OSHA 1910.212 – Machine Guarding Standards.
ISO 45001 – Occupational Health & Safety Management.
GMP guidelines for tablet packaging and handling.

10. Approval Section

Name	Designation	Signature	Date
[Name]	Prepared By
[Name]	Checked By
[Name]	Approved By

Job Safety Analysis for Dedusting Conveyor for Tablets

Fri, 14 Mar 2025 15:36:00 +0000

Job Safety Analysis for Dedusting Conveyor for Tablets

JSA for Safe Operation of Dedusting Conveyor for Tablets

JSA Number	JSA/OralDosage/049/2025	Department	Oral Dosage
Revision Number	V 1.0	Issue Date	01/02/2025
Effective Date	05/02/2025	Review Date	05/02/2026

1. Purpose

The purpose of this JSA is to identify and mitigate potential hazards associated with the operation of the Dedusting Conveyor for Tablets. This equipment is used in pharmaceutical manufacturing to remove excess powder or dust from tablets before further processing or packaging. Proper handling and operation are essential to ensure product quality, prevent contamination, and maintain workplace safety.

2. Scope

This JSA applies to all operators, supervisors, and maintenance personnel involved in using, cleaning, and maintaining the Dedusting Conveyor for Tablets in the Oral Dosage department. Ensuring compliance with safety measures minimizes risks associated with airborne dust, mechanical hazards, and improper equipment calibration.

3. Responsibilities

Operators:

Follow the standard operating procedure (SOP) while operating the Dedusting Conveyor.
Ensure the machine is properly calibrated before use.
Wear appropriate Personal Protective Equipment (PPE) to prevent exposure to airborne dust.
Monitor tablet movement and ensure proper dedusting.
Ensure proper cleaning and avoid cross-contamination between batches.
Report any machine malfunctions immediately to the supervisor.

Supervisors:

Ensure compliance with GMP and workplace safety regulations.
Monitor machine efficiency and ensure calibration is performed as scheduled.
Conduct routine inspections of the Dedusting Conveyor and maintenance logs.

Safety Officers:

Perform risk assessments and ensure compliance with occupational safety standards.
Ensure that dust control and ventilation systems are functioning correctly.
Verify that PPE, such as respirators and protective gloves, are used correctly.

4. Definitions & Abbreviations

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

5. Procedure

Step	Task Description	Potential Hazard	Risk Level (L/M/H)	Control Measures
1	Machine setup and calibration	Electrical hazards, incorrect calibration	Medium	Ensure proper grounding and calibration before operation.
2	Loading tablets onto the conveyor	Manual handling strain, tablet contamination	Medium	Use clean handling tools; wear gloves.
3	Adjusting conveyor speed and airflow	Dust exposure, incorrect dedusting	High	Follow SOP guidelines for setting dedusting parameters.
4	Dedusting process	Airborne dust, tablet damage	High	Ensure proper dust extraction and avoid excessive airflow.
5	Unloading and collecting dedusted tablets	Cross-contamination, handling errors	Medium	Follow GMP cleaning procedures and use designated collection containers.
6	Cleaning and maintenance	Residual powder exposure, electrical shock	High	Follow LOTO procedures before servicing; wear PPE during cleaning.

6. Risk Assessment

Likelihood	Consequence	Risk Level
Rare	Minor tablet misalignment	Low
Possible	Tablet rejection due to incomplete dedusting	Medium
Likely	Dust inhalation causing respiratory discomfort	High

7. Emergency Procedures

In case of excessive dust exposure, move to fresh air and seek medical assistance.
If the system malfunctions, shut it down and report to maintenance.
For equipment entrapment, activate the emergency stop and seek immediate assistance.
All incidents must be reported and logged for investigation.

8. Required PPE & Safety Controls

Respiratory mask: Prevents inhalation of airborne dust.
Safety glasses: Shields eyes from fine dust exposure.
Protective gloves: Prevents direct contact with tablets.
Machine guards: Ensures safety from moving parts.
Dust extraction unit: Reduces airborne powder concentration.

9. References

OSHA 1910.94 – Ventilation Standards.
ISO 45001 – Occupational Health & Safety Management.
GMP guidelines for tablet dedusting and handling.

10. Approval Section

Name	Designation	Signature	Date
[Name]	Prepared By
[Name]	Checked By
[Name]	Approved By

Job Safety Analysis for High-Speed Capsule Sorter

Thu, 13 Mar 2025 22:56:00 +0000

Job Safety Analysis for High-Speed Capsule Sorter

JSA for Safe Operation of High-Speed Capsule Sorter

JSA Number	JSA/OralDosage/048/2025	Department	Oral Dosage
Revision Number	V 1.0	Issue Date	01/02/2025
Effective Date	05/02/2025	Review Date	05/02/2026

1. Purpose

The purpose of this JSA is to identify and mitigate potential hazards associated with the operation of the High-Speed Capsule Sorter. This equipment is used in pharmaceutical manufacturing to rapidly separate acceptable capsules from defective ones based on size, shape, weight, or visual defects. Proper handling and operation are essential to ensure product quality, prevent contamination, and maintain workplace safety.

2. Scope

This JSA applies to all operators, supervisors, and maintenance personnel involved in using, cleaning, and maintaining the High-Speed Capsule Sorter in the Oral Dosage department. Ensuring compliance with safety measures minimizes risks associated with capsule misalignment, moving parts, and dust exposure.

3. Responsibilities

Operators:

Follow the standard operating procedure (SOP) while operating the High-Speed Capsule Sorter.
Ensure the machine is properly calibrated before use.
Wear appropriate Personal Protective Equipment (PPE) to prevent contamination and exposure to airborne particles.
Monitor capsule sorting accuracy and adjust settings as required.
Ensure proper cleaning and maintenance to prevent cross-contamination.
Report any machine malfunctions immediately to the supervisor.

Supervisors:

Ensure compliance with GMP and workplace safety regulations.
Monitor machine efficiency and ensure calibration is performed as scheduled.
Conduct routine inspections of the High-Speed Capsule Sorter and maintenance logs.

Safety Officers:

Perform risk assessments and ensure compliance with occupational safety standards.
Ensure that dust control and material handling procedures are followed.
Verify that PPE, such as gloves, safety glasses, and protective clothing, are used correctly.

4. Definitions & Abbreviations

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

5. Procedure

Step	Task Description	Potential Hazard	Risk Level (L/M/H)	Control Measures
1	Machine setup and calibration	Electrical hazards, incorrect calibration	Medium	Ensure proper grounding and calibration before operation.
2	Loading capsules into the feeder	Manual handling strain, capsule contamination	Medium	Use clean handling tools; wear gloves.
3	Adjusting sorting parameters	Misalignment, incorrect sorting	High	Follow SOP guidelines for setting sorting thresholds.
4	Sorting process	Moving parts hazards, capsule breakage	High	Ensure safety guards are in place; do not reach into moving parts.
5	Unloading and collecting sorted capsules	Cross-contamination, handling errors	Medium	Follow GMP cleaning procedures and use designated collection containers.
6	Cleaning and maintenance	Electrical shock, residual powder exposure	High	Follow LOTO procedures before servicing; wear PPE during cleaning.

6. Risk Assessment

Likelihood	Consequence	Risk Level
Rare	Minor capsule misalignment	Low
Possible	Capsule rejection due to incorrect sorting parameters	Medium
Likely	Entrapment due to moving parts	High

7. Emergency Procedures

In case of capsule contamination, stop the machine and notify the supervisor.
If the system malfunctions, shut it down and report to maintenance.
For equipment entrapment, activate the emergency stop and seek immediate assistance.
All incidents must be reported and logged for investigation.

8. Required PPE & Safety Controls

Respiratory mask: Prevents inhalation of airborne powder from capsule handling.
Safety glasses: Shields eyes from dust exposure.
Protective gloves: Prevents direct contact with capsules.
Machine guards: Ensures safety from moving parts.
Designated sorting bins: Prevents cross-contamination.

9. References

OSHA 1910.212 – Machine Guarding Standards.
ISO 45001 – Occupational Health & Safety Management.
GMP guidelines for capsule sorting and handling.

10. Approval Section

Name	Designation	Signature	Date
[Name]	Prepared By
[Name]	Checked By
[Name]	Approved By

Job Safety Analysis for Capsule Printing Machine

Thu, 13 Mar 2025 06:16:00 +0000

Job Safety Analysis for Capsule Printing Machine

JSA for Safe Operation of Capsule Printing Machine

JSA Number	JSA/OralDosage/047/2025	Department	Oral Dosage
Revision Number	V 1.0	Issue Date	01/02/2025
Effective Date	05/02/2025	Review Date	05/02/2026

1. Purpose

The purpose of this JSA is to identify and mitigate potential hazards associated with the operation of the Capsule Printing Machine. This equipment is used in pharmaceutical manufacturing to imprint identification codes, logos, or brand names onto capsules. Proper handling and operation are essential to ensure accurate printing, prevent contamination, and maintain workplace safety.

2. Scope

This JSA applies to all operators, supervisors, and maintenance personnel involved in using, cleaning, and maintaining the Capsule Printing Machine in the Oral Dosage department. Ensuring compliance with safety measures minimizes risks associated with ink exposure, mechanical hazards, and misprinted capsules.

3. Responsibilities

Operators:

Follow the standard operating procedure (SOP) while operating the Capsule Printing Machine.
Ensure the machine is properly calibrated before use.
Wear appropriate Personal Protective Equipment (PPE) to prevent exposure to printing inks and solvents.
Monitor capsule alignment and printing quality.
Ensure proper cleaning and avoid cross-contamination between batches.
Report any machine malfunctions immediately to the supervisor.

Supervisors:

Ensure compliance with GMP and workplace safety regulations.
Monitor machine efficiency and ensure calibration is performed as scheduled.
Conduct routine inspections of the Capsule Printing Machine and maintenance logs.

Safety Officers:

Perform risk assessments and ensure compliance with occupational safety standards.
Ensure that ventilation and solvent-handling procedures are followed.
Verify that PPE, such as gloves, safety glasses, and protective clothing, are used correctly.

4. Definitions & Abbreviations

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

5. Procedure

Step	Task Description	Potential Hazard	Risk Level (L/M/H)	Control Measures
1	Machine setup and calibration	Electrical hazards, incorrect calibration	Medium	Ensure proper grounding and calibration before operation.
2	Loading capsules into the feeder	Manual handling strain, capsule contamination	Medium	Use clean handling tools; wear gloves.
3	Filling ink reservoirs	Solvent exposure, inhalation risk	High	Ensure proper ventilation; wear respirator if required.
4	Printing process	Ink smudging, capsule misalignment	Medium	Monitor capsule positioning and printing speed.
5	Unloading and sorting printed capsules	Cross-contamination, handling errors	Medium	Follow GMP cleaning procedures and use designated collection containers.
6	Cleaning and maintenance	Residual ink exposure, electrical shock	High	Follow LOTO procedures before servicing; wear PPE during cleaning.

6. Risk Assessment

Likelihood	Consequence	Risk Level
Rare	Minor capsule misalignment	Low
Possible	Capsule rejection due to ink smudging	Medium
Likely	Solvent inhalation causing respiratory discomfort	High

7. Emergency Procedures

In case of ink spillage, stop the machine and clean the affected area.
If solvent inhalation occurs, move to fresh air and seek medical assistance.
If the system malfunctions, shut it down and report to maintenance.
For equipment entrapment, activate the emergency stop and seek immediate assistance.
All incidents must be reported and logged for investigation.

8. Required PPE & Safety Controls

Respiratory mask: Prevents inhalation of solvent fumes.
Safety glasses: Shields eyes from ink splashes.
Protective gloves: Prevents direct contact with ink and solvents.
Machine guards: Ensures safety from moving parts.
Designated ink handling area: Prevents accidental spills and exposure.

9. References

OSHA 1910.212 – Machine Guarding Standards.
OSHA 1910.1000 – Air Contaminants Standard for Solvent Handling.
ISO 45001 – Occupational Health & Safety Management.
GMP guidelines for capsule printing and handling.

10. Approval Section

Name	Designation	Signature	Date
[Name]	Prepared By
[Name]	Checked By
[Name]	Approved By

Job Safety Analysis for Encapsulation Leak Test Apparatus

Wed, 12 Mar 2025 13:36:00 +0000

Job Safety Analysis for Encapsulation Leak Test Apparatus

JSA for Safe Operation of Encapsulation Leak Test Apparatus

JSA Number	JSA/OralDosage/046/2025	Department	Oral Dosage
Revision Number	V 1.0	Issue Date	01/02/2025
Effective Date	05/02/2025	Review Date	05/02/2026

1. Purpose

The purpose of this JSA is to identify and mitigate potential hazards associated with the operation of the Encapsulation Leak Test Apparatus. This equipment is used in pharmaceutical manufacturing to verify the integrity of encapsulated drug products by assessing the presence of leaks or defects. Proper handling and operation are essential to maintain the accuracy of leak tests, prevent contamination, and ensure product quality.

2. Scope

This JSA applies to all operators, supervisors, and maintenance personnel involved in using, cleaning, and maintaining the Encapsulation Leak Test Apparatus in the Oral Dosage department. Ensuring compliance with safety measures minimizes risks associated with vacuum testing, exposure to liquid or powder leaks, and incorrect equipment calibration.

3. Responsibilities

Operators:

Follow the standard operating procedure (SOP) while operating the Encapsulation Leak Test Apparatus.
Ensure the equipment is properly calibrated before use.
Wear appropriate Personal Protective Equipment (PPE) to prevent exposure to pharmaceutical powders or liquids.
Monitor the leak testing process and document results accurately.
Ensure proper cleaning and maintenance of the equipment.
Report any equipment malfunctions immediately to the supervisor.

Supervisors:

Ensure compliance with GMP and workplace safety regulations.
Monitor equipment efficiency and ensure calibration is performed as scheduled.
Conduct routine inspections of the Encapsulation Leak Test Apparatus and maintenance logs.

Safety Officers:

Perform risk assessments and ensure compliance with occupational safety standards.
Ensure that liquid or dust containment procedures are followed to prevent cross-contamination.
Verify that PPE, such as gloves, safety glasses, and protective clothing, are used correctly.

4. Definitions & Abbreviations

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

5. Procedure

Step	Task Description	Potential Hazard	Risk Level (L/M/H)	Control Measures
1	Machine setup and calibration	Electrical hazards, incorrect calibration	Medium	Ensure proper grounding and calibration before operation.
2	Loading encapsulated products for testing	Manual handling strain, capsule contamination	Medium	Use clean handling tools; wear gloves.
3	Adjusting vacuum pressure settings	Misalignment, incorrect testing	High	Follow SOP guidelines for setting vacuum levels.
4	Leak testing process	Vacuum-related hazards, capsule breakage	High	Ensure proper containment of broken capsules and clean spillages immediately.
5	Unloading tested capsules	Cross-contamination, handling errors	Medium	Follow GMP cleaning procedures and use designated collection containers.
6	Cleaning and maintenance	Residual chemical exposure, electrical shock	High	Follow LOTO procedures before servicing; wear PPE during cleaning.

6. Risk Assessment

Likelihood	Consequence	Risk Level
Rare	Minor capsule misalignment	Low
Possible	Capsule breakage due to excessive vacuum pressure	Medium
Likely	Leakage leading to cross-contamination	High

7. Emergency Procedures

In case of capsule leakage, stop the machine and notify the supervisor.
If the system malfunctions, shut it down and report to maintenance.
For vacuum failure, activate the emergency stop and seek immediate assistance.
All incidents must be reported and logged for investigation.

8. Required PPE & Safety Controls

Respiratory mask: Prevents inhalation of airborne powder from broken capsules.
Safety glasses: Shields eyes from liquid splashes or powder leaks.
Protective gloves: Prevents direct contact with potentially contaminated capsules.
Machine guards: Ensures safety from moving parts.
Vacuum containment unit: Prevents capsule debris from dispersing.

9. References

OSHA 1910.212 – Machine Guarding Standards.
ISO 45001 – Occupational Health & Safety Management.
GMP guidelines for encapsulation integrity testing.

10. Approval Section

Name	Designation	Signature	Date
[Name]	Prepared By
[Name]	Checked By
[Name]	Approved By

Job Safety Analysis for Capsule Sorting Machine

Tue, 11 Mar 2025 20:56:00 +0000

Job Safety Analysis for Capsule Sorting Machine

JSA for Safe Operation of Capsule Sorting Machine

JSA Number	JSA/OralDosage/045/2025	Department	Oral Dosage
Revision Number	V 1.0	Issue Date	01/02/2025
Effective Date	05/02/2025	Review Date	05/02/2026

1. Purpose

The purpose of this JSA is to identify and mitigate potential hazards associated with the operation of the Capsule Sorting Machine. This equipment is used in pharmaceutical manufacturing to separate defective capsules from acceptable ones based on weight, size, or visual defects. Proper handling and operation are essential to ensure product quality, prevent cross-contamination, and maintain a safe working environment.

2. Scope

This JSA applies to all operators, supervisors, and maintenance personnel involved in using, cleaning, and maintaining the Capsule Sorting Machine in the Oral Dosage department. Ensuring compliance with safety measures minimizes risks associated with capsule misalignment, moving parts, and dust exposure.

3. Responsibilities

Operators:

Follow the standard operating procedure (SOP) while operating the Capsule Sorting Machine.
Ensure the machine is properly calibrated before use.
Wear appropriate Personal Protective Equipment (PPE) to prevent contamination and exposure to airborne particles.
Monitor capsule sorting accuracy and adjust settings as required.
Ensure proper cleaning and maintenance to prevent cross-contamination.
Report any machine malfunctions immediately to the supervisor.

Supervisors:

Ensure compliance with GMP and workplace safety regulations.
Monitor machine efficiency and ensure calibration is performed as scheduled.
Conduct routine inspections of the Capsule Sorting Machine and maintenance logs.

Safety Officers:

Perform risk assessments and ensure compliance with occupational safety standards.
Ensure that dust control and material handling procedures are followed.
Verify that PPE, such as gloves, safety glasses, and protective clothing, are used correctly.

4. Definitions & Abbreviations

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

5. Procedure

Step	Task Description	Potential Hazard	Risk Level (L/M/H)	Control Measures
1	Machine setup and calibration	Electrical hazards, incorrect calibration	Medium	Ensure proper grounding and calibration before operation.
2	Loading capsules into the feeder	Manual handling strain, capsule contamination	Medium	Use clean handling tools; wear gloves.
3	Adjusting sorting parameters	Misalignment, incorrect sorting	High	Follow SOP guidelines for setting sorting thresholds.
4	Sorting process	Moving parts hazards, capsule breakage	High	Ensure safety guards are in place; do not reach into moving parts.
5	Unloading and collecting sorted capsules	Cross-contamination, handling errors	Medium	Follow GMP cleaning procedures and use designated collection containers.
6	Cleaning and maintenance	Electrical shock, residual powder exposure	High	Follow LOTO procedures before servicing; wear PPE during cleaning.

6. Risk Assessment

Likelihood	Consequence	Risk Level
Rare	Minor capsule misalignment	Low
Possible	Capsule rejection due to incorrect sorting parameters	Medium
Likely	Entrapment due to moving parts	High

7. Emergency Procedures

In case of capsule contamination, stop the machine and notify the supervisor.
If the system malfunctions, shut it down and report to maintenance.
For equipment entrapment, activate the emergency stop and seek immediate assistance.
All incidents must be reported and logged for investigation.

8. Required PPE & Safety Controls

Respiratory mask: Prevents inhalation of airborne powder from capsule handling.
Safety glasses: Shields eyes from dust exposure.
Protective gloves: Prevents direct contact with capsules.
Machine guards: Ensures safety from moving parts.
Designated sorting bins: Prevents cross-contamination.

9. References

OSHA 1910.212 – Machine Guarding Standards.
ISO 45001 – Occupational Health & Safety Management.
GMP guidelines for capsule sorting and handling.

10. Approval Section

Name	Designation	Signature	Date
[Name]	Prepared By
[Name]	Checked By
[Name]	Approved By

Job Safety Analysis for Capsule Polishing Machine

Tue, 11 Mar 2025 04:16:00 +0000

Job Safety Analysis for Capsule Polishing Machine

JSA for Safe Operation of Capsule Polishing Machine

JSA Number	JSA/OralDosage/044/2025	Department	Oral Dosage
Revision Number	V 1.0	Issue Date	01/02/2025
Effective Date	05/02/2025	Review Date	05/02/2026

1. Purpose

The purpose of this JSA is to identify and mitigate potential hazards associated with the operation of the Capsule Polishing Machine. This equipment is used in pharmaceutical manufacturing to remove excess powder and polish hard gelatin or HPMC capsules, ensuring a smooth, clean surface before packaging. Proper handling and operation are essential to prevent contamination, mechanical hazards, and exposure to airborne particles.

2. Scope

This JSA applies to all operators, supervisors, and maintenance personnel involved in using, cleaning, and maintaining the Capsule Polishing Machine in the Oral Dosage department. Ensuring compliance with safety measures minimizes risks associated with capsule damage, dust exposure, and improper handling of polished capsules.

3. Responsibilities

Operators:

Follow the standard operating procedure (SOP) while operating the Capsule Polishing Machine.
Ensure the machine is properly calibrated before use.
Wear appropriate Personal Protective Equipment (PPE) to prevent exposure to airborne particles.
Monitor capsule flow, polishing efficiency, and dust collection.
Ensure proper cleaning and avoid cross-contamination between batches.
Perform post-operation maintenance as required.

Supervisors:

Ensure compliance with GMP and workplace safety regulations.
Monitor machine efficiency and ensure calibration is performed as scheduled.
Conduct routine inspections of the Capsule Polishing Machine and maintenance logs.

Safety Officers:

Perform risk assessments and ensure compliance with occupational safety standards.
Ensure that dust extraction and ventilation systems are functioning correctly.
Verify that PPE, such as respiratory masks and protective gloves, are used correctly.

4. Definitions & Abbreviations

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

5. Procedure

Step	Task Description	Potential Hazard	Risk Level (L/M/H)	Control Measures
1	Machine setup and calibration	Electrical hazards, incorrect calibration	Medium	Ensure proper grounding and calibration before operation.
2	Loading capsules into the hopper	Manual handling strain, capsule contamination	Medium	Use clean handling tools; wear gloves.
3	Adjusting polishing settings	Machine misalignment, improper polishing	High	Follow SOP guidelines for setting polishing speed and airflow.
4	Polishing process	Dust exposure, capsule breakage	High	Ensure dust extraction is functional; avoid overloading capsules.
5	Unloading and collecting polished capsules	Cross-contamination, handling errors	Medium	Follow GMP cleaning procedures and use designated collection containers.
6	Cleaning and maintenance	Electrical shock, residual powder exposure	High	Follow LOTO procedures before servicing; wear PPE during cleaning.

6. Risk Assessment

Likelihood	Consequence	Risk Level
Rare	Minor capsule misalignment	Low
Possible	Capsule breakage due to excessive polishing force	Medium
Likely	Entrapment due to moving parts	High

7. Emergency Procedures

In case of capsule contamination, stop the machine and notify the supervisor.
If the system malfunctions, shut it down and report to maintenance.
For equipment entrapment, activate the emergency stop and seek immediate assistance.
All incidents must be reported and logged for investigation.

8. Required PPE & Safety Controls

Respiratory mask: Prevents inhalation of airborne powder from capsule polishing.
Safety glasses: Shields eyes from dust exposure.
Protective gloves: Prevents direct contact with capsules.
Machine guards: Ensures safety from moving parts.
Designated collection bins: Prevents cross-contamination.

9. References

OSHA 1910.212 – Machine Guarding Standards.
ISO 45001 – Occupational Health & Safety Management.
GMP guidelines for capsule polishing and handling.

10. Approval Section

Name	Designation	Signature	Date
[Name]	Prepared By
[Name]	Checked By
[Name]	Approved By

Job Safety Analysis for Tablet Inspection System

Mon, 10 Mar 2025 11:36:00 +0000

Job Safety Analysis for Tablet Inspection System

JSA for Safe Operation of Tablet Inspection System

JSA Number	JSA/OralDosage/043/2025	Department	Oral Dosage
Revision Number	V 1.0	Issue Date	01/02/2025
Effective Date	05/02/2025	Review Date	05/02/2026

1. Purpose

The purpose of this JSA is to identify and mitigate potential hazards associated with the operation of the Tablet Inspection System. This equipment is used in pharmaceutical manufacturing to visually and mechanically inspect tablets for defects such as cracks, discoloration, weight variation, and surface irregularities. Proper handling and operation are essential to ensure accurate defect identification, maintain quality standards, and prevent cross-contamination.

2. Scope

This JSA applies to all operators, supervisors, and maintenance personnel involved in using, cleaning, and maintaining the Tablet Inspection System in the Oral Dosage department. Ensuring compliance with safety measures minimizes risks associated with moving parts, exposure to fine dust, and improper sorting mechanisms.

3. Responsibilities

Operators:

Follow the standard operating procedure (SOP) while operating the Tablet Inspection System.
Ensure the machine is properly calibrated before use.
Wear appropriate Personal Protective Equipment (PPE) to prevent contamination and exposure to airborne particles.
Monitor the quality of inspected tablets and adjust machine settings as needed.
Ensure proper cleaning and maintenance to prevent cross-contamination.
Report any machine malfunctions immediately to the supervisor.

Supervisors:

Ensure compliance with GMP and workplace safety regulations.
Monitor machine efficiency and ensure calibration is performed as scheduled.
Conduct routine inspections of the Tablet Inspection System and maintenance logs.

Safety Officers:

Perform risk assessments and ensure compliance with occupational safety standards.
Ensure that dust control and material handling procedures are followed.
Verify that PPE, such as gloves, safety glasses, and protective clothing, are used correctly.

4. Definitions & Abbreviations

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

5. Procedure

Step	Task Description	Potential Hazard	Risk Level (L/M/H)	Control Measures
1	Machine setup and calibration	Electrical hazards, incorrect calibration	Medium	Ensure proper grounding and calibration before operation.
2	Loading tablets into the inspection conveyor	Manual handling strain, tablet contamination	Medium	Use clean handling tools; wear gloves and mask.
3	Adjusting inspection parameters	Misalignment, incorrect sorting	High	Follow SOP guidelines for setting inspection thresholds.
4	Inspection process	Moving parts hazards, tablet breakage	High	Ensure safety guards are in place; do not reach into moving parts.
5	Unloading and sorting tablets	Cross-contamination, handling errors	Medium	Follow GMP cleaning procedures and use designated collection containers.
6	Cleaning and maintenance	Electrical shock, residual powder exposure	High	Follow LOTO procedures before servicing; wear PPE during cleaning.

6. Risk Assessment

Likelihood	Consequence	Risk Level
Rare	Minor tablet misalignment	Low
Possible	Tablet rejection due to incorrect parameters	Medium
Likely	Entrapment due to moving parts	High

7. Emergency Procedures

In case of tablet contamination, stop the machine and notify the supervisor.
If the system malfunctions, shut it down and report to maintenance.
For equipment entrapment, activate the emergency stop and seek immediate assistance.
All incidents must be reported and logged for investigation.

8. Required PPE & Safety Controls

Respiratory mask: Prevents inhalation of airborne powder from broken tablets.
Safety glasses: Shields eyes from dust exposure.
Protective gloves: Prevents direct contact with tablets.
Machine guards: Ensures safety from moving parts.
Designated sorting bins: Prevents cross-contamination.

9. References

OSHA 1910.212 – Machine Guarding Standards.
ISO 45001 – Occupational Health & Safety Management.
GMP guidelines for tablet inspection and handling.

10. Approval Section

Name	Designation	Signature	Date
[Name]	Prepared By
[Name]	Checked By
[Name]	Approved By

Job Safety Analysis for Tablet Sorting Machine

Sun, 09 Mar 2025 18:56:00 +0000

Job Safety Analysis for Tablet Sorting Machine

JSA for Safe Operation of Tablet Sorting Machine

JSA Number	JSA/OralDosage/042/2025	Department	Oral Dosage
Revision Number	V 1.0	Issue Date	01/02/2025
Effective Date	05/02/2025	Review Date	05/02/2026

1. Purpose

The purpose of this JSA is to identify and mitigate potential hazards associated with the operation of the Tablet Sorting Machine. This equipment is used in pharmaceutical manufacturing to automatically sort tablets based on size, weight, or visual defects to ensure quality compliance. Proper handling and operation are essential to prevent contamination, mechanical hazards, and ensure accurate tablet sorting.

2. Scope

This JSA applies to all operators, supervisors, and maintenance personnel involved in using, cleaning, and maintaining the Tablet Sorting Machine in the Oral Dosage department. Ensuring compliance with safety measures minimizes risks associated with moving parts, tablet contamination, and improper sorting mechanisms.

3. Responsibilities

Operators:

Follow the standard operating procedure (SOP) while operating the Tablet Sorting Machine.
Ensure the machine is properly calibrated before use.
Wear appropriate Personal Protective Equipment (PPE) to prevent contamination.
Monitor tablet sorting accuracy and adjust settings as needed.
Ensure proper cleaning and maintenance to prevent cross-contamination.
Report any machine malfunction immediately to the supervisor.

Supervisors:

Ensure compliance with GMP and workplace safety regulations.
Monitor machine efficiency and ensure calibration is performed as scheduled.
Conduct routine inspections of the Tablet Sorting Machine and maintenance logs.

Safety Officers:

Perform risk assessments and ensure compliance with occupational safety standards.
Ensure that dust control and material handling procedures are followed.
Verify that PPE, such as gloves, safety glasses, and protective clothing, are used correctly.

4. Definitions & Abbreviations

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

5. Procedure

Step	Task Description	Potential Hazard	Risk Level (L/M/H)	Control Measures
1	Machine setup and calibration	Electrical hazards, incorrect calibration	Medium	Ensure proper grounding and calibration before operation.
2	Loading tablets into the hopper	Manual handling strain, tablet contamination	Medium	Use clean handling tools; wear gloves.
3	Adjusting sorting parameters	Misalignment, incorrect sorting	High	Follow SOP guidelines for setting sorting thresholds.
4	Sorting process	Moving parts hazards, tablet breakage	High	Ensure safety guards are in place; do not reach into moving parts.
5	Unloading and collecting sorted tablets	Cross-contamination, handling errors	Medium	Follow GMP cleaning procedures and use designated collection containers.
6	Cleaning and maintenance	Electrical shock, residual powder exposure	High	Follow LOTO procedures before servicing; wear PPE during cleaning.

6. Risk Assessment

Likelihood	Consequence	Risk Level
Rare	Minor tablet breakage	Low
Possible	Tablet misalignment leading to incorrect sorting	Medium
Likely	Entrapment due to moving parts	High

7. Emergency Procedures

In case of tablet contamination, stop the machine and notify the supervisor.
If the system malfunctions, shut it down and report to maintenance.
For equipment entrapment, activate the emergency stop and seek immediate assistance.
All incidents must be reported and logged for investigation.

8. Required PPE & Safety Controls

Respiratory mask: Prevents inhalation of airborne powder from broken tablets.
Safety glasses: Shields eyes from dust exposure.
Protective gloves: Prevents direct contact with tablets.
Machine guards: Ensures safety from moving parts.
Designated sorting bins: Prevents cross-contamination.

9. References

OSHA 1910.212 – Machine Guarding Standards.
ISO 45001 – Occupational Health & Safety Management.
GMP guidelines for tablet sorting and handling.

10. Approval Section

Name	Designation	Signature	Date
[Name]	Prepared By
[Name]	Checked By
[Name]	Approved By

Job Safety Analysis for Effervescent Tablet Compression Machine

Sun, 09 Mar 2025 02:16:00 +0000

Job Safety Analysis for Effervescent Tablet Compression Machine

JSA for Safe Operation of Effervescent Tablet Compression Machine

JSA Number	JSA/OralDosage/041/2025	Department	Oral Dosage
Revision Number	V 1.0	Issue Date	01/02/2025
Effective Date	05/02/2025	Review Date	05/02/2026

1. Purpose

The purpose of this JSA is to identify and mitigate potential hazards associated with the operation of the Effervescent Tablet Compression Machine. This equipment is used in pharmaceutical manufacturing to compress effervescent powder formulations into tablets that dissolve quickly in liquid. Proper handling and operation are essential to prevent contamination, exposure to hygroscopic materials, mechanical hazards, and ensuring precise moisture control.

2. Scope

This JSA applies to all operators, supervisors, and maintenance personnel involved in using, cleaning, and maintaining the Effervescent Tablet Compression Machine in the Oral Dosage department. Ensuring compliance with safety measures minimizes risks associated with powder handling, moisture sensitivity, and improper calibration.

3. Responsibilities

Operators:

Follow the standard operating procedure (SOP) while operating the Effervescent Tablet Compression Machine.
Ensure the machine is properly calibrated before use.
Wear appropriate Personal Protective Equipment (PPE) to prevent exposure to airborne powders.
Monitor compression force, punch alignment, and weight variation to ensure uniformity.
Ensure proper cleaning and avoid moisture contamination.
Perform post-operation maintenance as required.

Supervisors:

Ensure compliance with GMP and workplace safety regulations.
Monitor machine efficiency and ensure calibration is performed as scheduled.
Conduct routine inspections of the Effervescent Tablet Compression Machine and maintenance logs.

Safety Officers:

Perform risk assessments and ensure compliance with occupational safety standards.
Ensure that humidity control and ventilation systems are functioning correctly.
Verify that PPE, such as respiratory masks and protective gloves, are used correctly.

4. Definitions & Abbreviations

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

5. Procedure

Step	Task Description	Potential Hazard	Risk Level (L/M/H)	Control Measures
1	Machine setup and calibration	Electrical hazards, incorrect calibration	Medium	Ensure proper grounding and calibration before operation.
2	Loading powder blend into the hopper	Manual handling strain, dust exposure	Medium	Use lifting aids; wear a respirator and gloves.
3	Adjusting compression force	Mechanical hazards, misalignment	High	Ensure hands are clear of moving parts; follow SOP for force adjustment.
4	Compression process	Tablet breakage, weight variation	High	Ensure uniform feed and monitor weight variation.
5	Unloading and packaging of tablets	Moisture contamination, handling errors	Medium	Ensure packaging area is humidity-controlled.
6	Cleaning and maintenance	Electrical shock, residual powder exposure	High	Follow LOTO procedures before servicing; wear PPE during cleaning.

6. Risk Assessment

Likelihood	Consequence	Risk Level
Rare	Minor powder spillage	Low
Possible	Respiratory irritation due to airborne powders	Medium
Likely	Tablet breakage due to excessive moisture exposure	High

7. Emergency Procedures

In case of excessive powder exposure, move to fresh air and seek medical help.
If the machine malfunctions, shut it down and report to maintenance.
For equipment failure, activate the emergency stop and seek immediate assistance.
All incidents must be reported and logged for investigation.

8. Required PPE & Safety Controls

Respiratory mask: Prevents inhalation of airborne powder.
Safety glasses: Shields eyes from fine dust exposure.
Protective clothing: Prevents dust adherence to skin and garments.
Humidity control system: Ensures moisture-free tablet production.
Dehumidified storage: Prevents premature effervescence.

9. References

OSHA 1910.94 – Ventilation Standards.
ISO 45001 – Occupational Health & Safety Management.
GMP guidelines for effervescent tablet manufacturing.

10. Approval Section

Name	Designation	Signature	Date
[Name]	Prepared By
[Name]	Checked By
[Name]	Approved By