Writing Safety Protocols

Entering Confined Spaces Is Not a Joke The Importance of Gas Testing, Having a Safety Monitor, and Obtaining a Permit Before Entering Confined Spaces confined spaces poses significant safety risks, which is why strict safety procedures must be followed before entering these environments. Among the most crucial safety measures are: 1. Gas Testing: Before entering any confined space, it is essential to conduct a gas test using specialized detection equipment. This step ensures that the atmosphere inside the confined space is safe. Confined spaces can contain hazardous gases, such as carbon monoxide, hydrogen sulphide or oxygen-deficient air, which can lead to unconsciousness or even death if not properly assessed. Gas testing helps identify these dangers and ensures the air quality is safe for workers to breathe. 2. Having a Safety Monitor: A safety monitor or safety supervisor must be present whenever workers enter a confined space. The safety monitor is responsible for observing the conditions inside the space, ensuring that safety procedures are being followed, and being ready to respond in case of an emergency. In the event of a hazardous situation, the safety monitor is the first line of defense and can take immediate action to protect the worker's safety. in addition to presence of watcher beside the confined space to log the names of workers inside in the log sheet and maintain the allowed number inside 3. Permit to Work (Entry Permit): Before entering a confined space, a permit to work must be obtained. This is an official document issued only after confirming that all safety checks have been made, including gas testing, equipment readiness, emergency plans, and worker training. The permit ensures that the environment is safe for entry and that all necessary precautions have been taken. In Conclusion: Adhering to gas testing, having a safety monitor, and obtaining a work permit are not just routine procedures—they are critical steps to ensure the safety of workers entering confined spaces. These measures help prevent accidents, protect lives, and ensure compliance with safety regulations. Safety should always be the top priority, and these procedures should never be overlooked. #SafetyFirst #ConfinedSpaceSafety #GasTesting #WorkplaceSafety #RiskManagement #HSE #MSA #OccupationalSafety #SafetyProcedures #SafetyTraining #HealthAndSafety

New USP Chapter <1110>: Microbial Contamination Control Strategy Considerations The United States Pharmacopeia (USP) has introduced a new general chapter <1110> titled "Microbial Contamination Control Strategy Considerations." This chapter provides a comprehensive framework for developing and implementing an effective contamination control strategy (CCS) throughout the entire product lifecycle, applicable to both sterile and nonsterile products. This initiative aligns with international regulatory expectations and emphasizes the integration of Quality Risk Management (QRM) principles. It encourages manufacturers to proactively identify, evaluate, and control microbiological risks by establishing a documented and science-based CCS. Key elements of Chapter <1110> include: Facility Design and Cleanroom Classification: The chapter highlights the importance of cleanroom design in accordance with ISO 14644-1 standards. ISO Class 5 conditions are required for aseptic processing areas to ensure minimal contamination. Environmental Monitoring (EM): A robust EM program should monitor both viable (microbiological) and nonviable particles. Data should be reviewed regularly (e.g., quarterly) to identify trends and adjust alert and action limits accordingly. Risk Assessment Methodologies: Tools such as Hazard Analysis and Critical Control Points (HACCP) and Failure Modes and Effects Analysis (FMEA) are recommended to identify critical control points. Risk mitigation strategies must be justified and documented. Ongoing Verification: The CCS should be reviewed periodically, incorporating existing site-specific and global microbial risk assessments to ensure continuous improvement and compliance. Why is Chapter <1110> Important? Chapter <1110> marks a significant step toward unifying standards for microbial contamination control. It promotes a proactive, lifecycle-based approach that enhances product quality and patient safety. The new guidance is also closely aligned with current global regulations, including the EU GMP Annex 1 revisions. The draft chapter was published in Pharmacopeial Forum 51(2) in March 2025, and stakeholders are invited to provide feedback during the public comment period before it is finalized.

Confined spaces can be hazardous due to limited access, poor ventilation, and potential exposure to toxic gases. Here are key precautions to take when working in confined spaces: 1. Pre-Entry Precautions ✔ Identify and Assess Hazards – Determine potential risks like lack of oxygen, toxic gases, or fire hazards. ✔ Obtain Permits – Follow the permit-required confined space (PRCS) procedures. ✔ Ventilate the Space – Ensure adequate airflow to prevent buildup of toxic gases. ✔ Gas Detection – Use calibrated gas detectors to check for oxygen levels (19.5%-23.5%), toxic gases (H₂S, CO), and flammable vapors. ✔ Lockout/Tagout (LOTO) – Deactivate any machinery or energy sources to prevent accidental activation. 2. Entry Precautions ✔ Use PPE – Wear proper personal protective equipment (respirators, gloves, protective clothing, etc.). ✔ Lifeline & Harness – Workers should wear a full-body harness with a retrieval system. ✔ Trained Attendant – Assign an attendant outside the confined space to monitor workers. ✔ Communication System – Maintain constant communication with the worker inside. ✔ Emergency Plan – Ensure rescue equipment is ready, and personnel are trained for emergencies. 3. While Inside ✔ Monitor Atmosphere Continuously – Use gas detectors to ensure safe air quality. ✔ Work in Teams – Avoid working alone in confined spaces. ✔ Watch for Symptoms – Be aware of dizziness, breathing issues, or unusual fatigue. 4. Exit and Post-Work Procedures ✔ Exit Immediately if Unsafe – If conditions change, workers must leave the space immediately. ✔ Decontaminate – If hazardous materials were present, follow proper decontamination procedures. ✔ Document and Review – Record observations and incidents for future safety improvements. Would you like specific precautions for a particular industry or type of confined space?

12 Simple Steps (LOTOTO) 1) Ask for LOTO Permit Before beginning any maintenance or servicing on a machine you must first request and obtain a Lockout Tagout permit from the authorized personnel. This permit confirms that all required safety precautions are in place for the work being performed 2) Inform All Related Persons Inform all workers team members & anyone else who may be in the vicinity of the machine that a Lockout Tagout procedure is being initiated. This ensures that everyone is aware of the machine's status and any potential hazards 3) Isolate & Conserve the Energy of the Machine Isolate the machine from all energy sources (electrical mechanical hydraulic pneumatic etc.) to prevent accidental startup. Use isolation devices like circuit breakers or valve closures to stop the flow of energy 4) Test Whether the Energy is Zero After isolating the energy sources test the machine to ensure there is no residual energy. This could involve checking electrical circuits verifying hydraulic pressure or attempting to move parts of the machine manually. Ensure the machine is fully deenergized 5) Put the Lock & Tag Place your lock & tag on the energy-isolating device(s) (such as electrical breakers or valves). The lock will physically prevent the device from being operated & the tag provides a clear warning of your maintenance work 6) Start Maintenance Work on the Machine Once the machine is locked out & tagged, begin your maintenance or repair work. Be sure to follow all safety protocols while performing the task 7) Complete the Work Ensure that all maintenance work is fully completed according to the task requirements. Double-check all repairs and modifications made on the machine before moving forward with the restart process 8) Keep the Workplace Clean and Neat After completing the maintenance clean up the work area. Ensure that all tools materials & waste have been properly stored or disposed of. A clean workplace reduces hazards and ensures a safe environment for restarting the machine 9) Check the Work Done Before removing any locks or tags conduct a final check to verify that the work was done correctly. Ensure all safety measures are intact and confirm that the machine is ready for operation 10) Remove the Lock & Tag Once the work is confirmed and everything is in order, carefully remove the lock and tag from the isolation devices. Be sure that only the authorized personnel removes the lock & no one else can re-energize the machine unintentionally 11) Turn On the Machine After removing the lock and tag proceed to safely turn on the machine. Ensure all control systems safety features and monitoring devices are in working order before starting the machine 12) Check Whether the System Runs Correctly Once the machine is powered on test its operation. Make sure that all functions are performing as expected & monitor for any unusual sounds vibrations or system alerts. Ensure the machine is fully operational and safe for continued use

🚧 Hazardous Chemical Handling Safety Precautions 🚧 Ensuring safety when handling hazardous chemicals is paramount. Here are 13 crucial safety precautions to mitigate risks effectively: 1. **COSHH & Risk Assessment**: Begin by conducting comprehensive COSHH and risk assessments to safeguard both individuals and the environment. 2. **Identity & Label Hazardous Chemicals**: Properly label containers with chemical names, hazard warnings, and safety instructions. Ensure easy access to Material Safety Data Sheets (MSDSs) for each chemical. 3. **Appropriate Storage Facilities**: Store hazardous chemicals in dedicated, well-ventilated areas, keeping them away from heat sources and incompatible substances. 4. **Access Walkways & Demarcation**: Maintain clear access walkways and demarcation within chemical storage areas, including decontamination zones, bund walls, and safety signage. 5. **Eyewash & Shower Facilities**: Have eyewash and shower facilities nearby in case of emergencies within chemical storage locations. 6. **Emergency Equipment & Materials**: Keep an adequate supply of fire extinguishers, detectors, spill kits, first aid kits, and temperature monitoring devices readily available. 7. **Segregation of Chemicals**: Prevent potential hazards by segregating incompatible chemicals to avoid reactions leading to fires, explosions, or toxic fumes. 8. **Use of Proper Containers**: Store hazardous chemicals only in approved containers specifically designed for each chemical. 9. **Adequate Ventilation**: Ensure proper ventilation in chemical storage areas to maintain safe temperatures and prevent the buildup of hazardous fumes. 10. **Personal Protective Equipment (PPE)**: Equip workers handling hazardous chemicals with suitable PPE such as gloves, goggles, and respirators as necessary. 11. **Training & Education**: Provide comprehensive training to employees on safe chemical handling practices and emergency protocols. 12. **Emergency Response Plan**: Establish and communicate a detailed emergency response plan for addressing spills, leaks, or accidents involving hazardous chemicals. 13. ** . *Regular Inspections & Monitoring*: Conduct regular inspections of storage areas, containers, and equipment to identify and address safety hazards. #safety #chemicalhandling #EHS #hazardouschemical

4M CONDITION CHECKLIST FOR MANUFACTURING PROCESS 4M Condition Table specifically tailored for the manufacturing sector, focusing on production process control, machine reliability, material conformity, and operator discipline. 1. Man (Operator) The operator is at the heart of any manufacturing process. Ensuring their readiness and discipline is critical. Operators must be trained and certified for the specific machines or tasks they handle. They should have clear awareness of safety procedures, quality standards, and work instructions. Physical and mental fitness must be monitored to avoid fatigue-related errors. Proper use of PPE (Personal Protective Equipment) such as gloves, helmets, and goggles is mandatory. Adherence to 5S and standard operating procedures (SOPs) ensures a clean and organized work area. 2. Machine (Equipment) The condition of machines directly affects production performance and product quality. Machines should be well-maintained, with preventive maintenance done as per schedule. Tools, jigs, and fixtures must be properly set and in good working condition. Safety systems like guards and emergency stops must be functional at all times. Machines should be free from abnormal noise, vibration, or leakage, indicating stable health. Critical spares must be available to avoid production delays due to breakdowns. 3. Material (Raw and In-process) Material quality and handling significantly influence the final product outcome. All materials must be received as per BOM (Bill of Materials) specifications and verified through incoming inspection. Proper labeling and traceability (batch number, lot number) must be maintained. Storage conditions should be appropriate to avoid damage, contamination, or rust. FIFO (First In, First Out) must be followed to manage shelf life and batch usage. Material must be available in the right quantity at the right time to prevent stoppages. 4. Method (Process) A standardized and controlled method ensures consistency and reduces variation. SOPs or work instructions must be available at the workplace and strictly followed. All process parameters (like temperature, pressure, torque) should be defined and monitored. In-process quality checks should be performed and recorded regularly. Cycle time and takt time must be maintained as per planning. Any changes in methods or processes must be documented through change control procedures.

NEW REGULATION UPDATE On 6 March 2025 the Minister of Employment and Labour signed into law the: - Physical Agents Regulations (replacing the Environmental Regulations for Workplaces, 1987) - Noise Exposure Regulations (replacing the Noise-Induced Hearing Loss Regulations, 2003) "Physical agents" means a source of energy which may result in injury or disease after exposure and includes, but is not limited to: - cold stress; - heat stress; - vibration; - radiation; and - illumination. Employers who undertakes activities that expose their employees to the abovementioned physical agents, must: - Develop a comprehensive training programme and refresher training must be provided; - A physical agent-specific risk assessment must be carried out by a competent person, which must be updated every two years. - Where the risk assessment indicates that employees may be exposed to physical agents, exposure monitoring or surveys must be performed every two years. - Develop a system of medical surveillance for employees exposed to physical agents. In addition to the above, each listed physical agent also has a specific section dedicated to it in the Regulations, which outlines how employers must manage the specific risks, what the relevant exposure limits are, etc. No mention is made of when the new Regulations will enter into effect, but both the Physical Agents Regulations and Noise Exposure Regulations indicate that the Regulations they are replacing will be repealed 18-months after the date of promulgation of the new Regulations. This will imply that there is a grace period in place for Employers to align themselves with all the new requirements. #safety #legislation #health #compliance

Identification of Unexpected Workplace Hazards & Preparations. In any workplace, dangers can arise suddenly and unexpectedly. Here are some of the key hazards to stay aware of, along with essential safety tips to help prevent accidents: Electrical Hazards: Always ensure that live wires are properly insulated and kept away from work areas. Never anchor safety equipment like belts onto potentially live wires. Falling Hazards: Use guardrails and safety harnesses in areas where there is a risk of falling. Regularly inspect anchor points to ensure they're safe and stable. Rotating Machinery: Stay cautious around machinery with moving parts. Loose clothing or jewelry can get caught and lead to serious injuries—always keep a safe distance and use protective barriers. Poor Housekeeping (Falling Objects): Small objects or debris can fall or get kicked up by machinery, causing head injuries. Keep your workspace tidy and wear hard hats in areas where this is a risk. Tire Pressure and Small Objects: Be careful around heavy machinery; small objects under pressure can become projectiles if crushed by tires. Always inspect the area before moving equipment. Proper Safety Gear and Practices: Consistently use the correct personal protective equipment (PPE) and ensure it's in good condition. PPE is the first line of defense against unexpected hazards!

World Health Organization updates #laboratory #biosecurity #guidance WHO recently issued updated guidance for national #authorities and #biomedical #laboratories to manage #biological #risks. Laboratories are essential components of #health #systems, critical for patient #diagnosis and rapid #clinical #care, #disease #surveillance, #pathogen characterization, and #research and #development for #treatments and #vaccines. Appropriately designed and equipped facilities, trained #staff, evidence-based risk mitigating measures, transparent reporting and layered oversight mechanisms will safeguard the #workforce and the community from pathogenic #microorganisms and #toxins. New updates in the guidance include the strengthening of #cybersecurity measures and handling of confidential information such as patient records; reducing risks from new #technologies, including those related to #genetic modification and #manipulation of pathogens, and #artificial #intelligence (AI); and advice on keeping laboratories #safe and #secure during #emergencies like #wars, civil unrest, and #disasters from natural #hazards. WHO’s updated laboratory biosecurity guidance helps all countries, especially those lacking #regulations, establish or strengthen frameworks for handling high-consequence pathogens. It highlights the importance of strong institutional governance through an Institutional Biosafety Committee with national oversight. The updated guidance provides best #practices and #recommendations, while encouraging Member States to adopt a risk-based approach, stipulated in the resolution on ‘Strengthening laboratory biological risk management’ adopted at the World Health Assembly this year. The guidance was developed in consultation with wide range of stakeholders including WHO collaborating centres and technical advisory groups, in particular, the WHO Technical Advisory Group on Biosafety (TAG-B).    By promoting engagement and #commitment from institutions and national authorities, the guidance mitigates risks associated with high-consequence pathogens and research work. These measures aim to safeguard communities from misuse and release of biological materials, be it intentional or inadvertent, all while allowing legitimate biomedical research to continue. https://lnkd.in/enwAEeFb