SOP for Operating the Pill Press Machine According to WHO Standards

1. Purpose

Ensure that the operation of the pill press machine is carried out safely, efficiently, and in compliance with WHO standards.
Guarantee that the final product meets the required safety and quality criteria.

Applicable to all operators of the pill press machine at the pharmaceutical manufacturing facility.
Covers quality control, maintenance, and occupational safety procedures related to the pill press machine.

Pill Press Machine: Equipment specifically used for compressing and shaping tablets according to specified formulations.
WHO: World Health Organization, which provides standards for safety, quality, and effectiveness in pharmaceutical production.
SOP: Standard Operating Procedure – a documented process intended to ensure consistent and safe operations.

Machine Operators: Execute the machine operation procedures accurately as outlined in the SOP.
Production Managers: Ensure that operators are properly trained and that the operational process adheres to WHO standards.
Maintenance Department: Conduct regular inspections and scheduled maintenance of the pill press machine to ensure its proper functioning.

Safety Check:
- Ensure that the work area is clean, well-ventilated, and free of obstructions.
- Wear all required personal protective equipment (face masks, gloves, safety goggles).
Machine Inspection:
- Check the condition of the machine components (electrical, mechanical, and hydraulic, if applicable).
- Confirm that the machine is free from dust, production residues, and contaminants.
- Verify that the power supply and safety connections are secure.

Step 1: Machine Startup
- Power on the machine and allow it to initialize according to the displayed startup procedure.
- Confirm that all error indicators are within normal operational limits.
Step 2: Adjusting Parameters
- Set the speed, compression pressure, and other technical parameters as directed by the production manager.
- Ensure that all settings comply with WHO standards and production requirements.
Step 3: Loading Materials
- Load the tablet ingredients uniformly into the machine, ensuring no contaminants are present.
- Monitor the material feed to guarantee a continuous and accurately proportioned supply.
Step 4: Monitoring the Compression Process
- Observe the machine’s display to ensure operating parameters remain within specified limits.
- Record and immediately report any abnormal occurrences.

Follow the prescribed sequence to halt the machine safely.
Power off the machine and complete the cleaning procedures.
Complete the end-of-shift report, including:
- Operational parameters.
- Any faults encountered and corrective actions taken.
- The overall condition of the pill press machine after operation.

Scheduled Maintenance:
- Follow the established maintenance schedule.
- Record all maintenance activities and note any parts that were replaced or repaired.
Cleaning:
- Clean the machine and the surrounding area after each production shift.
- Use cleaning agents as recommended by the machine manufacturer and WHO guidelines.

Provide regular training on occupational safety and emergency procedures.
Keep an emergency response guide readily available, and contact the maintenance department immediately in the event of a severe fault.
Periodically inspect all safety devices and alarms on the machine.

Note: This document should be reviewed and updated periodically to ensure compliance with current standards and production requirements.