Standard Operating Procedure for Cleanroom Behavior and Monitoring

1) Purpose

This SOP outlines the procedures for maintaining appropriate behavior and monitoring conditions within cleanrooms to ensure cleanliness and minimize contamination risks.

2) Scope

This SOP applies to all personnel entering and working in cleanrooms within the pharmaceutical manufacturing facility.

3) Responsibilities

All personnel are responsible for adhering to cleanroom behavior guidelines outlined in this SOP. Quality Assurance (QA) oversees compliance with this SOP and regulatory requirements.

4) Procedure

4.1 Cleanroom Entry

1. Undergo gowning and entry procedures as specified in the Gowning Procedure SOP.
2. Enter the cleanroom only after completing required gowning and hygiene practices.

4.2 Cleanroom Behavior

1. Follow established behavior guidelines to minimize contamination risks, including no eating, drinking, or smoking inside the cleanroom.
2. Adhere to specified movements and workflows to prevent cross-contamination between different zones within the cleanroom.

4.3 Monitoring Parameters

1. Monitor and record environmental parameters such as temperature, humidity, and particulate levels at defined intervals.
2. Use calibrated instruments and follow approved methods for environmental monitoring.

4.4 Cleanroom Cleaning

1. Follow cleaning and disinfection procedures outlined in the Cleaning and Sanitation SOP for cleanrooms and equipment.
2. Document cleaning activities and ensure all cleaning agents and methods comply with validated procedures.

4.5 Behavior Correction

1. Correct any observed deviations from cleanroom behavior guidelines immediately.
2. Report incidents or deviations to supervisors or Quality Assurance for investigation and corrective actions.

4.6 Training and Documentation

1. Provide initial and ongoing training on cleanroom behavior and environmental monitoring procedures for all personnel.
2. Maintain records of cleanroom behavior observations, environmental monitoring results, and corrective actions taken.

5) Abbreviations, if any

SOP: Standard Operating Procedure
QA: Quality Assurance

6) Documents, if any

Cleanroom Behavior Guidelines, Environmental Monitoring Records, Incident Reports

7) Reference, if any

Regulatory guidelines such as EU GMP Annex 1 Manufacture of Sterile Medicinal Products, ISO 14644 Cleanrooms and associated controlled environments, FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice

8) SOP Version

Version 1.0