Standard Operating Procedure for Maintaining Sterility in Creams Production
1) Purpose
The purpose of this SOP is to establish procedures for maintaining sterility throughout creams production processes to ensure product quality, safety, and compliance with regulatory requirements.
2) Scope
This SOP applies to all personnel involved in creams production, including production operators, technicians, and quality control (QC) personnel. It covers procedures for maintaining sterility during formulation, filling, and packaging of creams.
3) Responsibilities
It is the responsibility of production supervisors, QC personnel, and maintenance personnel to follow this SOP. Production supervisors ensure adherence to sterile processing procedures, QC personnel monitor sterility controls, and maintenance personnel maintain equipment and facilities to prevent contamination.
4) Procedure
4.1 Facility and Equipment Preparation
4.1.1 Clean and disinfect production areas, including formulation rooms, filling rooms, and packaging areas, before starting operations.
4.1.2 Ensure HVAC systems are operational and maintain appropriate air quality and pressure differentials.
4.1.3 Calibrate and maintain sterilization equipment (e.g., autoclaves, sterilizing filters) according to schedule.
4.2 Personnel Hygiene
4.2.1 Follow strict gowning and hygiene procedures, including handwashing, use of sterile gloves, and wearing of sterile gowns and masks.
4.2.2 Conduct personnel training on aseptic techniques and hygiene practices to minimize contamination risks.
4.2.3 Restrict access to production areas to authorized personnel only.
4.3 Sterilization of Components and Equipment
4.3.1 Ensure all components (e.g., containers, closures) and equipment (e.g., mixing vessels, filling machines) are sterilized before use.
4.3.2 Validate sterilization processes and maintain records of sterilization cycles and parameters.
4.3.3 Use validated sterilization methods such as steam sterilization, dry heat, or chemical sterilization as appropriate.
4.4 Environmental Monitoring
4.4.1 Perform environmental monitoring of critical areas using viable and non-viable methods to assess cleanliness and sterility.
4.4.2 Monitor air quality, surface bioburden, and particulate levels regularly during production activities.
4.4.3 Take corrective actions promptly if environmental monitoring results exceed established limits.
4.5 Process Controls
4.5.1 Implement barrier systems (e.g., laminar flow hoods, isolators) and closed processing systems to minimize microbial contamination.
4.5.2 Monitor and control process parameters (e.g., temperature, pressure, humidity) to ensure sterility is maintained throughout production.
4.5.3 Conduct in-process controls such as media fill simulations to validate aseptic processing procedures.
5) Abbreviations, if any
QC: Quality Control
HVAC: Heating, Ventilation, and Air Conditioning
SOP: Standard Operating Procedure
6) Documents, if any
Sterilization Validation Records
Environmental Monitoring Reports
Training Records on Aseptic Techniques
7) Reference, if any
USP (United States Pharmacopeia) Chapter on Sterility Assurance
ISO (International Organization for Standardization) 13408: Aseptic Processing of Healthcare Products
8) SOP Version
Version 1.0