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SOP for Maintaining Sterility in Creams Production

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SOP for Maintaining Sterility in Creams Production

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.

See also  SOP for Handling Hazardous Materials in Creams Production

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.

See also  SOP for Analytical Method Development for Creams

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

See also  SOP for Corrective and Preventive Actions (CAPA) in Creams Production

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

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Standard Operating Procedures V 1.0

  • Aerosols
  • Analytical Method Development
  • Bioequivalence Bioavailability Study
  • Capsule Formulation
  • Clinical Studies
  • Creams
  • Data Integrity
  • Dental Dosage Forms
  • Drug Discovery
  • Environment, Health and Safety
  • Formulation Development
  • Gels
  • Good Distribution Practice
  • Good Warehousing Practices
  • In-Process Control
  • Injectables
  • Liquid Orals
  • Liposome and Emulsion Formulations
  • Lotions
  • Lyophilized Products
  • Maintenance Dept.
  • Medical Devices
  • Metered-Dose Inhaler
  • Microbiology Testing
  • Nanoparticle Formulation
  • Nasal Spray Formulations
  • Nebulizers
  • Ocular (Eye) Dosage Forms
  • Ointments
  • Otic (Ear) Dosage Forms
  • Pharmacovigilance
  • Powder & Granules
  • Purchase Departments
  • Quality Assurance
  • Quality Control
  • Raw Material Stores
  • Regulatory Affairs
  • Tablet Manufacturing
  • Rectal Dosage Forms
  • Transdermal Patches
  • Vaginal Dosage Forms
  • Validations and Qualifications

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NEW! Revised SOPs – V 2.0

  • Aerosols V 2.0
  • Analytical Method Development V 2.0
  • API Manufacturing V 2.0
  • BA-BE Studies V 2.0
  • Biosimilars V 2.0
  • Capsules V 2.0
  • Creams V 2.0
  • Elixers V 2.0
  • Ointments V 2.0
  • Raw Material Warehouse V 2.0
  • Tablet Manufacturing V2.0

New Publication: A must for All.

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