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Aseptic Processing

​1. Overview

 

Our Aseptic Processing Consulting Services are designed to assist pharmaceutical and biotechnology companies in optimizing their aseptic manufacturing processes, ensuring compliance with global regulatory standards, and maintaining product sterility and safety.

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2. Scope of Services

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    2.1 Facility Design and Qualification

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  • Review and design of cleanrooms and controlled environments.

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  • Qualification of HVAC systems, laminar airflow systems, and isolators.

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  • Optimization of facility layouts to support aseptic workflows.

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    2.2 Process Development and Validation

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  • Development of robust aseptic processing techniques.

 

  • Validation of aseptic filling lines and sterilization cycles.

 

  • Assistance with media fill simulations and process validation studies.

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    2.3 Regulatory Compliance Support

 

  • Gap assessments against FDA, EMA, WHO, and PIC/s guidelines.

 

  • Preparation for regulatory inspections and audits.

 

  • Development and review of standard operating procedures (SOPs).

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    2.4 Training and Workforce Development

 

  • Customized training programs on aseptic techniques and best practices.

 

  • Hands-on workshops for personnel working in aseptic environments.

 

  • Guidance on strategies to improve contamination control.

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    2.5 Risk Assessment and Mitigation

 

  • Conducting risk assessments for contamination control.

 

  • Identifying critical control points in aseptic processes.

 

  • Recommending corrective and preventive actions (CAPA) for identified risks.

 

  • Developing CCS to comply with Annex 1

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3. Deliverables

 

  • Comprehensive reports with actionable recommendations.

 

  • Validated aseptic process designs and protocols.

 

  • Training materials and certification for personnel.

 

  • Regulatory submission-ready documentation.

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4. Why Choose Us?

 

  • Expertise: Decades of experience in aseptic processing and regulatory compliance.

 

  • Custom Solutions: Tailored services to meet the unique needs of your facility and operations.

 

  • Proven Success: Track record of successful project implementations and regulatory approvals.

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