Aseptic Excellence Partner (AEP) is a service providing company for the life science industry that guides and supports companies in quality risk mitigation in product development, production and distribution of high value sterile products. The ambition of the company is to become the partner of choice in sterile products manufacturing for the global life science industry, with specific focus on biopharmaceutical and biotechnological companies.
The organization's philosophy is based on establishing pragmatic and tailored made approaches in order to provide solutions that add value and increase profitability while complying with strict quality requirements and regulations.
AEP supports and guides his customers through following areas in primary and secondary manufacturing/quality operations:
- Support for Audit readiness, assessment and remediation
- Identification and Mitigation of Quality Risk in Aseptic Processes and Design
- Observation and guidance in aseptic best practices
- Training services for Aseptically processed product
- Guidance in contamination control, including cleaning & disinfection guidance
- CAPA, deviation management support.
- Support in Validation Life Cycle Management.
- Revision, creation and designing documentation systems
- Problem solving, risk assessment and Process Improvement in aseptic manufacturing.
- Extensive expertise in lyophilization and aseptic filling technology
- Technology Transfer for manufacturing processes.
- Providing leadership for the design of manufacturing facilities.
Industrial and Quality Operations Management:
- Mentoring/coaching on the job for all roles and levels in Quality and Operational environment.
- Interim management/ transition management.
- Project Management