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Körber LOCK solution for accelerated Machine Qualification
The Pharma Consulting experts from Körber have created LOCK as an end-to-end packaging and inspection machine qualification service that speeds up design, specification, commissioning, qualification, and regulatory validation throughout the equipment lifecycle.
The service emphasizes fast-track processes to enable rapid on time production start, accelerating time-to-market, and increasing competitive edge. It goes further than documentation and test execution to enable seamless interaction between machinery delivery and customer project objectives.
Integration of new machinery, extensive retrofit of existing equipment, and maintenance of validated status throughout entire lifecycle all require a high degree of coordination to reduce downtime and secure rapid regulatory approval.
The LOCK methodology is based on close cooperation between Körber Pharma Consulting, Inspection and Packaging specialists, with consulting experts involved from the start of the project. The LOCK process can handle all aspects including project management, liaison with the equipment supplier, commissioning, qualification testing, and regulatory documentation.
Körber experts in qualification know the requirements of the regulated industry and follow GxP principles and best practices (EU GMP Annex 15, ASTM E2500, ISPE Baseline Guide, etc.). They receive continuous training on Körber inspection and packaging machines to optimize qualification activities.
The LOCK methodology adapts to customer framework and processes: from the traditional V-model to an agile approach following the ASTM E2500 guidelines for specification, design, and verification of pharmaceutical and biopharma manufacturing systems and equipment.
The service relies on proven templates, training, and procedures to provide capabilities that go far beyond simply performing tests.
Bringing together equipment and validation specialists from the outset results in better control and expedites all steps and activities during commissioning and qualification. For customers, using Körber knowledge throughout the qualification process can significantly shorten time to production.
Specific benefits of the LOCK machine qualification approach include:
- Knowledge: Körber machine qualification experts are fully trained on the full range of solutions providing then with enhanced insights to guide the customer from initial design to go-live.
- Organization: Using only trained Körber equipment experts allows the service to minimize time and optimize effort for customer benefit.
- Leverage: Cross-discipline involvement of all experts from first stage allows technical and regulatory expertise to be leveraged throughout the project for faster and better results.
- Coordination: Working closely together, the disciplinary teams track actions daily, utilizing efficient channels while remaining independent and fully committed to customer needs.