【Delivery Example】DI-Compatible Fully Automatic Centrifuge DMNβ
ALCOA principles compliant. A centrifuge that can safely handle audits in the pharmaceutical industry.
We received an inquiry from pharmaceutical company T regarding the desire to introduce a centrifuge that complies with GMP and data integrity (DI) standards, and we proposed and delivered the DMNβ model. In recent years, the importance of DI-compliant equipment has increased significantly in the pharmaceutical industry from the perspectives of audit compliance and quality assurance. The DMNβ model encompasses not only operational information but also operator operation records and login management based on authority settings. It is equipped with a system that adheres to the ALCOA principles (Attributable, Legible, Contemporaneous, Original, and Accurate), ensuring reliable traceability. After the introduction, we received high praise from company T, stating, "We can now ensure DI compliance and approach audits with confidence." This model is a highly reliable centrifuge specialized for the pharmaceutical field and has been adopted by many customers.
basic information
The DMNβ model can be equipped with standard and optional features to meet the data integrity (DI) requirements in the pharmaceutical industry. The main specifications are as follows: - Login functionality (ID and password method) - Granting of multi-level operational permissions - Recording and storage functions for operational information, operation logs, product recipes, etc. This allows for accurate recording of who performed what operation and when, preventing fraud and operational errors. All records are stored in a tamper-proof manner, ensuring they can be confidently presented during audits and inspections. Additionally, it can be flexibly customized to fit the user's manufacturing process. If necessary, DI-compliant touch panels and dedicated logging systems can also be added.
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Applications/Examples of results
In the manufacturing processes of active pharmaceutical ingredients and intermediates, consistency in product quality and complete record-keeping are required. Company T had concerns about the integrity of operational records with conventional centrifuges and faced challenges in audit compliance. The introduced DMNβ model electronically stores all operational data, operation logs, and product recipes, allowing for immediate search and presentation as needed. By managing login access, it clarified the authority for each responsible person, contributing to the prevention of fraud and reduction of human errors. After implementation, the preparation of materials for audits and inspections became smoother, and the mental burden on operators was reduced. This achieved a balance between strengthening the quality assurance system and improving operational efficiency. As a result, Company T has expressed high trust, even consulting about additional equipment.
