(Download: Medistri’s Integrated Manufacturing: From Assembly to Final Delivery in PDF by Medistri)
For a product to reach its final users in full compliance with its specifications, assembly and finishing activities must take place in a controlled and well-defined environment. From order intake through final delivery, Medistri follows a structured and validated manufacturing workflow designed to ensure consistency, quality, and regulatory compliance at every stage.
Our integrated approach allows manufacturers to rely on a single partner for assembly, packaging, sterilization, degassing, and quality control, all within a coordinated and traceable process.
A Structured Manufacturing Workflow
1. Technical Alignment and Preparation
Each project begins with a detailed technical alignment phase. Customers complete a technical information sheet to define product specifications, components, packaging requirements, and any applicable constraints. This step ensures that all downstream activities are aligned with the intended use and regulatory expectations.
2. Packaging Selection
Based on the product configuration and requirements, Medistri supports the selection of appropriate packaging solutions to be used during assembly and beyond. Common options include:
- Sterile packaging
- Standard plastic packaging
- Sustainable and recyclable packaging
Packaging choices are assessed to ensure compatibility with assembly, sterilization, and degassing requirements.
3. Incoming Visual Inspection
Upon receipt of components, Medistri performs incoming inspections to verify conformity with defined specifications. This step helps ensure material quality and reliability before products enter the manufacturing process.
4. Disinfection, Assembly, and Packaging
Before assembly, the incoming material is assessed to determine its microbiological status. When required, appropriate disinfection measures are applied to ensure controlled manufacturing conditions. Laboratory testing, such as bioburden analysis, is performed to establish the initial state and define the most suitable approach.
Assembly and packaging activities are then carried out after material release by the Quality team, ensuring safe, controlled, and compliant operations.
5. Sterilization and Degassing
Once packaged, products proceed to sterilization. When EO sterilization is applied, a controlled degassing phase follows to remove residual EO and bring products back to safe levels for handling and use.
During this phase, samples are taken for Biological testing, Endotoxin (LAL), residuals, and sterility testing in Medistri’s in-house laboratory, confirming that the process meets the predefined method and regulatory requirements before product release.
6. Quality Control
Quality control activities are performed throughout the entire manufacturing process. In-process and final inspections ensure that products meet defined quality requirements and that all operations are executed in accordance with applicable standards and procedures.
7. Delivery
Finished products are delivered to the customer’s logistics center or directly to the final destination, supported by complete documentation and full traceability.
An Integrated, Cross-Functional Approach
Medistri’s Manufacturing team works closely with our Quality, Sterilization, and Laboratory teams to provide a fully integrated scope of services. This collaboration enables efficient coordination between assembly, sterilization, degassing, and quality verification activities. Our manufacturing process supports the creation of fully customized kits, allowing customers to source quality products through a streamlined and controlled workflow.
With Medistri’s GMP authorization, pharmaceutical products can also be integrated into personalized kits, expanding the scope of compliant manufacturing solutions available to our customers.
To learn more about Medistri’s Manufacturing services, visit our website here or contact our team at contact@medistri.com.
— The Medistri Team
Frequently Asked Questions
1. What is meant by integrated manufacturing in a regulated environment?
Integrated manufacturing refers to a coordinated workflow that combines assembly, packaging, sterilization, degassing, and quality control within a single controlled process. This approach ensures consistency, traceability, and compliance from order intake through final delivery.
2. Why is early technical alignment critical in the manufacturing process?
Technical alignment defines product specifications, packaging requirements, and regulatory constraints before manufacturing begins. This step ensures that all downstream activities are correctly designed and reduces the risk of deviations later in the process.
3. How are materials assessed before assembly and packaging?
Incoming components undergo visual inspection and microbiological assessment to determine their initial condition. When required, laboratory testing such as bioburden analysis is performed to define appropriate disinfection and handling measures before quality release.
4. When are sterilization and laboratory testing performed during manufacturing?
Sterilization occurs after products are assembled and packaged, followed by controlled degassing when EO is used. During this phase, samples are tested for sterility, endotoxins, residuals, and biological indicators to confirm compliance before product release.
5. How does Medistri ensure quality and traceability throughout the manufacturing workflow?
Medistri applies quality control activities at each stage of manufacturing, supported by close collaboration between Manufacturing, Quality, Sterilization, and Laboratory teams. This integrated structure ensures documented traceability, regulatory compliance, and reliable delivery of finished products.