Micronova ICS provides comprehensive kitting services tailored to your product and process needs. From ordering components to shipping sterile kits, we manage every step. We offer stability studies, irradiation, validation, quarterly dose audits, sterility testing, and certificates. Our facilities and experts are ready to support you.
- Ordering and storing components: our team manages the entire process, from ordering to receiving and storage. We utilize a validated ERP system that includes batch records, inventory control, labels, and lot traceability. Our warehouses are secure, climate-controlled facilities with pest management.
- Cleanrooms: Our cleanrooms meet ISO 14644-1standards. All cleanroom technicians are highly trained, and we maintain a comprehensive environmental monitoring program.
- Stability Studies: Our team can conduct stability testing and provide data to determine and confirm your product’s shelf life. This includes all required documentation and the final summary report.
- Gamma Irradiation Processing: Our experts can assist you with validation and routine quarterly dose audits. The ISO 11137 standard supports this process, which is an effective method for treating a wide range of products made from various materials with different densities, configurations, and orientations.
- Sterility: Our specialists can assist with sterility testing of your product or kit, particularly if you wish to conduct batch-by-batch testing before releasing product.
- Certificates: All products and kits include certificates before release. The final step is to create a certificate that contains all the information and quality approval.
