With our FDA approved cleanroom facility and ISO 13485:2016 certification, NovoSci is a leading company in the area of medical device contract packaging. We have a strong history serving the medical device community and the resources to address any packaging challenge. Our primary focus is on packaging medical instruments and medical kits that require a sterile package to ensure the highest level of patient safety.
Inside our packaging department, we have state of the art equipment for creating flexible packages, such as pouches and packets, as well as thermoformed plastic trays and cardboard boxes. Depending on the project, we use either manual or automated methods put all the necessary components into a kit for sealing. We use closure methods such as ultrasonic welding and solvent and adhesive bonding to form an impenetrable seal against the environment, while our low-temperature ethyl oxide sterilization process protects the integrity of heat and moisture-sensitive components. Sterilized items can be placed in boxes for easy shelf storage or packed in cartons for shipping.
Our processes are reliable and consistent, and we have foolproof procedures in place for package verification. As part of our quality assurance regimen, we leverage ASTM compliant test methods to test the seal strength and ensure that there are no defects in the package's barrier system.
Along with medical device packaging, we offer a comprehensive mix of services to fulfill the entirety of our customers' packaging needs. We assist with packaging design, print and apply labels, as well as offer warehousing and distribution services for a full supply chain solution. Our packaging lines are organized to handle both low volume and high volume quantities and our prices are competitive and affordable. For more detailed information about our medical device contract packaging solutions or to schedule a consult, contact us directly.
N/AASTM 2096 - Gross Leak Test ASTM F1929 - Dye Penetration Test ASTM F88 - Peel Test
Secondary Services Offered
N/AAssembly Bar Coding Component Sourcing Distribution Drop Shipping Labeling Lot Inspection Package Design Supply Chain Management Validating Warehousing
Production Volume
N/ABlanket Orders High Volume Low Volume Prototype
Lead Times
N/AEmergency Services Available Quoted on Job by Job Basis Rush Services Available
Efficiency
N/AKaizen/5S Lean Manufacturing
Certifications
N/AFDA Registered ISO 13485:2016
Additional Information
Industry Focus
N/AManufacturing Material Handling and Processing Medical Medical Devices Packaging
Industry Standards
N/AANSI (American National Standards Institute) CE (The CE mark (officially CE marking) is a mandatory conformity mark on many products placed on the single market in the European Economic Area (EEA).) FDA (Food and Drug Administration) ISO (International Organization for Standardization)
File Formats
N/AJPG or JPEG (Joint Photographic Experts Group) PDF (Portable Document Format) TIFF (Tagged Image File Format)