capabilities
Medical device cleanroom assembly and packaging production is conducted using Lean Manufacturing processes that ensure efficiency, quality, and accountability. A team of representatives from Quality, Manufacturing, Engineering, and Purchasing is established to ensure all the documentation, routers, procedures, and validations are successfully completed enabling us to move to the production phase with our customers.
Process Validation
Assembly and packaging processes are validated based on the established critical specifications. Assembly processes undergo a formal process including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Our Performance Qualification process involves running multiple separate lots over multiple production operators, shifts, and raw material lots to ensure all processes meets customer specifications.
Installation Qualification (IQ)
Operational Qualification (OQ)
Performance Qualification (PQ)
assembly
Advanced cleanrooms boast robust assembly applications from flexible automation using robot integration to fully automated assembly. Manual stations, stand-alone operations, semi-automated lines and fully automated cells prove expertise in producing low and high-volume solutions.
- Bowl Feeders
- Ultrasonic Welding
- Gluing
- UV Curing
- Automated Feed systems
- In-Process Inspection
Assembly Lines Designed to Your Needs
We collaborate with our customers and leading automated machinery manufacturers to design and build the most advanced tailor-made production machinery, fully automated, semi-automatic or as a manual workstation.
packaging services
Our team has the experience and expertise to be your go- to- manufacturing partner and support your needs with all aspects related to your product packaging, whether in bulk, blister or pouch, ranging from manual to fully automatic packaging solutions.
- Sterile medical device cleanroom Packaging
- Manual and automated packaging
- Sterile medical device packaging design and validation
- Packaging assembly process development and validation
- Medical device packaging sterilization process validation and routine processing
Sterile medical device packaging design and validation
FDA and ISO regulations require protocols and test reports to validate that a package protects its device and device sterility from factory, storage, distribution, and aseptic transfer to the end-user. We provide you with all the necessary protocols and reports of your packaging validation for your technical and regulatory files including sterilization, packaging integrity, transportation and shelf life.
custom pad printing
We provide pad printing services including single color or multicolor pad printing, multiple locational pad printing, fixtures for production and automation for high volume pad printing projects. Our services include pad printing machines for low volumes and automated machines designed for customer needs and high volumes.
laser marking
We provide laser marking techniques on metals, ceramics and plastics for single-use devices, implanted medical devices or any other devices that require permanent marking. This technique is also used to mark reusable medical and other critical appliances where extremely harsh sanitization chemicals or high heat circumstances apply, and durable marking is necessary. Our machinery ranges from Laser Marking machines for versatile, low volumes projects and custom automated machines designed for customer needs and high volumes.
