Your Complete Contract Manufacturing Experts
With extensive experience in OEM and Contract Manufacturing, Norgen Biotek ensures the production of market-ready products meeting the highest industry standards in ISO 9001:2015 and ISO 13485:2016 registered facilities, featuring state-of-the-art, GMP compliant manufacturing, cleanroom capabilities, and a Filamatic liquid filling machine for high throughput filling.
SERVICES
Custom Manufacturing at Norgen Biotek
Norgen manufacturing services will be catered to each client individual's needs and may include:
- SOPs
- QC documents
- Product packaging and literature
- Product Specifications
- Completed products manufactured and filled to the highest standards
MANUFACTURING FACILITIES
Norgen fulfills all your needs, from concept to product, leveraging our extensive expertise in product development and manufacturing
Norgen is an ISO 9001:2015 and ISO 13485:2016 registered company with an excellent Quality Management System and we follow strict SOPs for production and QC. Norgen operates in a 32,000 square foot facility with full development labs and dedicated manufacturing quarters that are maintained according to ISO and GMP requirements.
CERTIFIED CLEAN ROOMS
Precision in Production: ISO Class 7 Cleanroom with State-of-the-Art Filamatic Liquid Filling Machine
We have an ISO Class 7 certified clean room housing an ISO Class 5 certified Filamatic liquid filling machine. The clean room is routinely monitored for viable airborne contamination, viable contamination on surfaces and non-viable airborne contamination to maintain the ISO classification of the clean room environment.
HIGH THROUGHPUT LIQUID HANDLING
Versatile Liquid Handling in Our Cleanroom with High Throughput Capabilities
Within our clean room we have high throughput liquid handling capabilities that would meet any job size, and we have validated liquid filling protocols for all types of bottle sizes. With our Filamatic liquid filling machine we are able to perform high throughput liquid filling and capping of bottles ranging in size from 0.1 mL to 500 mL with a ± 0.5% accuracy. Our Filamatic machine can be used to fill low, moderate and high viscosity fluids, making this a very versatile service for the biotechnology and pharmaceutical industry.
Dedication to delivering unparalleled quality and cost-effective products.
- Extensive experience in OEM and Contract Manufacturing
- Market-ready products are manufactured to the highest industry standards
- ISO 9001:2015 and ISO 13485:2016 registered company
- State-of-the-art, GMP compliant facilities
- Conversion of R&D outputs into full product specifications including BOMs and packaging
- Manufacturing of all solutions and buffers, sourcing of all other required components
- Development of quality control procedures and strict release criteria
- ISO Class 7 certified cleanroom for liquid filling capabilities down to Class 4
- Filamatic liquid filling machine for high throughput filling
OUR GUARANTEE
Norgen Biotek's OEM & Contract Manufacturing Guarantee
Norgen’s manufacturing services will ensure that you have a complete product that will be ready to be brought to market in a rapid and cost effective manner. Let Norgen’s experience and expertise save you time, money and frustrations as we help you to productize your idea.
Development of laboratory procedures into standardized SOPs and product inserts / instructions for use (IFU)
Conversion of R&D outputs into optimized product specifications, including kit contents
Development of Bill of Materials (BOM)
Procurement of all required chemicals and components, as well as supplier qualification
Development of SOPs for manufacturing of all solutions and buffers
Development of Quality Control procedures for all solutions and buffers
Formulating solutions and buffers according to SOPs
Filling of solutions and buffers in our Class 7 certified cleanroom with capabilities down to Class 4
Development of Quality Control procedures for the final QC and release of the finished product
Design and procurement of product packaging, including art work and all product labels
Maintenance of batch records for full traceability to meet industry standards
HERE'S HOW IT WORKS
Three Steps to Start OEM & Contract Manufacturing
Let Norgen's experience and expertise save you time, money and frustrations as we help you to productize your idea.