Contract Manufacturing

Contract Manufacturing Services

• Norgen Biotek has tremendous expertise in OEM and contract manufacturing of kits and reagents for the molecular biology and diagnostics markets
• We currently manufacture OEM products for 6 companies on a continual basis. These companies are various sizes from small to large global companies
• Norgen Biotek is an ISO 9001:2008 and ISO 13485:2003 registered company with an excellent quality management system and we follow strict SOPs for production
• We operate in 24,000 square foot facility with full development labs and dedicated manufacturing quarters
• 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.
• 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 sterile 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.

We will be able to meet all of your requirements from concept to product:

1. Development of laboratory procedures into standardized SOPs and product instructions
2. Conversion of R&D outputs into optimized products specifications, including kit contents
3. Bill of materials and supplier qualification
4. Development of SOPs for manufacturing of all solutions and buffers
5. Development of Quality Control procedures for all solutions and buffers
6. Formulating solutions and buffers according to SOPs
7. Filling of solutions and buffers in our Class 7 certified clean room
8. Quality Control procedures for the finished product
9. Design and procure product packaging, including art work
10. Write and design product literature and labels that meet standards, including product insert / user instructions

Let us know what your requirements are and we will be able to meet them.

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.

We Deliver Quality Products:

Norgen’s manufacturing services will be catered to each individual’s needs. Deliverables may include:

1. SOPs;
2. QC documents;
3. Product specifications;
4. Completed products manufactured and filled to the highest standards;
5. Product packaging and literature.

Please contact us in order to discuss your requirements and how Norgen can assist you.

Toll Free: 1.866-667-4362
Tel: 1.905.227.8848
Fax: 1.905.227.1061
E-mail: info@norgenbiotek.com

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