New York Manufacturing Extension Partnership
Growth Strategy Leads to Increased Sales and New Product Development
Asept Pak is located in Malone, NY. The company currently employs 20 people and was founded in 2007. It manufactures and packages sterilized saline solutions marketed to the eye care industry.
Asept Pak needed to improve their processes and controls and wanted to be FDA certified. The company needed assistance in meeting FDA requirements for Current Good Manufacturing Practices (cGMP) under the 820 regulations for clean rooms. Asept Pak also needed to put together a strategy to grow once FDA approval was secured. They needed a plan that would address production schedules, capacity constraints, equipment needs, and personnel support.
The company turned to CITEC, part of the New York Manufacturing Extension Partnership and a NIST MEP affiliate. CITEC provided support to move Asept Pak to a highly controlled aseptic filling operation using lean. CITEC created a project plan and helped manage resources to implement the necessary steps to create standard operating procedures to meet FDA requirements, protocol development, and validation implementation. CITEC also provided support and guidance in conducting market analysis for the company and guided the evaluation of capital requirements for new product development. This led to Asept Park’s successful expansion into three new markets.
- Increased sales of $1,000,000.
- Created 10 new jobs.
- Expanded into new markets.
Thanks to the support and expertise of CITEC, this project has been a big success in creating jobs here.
Terry Wiley, Vice President, Manufacturing