Initial samples of the raw materials were delivered to the customer for risk assessment. The risk assessment involved extensive characterization of the materials by GC-FID, GPC-MALLS, and reversed phase HPLC. Once the materials met the customer’s specifications via analytical means, they were then used in formulation of the customer’s product. The quality of the final products was evaluated to ensure the raw materials would meet historical performance. All quality criteria were met for the initial assessment of raw materials supplied by Ortec, therefore, the Ortec team moved to the next phase, commercial production.
The Ortec team developed and executed the commercial production of the raw materials under cGMP protocols. The development of the process included the construction of a new production suite, warehousing and bulk chemical storage area. In addition, 15 test methods were transferred into Ortec’s QC lab, new lab space was built and multiple instruments were acquired and qualified for use to support the increase testing requirements. The customer qualified the different raw materials using multiple batches made at a commercial scale. The customer met all internal deadlines for securing an alternate supplier of critical raw materials.
While the technology successfully produced the polymer properties the customer desired, it was not refined to a point where it could be commercially scaled up with a reliable process and manufacturing cost. Ortec’s technical team worked with the customer through several iterations to create a robust formula that would maintain the end use performance while adapting to processing and cost requirements. Our process expertise and transparency between the technical teams were the keys to success. We conducted scale up steps at 75 gallon, 310 gallon and 2,500 gallon sizes to lock in the process and demonstrate the feasibility of scaling.
After successfully scaling and optimizing the process, Ortec completed testing and process control verifications. We then created a cost model with the customer to support a sustainable product and process for the market. We also provided information to support filing with the EPA to determine TSCA status. In order to meet the large demand for our customer, it was mutually decided that a new reactor train would need to be created. Ortec designed and installed this reactor train with a “daisy chain” concept for the two stages and a capacity of 25 million lbs / year. The installation was completed within the agreed budget and on time for the customer product launch.
The product was launched successfully in the market and Ortec has supplied this polymer for our customer for several years!