Smith Engineering Custom Designed Mobile Hybrid Mixer Package
A medical device company came to Smith Engineering for a solution to a chemistry make up process. After process review and consultation with the customer, Smith’s engineering group designed a fully contained mixing process in order to retain CO2. Meeting cGMP requirements for construction and operation for products intended use in Point-of-Care (POC) blood diagnostics.
The process consists of: Rapid mixing of a bicarbonate solution which is distributed via peristaltic pump to sealed bulk storage bags. The solution is then pumped to high-speed filling machines which fills small sealed pouches. These vapor membrane pouches allow low/slow release of CO2 which provides stability for diagnostic analyzer chips sealed in the packaging.
The mobile Blends Mixing vessel capacity is 1420 Liter with designed head-space (15-20%) to allow for adequate mixing of solution. Automated sterilization cleaning and rinse between batches simplified method and protocol.
Designed system complies with cGMP requirements for construction and operation for products intended use in Point-of-Care (POC) blood diagnostics.
The HMI interface controller is used for setting fill weights and mixing times. The upgraded HMI controls collects information that will be written to SD card in CSV format. Included data collection capability for critical process parameters and functions and recordability.
The customer is very satisfied. With their input in design and some small changes during F.A.T. their production of product speed was better than 60% improved. Solution sterility remained stable, reducing lost makeup solutions with new mixing process. Mixing time from start to finish was approximately 70% improvement over previous methods used to produce their solution.
The repeatability of solutions after 3 months to finalize validation, this new mixing process achieved lowered cost of production and returned investment in 23 months.