Pure Quality
Quality for the SteriCare™ Solutions products is paramount. Since June 2018 a total transformation has occurred in people, systems, processes and equipment. This change is to ensure the SteriCare Solutions product is safe and reliable every day for every patient.
These are some of the changes that have taken place since this transformation began with more to come!
- People
- Added two full-time Microbiologists and two dedicated resources for change control and documentation
- Experts
- Nationally recognized outside Quality and Regulatory experts and dedicated Validation Resources
- Processes
- Revalidations in cleaning/mixing and water systems
- Documentation
- Centralized, secure Documentation Library and improved batch document documentation and accurate and detailed cleaning documentation
- Conductivity
- Conductivity testing performed after each cleaning process
- Attribute Inspection
- Increased attribute inspection of in-process and finished product
- Testing
- Changed chemistry/micro testing to beginning/middle/end of batch (3X the testing as previous)
- TOC/Conductivity
- Implemented inline TOC/Conductivity monitoring
- Ozone Sanitation
- Implemented /validated ozone sanitization of water system loop and saline loop
- Sampling & Testing
- Routine sampling and testing of all water system drops on a weekly basis
- USP WFI Standard
- Implemented for TOC, Microbial Count, Conductivity & Endotoxin
- Lab Equipment
- New incubators for laboratory and new hood for bioburden testing