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
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