Disinfection Systems in Indiana

EnPak LLC is a B2B logistics and operations service provider specializing in medical device manufacturers and life science companies of all sizes. Located in Warsaw, Indiana—the Orthopedic Capital of the World—EnPak offers integrated, scalable solutions across the entire device lifecycle including kit management and assembly, medical device cleaning, packaging and labeling, inspection, logistics, operations support, and recall/rework management. The company has partnered with Ecoclean to establish the Clean & Pack Technology Center, delivering pre-cleaning, final cleaning, and contract cleaning services for medical device operations. FDA-registered and ISO 13485:2016 certified with FDA 21 CFR Part 820 compliance, EnPak combines over 60 years of combined medical device industry experience with a problem-solving mindset to support manufacturers from startup through post-market operations. The company serves as a flexible extension of customer operations teams, managing supply chain challenges, inventory, UDI support, post-market surveillance, and regulatory compliance.

Serim Research Corporation is a manufacturer of specialty diagnostic test strips founded in 1988. The company specializes in FDA-cleared rapid testing solutions for dialysis centers, hospitals, surgery centers, and food production facilities. Core product lines include GUARDIAN® test strips for dialysis water quality and disinfectant monitoring, DISINTEK™ strips for high-level disinfectant verification in endoscopy and sterile processing, PINNACLE™ strips for cleaning validation in central service departments, MONITOR™ strips for food safety and sanitization applications, and PyloriTek® rapid urease tests for H. pylori detection. The company also provides custom test strip development, contract manufacturing, and private label solutions serving multiple industries including healthcare, food production, and laundry disinfection.

Trinity Guardion, Inc. manufactures the Soteria Bed Barrier, an FDA-cleared launderable protective barrier designed to protect hospital beds and mattresses from patient soiling and contamination. The product is engineered to reduce healthcare-acquired infections (HAIs) and meet FDA 2015 high-level disinfection standards (log 6 or 99.9999% kill of vegetative bacteria, mycobacteria, and spores) through a validated laundry process. Soteria is available in configurations for standard hospital beds (compatible with major manufacturers including Hill-Rom and Stryker) and for neonatal warmers and incubators (Panda Warmer and Giraffe Incubator models, patent-protected). Clinical studies demonstrate mattress pathogen reduction, approximately 10-minute time savings in room turnover compared to standard manufacturer instructions, and a 50% reduction in C. difficile transmission in long-term acute care settings. The company addresses a persistent industry challenge: contaminated hospital mattresses remain a known vector for HAI transmission despite emphasis from FDA, CDC, CMS, AMA, ECRI, and The Joint Commission. Soteria simplifies reprocessing by shifting disinfection-equivalent cleaning to the laundry cycle rather than requiring intensive chemical reprocessing during room turnover.