CRITICAL CLEANING SOLUTIONS FOR REGULATORY COMPLIANCE

Annex 1 provides technical guidance on the principles and guidelines of Good Manufacturing Practice (GMP) for medical products. It applies principles of Quality Risk Management (QRM) and requires the implementation of Contamination Control Strategies (CCS) to ensure that microbial, particulate, and endotoxin/pyrogen contamination is prevented in the final product.

USP Chapter <797>, Pharmaceutical Compounding: Sterile Preparations, delineates the standards and outlines the required procedures for compounding sterile preparations (CSPs) in all pharmacy settings to ensure patient benefit and reduce risks.

USP <800> provides standards for safety handling of hazardous drugs (HD) to minimize the risk of exposure to healthcare personnel, patients and the environment. Section 15.3 specifies that cleaning is a process that results in the removal of contaminants (e.g., soil, microbial contamination, HD residue) from objects and surfaces using water, detergents, surfactants, solvents, and/or other chemicals.

One commonality across all these regulatory standards is risk reduction. Saturix is a comprehensive surface cleaning system that pairs our expertise in specialty textiles with patented innovative hardware. It can help you enhance your regulatory compliance by significantly reducing risk during cleaning for all surfaces in critical environments.

 

How Saturix Reduces Risk for Surface Cleaning

Saturix lowers the risk profile of the entire cleaning process by 80% by eliminating high risk touchpoints and human process variations.1   This is achieved by following technologies:

 

Precision Dosing

Both the Saturix Mopping System and the ICT+ Isolator Cleaning Tool feature Precision Dosing to ensure every mop or pad is consistently saturated with the same amount of cleaning solution. Compared to conventional cleaning tools, there is no more mop rinsing or wringing and you always clean with clean mops or pads and clean chemicals.

Precision Dosing also eliminates the need to frequently change the cleaning solution throughout the shift, resulting in 90% chemical savings.2 In conjunction with Precision Dosing, the Saturix Mopping System is a closed system to minimize chemical emissions, reducing VOCs by 60%.3

 

Touch-Free Mop Attachment and Removal

Conventional cleaning tools require extensive handling to attach and remove mops and pads which poses a significant risk for cross contamination. The Saturix Mopping System and ICT+ Isolator Cleaning Tool allow for quick and easy mop or pad attachment and disposal without the assistance of hands to minimize risk while improving productivity.

99.9% Particulate Residue Removal down to .1 Micron in Size

With our advanced textile technology, Saturix microfiber mops, pads, and wipes are proven to remove 99.9% of particulate residue down to 0.1 micron in size.4 They mechanically remove disinfectant residues and other harmful particulates from the surface to minimize chemical, microbial, and particulate contamination during the cleaning process and prior to disinfection.

 

 

To Learn More About Our Solutions for Regulatory Compliance, Visit FG Clean Wipes on Thomas Scientific.


1 Based on internal analysis of a 5,000 ft2 ISO 7 facility.

2 Based on internal analysis of a 5,000 ft2 ISO 7 facility.

3 Based on third party lab testing.

4 Based on third party lab testing.

Latest Articles

Jan05

Thomas Scientific Leaders Partner with The Salvation Army Sending Warm Wishes to Those in Need

1500 Salvation Army older adults and youth to receive cold weather essentials

Read More >

Nov06

How an independent lab overcame the challenges of a post-pandemic world.

While many are familiar with the general upheavals in the healthcare industry as a result of the COVID-19 pandemic, one of the oft-forgotten stars of the drama are diagnostic laboratories. These labs played a critical part right from the very beginning...

Read More >

Oct18

THOMAS SCIENTIFIC BROADENS PORTFOLIO AND SALES EXPERTISE WITH THE ACQUISITION OF ARROWHEAD FORENSICS

120+ year industry veteran increases its expertise and expands capabilities and product portfolio into the Forensics market

Read More >

Write A Comment