Bioburden Reduction Services

Cleaning & Disinfection

GMP regulations state that manufacturers of finished pharmaceuticals must clean their facilities and equipment to ensure product safety. A clean surface is easier to disinfect and so cleaning and disinfection programs complement each other.

The facility should be disinfected regularly using validated sanitizers and sporicides. Sterile Science can execute an existing contamination control plan or develop one to meet the process requirements.

Surface Sterilization

Sterile Science provides manual cleaning and disinfection of cleanroom or clean zone surfaces. High quality detergents and pharmaceutical grade disinfectants are used in accordance with current Good Manufacturing Practices and client SOPs. Product selection and cleaning techniques are all properly documented.

When necessary, two disinfectants of different modes of activity can be provided to meet regulatory expectations that disinfectants are rotated. For sterile areas, a sporicidal disinfectant can be incorporated on a periodic basis.

Cleaning Validation

Sterile Science can provide tracking and validation of decontamination activities. Fluorescent marking systems and ATP bioluminescence assays can be used for evaluating cleaning practices and providing process feedback.

Sterile Science can ensure that your cleanroom has been cleaned in compliance with your SOPs and that the cleaning is documented properly.

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