Technical Services

M-BioLabs assists the health care community by offering expertise in identifying areas of risk, aiding in developing and implementing environmental monitoring programs, and identifying growth found in your facility. We are poised to help our clients achieve USP <797> and <800> conformity. Speak to a staff member today about your current or future risk assessments and together we will develop a robust sampling plan.

USP <797>/<800>

USP <797>/<800> is designed for health care institutions, pharmacies, and other related facilities to ensure the sterilization of drugs that are used in compounding sterile preparations. (e.g. sites include, hospitals and other healthcare institutions, patient treatment clinics, pharmacies, physicians' practice facilities, and other locations and facilities in which compounding sterile preparations (CSPs) are prepared, stored, and transported). The environmental monitoring and the microbial evaluation of staff’s sterile techniques in CSPs are critical to patient care.

Analysis And Testing

Capabilities:

• Incubation, Enumeration and Identification
• Bacteria, Yeasts, and Molds
• Sterility Testing
• Growth Promotion
• Biological Indicators

Indoor Air Quality

Environmental sampling provides information to personnel and leadership, demonstrating a primary engineering control (PEC) is maintaining an environment consistently ensuring low viable and nonviable particle levels. A comprehensive quality management system includes environmental sampling, at minimum:

• At initial commissioning and certification of new facilities and equipment
• After servicing of facilities and equipment
• Every six months as part of re-qualification of facilities and equipment
• In response to identified problems with end products or staff technique
• And in response to issues with CSPs, observed compounding personnel work practices, or patient-related infections