ENVIRONMENTAL MICROBIOLOGICAL MONITORING PROGRAM

PROGRAM DESCRIPTION

Nova Biologicals’ Environmental Monitoring Program is an environmental assessment and verification program for the compounding pharmacy.

It is a comprehensive external quality assurance program that meets the requirements of US Pharmacopeia 27 Chapter <797>, Pharmaceutical Compounding, Environmental Monitoring for Airborne Microorganisms.

Nova’s program is recognized by the U.S. Food and Drug Administration (FDA), Joint Commission on Accreditation of Healthcare Organizations (JCAHO), and State licensing agencies as an environmental monitoring program for airborne microorganisms.

It is used to evaluate the various controlled air environment areas [laminar air flow workbench (LAFW), barrier isolators, buffer or clean area, and anteroom area] of the sterile compounding facility.

For sterile compounding areas used for low- and medium-risk preparations*, a minimum of monthly evaluation is indicated. For sterile compounding areas used for high-risk preparations*, at least weekly evaluations are indicated.
*Note: The appropriate risk level – low, medium, or high – is assigned according to the corresponding probability of contaminating a compounded sterile preparation (CSP) with (1) microbial contamination (microbial organisms, spores, and endotoxins) and (2) chemical and physical contamination (foreign chemicals and physical matter).

PROGRAM OUTLINE

Nova’s program is designed with the flexibility to satisfy the needs of all compounding pharmacies.

Nova offers four programs:

Weekly: Six environmental sample collection devices (ESCD) per week for sterile compounding areas used for high-risk preparations.

Monthly: Six environmental sample collection devices (ESCD) per month for sterile compounding areas for low- and medium-risk compounding preparations.

3 Month Trial: Six environmental collection sample devices (ESCD) per month for 3 months.

1 Sample Set: Six environmental collection sample devices (ESCD) (individual order / no subscription).

Upon enrollment, participants will receive a Certificate of Participation that recognizes them as active participants in Nova’s external quality assurance program.

Each environmental evaluation package includes the appropriate number of environmental sample collection devices (ESCD). ESCDs are ready to use and are used according to written plans and schedules. Each package comes with step-by-step instructions and diagrams that show exactly how to use and where to place the ESCDs.

After sample collection, simply return the ESCDs and data sheet in the provided prepaid shipping container. ESCDs will be analyzed and results will be reported immediately upon test completion.

RESULTS

Results of each assessment and evaluation event are sent to the participant immediately upon test completion. Cumulative reports demonstrating airborne microbiological counts of the past four testing events are also included.

Participant statistics are available electronically at the time your results are released.

©2004. Nova Biologicals,Inc., Conroe, TX

For more information on Nova's third-party environmental microbiological monitoring program, contact us at 800-282-5416.