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EDLAB Offers Environmental Monitoring Lab Analysis for USP 797 Compliance
Endorsed by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) with an aggressive compliance schedule, United States Pharmacopoeia (USP) 797 has received great attention from hospital administrative, clinical and pharmacy staff.
The USP 797 guidelines are described the protocol and methodology to monitor the handling and contamination of sterile compounds for certain drugs or biologic preparations. These items includes but are not limited to: 1) baths for live tissues and organs, 2) opthalmics, 3) parenterals, 4) tissue implants, 5) aqueous nasal and bronchial inhalations 6) irrigating solutions.
These guidelines are designed to assess not only the people who prepare the compounded sterile pharmaceuticals (CSPs) but also the areas where theses drugs are prepared and stored including commercial and hospital pharmacies, clinics, doctor’s offices and other facilities. USP 797 guideline provides a sound knowledge about the sterility and stability principals for clean area designs, storage specifications, quality Assurance plans that include environmental monitoring, and employee training programs to accomplish the safe handling of these preparations in order to meet the compliance requirements. These guidelines specifically address: 1) microbial contamination, 2) endotoxins, 3) physical or chemical contamination, 4) preparation of incorrect concentrations and 5) incorrect ingredients. A mistake in any of these 5 areas can cause serious injury or even death.
Air and surface sampling is an integral part of ensuring that the microbiological integrity of controlled compounding environments is maintained. Routine monitoring of air and surfaces in the compounding environment assesses the effectiveness of cleaning and sanitizing procedures and personnel who have the potential to impact the bioburden with the pharmacy compounding areas.
Dr. Rajiv Sahay, director of lab services at Environmental Diagnostics Laboratory (EDLab) indicated that "we are pleased to offer pharmacies in the healthcare industry with quaility assurance and quality control for USP 797 compliance".
While a good portion of the USP 797 guidelines deal with improving air quality in these facilities, an equally important goal is to prevent physical contact with and contamination of these preparations during manufacture. Products are manufactured according to risk levels: low, medium or high. Products that are to be injected carry the greatest risk of serious health effects; therefore these products must be manufactured in an area having the lowest risk level for contamination. The lowest risk level required under USP 797 for a critical area is an ISO Class 5 area designation.
The design of Class 5 clean areas for preparation and Class 7 buffer areas, surrounding Class 5 areas, is a requirement. Semi-annual monitoring for viable bacteria and fungi in air, gloved fingertip, surface contact plates, and particulates is required for both Class 5 and Class 7 designated areas. These monitoring results trended over time will provide information on any deterioration in air quality and aseptic technique. Generally, this monitoring should be conducted semi-annually.
Regardless of the number of CFUs recovered, corrective actions are required if any pathogenic organisms are identified. Therefore, when any colonies are seen on the plates, those colonies must be identified to determine the presence of potential pathogens.
You can contact EDLab at 1-800-422-7873 ext 301 for your USP 797 compliance programs.
About Pure Air Control Services:
Pure Air Control Services is a national provider of the following IAQ services: Building Sciences Evaluation; Building Health Check (USP 797 monitoring compliance); Environmental Diagnostics Laboratory (EDLab) an AIHA accredited micro laboratory (USP 797 Lab analysis); DIY IAQ Green Check test kits, Environmental Project Management; HVAC System Cleaning and Mold Remediation Services, among other indoor environmental services.
The company’s expanding valued client roster includes the General Services Administration (GSA); Federal Aviation Administration (FAA), Allstate Insurance; Carrier Air Conditioning; Naval Air Warfare Center, Orlando; and Naval Air Station - King's Bay, Georgia, and many other Fortune 500 companies, school boards, and city, state, and county governments, making Pure Air Control Services the reliable industry leader in IAQ.
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