Hartley Medical’s compounding facility was specifically designed for the aseptic compounding of intra-spinal medications. We have taken great care to ensure that clean room air particle quality is the absolute cleanest achievable, and we consider it a unique and defining factor in our service.
Hartley Pharmacy employs extensive end-product testing for the detection of bacteria, endotoxins (pyrogens), and for concentration accuracy. We apply the following methods and equipment to certify our solutions.
Our FDA-approved method to determine the endotoxin concentration uses equipment and procedures utilizing the Limulus Amoebocyte Lysate (LAL)—a method accepted by large-scale manufacturers—to assay our parenteral compounds to quantify the endotoxin levels. This technique is far more advanced than rudimentary shortsighted products on the market. Our technologically advanced instruments have the ability to detect endotoxins to a level of 0.001 Endotoxin Units per milliliter.
Hartley Medical's state-of-the-art facility encompasses a dedicated "clean room" area consisting of three distinct compounding quarters – certified at Classes 100/1,000/10,000, respectively. This provides an aseptic preparation environment that surpasses state and federal guidelines by a factor of 10. On a daily basis, we exceed USP <797> requirements to ensure patients' safety.
|USP <797> Guidelines||Hartley Medical's Compliance||Why This Is Vitally Important|
|Personnel Training and Evaluation|
|Personnel shall be trained conscientiously and skillfully in the principles of aseptic compounding.||In compliance with USP <797>.||Staff are a critical factor in sterile compounding. A substantial and documented training program must be in place to ensure quality.|
|Personnel must be initially evaluated on skills to aseptically prepare compounded sterile preparations (CSPs) utilizing written exam, visual observation and media fill tests.||We exceed this requirement by quantitatively testing employees for accuracy of CSP's.||Staff are a critical factor in sterile compounding. A substantial and documented training program must be in place to ensure quality. Initial training is important in order to show competency of new employees before compounding actual prescriptions.|
|Personnel must undergo bi-annual evaluation for high-risk CSPs.||In compliance with USP <797>. Hartley Medical staff perform media fills monthly for high-risk CSPs.||An enhanced evaluation program provides assurance of aseptic technique employed to compound. Media fills shall simulate the most complex and challenging manipulations in everyday compounding.|
|Personnel shall properly wash hands, don sterile gloves and perform finger tip test with zero colony forming units (CFU) in triplicate.||In compliance with USP <797>.||This test is important to demonstrate proper hand washing and aseptic gloving.|
|Fingertip testing shall be performed periodically.||We exceed this requirement by performing fingertip testing on a weekly basis under dynamic conditions.||An enhanced evaluation on the aspetic technique of personnel during compounding.|
|Random testing: Not required by USP <797>||We perform random testing of finished sterile preparations compounded by staff for sterility and accuracy twice a month.||This provides greater documentation to substantiate that staff can compound sterile preparations aseptically and accurately.|
|Personnel must adhere to proper hand washing, gloving, and gowning prior to compounding CSPs to prevent potential microbial contamination.||In compliance with USP <797>.||Humans are intimately involved in the process of sterile compounding, hence this is a critical area of ensuring measures to eliminate contamination of CSP's.|
|Laminar Airflow Workbenches (LAFWs) with HEPA filters to produce Class 5 air quality for sterile compouding.||Our LAFW utilize Ultra-Low Particle Air filters to provide Class 4 air quality. This greater filtrations exceeds standards by a factor of 10.||Greater filtration reduces possible contamination for particulates and microbials. For reference: the smaller the Class number, the higher air quality.|
|Buffer Room (area where sterile compounding occurs) are designed to maintain at least Class 6 conditions and Class 7 air quality for the ante-room.||Exceeding USP <797>. The air quality surpasses the minimum standard times required.||A room in higher air quality reduces possible contamination for particulates and microbials.|
|The sterile preparation areas must contain an adequate HEPA-filtered air system that changes a minimum of 30 times per hour.||Exceeding USP <797>. Our HEPA filtration system currently supplies 160+ air changes per hour.||From a quality stand point, 30 air changes per hour is very effective. However, enhancing the number of air changes significantly reduces contaminates in the air.|
|Workstations, counters and surfaces, and floors must be cleaned daily; and walls, ceilings, and storage monthly.||In compliance with USP <797>. Hartley Medical staff cleans walls, ceilings, and storage weekly.||Enhanced cleaning and disinfection procedures and frequencies mitigate risk of contamination.|
|Facility provides comfortable well lighted area with a temperature of 20°C or cooler.||In compliance with USP <797>.||Temperature is important for two reasons: lower temperature retard microbial growth and provides a suitable environment for gowned staff to compound.|
|Active air sampling to test for airborne microorganisms must be performed at least every six months.||Exceeding USP <797>. Hartley Medical performs active air sampling weekly.||Active air sampling is a more optimal method for assessing air quality. The frequency of testing weekly provides greater control of microbials.|
|Viable and nonviable environmental sampling testing must be performed every six months.||In compliance with USP <797>. Hartley Medical performs environmental sampling for viable and nonviable airborne particles weekly.||Weekly testing of viable and non-viable sampling produces a foundation for trending and documentation of microbials found in the cleanroom. This data helps in determining critical areas that need to be addressed and remedial action to be taken when necessary.|
|No requirement||Hartley Medical utlilizes: laser air particle counter, SAS active air microbial sampler, endotoxin testing and High Performance Liquid Chromatography instruments.||To provide technology and staff to test our compounded preparations and facility such that they are of the highest quality.|
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