Comprehensive Solutions to USP797 and USP800
Aseptic Enclosures 800-418-9289 3720 Hampton Avenue St. Louis, MO 63109 www.asepticenclosures.com Founded in 1992
1. Company Background:
Parenteral production has been one of our company’s focal points since its founding in 1992. First, in cGMP compliant FDA registered pharmaceutical manufacturing facilities, and now, since 2005, the “end user” Pharmacy Sterile Compounding segment.
Aseptic Enclosures first brought our expertise into the compounding market with the introduction of our CAI “compounding aseptic isolators” and CACI “compounding aseptic containment isolators”. Since that time our product line has grown to offer the most comprehensive range of solutions for USP 797 and USP 800 compliance available today!
2. Our Product Line Includes:
Equipment: Cleanrooms, Negative Pressure Rooms, Portable Cleanrooms, Isolators, Glove Boxes, Custom Engineering Controls, Fan Filter Units, CAIs, CACIs, Hoods & Clean Benches, Hazardous Material Storage Solutions, Exhaust Systems, C—SCAs.
One of the more recent additions to our product line is our patent pending XLTC isolators that incorporate a completely segmented, large and aseptic area for incoming product to be properly disinfected.
Training/Consulting/Testing: Comprehensive Cleanroom Training including, Gowning, USP800/HazMat compliance Testing, Microbiological Fingertip Testing, Cleanroom Cleaning and Maintenance Training, Engineering Control’ s Compliance evaluations, Competency Evaluations and related Microbiological and Sterility Testing Training.
Containment and Contamination Control: Disinfectants, Sterilants, Decontaminates, Alcohol, Diluents, Sterile Wipes and Mopping supplies, Gloves, ASTM 6978-05 compliance testing.
Garbing and gowning supplies: Gowns, Gloves, Booties, Hair Nets, Sticky mats, Storage, Waste Containers.
Sterility,’Microbiological Testing supplies: Media Test Kits for Low, Medium and High Risk procedural testing. Fingertip Testing Kits for gowning competency and aseptic technique. Surface Contact Plates for engineering controls evaluation. Impact Air Plates for air and HVAC aseptic quality assurance. Laboratory services: Sample Incubation and Contamination Speciation.
3. Design philosophy, aseptic cost-containment:
Our first priority is to help your facility create the most aseptic and safest working environment possible. Having as broad of a product line as we do provides us the opportunity to look at solutions from multiple potential platforms to secondarily help create an environment that is ergonomic, functional, efficient and cost-effective.
– A “properly” gowned person generates 1,000 CFUs of viable live organisms every hour!!!
– The number one cause of HAIs is touch contamination from poor technique.
– The more experienced the compounding technician, the more likely they are to contaminate their work.
– HAIs are the leading cause of death in US hospitals, 200/day.
*references upon request