About Us
Aseptic Enclosures
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:
Since our founding in 1992, parenteral production has been a central focus of our work. Our early experience was in cGMP-compliant, FDA-registered pharmaceutical manufacturing facilities. Since 2005, we have also applied that experience to the pharmacy sterile-compounding market.
Aseptic Enclosures entered the sterile-compounding market by introducing compounding aseptic isolators (CAIs) and compounding aseptic containment isolators (CACIs). Since then, our product line has expanded to provide a broad range of solutions designed to support USP <797> and USP <800> compliance.
We also offer equipment-rental options, giving facilities a flexible and cost-effective alternative to purchasing equipment outright.
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 the XLTC isolator, which includes a large, segmented aseptic area designed to support the disinfection of incoming materials.
Training, Consulting, and Testing: Comprehensive cleanroom training, including gowning procedures, USP <800> and hazardous-material compliance testing, microbiological fingertip testing, cleanroom cleaning and maintenance training, engineering-control compliance evaluations, competency evaluations, and related microbiological and sterility testing training.
Containment and Contamination Control: Disinfectants, sterilants, decontamination products, alcohol, diluents, sterile wipes, mopping supplies, gloves, and ASTM D6978 compliance-testing resources.
Garbing and Gowning Supplies: Gowns, gloves, shoe covers, hair covers, sticky mats, storage products, and waste containers.
Sterility and Microbiological Testing Supplies: Media-fill test kits for Category 1, Category 2, and Category 3 compounding procedures; fingertip-testing kits for gowning competency and aseptic technique; surface-contact plates for evaluating engineering controls; viable-air sampling supplies; and laboratory services for sample incubation and organism identification.
3. Design Philosophy and Cost-Effective Aseptic Solutions:
Our first priority is to help facilities create safer, cleaner, and more effective working environments. Because we offer a broad range of equipment, supplies, training, and support services, we can evaluate multiple solutions and recommend an approach that is practical, ergonomic, efficient, and cost-effective.
Why Contamination Control Matters
Effective contamination control depends on properly designed facilities, suitable engineering controls, validated procedures, staff training, environmental monitoring, and consistent adherence to aseptic technique. Aseptic Enclosures helps facilities evaluate these areas and develop practical solutions for sterile and hazardous-drug compounding environments.
About Aseptic Enclosures
Aseptic Enclosures, located in St. Louis, Missouri, manufactures air-filtration and containment equipment for sterile-processing and controlled-environment applications. We also provide supplies, training, testing, consulting, and technical support to help facilities operate clean and controlled environments effectively.
Aseptic Enclosures is committed to helping customers improve sterile-processing and controlled-environment facilities. Our team brings decades of experience supporting pharmaceutical manufacturing, sterile compounding, research laboratories, and other applications requiring clean or contained environments. We work with organizations of many sizes, from established multinational companies to smaller facilities and start-ups, and provide project support based on each customer’s operational and compliance needs.
Our team can assist with equipment selection, facility planning, sterility and microbiological support, gap assessments, staff training, equipment design, computational fluid dynamics analysis, CAD and SolidWorks layouts, aseptic audits, validation support, testing, protocol development, and custom research projects. Our representatives are available by phone and through the website chat application to discuss your facility and project requirements.
Our Products and Services Include
• Custom-designed isolators • Compounding aseptic isolators • Compounding aseptic containment isolators • Clean benches and laminar airflow workbenches • Portable and modular cleanrooms • Powder hoods and downflow booths • Fan-filter units and custom HEPA filtration systems • Environmental-monitoring systems • Media-fill testing supplies • Gloved fingertip-testing supplies • Cleaning and disinfection supplies • Replacement isolator sleeves and liners • Facility planning and design • Cleanroom training and compliance support
For assistance, launch the chat application, or call us at 800-418-9289
Office hours: Monday–Friday, 8:00 a.m.–5:00 p.m. Central Time.
