ST. LOUIS, MO, June 15, 2026 — Aseptic Enclosures, a St. Louis-based manufacturer and solutions provider founded in 1992, today announced the continued expansion of its full-spectrum product and service portfolio designed to help pharmacies, hospitals, and research laboratories achieve and maintain compliance with USP 797 and USP 800 regulatory standards. With more than three decades of experience in aseptic processing and sterile compounding, Aseptic Enclosures has become a trusted partner for hundreds of healthcare facilities across the United States.
About Aseptic Enclosures
Originally rooted in cGMP-compliant, FDA-registered pharmaceutical manufacturing, Aseptic Enclosures entered the pharmacy sterile compounding market in 2005 and has since built one of the broadest product offerings in the industry. The company's mission is clear: to create the safest, most aseptic working environments possible — protecting patients, compounding technicians, and the integrity of sterile products.
Clients include leading health systems, academic medical centers, pharmaceutical manufacturers, government agencies, and independent pharmacies. Trusted partners include Johns Hopkins Medicine, Ascension Health, BJC Healthcare, SSM Health, the U.S. Department of Veterans Affairs, the National Institutes of Health (NIH), Labcorp Drug Development, AbbVie, and many others.
Industry-Leading Product Portfolio
Aseptic Enclosures offers a comprehensive lineup of aseptic engineering controls and cleanroom equipment, including:
• Compounding Aseptic Isolators (CAIs) & Compounding Aseptic Containment Isolators (CACIs) — including the patent-pending XLTC Glovebox Isolator with a fully segmented large aseptic zone for product disinfection
• Mobile and Modular Cleanroom Suites — self-contained, fully validated sterile compounding environments deployable on short notice
• Negative Pressure Isolators — for safe hazardous drug handling in compliance with USP 800
• HEPA Fan Filter Units, Portable Cleanrooms, Clean Benches, Powder Hoods, Sampling Booths, and Down-flow Booths
• Cleanroom Environmental Monitoring Systems (CRM) — including the newly launched AE Clean Room Monitor product line
• Particle Counters, Differential Pressure Monitoring Systems, and Hydrogen Peroxide Atomizers
• Sterility Testing Supplies, Garbing & Gowning Supplies, Disinfectants, Sterilants, and Cleanroom Consumables
• Rental Equipment — validated isolators, containment enclosures, and mobile cleanrooms available for immediate short-term deployment
Expert Consulting and Compliance Services
Beyond equipment, Aseptic Enclosures provides end-to-end compliance and professional services, including Pharmacy Planning & Design, Detailed Facility Design, Pharmacy Compliance Audits, Computational Fluid Dynamic (CFD) analysis, CAD/Solidworks layout development, USP 797/800 GAP analysis, Cleanroom Training (gowning, aseptic technique, hazardous drug handling), Microbiological and Sterility Testing, and Validation Support. The company's expert project team has successfully guided hundreds of USP 797 and USP 800 compliance projects to completion.
"Our first priority is always to help your facility create the most aseptic and safest working environment possible. With the broadest product line in the industry, we can look at solutions from multiple platforms — ensuring an environment that is not just compliant, but ergonomic, functional, and cost-effective."
— Aseptic Enclosures Management Team
Why Sterile Compounding Compliance Matters
Hospital-acquired infections (HAIs) remain the leading cause of preventable death in U.S. hospitals, claiming approximately 200 lives every day. Touch contamination from poor aseptic technique is the number one cause of HAIs — and ironically, experienced compounding technicians are often the most likely to unknowingly breach sterile technique. Properly designed and validated engineering controls are not optional; they are critical infrastructure for patient safety.
Flexible Options: Purchase, Custom Build, and Rental
Recognizing that every facility has unique needs and budgets, Aseptic Enclosures offers standard equipment, fully custom-engineered solutions, and short-term equipment rental programs. Rental isolators, containment enclosures, and mobile cleanrooms are available for immediate delivery and are fully USP 797/800 compliant. The company also offers Mobile Compounding Center demonstrations for organizations exploring modular or portable sterile compounding environments.
About Aseptic Enclosures
Founded in 1992 and headquartered at 3720 Hampton Ave., Suite 204, St. Louis, MO 63109, Aseptic Enclosures manufactures and distributes a comprehensive range of air filtration, cleanroom, and isolator equipment for aseptic processing and containment applications. The company serves pharmacies, hospitals, pharmaceutical manufacturers, government agencies, and research laboratories nationwide. Aseptic Enclosures is committed to patient safety and the highest standards of sterile compounding compliance.
Media & Sales Contact:
Aseptic Enclosures
3720 Hampton Ave., Suite 204, St. Louis, MO 63109
Phone: 1-800-418-9289
Email:
[email protected]
Website: www.asepticenclosures.com
Hours: Monday–Friday, 8:00 AM – 5:00 PM Central Time