ST. LOUIS, MO — Aseptic Enclosures, a St. Louis–based manufacturer of cleanrooms, isolators, and containment equipment for sterile pharmacy compounding, today announced an expanded full-scope program designed to take pharmacies from concept to a licensed, fully operational sterile compounding facility — without bringing in a second vendor.

The company, which has supplied parenteral production and containment equipment since 1992 and has focused on the pharmacy sterile compounding segment since 2005, says the new program addresses a gap many pharmacies run into when launching sterile compounding: managing design, construction, equipment, supplies, staff training, cleaning, and microbiological testing across a patchwork of separate vendors.

"Starting a sterile compounding operation is complex," the company said in describing the program. "We help pharmacies move from concept to licensed sterile operation with cleanroom design, containment equipment, supplies, training, cleaning, and micro testing support — from one partner."

What's Included

The program bundles seven areas of support that pharmacies have traditionally had to source separately:


Portable cleanrooms — modular, engineered containment environments that can be installed faster than traditional stick-built rooms
Cleanroom doors and PP CAIs — including 50˝ x 32˝ polypropylene Compounding Aseptic Isolators
Coveralls, gloves, and other PPE
Professional cleaning services to prepare and maintain a compliant, ready-to-compound environment
In-house micro lab support for processing competency samples using dedicated bacterial and fungal incubators
Category 3 competency training for compounding staff
Carts, chairs, and raw materials support to round out day-one operational readiness


According to the company, the goal is operational readiness on day one: equipment layout, workflow setup, and startup support are handled alongside the physical buildout, rather than treated as an afterthought once construction wraps.

Built on Decades in Containment Engineering

Aseptic Enclosures' equipment lineage traces back to cGMP-compliant, FDA-registered pharmaceutical manufacturing facilities before the company extended that expertise to pharmacy end users. Its product line has grown to include Compounding Aseptic Isolators (CAIs), Compounding Aseptic Containment Isolators (CACIs) for chemotherapy and hazardous drug handling, portable and modular cleanrooms, viable and particulate air monitoring equipment, and a range of cleaning and disinfection supplies — all positioned to support USP and USP compliance.

The company also offers equipment rental options, giving pharmacies a lower-commitment path to evaluate containment equipment before a full purchase.

Why It Matters for Pharmacies

Sterile compounding has become an increasingly attractive — and increasingly regulated — service line for both retail and hospital pharmacies. Compounded sterile preparations (CSPs) such as total parenteral nutrition, chemotherapy drugs, hormone therapies, and specialty IV medications often command cash-pay margins unavailable through standard insurance-reimbursed retail dispensing, while drug shortages have pushed more facilities to consider insourcing.

But the regulatory bar is high. USP governs sterility assurance for compounded preparations, while USP sets handling requirements for hazardous drugs, and both demand validated equipment, documented cleaning protocols, and trained, competency-tested personnel before a facility can legally compound.

Aseptic Enclosures argues that consolidating design, equipment, supply, training, cleaning, and testing under one vendor reduces the coordination burden — and the compliance risk — of stitching together multiple contractors for a single cleanroom buildout. "No competitor in this space matches our scope of support," the company said.

About Aseptic Enclosures

Founded in 1992, Aseptic Enclosures manufactures negative pressure rooms, portable and modular cleanrooms, isolators, glove boxes, fan filter units, and custom engineering controls for aseptic processing and containment applications. The company is headquartered at 3720 Hampton Avenue, St. Louis, MO 63109, and its services include cleanroom design, CAD/SolidWorks layouts, computational fluid dynamics analysis, aseptic audits and training, validation support, and custom research projects.

Contact:
Aseptic Enclosures
3720 Hampton Avenue, St. Louis, MO 63109
Phone: 800-418-9289
Web: asepticenclosures.com