Design. Build. Equip. Supply. Train. Clean. Test. One Partner.
Launching or upgrading a sterile compounding program is one of the most complex projects a hospital, health system, infusion center, or pharmacy can undertake. Compliance requirements continue to evolve, staffing shortages remain a challenge, and many facilities struggle to coordinate multiple vendors for cleanroom construction, equipment procurement, certification, training, and operational readiness.
At Aseptic Enclosures, we simplify the process by providing complete USP <797> and USP <800> cleanroom support—from initial design through certification and ongoing operational support.
Whether you are building a new sterile compounding pharmacy, converting existing space, expanding hazardous drug compounding capabilities, or replacing aging infrastructure, our team provides a turnkey solution that eliminates the complexity of managing multiple contractors and suppliers.
Why USP <797> and USP <800> Compliance Matters
USP <797> establishes standards for sterile compounding to help protect patients from contamination, infection, and medication errors.
USP <800> provides requirements for handling hazardous drugs to protect healthcare workers, patients, and the environment from exposure risks.
For hospitals and pharmacies, compliance is not optional. Proper facility design, engineering controls, environmental monitoring, cleaning procedures, staff competency, and documentation all play critical roles in maintaining compliance and ensuring patient safety.
A successful sterile compounding operation requires much more than equipment—it requires a complete system.
Complete Cleanroom Design and Planning Services
Many organizations begin with an empty room, underutilized storage area, or outdated cleanroom that no longer meets operational needs.
Our team works with customers during the earliest planning stages to develop a cleanroom strategy that aligns with:
- USP <797> requirements
- USP <800> requirements
- State Board of Pharmacy regulations
- Hospital operational workflows
- Future growth requirements
- Budget and facility constraints
By addressing compliance and workflow considerations before construction begins, facilities can avoid costly redesigns and delays.
Portable Cleanroom Solutions
Not every hospital or pharmacy has the time, budget, or available space for traditional construction projects.
Portable cleanrooms provide a flexible alternative that allows facilities to establish compliant sterile compounding environments more quickly and with less disruption.
Benefits include:
- Accelerated deployment
- Reduced construction costs
- Flexible facility placement
- Scalable expansion options
- Controlled environments for sterile compounding
- Support for USP <797> compliance
Portable cleanrooms are particularly attractive for retail pharmacies, critical access hospitals, infusion centers, and growing healthcare organizations seeking rapid implementation.
50 x 32 Positive Pressure Compounding Aseptic Isolators (CAIs)
Primary Engineering Controls (PECs) are the heart of every sterile compounding operation.
Our 50 x 32 Positive Pressure Compounding Aseptic Isolators provide controlled ISO-classified environments designed to support sterile compounding activities while reducing contamination risks.
Benefits include:
- Controlled aseptic work environment
- Enhanced contamination protection
- Consistent airflow performance
- Support for sterile preparation workflows
- Improved operator confidence
- Simplified implementation for startup facilities
For many new pharmacies, CAIs provide an effective path toward establishing compliant sterile compounding capabilities without the complexity of larger cleanroom suites.
Cleanroom Doors and Controlled Access Systems
Maintaining environmental control requires more than walls and filtration systems.
Proper cleanroom doors support:
- Controlled personnel movement
- Pressure differential management
- Environmental segregation
- Contamination prevention
- Workflow efficiency
Cleanroom access systems are often overlooked during project planning but play a critical role in maintaining compliance and operational effectiveness.
Sterile Garbing Supplies and PPE Support
Personnel are often the largest source of contamination within cleanroom environments.
Proper gowning procedures help reduce contamination risks and support regulatory compliance.
Our support includes:
- Coveralls
- Sterile gloves
- Garbing supplies
- PPE recommendations
- Workflow guidance
By ensuring facilities have access to the proper supplies and training, organizations can build a stronger contamination control strategy from day one.
Professional Cleanroom Cleaning Services
One of the biggest challenges facing startup pharmacies is the lack of trained personnel capable of properly cleaning controlled environments before certification and operational launch.
Many organizations invest heavily in cleanroom infrastructure but underestimate the importance of proper cleaning procedures.
Our professional cleanroom cleaning services help facilities:
- Prepare for certification
- Establish compliant cleaning practices
- Reduce startup risk
- Improve environmental readiness
- Build confidence among staff and leadership
Professional cleaning support is particularly valuable during initial startup, renovation projects, and periods of staff transition.
Category 3 Competency Training
Equipment does not create compliance—people do.
Successful sterile compounding programs require trained personnel who understand aseptic technique, contamination control principles, workflow requirements, and regulatory expectations.
Our Category 3 competency training helps personnel develop the knowledge and skills necessary to support sterile operations.
Training programs may include:
- Aseptic technique
- Garbing procedures
- Environmental awareness
- Workflow best practices
- Documentation requirements
- Competency evaluation support
By investing in staff development, organizations improve compliance, reduce risk, and strengthen patient safety programs.
Carts, Chairs, and Workflow Equipment
Small details often have a significant impact on daily operations.
Workflow support equipment such as carts and cleanroom-compatible seating helps facilities:
- Improve efficiency
- Reduce operator fatigue
- Support material movement
- Maintain organized workflows
- Enhance productivity
Selecting the proper support equipment contributes to both compliance and operational performance.
Microbiology Testing and Competency Samples
Environmental monitoring and competency testing remain critical components of sterile compounding programs.
Our dedicated microbiology laboratory supports:
- Competency sample processing
- Bacterial incubation
- Fungal incubation
- Personnel qualification programs
- Ongoing quality assurance initiatives
These services help pharmacies and healthcare organizations verify performance and maintain confidence in their sterile compounding operations.
A True Turnkey Sterile Pharmacy Startup Partner
Many vendors sell equipment.
Few provide complete sterile startup support.
Aseptic Enclosures supports customers through every stage of implementation:
Design
Facility planning and cleanroom strategy.
Build
Cleanroom infrastructure and installation support.
Equip
Primary engineering controls, cleanroom equipment, and operational tools.
Supply
Garbing materials, consumables, and startup resources.
Train
Category 3 competency training and operational guidance.
Clean
Professional cleanroom cleaning services.
Test
Microbiology support and competency sample processing.
Support
Certification coordination and operational readiness assistance.
Why Hospitals and Pharmacies Choose Aseptic Enclosures
Healthcare organizations increasingly seek partners capable of managing entire projects rather than isolated components.
By combining cleanroom design, equipment, supplies, training, cleaning services, microbiology support, and startup consulting under one roof, Aseptic Enclosures helps reduce project complexity and accelerate implementation timelines.
From a back storage room to a fully operational sterile compounding facility, our team provides the expertise, equipment, and support necessary to help organizations achieve compliance and operational success.
Ready to Launch or Upgrade Your Sterile Compounding Facility?
Whether you operate a hospital pharmacy, retail pharmacy, infusion center, health system, outpatient facility, or specialty compounding operation, Aseptic Enclosures can help you move from concept to certification with confidence.
Contact our team today to learn how our complete USP <797> and USP <800> support solutions can simplify your next cleanroom project.
