Cleanroom Training Courses | USP 797 Certification | St. Louis, MO
On-Site Training for Pharmacy Compounding Facilities
Aseptic Enclosures delivers comprehensive cleanroom training for hospital pharmacies, compounding facilities, and healthcare organizations throughout St. Louis and surrounding Missouri areas. Our programs address USP 797 compliance requirements, aseptic technique, and environmental monitoring protocols.
Every program begins with a facility assessment. We evaluate your engineering controls, certification reports, and current operational procedures. This evaluation allows us to customize curriculum specifically to your environment and staff requirements.
Course Options
One-Day Intensive Program
Lecture-based instruction covering core fundamentals. Ideal for facilities requiring annual refresher training or initial orientation for new staff members.
Includes:
- USP 797 compliance overview
- Gowning and garbing procedures
- Aseptic technique fundamentals
- Environmental monitoring basics
Comprehensive Certification Program
Full certification spanning 3-5 days depending on staff size. Combines classroom instruction with hands-on competency assessments.
Includes:
- Complete USP 797/800 modules
- Gloved fingertip sampling and testing
- Media fill testing procedures
- Surface sampling techniques
- Written and practical examinations
Extended Staff Program (1-2 Weeks)
For facilities training large teams or implementing new operations. Accommodates multiple shifts and includes cleaning staff certification.
Curriculum Overview
Our structured curriculum aligns with USP General Chapter 797 requirements:
Module 1: Fundamentals
- ISO classification standards
- Particle contamination sources
- Airflow patterns and HEPA filtration
- Primary and secondary engineering controls
Module 2: Personnel Practices
- Hand hygiene protocols
- Proper gowning sequence
- Movement within classified areas
- Aseptic manipulation techniques
Module 3: Environmental Monitoring
- Viable and non-viable sampling methods
- Gloved fingertip testing procedures
- Surface sampling requirements
- Action level responses
Module 4: Cleaning and Disinfection
- Approved cleaning agents
- Cleaning frequencies and documentation
- Sporicidal application protocols
- Cleaning validation methods
Module 5: Competency Assessment
- Written examination
- Media fill testing
- Gloved fingertip sampling
- Practical observation
Why Compliance Training Matters
USP 797 mandates that all personnel involved in compounding sterile preparations demonstrate competency through documented instruction. State boards of pharmacy in Missouri and across the United States enforce these requirements during inspections.
Inadequate preparation creates contamination risks and regulatory exposure. Failed gloved fingertip tests, positive environmental samples, and improper documentation can result in 483 observations, warning letters, or facility closure.
The Cleaning Staff Question
Most facilities overlook cleaning personnel during planning. This creates a significant compliance gap.
Cleaning staff enter classified areas regularly. They contact critical surfaces. Without proper instruction in aseptic protocols, they become a primary contamination vector.
We recommend pharmacy staff handle cleaning responsibilities within the aseptic environment. The rationale: cleaning personnel require the same gloved fingertip testing and gowning competency as compounding staff. Given typical housekeeping turnover rates, maintaining compliance becomes administratively burdensome and increases testing costs.
What Participants Receive
Upon successful completion, each participant receives:
- Certificate of Completion documenting hours and modules completed
- Competency Assessment Records including written exam scores and practical evaluation results
- Gloved Fingertip Testing Documentation with CFU counts and pass/fail determination
- Media Fill Test Results (for sterile compounding personnel)
- Validation Forms ready for surveyor review
All documentation meets USP 797 requirements and satisfies Missouri State Board of Pharmacy inspection standards.
Service Areas
Aseptic Enclosures serves healthcare facilities throughout St. Louis, greater Missouri, and the Midwest region. Our trainers travel to your location, eliminating staff travel costs and minimizing operational disruption.
Locations We Serve:
- St. Louis City and County
- St. Charles, Jefferson, and Franklin Counties
- Kansas City metropolitan area
- Columbia, Springfield, and outstate Missouri
- Southern Illinois facilities
Investment and Scheduling
Pricing Structure
Costs vary based on program length, staff size, and facility assessment scope. Contact us for a detailed quote specific to your requirements.
Factors affecting investment:
- Number of personnel requiring certification
- Program duration (1 day to 2 weeks)
- Initial certification vs. annual recertification
- Facility assessment and engineering controls evaluation
- Travel requirements
Scheduling Availability
We schedule sessions based on your operational needs. Most facilities prefer instruction during slower census periods or across multiple sessions to maintain pharmacy coverage.
Lead time: 2-4 weeks for scheduling after initial consultation.
Why Choose Aseptic Enclosures
Facility-Specific Customization We assess your engineering controls and certification reports before instruction begins. This allows targeted content addressing your actual compliance gaps rather than generic material.
Combined Equipment and Training Expertise As cleanroom equipment manufacturers, we understand the engineering controls your staff operates daily. Instruction includes equipment-specific guidance relevant to your primary and secondary controls.
Regulatory Alignment Curriculum reflects current USP 797 requirements, state board expectations, and Joint Commission standards. We update content as regulations evolve.
Documentation Support Complete records formatted for surveyor review. Reduces administrative burden during inspections.
Four Steps to Get Started
Step 1: Initial Consultation Contact our team to discuss your facility size, staff count, and compliance objectives. We identify the appropriate program structure.
Step 2: Facility Assessment We schedule an on-site evaluation of your engineering controls and current procedures. This typically occurs the day before instruction begins.
Step 3: Customized Program Development Based on assessment findings, we finalize your curriculum, focusing on identified gaps and facility-specific requirements.
Step 4: Delivery and Certification Our trainers deliver your program on-site. Participants complete competency assessments and receive documentation.
Request a Quote
Contact Aseptic Enclosures to discuss your facility’s compliance needs. Provide your staff count, preferred dates, and current compliance status for accurate pricing.
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Online: Complete the form below to request a consultation.
Aseptic Enclosures provides compliance training, certification services, and pharmaceutical equipment for compounding pharmacies throughout the Midwest.
