Cleanroom-ready, documentation-ready, and staff-supported for USP <797>/<800> facilities — led by certified pharmacy technicians, including CSPT® credentialing.
Most violations aren't dramatic. They're cleaning logs not maintained, SOPs not updated since the 2023 USP <797> revisions, and documentation that hasn't been reviewed — until an inspector does.
Areas where facilities often need additional support — and where we can help.
Unannounced state inspections can expose documentation gaps, cleaning inconsistencies, and SOP deficiencies. Ongoing preparation matters more than last-minute corrections.
Common citation areas
Cleaning logs, SOP currency, documentation completeness, and staff training records
How we support this
We help keep your cleanroom organized and documentation current through consistent cleaning support, log maintenance, and readiness walkthroughs.
USP <797> 2023 revisions introduced significant changes. Facilities still running legacy procedures may have documentation that no longer reflects current standards.
Common documentation concern
SOPs not updated to reflect the 2023 USP <797> revisions
How we support this
We assist with SOP organization and documentation review to help your facility identify where updates may be needed, in support of your team's pharmacist-led compliance program.
Consistent cleaning practices and well-maintained cleaning logs are foundational to a credible environmental monitoring program under USP <797>.
Common area of concern
Incomplete cleaning logs or inconsistent disinfection procedures
How we support this
We provide hands-on cleanroom cleaning support and help maintain accurate cleaning logs so your facility has a consistent, documented record of cleaning activity.
Sterile compounding facilities sometimes need additional technician coverage — for staffing gaps, planned absences, or increased workload — without compromising aseptic workflow.
Common staffing need
PRN sterile compounding technician coverage on a per-need basis
How we support this
We provide PRN sterile compounding technicians ready to integrate without disrupting your operations, performed under your facility's pharmacist supervision, SOPs, and applicable state requirements.
Both 503A compounding pharmacies and 503B outsourcing facilities have rigorous cleanroom, documentation, and staffing requirements under USP <797> and USP <800>.
Support scope
Cleanroom cleaning, documentation assistance, and PRN technician support for 503A and 503B facilities
How we support this
We provide hands-on cleanroom and documentation support for facilities operating in 503A and 503B environments, working alongside your pharmacist-led compliance team.
Seeing yourself in any of these? We can help identify your specific gaps.
Request a Free Cleanroom Readiness Assessment →Hands-on cleaning support, documentation assistance, and readiness walkthroughs in support of your facility's pharmacist-led compliance program.
Professional ISO-classified cleanroom cleaning by trained sterile compounding technicians. Scheduled or one-time service available.
Hands-on documentation assistance and readiness walkthroughs for facilities operating under USP <797> and <800> — in support of your pharmacist-led compliance program.
PRN sterile compounding technician support available on a limited basis. Ask us about current availability.
PRN sterile technician services are provided under the client facility's pharmacist supervision, policies, procedures, and applicable state requirements.
We discuss your facility's needs and review your current cleaning, documentation, and staffing concerns.
We recommend the right support services based on your facility's needs, scope, and location.
Our team provides cleanroom cleaning, documentation assistance, and technician coverage on your schedule.
Ongoing cleaning support, annual reviews, and pre-inspection readiness support your facility's compliance program.
ELITE Compounding & Aseptic Services is a Florida-based sterile cleanroom support company led by certified pharmacy technicians with hands-on sterile compounding experience, including PTCB Certified Compounded Sterile Preparation Technician® (CSPT®) credentialing. We support pharmacies and healthcare facilities operating under USP <797> and <800> with cleanroom cleaning support, documentation assistance, readiness walkthroughs, and PRN sterile technician coverage. Our role is to support the facility's pharmacist-in-charge, designated person, SOPs, and internal compliance program — we do not replace the PIC, designated person, cleanroom certifier, or regulatory authority.
Talk to our teamElite-Level Sterile Support for Critical Environments.
Check the items that apply to your cleanroom. Takes 30 seconds.
You're well-positioned. Let's make sure it stays that way.
Schedule a Maintenance Review →You have some exposure. A gap assessment would catch it early.
Request a Free Assessment →Your facility has significant compliance risk. Don't wait for an inspection to find out.
Talk to a Specialist Today →No forms lost in inboxes. No vague timelines. Here's exactly what to expect.
We look at your facility type and main concern to understand what kind of support will be most useful before we reach out.
Based on your preference and location, we'll set up a phone call or arrange a visit to your Florida facility — at no cost to you.
We review your cleaning protocols, documentation, SOPs, staffing, and environmental monitoring against current USP <797>/<800> standards.
You receive a clear, prioritized plan for addressing gaps — and we can stay on to provide the hands-on support your facility needs.
Tell us about your facility and we'll identify gaps in cleaning, documentation, SOPs, staffing, and environmental monitoring — before an inspection does.
Met us during a pharmacy visit? Request your free cleanroom readiness assessment here →
ELITE Compounding & Aseptic Services supports the facility's pharmacist-led compliance program. Services are performed according to the client facility's SOPs, policies, procedures, and applicable requirements. ELITE does not replace the pharmacist-in-charge, designated person, cleanroom certifier, or regulatory authority, and does not guarantee inspection outcomes.