SEPS is a New York-based testing and certification company. We help compounding pharmacies across New York meet USP <797> and USP <800> standards. Our CETA certified technicians test your cleanrooms, biosafety cabinets, isolators, and laminar flow units. You get clear reports and fast turnaround. You also get the records you need for your next State Board inspection.
We serve sterile and non-sterile compounding pharmacies. That includes hospital, retail, and 503A pharmacies. With more than 18 years of field experience, SEPS can often dispatch a technician within 24 hours across the New York metro area.
Schedule a USP <797> and USP <800> compliance check for your pharmacy.
Serving New York, New Jersey, Connecticut, Massachusetts, Rhode Island, and surrounding areas.
Understanding USP <797> and USP <800> Compliance
Before you choose a compliance partner, it helps to know what the rules cover. The U.S. Pharmacopeia sets two main standards for compounding pharmacies. USP <797> protects patients from contaminated sterile drugs. USP <800> protects workers from hazardous drugs. Both standards rely on a controlled facility, so it helps to understand the role of cleanrooms in pharmacy compounding before you plan a compliance program.
The 2023 USP <797> update changed how sterile preparations are classified. CSPs are no longer labeled low, medium, or high risk. They are now grouped into Category 1, Category 2, and Category 3 CSPs. Each category has its own beyond-use dating limits and its own facility rules. Additionally, each CSP category is tied to a specific room cleanliness level, which is set by ISO 14644 cleanroom classification.
Who needs USP <797> and USP <800> compliance:
- Hospital pharmacies that prepare IV medications, TPN, or chemotherapy
- Retail and community pharmacies that compound sterile products
- 503A compounding pharmacies that serve individual patient prescriptions
- 503B outsourcing facilities that compound in bulk for hospitals and clinics
- Any clinic, infusion center, or veterinary pharmacy that handles hazardous drugs
- Hospital and infusion-center teams that prepare chemotherapy face extra rules under USP <800>, which we cover in our guide to oncology compounding compliance.
Quick compare: USP <797> vs. USP <800>
| USP <797> | USP <800> | |
|---|---|---|
| What it covers | Sterile compounding of medications | Safe handling of hazardous drugs |
| Who it protects | Patients who receive compounded sterile drugs | Pharmacy staff and the public near hazardous drugs |
| Who must comply | Any pharmacy that prepares sterile drugs (hospital, retail, 503A, 503B) | Any site that receives, stores, compounds, or disposes of hazardous drugs |
| Key focus areas | Cleanroom design, air quality, beyond-use dating, staff training | Containment, PPE, ventilation, spill control, medical surveillance |
Environmental Monitoring and Gap Analysis
A certification visit shows that your rooms meet the standard on the day of the visit. Environmental monitoring shows that your pharmacy stays clean between visits. USP <797> requires both, and SEPS supports both.
Viable and non-viable environmental monitoring
SEPS helps you build and run a full sampling program. We test for living organisms and for tiny particles. We track results over time so you can spot trends early.
- Sampling plan design with a clear map of sample locations
- Active air sampling and settle plates
- Surface sampling for ISO 5, ISO 7, and ISO 8 rooms
- Gloved fingertip and garbing assessments for staff
- Media fill testing for sterile compounding personnel
- Trending reports aligned with USP <1116> guidance
- Genus and species level identification for out-of-tolerance results
For background on what a full cleanroom test visit covers, see our guide to the basics of cleanroom testing and certification.
USP <797> and USP <800> gap analysis
A gap analysis is a written review of your pharmacy. It checks your work against the current USP standards. It tells you what is working, what is missing, and what to fix first.
A pharmacy may need a gap analysis when:
- You are building a new compounding suite
- You are renovating an existing cleanroom
- Your last inspection had findings
- Your team is new to USP <797> or USP <800>
- You want a fresh second opinion before your next State Board visit
Why New York Pharmacies Choose SEPS
Pharmacy compliance is too important to guess. SEPS gives you trained people, the right tools, and clear paperwork. Here is what sets us apart.
- CETA certified technicians. Every SEPS field tech is trained to CETA standards for sterile compounding facility testing.
- NSF/ANSI 49 accreditation for BSC testing. We test biosafety cabinets to the leading industry standard. Learn more about how biosafety cabinet testing works.
- 18+ years in business. SEPS has supported labs and pharmacies in the Northeast since the early 2000s.
- Same-day and 24/7 emergency service. If your cleanroom or BSC fails, we can often be on site the same day.
- Stocked parts inventory. We keep HEPA filters, motors, and major parts in stock to cut your downtime.
- Full coverage for all major brands. Our techs are trained on every major BSC, isolator, and LAFW manufacturer.
- Reports your inspector can use. Every certification includes a signed report, calibration records, and equipment labels.
How Our Pharmacy Certification Process Works
SEPS uses the sample five step process below for every New York, New Jersey, Connecticut, Massachusetts, and Rhode Island pharmacy. It keeps things fast, simple, and audit ready.
| Step | Stage | What happens |
|---|---|---|
| 1 | Scoping call | We learn about your pharmacy, the rooms in scope, your equipment, and your inspection timeline. |
| 2 | Gap analysis | A SEPS technician reviews your facility against USP <797> and USP <800>. You get a written list of gaps and a path to fix them. |
| 3 | On-site testing | We test cleanrooms, primary engineering controls, HEPA filters, airflow, and room pressure. |
| 4 | Same-day report | You receive a preliminary report on site, so you know your status before we leave. |
| 5 | Final documentation | A signed report with all test data, sampling plans, and labels for your records and your next inspection. |
USP <797> Certification Frequency at a Glance
Under USP <797>, most pharmacy equipment must be certified every 6 months. Use this table as a quick guide. We can pull your records and tell you what is due next.
| Item or test | How often | Also required when |
|---|---|---|
| Cleanroom certification (ISO 5, 7, 8) | Every 6 months | After construction, renovation, or HEPA replacement |
| Biosafety cabinet (BSC) | Every 6 months | After install, relocation, or filter change |
| Laminar airflow workbench (LAFW) | Every 6 months | After install, relocation, or filter change |
| Compounding aseptic isolator (CACI) | Every 6 months | After install, relocation, or filter change |
| HEPA filter integrity (leak test) | Every 6 months | After any filter replacement |
| Airflow visualization (smoke study) | Every 6 months | After changes to room layout or airflow |
| Viable air and surface sampling | Per your sampling plan | After an out-of-tolerance result or remediation |
| Media fill testing (personnel) | At hire, then per USP <797> | After a failed gloved fingertip test |
Need a deeper look at the filter side of the table? Read our guide to HEPA filter testing, replacement, and maintenance.
If your visit involves a cabinet swap or move, our BSC decontamination and certification FAQs answer the most common questions.
For pharmacies using LAFWs, see our overview of laminar flow hood usage in the lab.
The smoke study row in the table covers airflow patterns. To see why this matters, read about the importance of uniform airflow.
Schedule a USP <797> and USP <800> compliance check for your pharmacy.
Serving New York, New Jersey, Connecticut, Massachusetts, Rhode Island, and surrounding areas.
Frequently Asked Questions
How often does a USP <797> cleanroom need to be certified?
Most pharmacy cleanrooms and primary engineering controls must be certified every 6 months. You also need a new certification after any major change. That includes a HEPA filter swap, a room layout change, or a move.
What is the difference between USP <797> and USP <800>?
USP <797> sets the rules for sterile compounding. The goal is to protect patients from contaminated drugs. USP <800> sets the rules for handling hazardous drugs. The goal is to protect staff and the public from exposure.
Both standards expect you to keep the space clean between certifications, which we cover in cleaning and sterilizing your cleanroom.
Who needs USP <800> compliance?
Any site that receives, stores, prepares, or disposes of hazardous drugs must follow USP <800>. That includes hospital pharmacies, oncology clinics, retail compounding pharmacies, infusion centers, and many veterinary clinics.
What does SEPS test during a pharmacy certification visit?
Our technicians test HEPA filter integrity, particle counts, air changes per hour, room pressure, and airflow patterns. We also test biosafety cabinets, laminar flow workbenches, and isolators. If you have a sampling plan, we can pull air and surface samples on the same visit.
Before your next visit, you can also review our biosafety cabinet decontamination checklist to prep your equipment.
How long does pharmacy certification take?
A sterile pharmacy certification takes about 4 to 8 hours on site. Larger sites or full USP <800> rooms can take longer. You receive a preliminary report before we leave. That way, you know your status the same day.
Do you offer same-day service in New York?
Yes. SEPS offers 24/7 emergency service across the New York metro area. We can often dispatch a technician within 24 hours. Same-day visits are available for urgent BSC, isolator, or cleanroom failures.
What documents will I get for State Board inspections?
Each visit ends with a signed certification report, calibration records, and equipment labels. You also get the raw test data and any corrective action notes. Everything is formatted for State Board and joint accreditation review.
Can SEPS help with a new pharmacy build or renovation?
Yes. We can review your design, run a pre-build gap analysis, and certify the rooms once construction is complete. Bringing SEPS in early often saves rework later.
Ensure Pharmacy Compliance & Safety with SEPS
At SEPS, we provide comprehensive services for pharmacies to ensure compliance and safety. Our professional team of experts specialize in testing and certifying all types of equipment used in pharmacies, from large to small. With SEPS, you can rest assured that your equipment is meeting all standards, and is safe to use.
When it comes to pharmacy compliance and equipment repair, you need a reliable and trusted partner. That’s why we offer complete testing, certifying, and repair services for all of your pharmacy equipment needs.
Expert Advice from SEPS
At SEPS, we understand the need for expert advice and guidance when it comes to pharmacy compliance. Our team of professionals are experts in the field and can provide you with the advice and guidance you need to ensure your pharmacy is compliant with all laws and regulations. We can help you create a plan that is tailored to your business, so you can achieve the highest level of compliance.
Types of Pharmacies We Work In
SEPS operates in several types of pharmacies. Each pharmacy requires various levels of precaution depending on the types of drugs and procedures involved.
Pharmacies include: Sterile Compounding Pharmacy, Hazardous Sterile Compounding Pharmacies, Non-Sterile Compounding Pharmacies, and Hazardous Non-Sterile Compounding Pharmacies
Service for All Your Pharmacy Cleanrooms
SEPS also provides services in cleanrooms that support different types of pharmacies.
Cleanrooms include: IV Room, Buffer Room, Ante Room, Chemo Room, and Hazardous Room.
Not sure where to start? Our primer on what is a cleanroom walks through how these rooms are built and what makes them different from a normal workspace.
Pharmacy Compliance:
- USP 797
- USP 800
- USP 795
- CAG:003
USP 800 Surface Wipe Sampling
Hazardous Drugs are regularly compounded in Hazardous Compounding Pharmacies. Unintended Hazardous Drug exposure can pose concern to pharmacists, patients & staff. Surface residue is a common method of exposure, but the vector of exposure may not be evident. Hazardous Drug Testing of surfaces in the pharmacy can help to determine areas of concern/vectors for unintended residue transport (Ex. HD Pass though tray, IV bags, floor)
We break this down in detail in our post on USP 800 surface wipe sampling explained.
Pharmacy Renovation & Move
Is your pharmacy undergoing renovation soon? Do you need to move/replace pharmacy equipment and require recertification ASAP to minimize downtime? And don’t want to deal with the hassle of scheduling with multiple companies & receiving multiple quotes?
SEPS can streamline this process! We can perform a same or next day Decon/Move/Cert of your units, all on 1 quote & scheduled with 1 contact.
Recertification after a move is not optional, and our post on why lab equipment certification matters explains the reasons in plain terms.
Get in Touch with SEPS (516) 997-9006
Whether you need a routine certification, a fresh gap analysis, or help after a failed test, SEPS can help. Our New York technicians are ready. Your free assessment is just a call away.
SEPS takes great pride in our affiliation with the Controlled Environment Test Association (CETA). It is important to us to maintain the highest level of expertise when it comes to testing and balancing controlled environments. Being a part of CETA means that we have access to the latest training, information, and technology in the industry.
SEPS provides CETA National Board of Testing (CNBT) certified technicians to conduct testing and other critical quality processes in pharmacies across New York.