SEPS technicians – who are all CETA professionals – offer pharmacy services to increase patient safety in pharmacies across New York, New Jersey, and surrounding areas.
USP 797 Compliance Consulting
In order to protect patient’s safety, the U.S. Pharmacopeia has implemented USP 797 to control the compounding and administration of pharmaceutical products in the United States.
At SEPS, we know how critical compliance with all safety standards is to your pharmacy’s success. Our accreditations and affiliations verify our status as a qualified service provider for several scientific fields. Therefore, we’ve collaborated closely with CETA in order to give our clients the education and resources they need to easily pass FDA inspection requirements.
With professional service and unbeatable experience in meeting USP-797 and FDA expectations, we will have your pharmacy passing and working in a timely manner.
What is USP 797 Environmental Testing?
USP 797’s standards aim to protect patients by significantly reducing the possibility of contamination during the compounding process. For pharmacies compounding medications (combining, mixing or changing a drug for an individual patient’s needs), maintaining conditions that adhere to these standards is critical. These policies don’t just keep the patients safe. In addition, they’re instrumental in protecting employees and the general public from exposure to hazardous agents during the process.
Labs and pharmacies require clean facilities for sterile compounding procedures. USP 797 standards apply to hospitals, pharmacies, physician practice facilities, and anywhere else CSPs are prepared, stored, or transported.
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SEPS USP 797 Compliance Testing & Certification
In order to make sure we keep our clients well within the right standards, we offer a variety of diverse testing techniques. USP 797 and other policies are in place for the betterment of public health. Therefore, they’re extremely important for compounding pharmacies. Without a doubt, your pharmacy’s reputation and customer service depends largely on your compliance with USP 797.
At SEPS, our Compliance, Testing & Certification services include:
- Room Pressure Gauge Calibration
- Laminar Airflow Units/Work Benches Testing & Certification
- HEPA Fan & Filter Integrity Testing
- Room Air Exchange Rates (Verifying proper ventilation)
- Airflow Visualization Studies
- Non-Viable Airborne Particulate Counting
- Biosafety Cabinet Testing & Certification
Consultation Services
With a team of certified experts, SEPS provides a singular point of view to easily bring you within compliance standards. We’ll analyze your pharmacy’s operations, examine protocol and assess your equipment, personnel and more.
Based on our assessment, we’ll consult with you one-on-one to acknowledge potential deficiencies and improvements. Ultimately, our team maintains decades of experience and useful insight we’ll share for the benefit of your pharmacy. Additionally, your patients will remain safe and, as a result, loyal.
UV Cleaning Verification Studies
Nowadays, the efficiency of cleaning protocol is an essential consideration for all pharmacies. Therefore, SEPS provides data which effectively negates or endorses each procedure based on our experts’ assessment.
For all of our clients, we bring to light specific variables that they would be unaware of otherwise. Basically, we help them to refine their cleaning protocol in order to ensure maximum impact. In addition, we can schedule studies during staff training to inform everyone firsthand. Each study uses a UV fluorescent agent that cleaning personnel can’t detect. Our team selects hard-to-clean, high-traffic areas or porous materials and applies the agent to these surfaces. Then, we can produce clear, visible data that provides an accurate idea of your practices.
GAP Analysis Consultation
This comprehensive analysis will elevate your pharmacy to a brand-new level of total, unprecedented efficiency. Whether in the wake of construction, or for a newly built pharmacy, all will need reliable, industry-standard quality assurance services.
SEPS Quality Assurance practices include:
- Routine disinfection and air quality testing of the direct compounding environment. Basically, this minimizes microbial surface contamination. Also, we’ll help you maintain ISO Class 5 air quality (under 100 particles)
- Visual air testing to ensure proper clean room operation; Including professional testing of your equipment such as laminar flow hoods, chemo hoods, glove box isolators; All tests performed by NSF Accredited technicians for maximum assurance of safety for your staff.
- For your convenience, SEPS stocks HEPA filters, motors and other parts for all equipment that we service, which will help maintain your laboratory equipment and minimize downtime.