You need to ensure your product’s sterility to protect patient safety, but does your current testing lab meet your needs? Element understands your urgent timelines and will work with you to meet your deadlines to get your product to market quickly.
Element provides USP <797>, USP <800> and cGMP FDA compliance expertise and testing solutions for home infusion, pharmacies, hospital pharmacies and human drug outsourcing compounding facilities.
USP <797> Pharmaceutical Compounding – Sterile Preparation
Compounding medications allows pharmacists to prepare individual prescriptions for patients who may have unique dosing requirements, allergies or rare diseases that prevent them from using commercially available formulations. Medications that are required to be sterile include injectables, IV, intraocular or intrathecal. USP <797> compounding standards establish baseline practices to ensure patient safety. We provide products and services designed to help you maintain control of your spaces and the efficacy of your methods.
Products and Services
- Compliance on Demand™ Proficiency Test Kits
- Environmental monitoring program implementation
- Full service on-site environmental monitoring
- Incubation and enumeration/genus ID for environmental monitoring samples
- Growth promotion testing of media/plates
- Cleanroom validation services (IQ/OQ/PQ)
- ISO 14644-1 Classification of air cleanliness certifications
- Air flow visualization (AFV)
- Cleanroom cleaning and disinfection program implementation
- USP <1072> disinfection qualification
- Compliance gap analysis
USP <800> Hazardous Drugs – Handling in Healthcare Settings
USP Chapter <800> provides standards for the safe handling of hazardous drugs. These standards are meant to minimize the risk of exposure to healthcare personnel, patients and the environment. We are available for consultation and compliance gap analysis reviews to ensure your team adheres to these standards.
For more information about our sterile compounding testing services or to request a quote, contact us today.
Our Environmental Monitoring programs allow pharmaceutical manufacturers and compounders to measure and monitor cleanliness and contamination levels within their facilities.
Compliance on Demand
Our Compliance on Demand™ program provides aseptic compounding proficiency test kits that validate confidence in your aseptic procedures.
On-demand Webinar: EM and Contamination Control in the Compounding Pharmacy
Watch a free webinar on USP <797> controlled environments and environmental monitoring.
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