SAFETY & QUALITY
We are committed to operational excellence at every level.
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RELIABILITY
A CONSISTENT, RELIABLE SUPPLY FROM A TRUSTED PARTNER
Our built-in manufacturing redundancies optimize production performance to help reduce the risk of a supply disruption.
We work to provide you the peace of mind that the drugs you need will be there when you need them.
Water purification
Our products are formulated as aqueous solutions for injection, therefore water quality is a critical part of our compounding process. To help ensure safety, we produce our water on site using a pharmaceutical-grade water filtration system that meets USP Water For Injection (WFI) specifications. Water quality test results are checked to ensure conformance prior to release of product batches.
QUALITY ASSURANCE
We follow the regulatory requirements and guidance for 503B compounding, utilizing Current Good Manufacturing Practice (cGMP) standards. Our team of experts evaluates every material that enters and exits our facility with an extensive, multi-layered QA process. When active pharmaceutical ingredients arrive, they are placed in quarantine until thoroughly examined and released for use by QA. After the product is formulated, we perform another quality check and test to confirm product meets cGMP-level standard release testing requirements prior to release. Explore more.
PRODUCT TESTING
Products meet strict cGMP release testing specifications. Every finished compounded drug batch tested according to United States Pharmacopoeia (USP) standards before released into the market:
Sterility: Sterility testing is performed on EVERY BATCH compounded per USP <71>1.
Endotoxin: Endotoxin testing is performed on EVERY BATCH compounded per USP <85>2 and cGMP guidelines.
Potency: Potency is performed as a release criterion on EVERY BATCH compounded per finished product specification.
OFFERING YOU MORE WITH LESS HUMAN INTERVENTION
Contact SterRx® 1-844-319-7799 or email customerservice@SterRx.com
to learn how ready-to-use 503B-compounded products can benefit your facility
1 USP STERILITY TESTS <71>. United States Pharmacopeia. https://www.usp.org/sites/default/files/usp/document/harmonization/gen-method/q11_pf_ira_34_6_2008.pdf. Accessed March 04, 2021.
2 USP BACTERIAL ENDOTOXINS TEST <85>. https://www.usp.org/sites/default/files/usp/document/harmonization/gen-method/q06_current_webpage_stage_6_monograph_23_nov_2011.pdf. Accessed March 04, 2021.