Every vial, every lot, every time.
Pharmaceutical-grade standards aren't a marketing claim. They're the baseline. Here's how we maintain them across every production run.
Full transparency, every batch.
Every production lot ships with a complete Certificate of Analysis. No exceptions, no delays, no "available upon request" runaround. The COA is part of the shipment.
Each COA documents sterility testing results, endotoxin levels (LAL test), pH measurement, benzyl alcohol concentration verification, particulate matter analysis, and container closure integrity. Testing is performed by accredited third-party laboratories.
Need to review a COA before placing an order? We'll send one from a recent production lot so your QA team can evaluate before committing.
What's on every COA
USP CHAPTER
797
Scope
Compounding of sterile preparations
Authority
United States Pharmacopeia
Requirements
Environmental controls, personnel training, process validation, quality assurance protocols
The sterile compounding standard.
USP Chapter 797 is the United States Pharmacopeia's standard for sterile preparation and compounding. It defines the minimum practices and quality standards for preparing compounded sterile preparations (CSPs).
Our manufacturing processes adhere to USP 797 requirements across every production variable: environmental monitoring and controlled cleanroom conditions, personnel gowning and aseptic technique training, validated sterilization processes, in-process quality controls, and end-product testing.
For wholesale buyers, USP 797 compliance means the product you receive was manufactured under the same framework your own facility operates within. No gaps in the chain.
Documented, inspectable, accountable.
Our bacteriostatic water is manufactured in a facility that operates under current Good Manufacturing Practice (cGMP) guidelines and is held to USP standards for pharmaceutical-grade water.
cGMP covers every aspect of production: facility design and maintenance, equipment calibration and validation, raw material sourcing and testing, production process controls, packaging and labeling accuracy, and record-keeping for full traceability.
Bacteriostatic water is a well-established USP-grade formulation. It is manufactured under cGMP conditions that meet or exceed USP standards for pharmaceutical-grade water.
cGMP covers
We don't grade our own homework.
Every production batch is sent to accredited, independent third-party laboratories for testing. We do not rely on internal QC alone. The labs that test our product have no financial relationship with our manufacturing operations.
Sterility Testing
Per USP <71>, samples are incubated in both fluid thioglycollate medium and soybean-casein digest medium for 14 days. Any microbial growth means the lot is rejected.
Endotoxin Analysis
Limulus Amebocyte Lysate (LAL) testing per USP <85>. Endotoxin levels must fall below established thresholds. Results are quantified and documented on the COA.
Particulate & Purity
USP <788> particulate matter testing and chemical purity analysis verify that each lot meets or exceeds pharmacopeial specifications for injectable-grade water.
From raw material to your receiving dock.
Every vial carries a lot number that traces back through the entire production chain. If you ever have a question about a specific unit, we can tell you exactly where it came from.
Raw Material Intake
Sourced, tested, logged
Compounding
Batch mixed, QC sampled
Fill & Seal
Aseptic fill, crimp sealed
Testing & Release
Third-party lab verified
Ship & Deliver
Lot-linked to your PO
Clean rooms, not cutting corners.
Production takes place in ISO-classified cleanroom environments with continuous environmental monitoring. Air quality, temperature, humidity, and differential pressure are tracked in real time throughout every production run.
All personnel undergo validated aseptic technique training before entering production areas. Gowning procedures, media fill testing, and competency assessments are conducted on a recurring schedule.
Equipment is validated to documented protocols, calibrated on documented schedules, and maintained under a preventive maintenance program. Water systems are qualified to USP purified water standards with routine monitoring for bioburden and conductivity.
ISO-Classified Cleanrooms
Controlled environments with HEPA filtration and continuous particle monitoring
Validated Personnel
Recurring aseptic technique training, media fill testing, and competency assessments
Equipment Qualification
IQ/OQ/PQ protocols, documented calibration schedules, preventive maintenance programs
Water System QC
USP purified water with routine bioburden and conductivity monitoring
Ready to see the documentation firsthand?
Request a sample COA or get wholesale pricing. Our team typically responds within one business day.