Cleanrooms often need sterile, documented water for routine dilution work and controlled handling steps—especially when your procedure requires lot traceability and predictable water-quality limits. AquaPur ST 8904 is positioned for that reality: a sterile, USP-specification purified water packaged for controlled environments, supported by case-level documentation and test-based quality parameters.

Example scenario: a pharmacy cleanroom mixes sterile disinfectants from concentrates on a defined schedule. If the incoming dilution water is inconsistent (or undocumented), the entire downstream cleaning record becomes harder to defend during audit. AquaPur ST is designed to reduce that friction by pairing sterile processing with traceable documentation and published water-quality limits.

• Dilution of sterile disinfectants where sterile water is required.
• General laboratory and cleanroom applications needing sterile, USP purified water at time of manufacture.
• Manufacturing utility use where lot documentation and defined water-quality limits are part of the quality system.

Important boundary: AquaPur ST is not intended for parenteral administration and is not for injection, irrigation, infusion, wound irrigation, or potable use.

• Sterilized and packaged in a double bag for controlled-area handling.
• Gamma-irradiated and tested to a sterility assurance level (SAL) of 1×10⁻⁶.
• Published water-quality limits (USP conductivity and TOC) and lot-specific documentation per case.
• Endotoxin and sterility testing referenced by USP methods (LAL for endotoxin; 14-day sterility test).
• Convenient case pack for inventory planning: four 1-gallon bottles per case.

Composition is water (CAS 7732-18-5), with the SDS identifying the product as non-hazardous under typical industrial handling. The technical documentation states the water contains no preservatives.

The product is produced through a validated system that incorporates deionization, reverse osmosis, UV treatment, and ultrafiltration, then processed by gamma irradiation for sterility assurance. The water is also filtered through a 0.2 µm filter.

“In context” means more than numbers: in regulated and inspection-driven environments, conductivity/TOC limits and lot documentation help reduce ambiguity in your cleaning records and support receiving inspection and batch traceability.

AquaPur ST is positioned as sterile purified water prepared and assayed to meet USP purified water specifications at time of manufacture, with published limits for USP conductivity and USP TOC. The documentation also describes endotoxin testing via USP LAL testing and sterility testing via a USP 14-day sterility test.

Practical cleanroom implication: when your process depends on dilution water quality, you are usually trying to avoid two predictable failure paths— (1) residues left behind by inconsistent water quality and (2) documentation gaps that complicate audit trails. Published limits plus lot documentation are the controls that typically matter most for that use case.

• Packaging: 1 gallon (3.8 L) bottles; 4 per case; double-bagged.
• Sterility approach: gamma-irradiated and tested to SAL 1×10⁻⁶.
• Traceability: each case ships with a traceable lot-specific document; manufacturer also notes QR-code access to lot documentation on the carton label.
• Handling note: sterility cannot be assured if the plastic bags are not sealed.
• Country of origin: not published in the source basis.

The “best” sterile water is the one that stays sterile and stays documented from receiving through point-of-use. Teams usually lose control in three places: receiving, staging, and decanting. The steps below are a practical template for protecting sterility intent and documentation value.

• Receiving/QA check: verify outer case integrity; confirm lot documentation is present (or accessible by QR code); confirm expiration date is within acceptance criteria.
• Bag integrity: before moving into a cleaner area, inspect the double-bag for punctures, broken seals, or moisture inside the bag. If the outer bag is compromised, quarantine per your quality system.
• Staging discipline: stage cases to reduce “open time” and avoid warm, high-traffic areas where bags are more likely to snag and tear.
• Aseptic transfer logic: if your process removes the outer bag at a transition point, define that step clearly (who removes it, where it is removed, and how the inner bag is handled).
• Decanting control: if you decant into smaller containers, treat the container as a new risk: define container cleanliness, closure method, labeling, hold time, and how you protect the bottle neck from contact contamination.
• Do not substitute for clinical uses: AquaPur ST is not for injection, irrigation, infusion, wound irrigation, potable use, or parenteral administration.

• Broken bag seal or puncture: sterility can’t be assumed once packaging integrity is compromised; quarantine and follow internal disposition rules.
• Loss of traceability: separating bottles from case documentation without relabeling creates a preventable audit gap.
• Neck contamination during use: touching the bottle finish/cap interior with gloves, wipes, or benches introduces avoidable bioburden risk.
• Improper substitution: using sterile purified water where sterile irrigation/injection-grade water is required is a compliance and patient-safety risk.
• Expired product use: shelf life is stated as 2 years with an expiration date on the bottle; define a clear hold/retest or disposal policy per your quality system.

In the sterile cleanroom-water category, the closest alternatives are other sterile purified water offerings packaged for controlled environments. When comparing, focus on what actually changes operational risk:

• Is the product sterile with a stated sterility assurance approach (and is it supported by lot documentation)?
• Is it double-bagged (or otherwise packaged for clean transfer), and are handling limitations clearly stated?
• Are conductivity/TOC limits published and aligned to your internal acceptance criteria?
• Are endotoxin statements and testing methods documented in the technical data sheet?

AquaPur ST 8904 fits environments that rely on sterile dilution steps and want predictable water-quality limits plus lot traceability—common in pharmaceutical, biotechnology, medical device, and cleanroom laboratory operations. It is most appropriate where your quality system expects: (1) documented incoming quality, (2) controlled packaging for transfer, and (3) clear product-use boundaries.