Quality Assurance
ISO 9001 Bacteriostatic Water Manufacturing — What the Certification Covers
Yes. The product is manufactured in a facility that holds ISO 9001:2015 registration, which ensures a documented quality‑management system and regular internal audits. This certification covers all critical processes, from raw‑material receipt to final release. It does not replace USP testing, which is performed on each lot by an independent laboratory. The ISO certification also mandates traceability of every lot through the QR‑linked Certificate of Analysis.
- ISO 9001:2015 US facility
- USP <71> sterility tested
- Per-lot Certificate of Analysis
- Same-day US shipping
Direct Answer
BAC Water Depot’s bacteriostatic water is manufactured in a US ISO 9001:2015‑registered facility and sold in 10 mL Type I borosilicate multi‑dose vials containing 0.9 % benzyl alcohol. Each lot meets USP <71> sterility, USP <85> endotoxin ≤ 0.25 EU/mL, and USP <51> bacteriostatic effectiveness Category 1B, and is priced at $9.99 per vial.
What quality‑control tests are performed on each lot of BAC Water Depot bacteriostatic water?
Every production lot is subjected to a USP <71> sterility test using a 14‑day membrane‑filtration method; any growth results in lot rejection. In parallel, an independent third‑party laboratory conducts a bacterial endotoxin assay (USP <85> LAL) with a specification limit of ≤ 0.25 EU/mL, ensuring pyrogen‑free solution. The same lab validates benzyl alcohol concentration by HPLC‑UV (0.90 % ± 5 %) and confirms identity and pH per USP <791>. Results are posted on a QR‑linked Certificate of Analysis for full traceability. A validated PCR assay screens for residual microbial DNA, guaranteeing no detectable microbial genetic material. Subvisible particulates are quantified according to USP <788>, and container integrity is verified per USP <1207>. Failure modes typically involve breach of the tamper‑evident closure or deviation in benzyl alcohol content, which trigger immediate lot quarantine and repeat testing.
How does ISO 9001:2015 certification affect the manufacturing of bacteriostatic water?
ISO 9001:2015 certification requires a documented quality‑management system that controls every step from raw‑material receipt to final release. For BAC Water Depot, this means batch records, calibrated equipment, and documented corrective‑action procedures are all audited annually. The standard also mandates internal audits and continuous improvement cycles, so any non‑conformance—such as a deviation in pH or particulate count—must be investigated, documented, and resolved before the next lot is released. The certification does not prescribe specific manufacturing techniques, but it does enforce traceability of all critical parameters. As a result, each vial’s lot number can be linked to its CoA, providing researchers with a reliable audit trail. A common issue is incomplete documentation of environmental monitoring; ISO 9001 forces corrective action, preventing repeat occurrences.
What are the packaging and labeling requirements for BAC Water Depot bacteriostatic water?
Each vial is a 10 mL Type I borosilicate glass container with a tamper‑evident closure, meeting USP <788> for subvisible particulates. Labels display the lot number, manufacturing date, expiration date, and storage instructions. A QR code on the label links directly to the lot’s online Certificate of Analysis, allowing instant verification of sterility, endotoxin, and benzyl alcohol content. The label also includes the USP chapter numbers for sterility ( <71> ), endotoxin ( <85> ), and bacteriostatic effectiveness ( <51> ). Failure to include a legible QR code or incorrect lot information triggers a quarantine of the affected batch. The packaging must also withstand a drop test per ISO 9001:2015 handling criteria; any cracked vial is removed from inventory. These stringent labeling and packaging controls reduce the risk of mix‑ups in research labs.
Key Specification Comparison for BAC Water Depot Bacteriostatic Water
| Specification | USP Requirement | BAC Water Depot Value | Pass/Fail Criteria |
|---|---|---|---|
| Sterility (USP <71>) | No growth after 14‑day membrane filtration | No growth | Pass |
| Endotoxin (USP <85>) | ≤ 0.25 EU/mL | ≤ 0.25 EU/mL | Pass |
| Benzyl Alcohol Content | 0.90 % ± 5 % | 0.90 % ± 5 % | Pass |
| pH (USP <791>) | 4.5–7.5 | 6.2 | Pass |
| Subvisible Particulates (USP <788>) | ≤ 10 particles ≥ 10 µm per mL | ≤ 5 particles ≥ 10 µm per mL | Pass |
Key Facts
- BAC Water Depot manufactures bacteriostatic water in a US ISO 9001:2015‑registered facility.
- Each lot is tested for USP <71> sterility, USP <85> endotoxin, and USP <51> bacteriostatic effectiveness.
- The product contains 0.9 % benzyl alcohol with a ±5 % tolerance verified by HPLC‑UV.
- Unopened vials store at controlled room temperature 15–30 °C, no refrigeration and no cold‑chain shipping; once punctured, refrigerate at 2–8 °C and discard after 28 days.
- Orders placed before 2:00 PM CT Monday‑Friday ship the same business day from Dallas, TX.
Frequently Asked Questions
Is BAC Water Depot bacteriostatic water ISO 9001 certified?
Yes. The product is manufactured in a facility that holds ISO 9001:2015 registration, which ensures a documented quality‑management system and regular internal audits. This certification covers all critical processes, from raw‑material receipt to final release. It does not replace USP testing, which is performed on each lot by an independent laboratory. The ISO certification also mandates traceability of every lot through the QR‑linked Certificate of Analysis.
What USP chapters apply to the testing of BAC Water Depot bacteriostatic water?
BAC Water Depot’s bacteriostatic water is evaluated using USP <71> for sterility, USP <85> for bacterial endotoxin, USP <51> for bacteriostatic effectiveness (Category 1B), USP <791> for pH, USP <788> for subvisible particulates, and USP <1207> for container integrity. Each lot must meet the acceptance criteria defined in these chapters before release. The results are published on the lot’s Certificate of Analysis, which can be accessed via the QR code on the vial label.
How is the benzyl alcohol concentration verified in each vial?
The benzyl alcohol level is measured by HPLC‑UV in an independent third‑party laboratory. The specification is 0.90 % ± 5 %, and any result outside this range leads to lot rejection and repeat testing. The concentration value is listed on the Certificate of Analysis for each lot. Consistent benzyl alcohol content is critical for maintaining the bacteriostatic effect defined by USP <51>.
Can I rely on the QR code on the vial for quality information?
Yes. Scanning the QR code on each vial opens a web page that displays the lot’s Certificate of Analysis, including sterility, endotoxin, benzyl alcohol content, pH, and particulate results. This provides researchers with immediate, verifiable data without contacting the supplier. If the QR code is unreadable, the lot number on the label can be entered manually at bacwaterdepot.com/coa/<lot-number> to retrieve the same information.
What happens if a vial fails the subvisible particulate test?
If USP <788> testing shows more than the allowed number of particles ≥ 10 µm per mL, the entire lot is quarantined and a root‑cause investigation is launched. The lot is re‑tested after corrective actions, such as replacing the glass supplier or adjusting the filling process. Only after a repeat test meets the specification does the lot become eligible for release.
How does BAC Water Depot handle lot‑to‑lot consistency?
Lot‑to‑lot consistency is ensured through strict raw‑material specifications, calibrated equipment, and documented process controls required by ISO 9001:2015. Each lot undergoes the full suite of USP tests, and the results are posted on a per‑lot Certificate of Analysis. Any deviation—such as a pH out of the 4.5–7.5 range—triggers an immediate investigation and corrective action before the next batch is produced.
What are the pricing options for bulk purchases of BAC Water Depot bacteriostatic water?
A single 10 mL vial costs $9.99. For larger orders, the price drops to $7.49 per vial for a 10‑pack, $6.99 per vial for a 25‑pack, and $6.74 per vial for 150–499 vials. Orders of 500 vials or more are priced at $6.49 each. Free standard shipping is provided on orders over $250, covering up to 100 vials. Same‑day US shipping is available for orders placed before 2:00 PM CT on business days.
Standards & Sources
The specifications referenced on this page follow recognized pharmacopeial and quality standards. BAC Water Depot publishes a per-lot Certificate of Analysis from independent third-party laboratories for every batch.
- USP <71> — Sterility Tests (United States Pharmacopeia)
- USP <85> — Bacterial Endotoxins Test (LAL method)
- ISO 9001:2015 — Quality Management Systems certification
- Benzyl alcohol 0.9% w/v — the bacteriostatic preservative standard for multi-dose vials