Most problems with bacteriostatic water are handling problems: an undated vial, a tray stored in a freezer, a lot with no COA on file. A short standard operating procedure prevents all of them. The template below is written to be copied into a laboratory's own document format and adjusted to local rules. Section numbers follow common SOP practice.
1. Purpose
To define the receipt, storage, use, discard and record-keeping requirements for bacteriostatic water (sterile water containing 0.9% benzyl alcohol) used as a laboratory solvent and diluent.
2. Scope
Applies to all sealed multi-use vials of bacteriostatic water received, stored and used in [laboratory / facility]. Does not cover preservative-free sterile water, saline or buffers, which are handled under their own procedures.
3. Responsibilities
- Receiving: inspection on arrival, lot logging, COA filing.
- Stores / lab manager: storage conditions, stock rotation, issue to benches.
- Bench users: inspection before use, first-puncture dating, aseptic withdrawal, discard at 28 days, recording lot numbers in preparation records.
- Quality (if applicable): periodic review of records and storage.
4. Specification
Sterile water with 0.9% benzyl alcohol; bacterial endotoxins ≤ 0.5 EU/mL; pH 4.5 to 7.0; sealed vials of 3, 10 or 30 mL with crimped seal and flip-off cap; lot number and expiration date on each vial; lot-specific certificate of analysis. See USP water grades explained.
5. Receipt and inspection
- Inspect outer packaging for damage, water ingress or evidence of freezing.
- Inspect every vial: cap present, crimp intact, no cracks, contents clear and colorless, fill level uniform. Procedure: how to inspect a vial.
- Confirm all vials carry the same lot number and that it matches the certificate of analysis. Confirm expiration date meets the minimum remaining shelf life in [policy, e.g., 12 months].
- Record product, size, lot, expiration, quantity, date, inspector and COA reference in the inventory log. See lot traceability.
- Quarantine and report any non-conforming vials against the lot number; do not discard until the supplier has been notified.
6. Storage
- Controlled room temperature, 20 to 25 °C, in original cartons, away from direct light and heat sources. Do not freeze. Do not refrigerate sealed stock.
- Segregate lots; issue first-expiring, first-out.
- Monitor storage temperature per [facility practice]; investigate excursions below 15 °C or above 30 °C.
Detail: how to store bacteriostatic water.
7. Use
- Before each use, inspect the vial (Section 5, step 2). Discard on cloudiness, particles, color, almond odor or seal damage.
- On first puncture, write the date and the discard date (first puncture + 28 days) on the vial label. The discard-date calculator may be used.
- Wipe the stopper with 70% isopropyl alcohol and allow it to dry before every entry.
- Use a new sterile withdrawal device for every entry. Do not leave a device in the stopper. Do not return liquid to the vial. Do not pool vials.
- Record the lot number in the preparation record of every material prepared with the vial.
- Return the vial to its carton after use.
8. Discard
- Discard opened vials at the discard date regardless of remaining volume.
- Discard any vial past its printed expiration date, opened or not.
- Discard any vial failing inspection at any time.
- Dispose per Section 9.
9. Disposal
Residual bacteriostatic water is a dilute aqueous solution of benzyl alcohol. Follow [institutional] and local regulations for aqueous chemical waste; many facilities permit drain disposal with copious water for small residual volumes, but this must be confirmed locally. Empty glass vials go to the laboratory glass waste stream; withdrawal devices go to sharps waste. Vials that were quarantined for a supplier investigation are retained until the investigation closes. See disposal guide.
10. Records
- Inventory log (receipt, lots, issue, remaining).
- Certificates of analysis, filed by lot, retained for [period].
- Preparation records referencing lot numbers.
- Non-conformance reports for rejected vials or lots.
11. Training
All users read this SOP and demonstrate the inspection, dating and aseptic withdrawal steps before independent use. Retraining on revision.
12. References
Pharmacopeial water monographs and general chapters on sterility, bacterial endotoxins and particulate matter; manufacturer labeling and COA; BAC Water Supply knowledge base.
This template is provided for adaptation by qualified laboratory personnel and does not replace a facility's own quality system.
All BAC Water Supply products are supplied for laboratory research use only and are not for human or veterinary use.