Bacteriostatic water is a purchased reagent, and in a laboratory that operates under Good Laboratory Practice or is accredited to ISO/IEC 17025 it is subject to the same controls as any other reagent: it has to be bought from an evaluated supplier, checked on receipt, labeled, stored as specified, used within its dates and traceable in the records. None of that is onerous, but it has to be written down. This guide maps the requirements to the records a laboratory keeps for bacteriostatic water.
GLP: 21 CFR Part 58
The reagents clause of the GLP regulations (58.83) requires that all reagents and solutions in the laboratory be labeled to indicate identity, titer or concentration, storage requirements and expiration date, and that deteriorated or outdated reagents not be used. For bacteriostatic water the manufacturer’s label already carries identity, concentration (0.9% benzyl alcohol), storage conditions and expiration date; the laboratory adds the date of first opening and the resulting discard date, because an opened multi-use vial has an in-use expiry that is earlier than the printed one. See how to label vials in the laboratory.
ISO/IEC 17025:2017
- Clause 6.4 (equipment) defines equipment broadly to include reagents, consumables and reference materials, so the requirements to handle, store and use them in a way that prevents deterioration apply to bacteriostatic water.
- Clause 6.6 (externally provided products and services) requires the laboratory to define requirements for what it buys, evaluate and monitor suppliers, and verify that externally provided products conform to requirements before use. For bacteriostatic water that means a supplier evaluation on file, a specification (USP grade, 0.9% benzyl alcohol, COA per lot), and a receiving inspection record. See questions to ask a supplier and the printable receiving checklist.
- Clauses 7.5 and 8.4 (technical records and control of records) require that records allow the work to be repeated and that the identity of materials used is traceable. Recording the lot number of the bacteriostatic water in each preparation record satisfies this. See labeling and record-keeping for prepared solutions.
The records checklist
| Record | What it contains | Where it lives |
|---|---|---|
| Supplier evaluation | Supplier name, evaluation date, criteria (documentation, storage, shipping), outcome, review date | Approved supplier list |
| Specification | Product name, grade, preservative and concentration, vial size, documents required per lot | Purchasing specification |
| Certificate of analysis | Per lot: sterility, endotoxin, pH, particulates, benzyl alcohol assay, expiry | Reagent file, by lot |
| Receiving inspection | Date received, lot, expiry, quantity, condition, temperature indicator if used, accept/reject, initials | Receiving log |
| Storage record | Location, temperature monitoring for the storage area | Storage log; printable temperature log |
| Opened-vial log | Lot, date opened, discard date, initials, date discarded | Bench log; printable opened-vial log |
| Preparation records | Each solution prepared, with the bacteriostatic water lot used | Notebook or LIMS |
| Disposal record | Lot, date, quantity, route | Waste log |
What auditors ask
In practice an auditor picks a preparation from a notebook and works backward: which vial, which lot, was it in date and within 28 days of opening, where is the COA, was the supplier evaluated, was the vial inspected on receipt, where was it stored and what was the temperature. If each of those questions has a record, the audit trail is complete. The SOP template ties the records together in one procedure.
Related
Lot numbers and traceability · For contract research organizations · For university and institutional laboratories
All BAC Water Supply products are supplied for laboratory research use only and are not for human or veterinary use.