Aseptic Technique for Multi-Entry Containers
For a laboratory container that may be accessed more than once, establish what the supplier documents for the unopened presentation and what your laboratory permits after first access. Record each entry against the individual container so that its handling history can be assessed.
Separate the starting state from later history
| Starting record | Access-history record |
|---|---|
| Product and formulation | Date and purpose of each recorded access |
| Lot and container identifier | Laboratory procedure and responsible person |
| Closure specification | Any observed closure concern |
| Initial microbiological evidence | Relevant incidents or deviations |
| Stated storage conditions | Actual storage and status history |
A preservative may inhibit microbial growth under specified conditions. Its presence does not demonstrate the current state of an opened vial. USP chapter <51> describes antimicrobial preservation in a pharmaceutical setting. For a research container, check the relevant formulation, closure and documented conditions. [1]
What an in-use statement must cover
A usable in-use statement identifies the material, formulation, container and closure, permitted access conditions, time period and supporting evidence. A record for another volume or another manufacturer’s product leaves the current presentation unassessed.
An antimicrobial component can interfere with recovery of microorganisms in a test. USP chapter <1227> explains why a recovery method must be shown suitable in the presence of the product. Before interpreting a low recovery result, ask how the method accounted for that formulation. [2]
Retain the opening record with the laboratory preparation record. Use the comparison of bacteriostatic and sterile water for label terminology and the quality documentation guide to distinguish formulation evidence from a microbiological test.
When history is incomplete
Suppose the first dated entry is a second access and the opening time is blank. Record the known entry, the unknown opening time and who reviewed the gap. Starting the clock from the later entry would give the container an unsupported in-use history. Handle a compromised closure through the laboratory’s safety and quality procedure.
The research lot log connects the container to its supplier lot. Through batch documentation, identify the exact unopened presentation when requesting records. Keep the supplier’s information alongside the laboratory’s own access history.
For an issue present on arrival, retain the receiving record. For an issue first noticed after opening, use preparation troubleshooting to reconstruct the events. The research guides cover the associated handling and storage records.
Other records for this assessment
| Resource | Why open it |
|---|---|
| Storage and Stability Across the Catalogue | Check what supports a material-specific storage condition or duration. |
Sources and scope
- USP (2017). General chapter <51>, Antimicrobial Effectiveness Testing. Public chapter introduction describing the role of preservation in certain aqueous pharmaceutical products.
- USP (2017). General chapter <1227>, Validation of Microbial Recovery from Pharmacopeial Articles. Public introduction explaining product-specific suitability when recovering microorganisms in the presence of a formulation.