Michael Miller, Ph D, Microbiology Technical Services, LLC, Dunwoody, GA 30338. CDC and the National Institutes of Health addressed the topic in their publication Biosafety in Microbiological and Biomedical Laboratories, now in its 5th edition (BMBL-5).In 2008, CDC convened a Blue Ribbon Panel of laboratory representatives from a variety of agencies, laboratory organizations, and facilities to review laboratory biosafety in diagnostic laboratories.Laboratory reagents and solutions are used in analytical tests of components, in-process materials, and finished products.
The expiry date must be indicated on every standard substance and reagent and – where necessary – the shelf life after opening.The shelf life after opening should not exceed the expiry date of the unopened container.The impact of fresh or older reagents on the results can be determined when the analytical method is validated during the robustness evaluations.In accordance with ICH Q2B, the stability of solutions influences the analytical method and must be examined as part of the robustness.Storage under stricter conditions than required is normally permitted if appropriate for the substance.
However, not every standard substance or reagent is suitable for cool or cold storage (e.g. In order to minimise the impact of environmental conditions or freezing and thawing on the quality of a substance, the smallest possible containers or portions should be stored.For purchased laboratory reagents and solutions without a "use by" or expiry date, FDA would expect that an assessment be conducted (literature review may be acceptable) of that specific chemical's or chemical family's stability and that an appropriate "use by" or expiry date be determined.For in-house prepared solutions, such as mobile phases or other non-quantitative solutions, FDA would expect that an assessment be conducted (again, literature review may be acceptable) to determine an appropriate expiry period.When this date has been reached, the substances must be disposed of or their quality must be retested.If the result of the retest is positive, a new expiry date must be specified.They must be stored in climatically controlled rooms or storage areas.