At Lexamed, we are known for our ability to execute routine testing with the highest quality, accurate results, and predictable throughput on pharmaceutical lot release testing. Just as important, by specializing in routine release testing as well as stability testing to support labeling, we can offer our clients rapid turnaround times and concise, accurate reporting. This, combined with our relentless focus, monitoring and reviewing of the United States Pharmacopeia (USP) and its supplements, ensures our projects are on time, on budget, and in compliance with the latest regulations.
LexaMed offers a full complement of microbiology and
chemistry services in our state-of-the-art laboratories in Toledo, Ohio. With
tests from USP Sterility to Potency Assays, our technical experts partner with
you to develop appropriate and cost-effective programs, by applying more than
35 years of experience and regulatory compliance.
By working with LexaMed, you can be assured that you are
working with a fully FDA registered partner that is committed to quality, rapid
turnaround time, regulatory compliance and our clients’ satisfaction.
Sterility testing is necessary for pharmaceuticals and medical devices that claim to be sterile or free from viable microorganisms. Sterility testing methods are required to be accurate and reproducible, in accordance with 21CFR 211.194 and 211.165. USP Chapter <71> Sterility Test is the principal source used for sterility testing of sterile drug products produced by aseptic processing. The quantity and number of products to be tested is determined both by batch size and individual container fill volumes. It is important that the samples represent the entire batch and processing conditions. Samples should be taken at the beginning, middle, and end of the aseptic processing operation.
USP Chapter <85> Bacterial Endotoxins Test (BET) is an in-vitro assay to detect and quantity Gram negative bacteria, the source of endotoxin. The BET is performed as part of lot release testing for injectable pharmaceutical products with direct or indirect contact to the cardiovascular system, lymphatic system or cerebrospinal fluid. The assay is also used as a screening test for incoming components and as a Quality Control (QC) test for water used in the manufacturing process.
Particulate Matter consists of randomly sourced extraneous substances coming from a manufacturing environment that cannot be quantitated by a chemical analysis because of their heterogeneous composition. Injectables Solutions should be essentially free from visually observed particulates. USP Chapters <788> and <789> describe a two stage test approach for enumerating particles within specific size ranges stated for parenteral and ophthalmic solutions. Method 1 – Light Obscuration is the preferred method unless the product is not appropriate due to viscosity or clarity then Method 2 – Microscopic Analysis is applied. For all other solutions they are first tested by Method 1, if a solution fails to meet prescribed limits it must then be tested by Method 2.
The results obtained from testing a group of test articles cannot be extrapolated to other test units with certainty therefore it is important to develop a sound sampling plan. The plan should be based on operational factors, product volume, historical particulate numbers, particulate size distribution and variability of counts between units.
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