Frequently Asked Questions
Below are some of the common questions we receive. Contact our support team for additional assistance.
Our representatives are available Monday to Friday: 7-30 a.m. to 6 p.m.
What are the minimum sample requirements for testing?
We’ve put together a document with information on the minimum sample requirements for potency and microbiological tests. Follow the link below to access the document.
How often should we be testing our compounded sterile preparations (CSPs)?
It depends on a number of factors. If your business is licensed as an outsourcing facility, release testing is required on every batch of product. If your business is licensed as a compounding pharmacy, USP <797> minimally requires sterility and endotoxin testing for all batches of CSPs that are 1) greater than 25 units and/or 2) have an extended BUD. Eagle’s view is that every batch of CSPs being dispensed should be tested in order to ensure patient safety.
Why does USP 71 sterility testing sometimes take longer than 14 days?
If the presence or absence of microbial growth cannot be readily determined by Day 14 (i.e. the test is inconclusive), incubation must occur for an additional 4 days. This most often occurs when performing sterility tests on sterile pellets and suspensions.
Why do I need to perform a method suitability test for my sterile products?
A method suitability test is required in order to verify that the sterility testing method works for your formulation. Method suitability testing involves inoculating your sample with 6 challenge microorganisms in order to ensure that they can be detected by the test and that no components of the compounded preparation inhibit microbial recovery.
How much do I send for method suitability testing?
The amount required for method suitability is dependent on your batch size and is calculated using values taken from Tables 2 and 3 of USP <71>. A formulation you can follow to calculate the required amount of product for testing is Table 2 x Table 3 x 6 (# of challenge microorganisms). Product sent for method suitability testing can be sent in bulk containers; it does not need to be packaged in unit-dose containers.
How do I extend my BUD?
In order to justify an extended BUD for a compounded preparation, a science-based stability testing program should be designed with data collected and analyzed over the course of the desired BUD for the preparation. Potency must be analyzed using a stability-indicating assay, which is a potency testing method that is developed and validated in order to separate active ingredients, excipients, and degradant products to allow an accurate quantitation of the potency of the active ingredient(s). Depending on the nature of the product being evaluated, additional microbiological, chemical, and/or physical tests may be required to justify the extended BUD.
What information is required to be provided for USP 85 bacterial endotoxin testing?
When submitting for USP <85> Bacterial Endotoxin testing, you will be asked to provide to us the maximum dose (mL/hr), the average weight of patient (kg), and the route of administration. This information is required so that the endotoxin limit (EU/ml) for the sample can be calculated.
How do I get laboratory reports once logged into EagleTrax?
Is Eagle open on the weekend to receive samples?
Yes! Eagle receives samples on Saturdays from 7AM-2PM Central