Lab & Testing Services
|ScanRDI® Sterility Test Protocol
A rapid microbiological sterility test that utilizes the technology of fluorescent labeling and laser scanning to detect bacteria, mold, yeast and fungi.
|2 business days||$199|
|ScanRDI Method Suitability Test (required on file)||7 business days||$999|
|Anti-Microbial Effectiveness (AME) Test (USP <51>)
Demonstrates efficacy of anti-microbial preservatives in multi-dose containers.
|USP <51> Method Suitability Test (required on file) NEW
|Microbial Enumeration Test (USP <61>)
Identifies the presence of microorganisms within a non-sterile compound or product.
|7 business days||$195|
|USP <61>/<62> Method Suitability Test (required on file)||7 business days||$750|
|Objectionable Organisms (USP <62>)
Identifies the exact microorganism within a non-sterile compound or product.
|7 business days||$99/organism|
|USP <61>/<62> Method Suitability Test (highly recommended)||7 business days||$750|
|Sterility Test (USP <71>)|
|Identify bacteria, mold, yeast and fungi with two media at two separate temperatures.||14-18 business days||$95|
|Daily reading||14-18 business days||$100/day|
|USP <71> Method Suitability Test (required on file)||7 business days||$350|
Microbial ID, Media Fill, etc. — please call 800.745.8916
|Turbidimetric Bacterial Endotoxin Test System (USP <85>)*
Configured to compensate for beta-glucan interferences. All tests include a positive endotoxin spike to detect endotoxin inhibition/enhancement effects.
|2 business days||$99|
|USP <85> Method Validation – NEW||5 business days||$450|
|Particulate Count Test (USP <788>)
Ensures that solutions are free from particulate matter that cannot be quantitated by chemical analysis alone.
|5 business days||$150|
|Container Closure Integrity Test (USP <1207>)
Utilizing the “deterministic” method, evaluates the container closure system and its ability to maintain integrity of its microbial barrier.
|5 business days||$500|
Uses the advanced HPLC/UHPLC and Spectrographic instrumentation. Protocols have been developed based on USP <621> and <851> methodology.
|1-3 Actives||4 business days|
|4+ Actives||7 business days|
|Solid dosage forms: 1-3 Actives||5 business days|
|Solid dosage forms: 4+ Actives||7 business days|
Note: If Non PCCA API is used, send 25-40mg of API for use as a standard
|7 business days||$375|
|Pure API Assay||$500|
*Testing begins 1 business day after sample is received
* RUSH Service available for double the regular test price.
* Cancellation: Please note: A $50 cancellation fee will be assessed if cancellation is requested after samples have ar-rived at our facility. If testing has been initiated, the full price of the test will be charged.
† Certain topical pain preparations are $200/active. Common chemicals impacted may include, but are not limited to: amitripyline HCl; baclofen; clonidine HCl; cyclobenzaprine HCl; diclofenac sodium; flurbiprofen; fluticasone propionate; gabapentin; ketamine HCl; ketoprofen; lidocaine; lidocaine HCl; topiramate; and tramadol HCl.
All pricing in U.S Dollars and subject to change at any time.
Because the compendial method of testing takes 14 to 18 days to complete, it is extremely limiting in the compounding industry. A sterile compound with a standard 30 day expiry will lose approximately half of its shelf life due to sterility testing. This delay may discourage compounders from developing or adhering to a QA program, leaving them at risk of failing an FDA inspection.
However, there is a faster way to comply with USP <797> and ensure your patients are receiving quality compounds. The ScanRDI Sterility Test Protocol is an FDA-accepted alternative to the official compendial sterility test method. ScanRDI rapidly detects viable microbial cells down to one microorganism without the need for growth or cell multiplication. This removes the extended incubation period included in the USP <71> test method, so results are ready in just one day.
According to USP General Notices, alternate testing methods may be used if they can be shown to provide equivalent or better results. ScanRDI uses the same sampling protocols as USP <71>, detects all of the standard USP organisms
and has been shown to provide consistent and reliable results.1 Additionally, ScanRDI fulfills the method suitability requirement as outlined in USP <1223>. A
suitability test is performed on every unique drug formula sample submitted for ScanRDI testing. If the suitability of a compound does not pass this test, Eagle will inform the compounding pharmacist that it was incompatible with the ScanRDI method.
Want to learn more? Contact us at 800-745-8916, today.
1 Smith, R., Von Tress, M., Tubb, C., & Vanhaecke, E. (2010). Evaluation of the ScanRDI as a Rapid Alternative to the Pharmacopeial Sterility Test
Method: Comparison of the Limits of Detection. PDA Journal of Pharmaceutical Science and Technology, 64, 356-363
USP <51> Antimicrobial Effectiveness:
USP <61> Microbial Enumeration Test
USP <62> Tests for Specific Microorganisms
USP <71> Sterility Testing:
USP <71> Method Suitability Testing
Method development is the process of developing a stability indicating method through forced degradation studies that is appropriate for testing the potency of any given compounded formulation. Once the testing protocol is developed, method development includes method verification and method validation (see below).
Method Verification and Validation:
Method Verification is the process of testing a previously developed stability indicating assay to test the potency of a compounder’s specific formulation. Method Verification is performed to verify that no active or inactive ingredients in a compounder’s formulation are incompatible with the developed potency testing method, thus affecting the integrity of the results. This verification process also includes Method Validation, which is the process of building a statistical data package around the verified method that provides evidence of the accuracy, sensibility, specificity, and reproducibility of the testing methods used.
USP <85> Bacterial Endotoxin Testing:
USP <788> Particulate Count:
USP <1207> Container-Closure Integrity Testing:
USP Chapter <795> states: “… Compound preparations are to be prepared to ensure that each preparation shall contain not less than 90% and not more than 110% of the theoretically calculated and labeled quantity of an active ingredient.