Azzur Labs is dedicated to empowering our partners to maintain a safe environment for both patients and employees. To meet rigorous regulatory mandates, including USP <797> and USP <800>, Azzur Labs offers a simple testing kit for a variety of hazardous agents often handled in specialty pharmacies, including those that are hardest to test for and most difficult to clean.

Available Testing

To receive a testing kit(s), please select from the agents below to identify which drug you will be testing for.

The kit for all four compounds is available now to be purchased.  Azzur Labs has completed a robust validation, meeting USP requirements, using analytical testing methods for the recovery of these compounds.

Azzur Labs is committed to providing our partners with the most up-to-date testing resources. Currently, we are working to validate recovery methods for the following drugs, to ideally be available within 2020:

  • Variety of Platinum Drugs that can be tested with one sample: Carboplatin, Cisplatin, & Oxaliplatin

  • Variety of hydrophobic compounds including 5-Fluorouracil
     

Timing

Dec 2020 for above options
 

Process

Tests can either be ordered and delivered with step by step sampling guidance, or Azzur Labs staff can visit and test on site. 

USP<800> applies to handling of hazardous drugs (HDs) where there is a risk of exposure to patients, healthcare workers, and the environment and discusses testing for the presence of hazardous drug residues on possible product contact areas, eg: designated product receipt area through patient/administration areas.  Currently, there are no regulatory guidelines or standards for frequency of testing, method testing, specified areas to test, or limit criteria, however, any chosen method should be validated in accordance with ICHQ2 when conducting testing that falls under USP guidelines. Azzur Labs has validated an analytical method for the recovery of Methotrexate, Irinotecan, Cyclophosphamide, and Paclitaxel at a quantitation limit of 2ng/cm2.  The scope of this method meets USP standards for validation of methods and was completed on the most common material found in cleanroom environments (Stainless Steel) for recovery.  Azzur Labs will continue to add additional drugs to our testing capabilities as we develop validated methods.

Azzur Labs will report the results obtained to the client.  It is the client’s responsibility to interpret and apply the data provided for their specific needs.

If you have not ordered supplies from Azzur Labs before, please click here to set up an account.