While final adoption of USP <800> is still pending, this standard is meant to provide for safe handling of hazardous drugs so the risk of contamination to healthcare personnel, patients, and the environment is minimized. It’s important to recognize this is intended to regulate employee protection.
Azzur Labs is dedicated to empowering our partners to maintain a safe environment for both patients and employees. To that end, Azzur Labs offers a simple testing kit for collecting samples of a variety of hazardous drugs often handled in specialty pharmacies, including those that are hardest to test for and most difficult to clean.
Available Sampling and Testing
To enable our clients to meet the requirements of USP <800> Azzur Labs has completed a robust validation in accordance with ICHQ2 of swab sampling followed by analytical testing of several Group 1 hazardous drugs. The validation was completed on the most common material found in cleanroom environments (stainless steel). This validation meets USP requirements for the recovery of these hazardous drugs from stainless steel.
Sampling kits are available for you to purchase and subsequently use to collect samples of these hazardous drugs. Step by step instructions are included in the sampling kits to aid in the sampling process.
Group 1 Drugs: cyclophosphamide, methotrexate, irinotecan, daunorubicin, doxorubicin, paclitaxel (all tested within one sample)
Group 1 Platinum Drugs: carboplatin, cisplatin, and oxaliplatin (all tested within one sample)
Azzur Labs will continue to add additional drugs to our hazardous drug service offering as we develop validated methods. If you have a need to test for a specific hazardous drug that is not included in this list above, please contact us. We will work with you to develop a plan to address your unmet needs.
Sampling kits can either be ordered and delivered with step-by-step sampling guidance, or Azzur Labs staff can visit and sample on site. The kits are then returned to Azzur Labs where they are analyzed using ICP-MS (platinum drugs: carboplatin, cisplatin, and oxaliplatin) or LC-MS/MS (cyclophosphamide, methotrexate, irinotecan, daunorubicin, doxorubicin, paclitaxel).
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 operation.
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