Department of Pharmacy, Jean-Monnet Hospital, 3, avenue R.-Schuman, 88000 Épinal, France.
Biomed Pharmacother. 2011 Feb;65(1):17-21. doi: 10.1016/j.biopha.2010.12.014. Epub 2011 Jan 5.
We present the way to integrate gravimetric control (GC) in a centralized preparation of cytotoxic drugs unit. Two different modalities are described. In the first strategy, the balance is located inside the isolator, whereas in the second, it is located outside in order to remove many technical and ergonomic constraints. These two modalities are compared in terms of benefits and limits.
GC consists in comparing the observed weight variation with the expected weight variation using a precision balance. According to the B-in strategy, this variation is directly attributable to the weight of the cytotoxic solution injected, whereas with the B-out strategy, the weight of various additional components must be taken into account.
Five hundred and seventy-seven preparations have been weighed. For "B-in" strategy, the 95% confidence interval is [1.02-1.14%] and every preparation is below the threshold of 5%. For "B-out" strategy, the 95% confidence interval is [2.34-2.63%] and 94% of preparations are below the threshold of 5%. B-in strategy is distinctly more precise than B-out strategy and can be applied to all preparations. However, B-out strategy is a feasible option in practice and enables the detection of an important mistake. All in all, results obtained from B-out strategy can be considered as a quality indicator in the production line.
Results of GC are helpful in the final step of release, which the pharmacist is responsible for. Many contributions in the quality assurance policy could justify using of GC in every unit.
我们介绍了将重量控制（GC）集成到细胞毒性药物集中制备单元中的方法。描述了两种不同的模式。在第一种策略中，天平位于隔离器内部，而在第二种策略中，天平位于外部，以消除许多技术和人体工程学方面的限制。这两种模式在收益和限制方面进行了比较。
GC 是使用精密天平比较观察到的重量变化与预期的重量变化。根据 B-in 策略，这种变化直接归因于注入的细胞毒性溶液的重量，而在 B-out 策略中，必须考虑各种附加成分的重量。
已经对 577 个制剂进行了称重。对于“B-in”策略，95%置信区间为[1.02-1.14%]，每个制剂都低于 5%的阈值。对于“B-out”策略，95%置信区间为[2.34-2.63%]，94%的制剂低于 5%的阈值。B-in 策略明显比 B-out 策略更精确，可以应用于所有制剂。然而，B-out 策略在实践中是一种可行的选择，能够检测到一个重要的错误。总的来说，从 B-out 策略中获得的结果可以被认为是生产线质量指标的一部分。
GC 的结果有助于药剂师负责的放行的最后一步。在质量保证政策中的许多贡献可以证明在每个单元中使用 GC 的合理性。
