2010 年 36 巻 12 号 p. 906-912
The use of closed systems is recommended to prevent occupational exposure to anti-cancer agents during preparation.The PhaSeal closed-system consists of an“Injector”and a“Protector”.Named“SOLUS”,the Protector can be used with reconstitution drug vials as well as drug solution vials.We therefore studied the compatibility of SOLUS and 41 kinds of reconstitution drug,as well as durability.
After attaching SOLUS to the vials,needle insertion was performed 10 times by the Injector.Thereafter,they were injected with a mixture of distilled water and sodium fluorescein (FL-Dw) under pressurization.Immediately afterwards,after 1 hour and 24 hours,the vials were examined under UV light to determine whether there was any liquid leakage following injection of FL-Dw,and then the same test was performed without pressurization.Next,“Protector P 21”or SOLUS was attached to the vials and FL-Dw was injected into them.Needle insertion was then performed 30 times under both pressurized and unpressurized conditions and vials were examined under UV.
The surface or membrane of SOLUS was determined to be fluorescent for 10 kinds of vial tested.Five types of vial were excluded because their diameter did not match the apparatus.Under unpressurized conditions,the apparatus could be used safely for needle insertion by P 21 or SOLUS up to 30 times.However,when vials required pressurization,inserting the needle 5 times caused leakage.
Twenty-six kinds of reconstitution drug vial could be used safely with SOLUS.However,there is still the possibility of exposure to anti-cancer drugs due to leakage and SOLUS should therefore be operated carefully.