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Vial adapters are easy to use and pose less risk of needlestick injury than traditional syringe and needle manipulation. They not only provide needle-free transfer of liquid for reconstitution, but also enable consistent withdrawal of drug product from a vial. By providing such consistent withdrawal, the use of vial adapters can aid in reducing the amount of required overfill (extra drug product in a vial to address the fact that not all drug product can be removed), which may result in cost savings.
West has conducted a study examining this point: comparing the volumes of liquid (water for injection, or “WFI”) withdrawn from a vial via: (a) traditional needle penetration, and (b) use of a Vial Adapter 13mm female Luer lock (FLL). The study comprised three groups: 4 laboratory analysts experienced with vial adapters, and 20 persons not experienced with vial adapters (10 nurses and 10 persons suffering from hemophilia). Each person was trained on both withdrawal methods. Over 100 measurements were made with each. Data were weights of syringes before and after withdrawal.
*Internal data on file
Use of the Vial Adapter gave better consistency. The standard deviation for a 2 mL withdrawal was substantially lower with the Vial Adapter for all groups (see the table). From this it can be judged that delivery volume to the patient will likewise be more consistent – and with better volume of delivery, it follows that the amount of overfill can be reduced. As noted – this is a benefit to both the patient and to the pharmaceutical manufacturer. For more information visit the website or contact a Technical Customer Support representative.
Vial Adapters are 510(k) cleared by the United States Food and Drug Administration and carry the CE mark (0344). Products are shown for INFORMATION purposes only and may not be approved for marketing in specific regions. Distribution and use are subject to applicable regulatory approvals and requirements for medical devices. Please contact your West Pharmaceutical Services, Inc. (West) representative for product availability.Important product information, safety and warnings are included at: https://www.westpharma.com/products/vial-adapter-systems/vial-adapters
Cancer affects all of us, whether we are a patient, a family member, a friend, or a colleague of someone fighting cancer. Working together, we can increase our understanding of this disease and support the groundbreaking research that is ongoing in the fight against cancer.
Administration of cell therapy drug products requires the delivery of cell suspensions without loss of function or viability. Cells must be transferred aseptically from their original container closure system to the administration system by infusion. However, the common transfer practice of using needles and syringes to pierce vial stoppers to retrieve contents poses a risk, namely needle-stick injury to clinicians.
As cell therapies are making their way to the market, safe and efficient transfer/delivery presents a challenge. Needles and syringes are commonly used to retrieve cell therapies from vials, posing the risk of needle stick injury. To address this, West has evaluated the suitability of its needle-free polycarbonate vial adapters (VAs) for withdrawing contents from vials from both a compatibility and performance standpoint.
Designed to help improve consistency and reliability of intradermal inject.
With the growing importance of <strong>gene and cell therapies</strong>, storage of <strong>vial containment systems</strong> at ultra-low temperature (-80°C) and cryogenic temperature (vapor of liquid nitrogen, i.e., -130<sup>o</sup>C to -180°C) is more common. The primary consideration for storage at such temperatures is that the <strong>vial system</strong> can maintain <strong>container closure integrity </strong>(CCI) necessary for the <strong>drug product</strong>. There are two other considerations for the vial system, considerations more critical at such temperatures than at room temperature – proper filling and proper assembly. These have been discussed in two recent publications by West scientists:<br /><br />- <em>Volumetric Capacity of Daikyo Crystal Zenith® Vials Stored in Freezing Conditons </em>(Technical Report CZ TR 2022-039)<br />- <em>Potential Over-Pressurization Issues with Ultra-Low Temperature or Cryogenic Storage of Improperly Sealed Vial/Stopper Primary Package Systems </em>(Technical Service Bulletin TSB 2020-072)<br />
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