How EQUASHIELD Closed System Transfer Device (CSTD) Works?

EQUASHIELD's unique CSTD Syringe Unit features an integrated barrier type pressure equalization system, a leak-preventing dry disconnection mechanism, and an encapsulated closed back syringe with a metal plunger rod to mitigate hazardous drug contamination, preventing vapor escape and plunger contamination. EQUASHIELD is FDA cleared under ONB product code and CE marked.

The EQUASHIELD® Syringe Unit is uniquely designed with a closed-back structure and a fixed connector, preventing plunger detachment. With this feature EQUASHIELD® Syringe Unit eliminates more routes of hazardous drug exposure than alternative systems, providing enhanced safety while also enabling them to use the most accurate syringe size for compounding and administration procedures. The system’s closed Syringe Unit prevents intended and unintended syringe plunger detachment and can be used safely up to its maximal nominal volume with hazardous drugs [1]. [1] Clark Bernadette A. and Sessink Paul JM. “Use of a closed system drug-transfer device eliminates surface contamination with antineoplastic agents.” Journal of Oncology Pharmacy Practice 2013

The EQUASHIELD Syringe Unit features a factory-welded connector, streamlining setup and saving time[2] [2] Berdi F, Powell M, Sanz C, et al. “Assessing the efficiency of CSTDs for compounding”. PP&P Journal. 2015; 7(suppl):S4-S10. in comparison to the process of opening two packages and assembling a connector onto a regular off-the-shelf syringe. Furthermore, the welded EQUASHIELD Syringe Unit eliminates the risk of luer disconnection and potential spills.

The Vial Adaptor's elastic membrane port has been validated for up to 10 connections with the Syringe Unit, ensuring no leaks or drug residuals on its surfaces[3], [3] Migal Analytical Chemistry Laboratory 2009. “Fluorescent Evaluation of Dry Connections in the Equashield, Phaseal and Tevadaptor/Onguard CSTDs” and effectively preventing transfer of environmental contaminants into the vial[4, 5]. [4] Nelson Laboratories (Salt Lake City, UT) 2013/14. “A 7 Days Microbial Ingress Test of Single Use Vials Utilizing the Equashield® CSTD” [5] Milouda&Migal Laboratories 2014. “Evaluation of Equashield Close System Compatibility in Prevention of Environmental Contamination”

The EQUASHIELD's system's reliability is further confirmed by FDA clearance and labeled as Preventing Microbial Ingress for up to 7 days[6]. [6] Equashield® does not extend the sterility and expiration date of the drug beyond manufacturer recommendations. Please refer to individual drug labeling or USP compounding guidelines for beyond use dating of a drug.
Rigorous tests were conducted, where the Vial Adaptor's membrane in growth media-filled vials was exposed to bacteria over 10 times within 7 days, totaling 770 Syringe Units[7]. [7] Nelson Laboratories (Salt Lake City, UT) 2013/14. “A 7 Days Microbial Ingress Test of Single Use Vials Utilizing the Equashield® CSTD”

The Vial Adaptor also features an innovative telescoping mechanism that guides its spike accurately to the vial stopper's center, averting angular spiking errors and negating the need for space-consuming assembly fixtures. Inside the Vial Adaptor, two internal fluid channels exist – one for the drug and the other for gases, both separated by an internal hydrophobic barrier to block liquid passage.

A simple, straight motion effortlessly connects and disconnects any EQUASIHELD components. The expansive flow channels in all system components facilitate swift transfers with minimal effort.

When the Syringe Unit is matched with the Adaptor, their membranes seamlessly lock together. This action triggers internal needles to pierce both membranes, all within a secure housing, minimizing needle stick injuries. Upon disconnection, these needles slide against self-sealing membranes, ensuring a drug-free and dry contact area.

The EQUASHIELD® connectors, through 10 repeated activations, have been proven to exhibit no leaks or drug residuals on external surfaces[3] [3] Migal Analytical Chemistry Laboratory 2009. “Fluorescent Evaluation of Dry Connections in the Equashield, Phaseal and Tevadaptor/Onguard CSTDs” They also efficiently prevent the introduction of environmental contaminants[7, 8]. [7] Nelson Laboratories (Salt Lake City, UT) 2013/14. “A 7 Days Microbial Ingress Test of Single Use Vials Utilizing the Equashield® CSTD” [8] Milouda&Migal Laboratories 2014. “Evaluation of Equashield Close System Compatibility in Prevention of Environmental Contamination”

The FDA has acknowledged the effectiveness of the EQUASHIELD® system, labeling it as capable of Preventing Microbial Ingress for up to 7 days[9]. [9] Equashield® does not extend the sterility and expiration date of the drug beyond manufacturer recommendations. Please refer to individual drug labeling or USP compounding guidelines for beyond use dating of a drug.

EQUASHIELD® Syringe Units maintain a closed pressure equalization that prevents the escape of vapors and aerosols during compounding and administration. A unique dual-needle, air-to-liquid exchange system, combined with a closed-back sterile air chamber behind the syringe, ensures that pressure is equalized in a system throughout the hazardous drug handling process.

Upon disconnection, the retracting needles sweep across the resealing membranes, effectively preventing any contact between the drug and the outer membrane surface. This process ensures that the contact area remains dry and entirely free of residues.

EQUASHIELD® offers an extensive array of Adaptors, Connectors, and Tubing sets to cater to various drug transfer scenarios, accommodating diverse vial sizes, IV Bags, and IV pushes. Central to these offerings is the shared closed mechanism for connection and disconnection, ensuring a seamless and uniform process.