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BD PhaSeal™ Optima System

The next generation Closed System Drug Transfer Device (CSTD) from BD that advances hazardous drug protection

Overview
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The PhaSeal™ Optima System, a second generation Closed System Drug Transfer Device (CSTD), retains the architecture of the PhaSeal™ System and utilises the same physical barrier technology to help prevent hazardous drug exposure.¹ This includes a vapour-capturing mechanism integrated into the vial protector and self-sealing, membrane-to-membrane connections that maintain an airtight, leakproof seal—even upon disconnection—ensuring safe and secure drug transfer.^2-4

The PhaSeal™ System is the first Food and Drug Administration (FDA) cleared CSTD under the ONB product code for both preparation and administration.^5,6

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Every component of the PhaSeal™ Optima System⎯injector, protector, infusion adapter, connector⎯is designed with no inlets or air exchange for completely airtight transfers of hazardous drugs.^2,7

BD^® Texium™ System

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BD^® HD Check system

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Please note, not all products, services or features of products and services may be available in your local area. Please check with your local BD representative.

PhaSeal Optima Technical Data Sheet V201-069 Rev. 04, July 2025
Data on File: 922940-ES-0137 Evaluation of PhaSeal™ Optima Vial Adapter Pressure Loss During Assembly, April 2018
Data on File: 922940-E5-0125 Evaluation of PhaSeal™ Optima via NIOSH Vapor Containment Testing Report, July 2019
Data on File: Memo on Performance Assessment of the new PhaSeal™ Optima System, August 2020
Data on File: Memo on Summary of research for BD PhaSeal™ System as first FDA cleared CSTD, June 2022
FDA ONB Clearance Letter, January 2013
Data on File: 922940-ES-0115 Vapour Leakage Testing with Titanium TetraChloride w/Aging, November 2017
Centers for Disease Control and Prevention (CDC). Easy Ergonomics: A Guide to Selecting Non-Powered Hand Tools. https://www.cdc.gov/niosh/docs/2004-164/pdfs/2004-164.pdf. Published August 18, 2004. Accessed July 15, 2025.

With design innovations to address your clinical and economic concerns

Ease of use

The BD PhaSeal™ Optima System is easy to use, and connects with one step

PhaSeal™ Optima System provides an intuitive one-step straight-push connection for ease of use, aiding workflow integration.

Minimise learning curve

Designed to help minimise the learning curve with:

Intuitive one-step straight-push connection

No alignment or orientation needed to connect

Let our trained clinical specialists help you efficiently integrate the PhaSeal™ Optima System into the workflow of your facility.

Ergonomics

Offer your pharmacists and clinicians an ergonomic CSTD solution

We conducted head-to-head comparisons and asked both longstanding CSTD users and traditional technique users how we could improve our design. The feedback and validation we received guided us to optimise every component of the PhaSeal™ Optima System for user comfort.¹

Align with NIOSH recommendations²

Uses a power grip and straight motion to connect and disconnect
Aligns with NIOSH recommendations to avoid pinch grip for hand-held tools²

Our trained clinical specialists can also help train your pharmacists and clinicians in best practices for preparation and administration using the PhaSeal™ Optima System.

Performance

The BD PhaSeal™ Optima System can help you maximise drug extraction for each vial

In addition to meeting the NIOSH CSTD definition³, the PhaSeal™ Optima System protector was designed to maximise extraction of drug-vial contents and minimise residual drug loss, helping to reduce drug waste with each drug vial.⁴

Minimising residual fluid loss with a CSTD such as the PhaSeal™ Optima System may translate into a reduction in drug waste that can help optimise preparation of hazardous drugs for hospitals and healthcare professionals and their patients.⁴

Designed to maximise performance

Prevents microbial ingress* and may maintain drug vial sterility for up to 168 hours and 10 penetrations.^5-6
Meets the requirements of the NIOSH isopropanol (IPA) draft CSTD-test protocol, a robust test protocol applicable to barrier-type CSTDs.³*
Optimised spike-fluid channel and secure vial attachment engineered to common International Organisation for Standardisation (ISO) standards.
Compatible and connects with ISO-compliant syringes, IV sets, luer fittings and standard-size drug vials.

*Within an ISO Class V environment following aseptic technique. The ability to prevent microbial ingress for up to 168 hours should not be interpreted as modifying, extending or superseding a manufacturer's labelling recommendations for the storage and expiration dating of the drug vial. Refer to drug manufacturer's recommendations and USP compounding guidelines for shelf life and sterility information.

Safety

Designed to reduce the risk of surface and environmental contamination of hazardous drugs

The PhaSeal™ Optima System may help improve healthcare worker safety by reducing the risk of surface contamination to hazardous drugs. The PhaSeal™ Optima System incorporates the double membranes and vapor capture mechanisms pioneered by the PhaSeal™ System, which has been demonstrated to reduce the risk of hazardous drug exposure.

The PhaSeal™ Optima System meets the NIOSH definition of a CSTD³ that mechanically prohibits the transfer of environmental contaminants into the system and the escape of drug vapor concentrations outside the system, thereby minimising individual and environmental exposure to drug vapor, aerosols and spills.

Secure your luer lock connections with the option of the PhaSeal™ Optima N40-O locking injector

Locking feature that locks securely to the mated Luer device
Spinning collar enables rotation of syringe to view scale markings and prevent tangling of IV lines
May reduce drug leaks, large spills and waste.⁷
Helps prevent leaks in transport to clinical settings.⁸

Leakproof and airtight by design

Spike design prevents vapor leakage when puncturing a vial
Self-sealing membranes on all components
Airtight drug transfers in preparation and administration

Let our trained clinical specialists help you seamlessly upgrade your facility to the PhaSeal™ Optima System.

Data on File: Project Avalon, Commercial Excellence Review Development Phase Exit, April 2017
Centers for Disease Control and Prevention (CDC). Easy Ergonomics: A Guide to Selecting Non-Powered Hand Tools. https://www.cdc.gov/niosh/docs/2004-164/pdfs/2004-164.pdf. Published August 18, 2004. Accessed July 17, 2025
National Institute for Occupational Safety and Health (NIOSH). (2016, March). A vapor containment performance protocol for closed system transfer devices used during pharmacy compounding and administration of hazardous drugs (NIOSH Docket Number 288, CDC-2015-0075). Centers for Disease Control and Prevention. Accessed via https://www.cdc.gov/niosh/docket/archive/docket288.html on September 3, 2025
Data on File: 922940-ES-0136 Evaluation of PhaSeal Optima residual Drug Loss Performance Testing, June 2018
Nelson Labs Microbial Barrier Performance GLP Report, October 2018
Instructions for Use (IFU) for PhaSeal™ Optima Protectors, 10000239299 rev.07
Polovich, M., Olsen M., (2018). Safe handling of hazardous drugs (3rd ed.). Pittsburgh, PA: Oncology Nursing Society. https://openlibrary.org/books/OL53965215M/Safe_Handling_of_Hazardous_Drugs
The Joint Commission. (n.d.). Safe handling of hazardous drugs. Accessed via https://www.jointcommission.org/en-us/safe-handling-of-hazardous-drugs on September 4, 2025

Easy to use in the preparation and administration of hazardous drugs

See how pharmacists and clinicians can implement the airtight and leakproof PhaSeal™ Optima System.

Preparation

BD PhaSeal™ Optima System instructional video for preparation

Administration

BD PhaSeal™ Optima System instructional video for administration

And with ongoing product training and education, our trained clinical specialists can help your facility upgrade seamlessly from your current method to the PhaSeal™ Optima System.