Brand-independent consulting on closed system transfer devices (CSTD) for hospitals and pharmacies. We clarify whether using one makes sense in your facility, why, which perspectives need to be considered and which system fits your workflows in preparation and administration.
5 open transitions. Wherever the system opens, aerosols and drops can escape. Even when the work is done carefully.
System boundary closed. From the first puncture to disconnection the drug stays inside the system, and nothing gets in from outside.
Pressure equalizes through room air. Aerosols possible.
Pressure equalization without air exchange with the surroundings.
Microdroplets on needle and septum.
Closed coupling between vial and syringe.
Air and drug escape at the tip.
Venting inside the closed system.
Drops and leaks when injecting into the bag and connecting.
Drip-free connection to bag and line.
Drops and residual volume at open ends.
Drip-free disconnection, even when therapy is interrupted.
Exposure routes, contamination and consequences, from compounding to disposal.
EU directive, German Hazardous Substances Ordinance, TRGS 525, USP <800> and NIOSH, put into context for your facility.
Test evidence, pressure equalization and handling of the common CSTDs compared.
Pharmacy, nursing, occupational safety, infection control, QM, purchasing and management.
When technical prevention is possible, acceptance needs explaining.
nurses report symptoms that they attribute to handling cytotoxic drugs, mainly skin reactions, headaches and changes in taste.
of exposures happen during administration. That makes it the most frequent point in time, exactly where no safety cabinet protects.
80% of facilities have SOPs. But only 60% of nurses use gloves resistant to cytotoxic drugs.
Naegele M. German cancer nurses and occupational exposure to cytotoxic drugs: A cross-sectional study with a mixed-methods approach. Eur J Oncol Nurs. 2025;79:103014. View the study (sciencedirect.com)
At puncture, vials are under positive or negative pressure. Open systems equalize it through room air. This creates aerosols, or air with particles is drawn in. It happens even when the work is flawless.
Training reduces errors. A closed system transfer device reduces release. The two work on different levels.
Replace the hazardous substance. Generally not possible with cytotoxic drugs.
Safety cabinet, isolator and closed system transfer devices. They work regardless of behavior.
SOPs, training, cleaning instructions, spill kits, monitoring.
Gloves, protective gowns, respiratory protection. The last barrier.
There are clear guardrails for the preparation and administration of hazardous drugs. What matters is how they are implemented, justified and documented in your facility.
If a CMR substance cannot be replaced, it must be manufactured and used in a closed system as far as technically possible (Art. 5).
Hierarchy of protective measures: technical before organizational and personal measures (STOP principle, section 7).
Hazardous substances in healthcare facilities. Names transfer systems as suitable aids against release.
Protective measures must take the state of the art into account (section 4).
CSTDs are required when administering antineoplastic drugs, where the dosage form allows, and recommended for compounding.
NIOSH maintains the list of hazardous drugs and has drafted a test protocol for CSTDs. ONB is the US product class for closed system transfer devices.
Brief overview, not exhaustive. The assessment for your facility does not replace legal advice.
The term CSTD is not clearly defined in the European legal framework. Many systems are called "closed". What matters is what their test evidence actually proves.
Needle and syringe. Retains neither vapors nor aerosols. Spills and needlestick injuries are possible.
Spike with Luer connection or needle-free connector. Mechanically tight, but does not reliably retain vapors and aerosols. Drops at connection points remain possible.
No escape of drug, vapor or aerosol. No ingress of germs and particles from the surroundings. Drip-free disconnection.
Engineering tests prove function. Only a containment test shows whether a system retains hazardous drugs. In the consultation we go through the test reports of the systems relevant to you, across manufacturers.
Request a system comparison| Test | Proves |
|---|---|
| Pressure or air tightness | Components hold pressure without leaking. Mechanically tight. |
| Microbial tightness | Bacteria do not get in. A microbiological barrier is not a barrier against cytotoxic drugs. |
| Ethanol vapor test | Low evaporation of ethanol. Ethanol is not a cytotoxic aerosol. |
| Comparative test without a limit value | Differences between systems, but no proof of containment. |
| Containment test, e.g. following the NIOSH protocol | Retention of hazardous drugs and their vapors. |
The assessment is often made in the pharmacy, exposure mainly affects nursing, and the decision is made in purchasing and management. We look at CSTDs from each of these roles and bring them to one table.
Faster, safer compounding with a validated standard of protection.
Is the system boundary after vial puncture deliberately defined in your processes?
Protection of nurse and patient without extra effort.
Where do your nurses see drops today when disconnecting?
A verifiable standard of protection, visible in every wipe sample.
Which technical measures does your risk assessment provide for administration?
Transparency and legal certainty in every process step.
How do you demonstrate the state of the art today when handling CMR drugs?
Lasting cost-effectiveness with legal protection.
Under which parameters does use pay off for your facility?
Robust evidence: duty fulfilled, risk minimized.
Should your occupational safety rest on human perfection or on a system that limits release by design?
Visible safety builds trust in treatment and staff.
What degrees of freedom would be possible for your patients if the connections were technically secured?
Anyone who judges CSTDs by unit price alone overlooks the costs they avoid. These lie in waste, unused residual amounts, the choice of pack size and the organization.
The rest is discarded after preparation.
Residual amounts are used in a controlled way for subsequent preparations.
Whether using a CSTD pays off depends on the drug mix, pack sizes, multiple withdrawals and implementation. Model calculations from our practice show clear effects, depending on the facility. We run the numbers with your data.
Under which parameters is use cost-effective for your facility, and do you meet them?
Have cost-effectiveness reviewedEvery closed system transfer device covers the same four tasks, for preparation and administration. But manufacturers name their components differently. The comparison shows the common systems at a glance.
| Building block | BDPhaSeal™ Optima | SimpliviaChemfort™ | SimpliviaTevadaptor® | EquashieldEQUASHIELD® | ICU MedicalChemoLock™ | Epic MedicalProSeal™ | Yukon MedicalArisure™ |
|---|---|---|---|---|---|---|---|
| Vial adapterVial Adaptor, preparation | Protector | Vial Adaptor | Vial Adaptor | Vial Adaptor | Vial Spike | Vented Universal Vial Adaptor | Closed Vial Adapter |
| Syringe adapterSyringe Adaptor, preparation & administration | Injector | Syringe Adaptor (Lock) | Syringe Adaptor (Lock) | Syringe Unit | Injector | Transfer Injector | Closed Male Luer |
| Spike / bag adapterBag & Spike Adaptor, preparation | Infusion Adapter | Bag Adaptor SP / LL | Spike Port Adaptor | Spike Adaptor | Bag Spike | Bag Spike | Dry Spike |
| Luer lock / patient adapterLuer Lock Adaptor, administration | Connector | Luer Lock Adaptor | Luer Lock Adaptor | Luer Lock Adaptor | Port | Injection Site Male Luer Lock | - |
Component names according to manufacturer information and the US medical device database (FDA product code ONB), without sizes and variants. The mapping describes the function within the system and is not a comparison of equivalence or quality. - = not listed as a separate component in the documents reviewed.
Chemfort™ includes, among other components, the vial adapter with Toxi-Guard®, the syringe adapter Lock, the bag adapter SP and the LLm adapter. We assess Chemfort™ and Tevadaptor® independently of brands: in comparison with other CSTDs and in relation to your workflows in preparation and administration.
Request a system comparison for your facilityAll brand and product names mentioned are trademarks of their respective owners. They are named for context and do not constitute a recommendation. Not exhaustive; not every system is available in Germany.
As an expert conversation, as on-site consulting, as coaching for your project team or as training for your staff: we tailor content and format to your facility and your questions, online or on site at your facility.
Together with you we clarify whether using a CSTD makes sense in your facility, why, which perspectives need to be considered and which system fits your workflows.
A short initial conversation: which drugs and volumes, which workflows, and where is the system boundary after vial puncture defined today?
Compounding, transport, ward and outpatient clinic. We mark the transitions where the system opens and the protective measures that apply there.
Presentation, workshop or training for pharmacy, nursing, occupational safety, infection control and purchasing.
Regulatory assessment, cost-effectiveness based on your figures and a brand-independent system comparison.
On request we support trials, coaching of the project team and the changeover.
Closed system transfer device, CSTD: at its core every system consists of four building blocks. Select one.
also: Vial Adaptor, Vial Spike, Protector
Placed on the vial once and stays there. It punctures the septum and equalizes the pressure without exchanging air with the room. Depending on the system via a filter, a membrane or an expansion volume.
This is the first system boundary. If the vial stays closed after puncture, it can continue to be used in a controlled way.
Principle of pressure equalization, matching neck sizes (e.g. 13, 20 and 28 mm), residual volume in the vial.
also: Syringe Adaptor, Injector, Syringe Unit, Closed Male Luer
The counterpart to all other adapters. It sits on the Luer lock of the syringe, couples in a closed manner to vial, bag or line and disconnects drip-free.
It accompanies the preparation from compounding to administration. It determines whether connecting and disconnecting stay safe.
Number of steps, protection against accidental loosening of the Luer connection, suitability for automated compounding.
also: Bag Adaptor, Spike Adaptor, Bag Spike, Infusion Adapter, Spike Port Adaptor
Makes the injection port of the infusion bag compatible with the closed system. The drug is added through it and later administered.
The preparation leaves the pharmacy with a closed connection. On the ward nobody has to spike openly anymore.
Compatibility with the bag ports used in-house, universal or port-specific spike.
also: Luer Lock Adaptor, Connector, Port, patient adapter, LLm adapter
Closes the patient side at the infusion line, three-way stopcock or catheter. Bolus doses, connecting infusions and disconnecting all run through it.
Administration is the most frequent point of exposure. With this adapter even an interruption of therapy stays closed.
Fit with lines and access devices used in-house, dead volume, handling with protective gloves.
A transfer system that mechanically prevents drug, vapor or aerosol from escaping and contaminants from the surroundings from entering. CSTDs are used mainly with cytotoxic drugs and other hazardous drugs.
That depends on drugs, volumes, workflows in preparation and administration, existing protective measures and cost-effectiveness. That is exactly what we clarify in the consultation, with a view to pharmacy, nursing, occupational safety, purchasing and management.
Both. During preparation the CSTD protects when puncturing and drawing up. During administration it protects when connecting, during bolus administration and when disconnecting, in other words where there is no safety cabinet anymore.
The vial adapter stays permanently on the vial and provides pressure equalization. The syringe adapter sits on the syringe and couples in a closed manner to vial, spike or Luer lock adapters.
Among others BD (PhaSeal™ Optima), Simplivia (Chemfort™, Tevadaptor®), Equashield, ICU Medical (ChemoLock™, ChemoClave™), Epic Medical (ProSeal™), Yukon Medical (Arisure™), Vygon (Qimono™), Corvida (Halo®), JMS (NeoShield™) and Sidam (ClickLock™).
Yes. We advise independently of brands on all common CSTDs, including Chemfort™ and Tevadaptor® from Simplivia, BD PhaSeal™ Optima, EQUASHIELD® and ChemoLock™, and put them into context for your facility.
The isolator protects the compounding process. It does not protect pressure equalization at vial puncture outside the cabinet, nor transport, nor administration. Isolator = compounding barrier, CSTD = transfer barrier.
Not measured does not mean absent. Even with low values the probability of release physically remains. A CSTD lowers it structurally.
Training addresses behavior; release is caused by pressure differences and system opening. Training reduces errors, a CSTD reduces release. Under the STOP principle the technical measure comes first.
EU Directive 2004/37/EC requires a closed system for CMR substances that cannot be replaced, as far as technically possible. The German TRGS 525 names transfer systems as suitable aids. In the USA, USP <800> requires CSTDs when administering antineoplastic drugs. This assessment does not replace legal advice.
We prepare an individual quote based on scope and format before any costs arise. Your inquiry is non-binding.
Let us look at this along your workflows, ideally across disciplines with pharmacy, nursing, occupational safety, infection control and purchasing. We usually get back to you on the next working day.
Nothing selected yet. Go to CSTD Consulting for Oncology. You can also write to us without selecting anything.
Non-binding. You receive an individual quote before any costs arise.
Specialist information for healthcare professionals. quattramed Consulting advises independently of brands.