The only clinically proven Closed
System Drug Transfer (CSTD)
Device
Endorsed by FDA and the Ministry of Health,
Malaysia
About BD (Becton, Dickinson & Company)
BD is a leading medical technology company that manufacture and sell a broad range of medical supply devices, laboratory equipment and diagnostic products. It’s headquarter is in the United States and has offices in more than 50 countries worldwide.
Pharma Ace represents PhaSeal® – the only clinically proven Close System Drug Transfer Device (CSTD) that prevents hazardous drug interaction throughout your environment of care.
We aim to improve the quality of life for healthcare personnel who prepare, administer and handle waste from hazardous drugs. PhaSeal® is the one and only Close System Drug Transfer Device (CSTD) endorsed by FDA and the Malaysian Ministry of Health.
Pharma Ace’s role as a distributor includes the promotion of occupational safety in the preparation of cytotoxic drugs in healthcare.
The PhaSeal® closed drug transfer concept builds on a unique solution. The system uses a double membrane to create a leakproof connection. In addition, the closed expansion chamber makes the system airtight consequently containing all aerosols, particles and vapours. The expansion chamber also equalizes the pressure within the system.
Although the system uses few components and only one connection interface, PhaSeal can handle most types of IV sets and syringes to enable a totally safe and convenient administration of drugs.
“Let us keep you safe – in all
phases of handling.
phases of handling.
With PhaSeal®, you can focus
on the real values.”
on the real values.”
“Let us keep you safe – in all phases of handling.With PhaSeal®, you can focus
on the real values.”
Clinical Studies
Health Technology Assessment Report by The Malaysia Ministry of Health
Cytotoxic drugs used in the treatment of cancer as well as some non neoplastic diseases are of immense benefit to patients. However, they present serious risks to those routinely handling them, namely, the doctors, oncology nurses and pharmacy staff. These health care workers are the ones responsible for the drug preparation, handling of waste products and administering the cytotoxic drugs.
PhaSeal is the only close system device approved by the Malaysian Ministry of Health. It is the only clinically proven closedsystem drug transfer device that prevents hazardous drug interaction throughout your environment of care.
BD Phaseal Clinical Evidence
A summary of the published clinical evidence of the effectiveness of the BD Phaseal closed-system drug transfer device (CSTD)
www.bd.com/pharmacy/phaseal/evidence/studis.asp
- Studies evaluating fluid leakage during preperation and administration
- Studies evaluating vapour leakage during preperation and administration
- Studies examining the impact of BD Phaseal on environmental contamination and exposure of personnel
- Studies evaluating microbiological integrity and its impact on pharmacy cost-savings scenarious
- Studies evaluating the impact of BD PhaSeal on workflow and staffing
Frequently Asked Questions
Standard FAQs
Handling FAQs
Technical FAQs
General FAQs
Standard FAQs
In general, to avoid clogging the filter in the expansion chamber the system should always be pressurized with the syringe vertically above vial and the end of the needle in the air space above the fluid. Try to aspirate liquid back into the syringe with as little air as possible. The slower you aspirate the fewer air bubbles will be created.
Small bubbles can be pushed back; the whole assembly must first be inverted so that the vial is vertically above the syringe.
If you prefer working fast and need to push air bubbles back into the vial, we recommend that you push them back when you have aspirated two-thirds of the desired volume into the syringe. When you then aspirate the last third of the volume this will rinse the filter and maintain satisfactory performance of the expansion chamber.
Yes.
Yes. Store the vial with the Protector in an upright position and allow it to reach room temperature before use. Make sure to refer to the instructions of the drug manufacturer.
The Connector should be treated as an integral part in the patient’s IV line. Follow the local procedure for IV administration in your hospital.
All lines that fit regular infusion bags will fit the Infusion Adapter.
NOTE: A non-vented IV set should be used together with the C70 or C100 Infusion Adapter. If a vented set is used, make sure that the air inlet is closed throughout the infusion procedure.
The PhaSeal products should be disposed in the normal chemotherapy waste without taking the components apart. This means that the benefits of the closed system are maintained during the process of waste handling.
The PhaSeal products are packed in sterile packages. There is no need to swab the membranes before the first use, providing aseptic technique is used. The membranes can be wiped with alcohol, e.g. isopropanol (IPA) pads or swab sticks before reusing the port. Follow the local procedure for parenteral administration in your hospital.
Handling FAQs
Yes, attach the Injector to the Connector by pushing the two membranes together then turning clockwise to lock the pieces together. Slightly lift the latch on the Injector and push the Injector down to engage the needle. Push until only 1/3rd of the clear plastic sheath is visible. The port is now active. NOTE: If there is occlusion when trying to administer the drug, gently compress the Injector and pull back until unrestricted flow is achieved. Never disconnect the Connector from the CLAVE port.
Yes, the PhaSeal system can be used with syringe pumps. Some pumps may need a modified set-up with some sizes of syringes. Contact your local PhaSeal representative for details.
No, ampoules are open and PhaSeal is a closed system for handling hazardous drugs. It is only suitable for use with vials.
The local management needs to make a decision from a hygienic point of view about whether the Assembly Fixture will be used outside the BSC.
Yes.
Follow the local guidelines.
Injector Luer Lock (N35) is designed with ErgoMotionTM, a safety system that ensures that the needle can only be activated when the Injector is engaged with a Protector or Connector in a closed system. This eliminates the risk of needle exposure during normal use. With Injector Luer (N30), the red safety latch is in the flat position, parallel to the white part of the Injector.
Technical FAQs
Yes, but the rubber port or the Y-site needs to be converted to a Luer lock using an access pin. The Connector Luer Lock fits into all Luer lock connections.
You can also use the C80 Y-Site Connector for easy access.
The Injector Luer (N30) fits on to all Luer slip syringes and the Injector Luer Lock (N35) fits on to all Luer lock syringes.
The Injectors comply with OSHA’s needle safety guidelines.
Infusion Set C50 is equipped with inline 15 µm filters. Other PhaSeal products do not contain filters.
18 G, (OD 1.20 mm ID 0.90 mm)
0.04 ml
No, the end of the needle does not protrude beyond the Connector Luer Lock.
The internal volume of the Infusion Adapter, C100, is 0.16 ml.
There are two layers of plastic material, one layer of Polyamid (PA) and one layer of Polypropylene (PP)
Yes, all components in the PhaSeal system are Latex-free.
The Injector, Protector, Connector and Infusion Adapter C100 do not contain PVC. The Infusion Set C50, the Secondary Set C61 and the Y-Site Connector C80 contain PVC without DEHP plasticiser.The Infusion Adapter, C70, has a 4 cm long PVC tube between the spike and the connection port. All components can be used safely with Paclitaxel.
Yes, the Injector Luer Lock, N35, has a medical grade silicone seal which does not come in direct contact with the drug during normal use. Silicone is a frequently used material in disposable three-part syringes, These have a silicone seal or are sprayed with medical grade silicone oil for lubrication.
TPE (Thermo Plastic Elastomer)
All sterile products are packed as single units in blisters.
All membranes can be perforated up to 10 times.
General FAQs
Yes, PhaSeal is protected by a number of patents.
The use of PhaSeal will normally slow down the preparation time for one or two weeks before the staff gets used to the system. According to Poirier et al, J Oncol Pharm Practice, 2004,“pharmacy technicians were able to return to their pre-trial efficiency in preparation after a few hours in a biological safety cabinet. Nursing staff required a few days to experience regimen specific administration procedures. By the end of week two, pharmacy and nursing staff were back to pre-trial preparation and administration times.”
PhaSeal is a closed system with dry connections over double membranes and without any contact to the atmosphere. Neither particles nor vapour escape from the PhaSeal system. Chemospike are open vented with wet connections.
The steel cannula of the PhaSeal Protector makes the system compatible with most of the cytotoxic drugs on the market.
All products in the PhaSeal system are sterilized using ethylene oxide except for Syringe Tray M15, Infusion Clamp M20 and Infusion Clamp M25 which are non sterile.
Yes, when aspirating the last few mL it is possible to retract the Injector needle in order to minimize the residual drug volume in the vial.
Products
Protector
P14 – Protector
P21 – Protector
P50 – Protector
Injector
N35 – Injector Luer Lock
C90 – Connector Luer Lock
C35 – Connector Luer Lock
Administration Products
C100 – Infusion Adapter
C50 – Infusion Set
C61 – Secondary Set
C62 – Secondary Set
C110 – Cyto Inline Admin Set