> Can I use the PhaSeal system with CLAVE needle free valves?
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.

> Can I use the PhaSeal System with Medfusion 3500™ Syringe Pumps?
Yes, The PhaSeal system may be utilized with the Medfusion™ 3500 syringe pumps with syringes that are 10 mls or larger. Syringes that do not meet the manufacturer’s instructions for set up or are smaller than 10 mls should not be used for administration of hazardous drugs with the Medfusion™ 3500 in conjunction with the PhaSeal system. NOTE: When using the PhaSeal system with a 60 ml syringe there is a risk of tubing dislodgement.

> Can I use PhaSeal with drugs that come in ampoules?
No, ampoules are open and PhaSeal is a closed system for handling hazardous drugs. It is only suitable for use with vials.

> Can I use the Assembly Fixture and cap the vials outside the BSC?
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.

> If I have an air bubble in the syringe can I push back into the vial and keep the performance of the expansion chamber?
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.

> Can I check for blood return while administering a chemotherapeutic agent via IV Push?
Yes.

> Do I still need to double glove?
Follow the local guidelines.

> How can I be sure that the Injector needle is in the locked position?
The blue/red safety latch is in the flat position, parallel to the white part of the Injector.

> How long can the Connector stay on the patient’s IV line?
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.

> Can I attach the Connector Luer Lock to tubing with rubber ports or Y-sites?
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.

> What IV tubings are compatible with the PhaSeal Infusion Adapter?
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.

> Does the Injector fit on to a 1 ml (TB) syringe?
The Injector Luer (red safety latch) fits on to all Luer slip syringes and the Injector Luer Lock (blue safety latch) fits on to all Luer lock syringes.

> Can I use PhaSeal with syringes pumps?
There are some Luer Lock syringes designed specifically for infusion pumps. Some of these are not compatible with the PhaSeal system.

> What does Occupational Safety and Health Administration (OSHA) say about PhaSeal and needle safety?
The Injectors comply with OSHA’s needle safety guidelines.

> How should PhaSeal products components be disposed of?
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.

> Do I need to swab the membranes with alcohol before connecting the Injector with the Protector or the Connector Luer Lock?
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 alcoholic swabs before reusing the port. Follow the local procedure for parenteral administration in your hospital.

> Can PhaSeal be used on drugs where the package insert states “do not use filter”?
Infusion Set C50 and C55 are equipped with inline 15 µm filters. C55 is also equipped with a 0.2 µm filter intended for filtering Taxol.

Other PhaSeal products do not contain filters.

> What is the gage of the Injector Luer Lock needle?
18 G, (OD 1.20 mm ID 0.90 mm)

> What volume of fluid does the 18G needle hold?
0.04 ml

> Can the Injector needle damage any valves?
No, the end of the needle does not protrude beyond the Connector Luer Lock.

> What is the internal volume of a PhaSeal Infusion Adapter C100?
The internal volume of the Infusion Adapter, C100, is 0.16 ml.

> What type of material is the expansion chamber in the Protector made of?
There are two layers of plastic material, one layer of Polyamid (PA) and one layer of Polypropylene (PP)

> Is PhaSeal Latex-free?
Yes, all components in the PhaSeal system are Latex-free

> Do any of the PhaSeal components contain PVC?
The Injector, Protector, Connector and Infusion Adapter C100 do not contain PVC. The Infusion Sets, C50, C55 and C61 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.

> What material is the membrane made of?
TPE (Thermo Plastic Elastomer)

> Do all the PhaSeal components come individually packaged?
Yes, all products are packed as single units in blisters.
Click here for more information regarding the number of products per user and transport box.

> How many times can the membranes be perforated?
All membranes can be perforated up to 10 times.

> Is there a patent on PhaSeal ?
Yes, there is a worldwide patent on PhaSeal.

> How long will it take a Pharmacist or Technician to learn how to use PhaSeal and return to their previous work rate?
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.”

Click here to read the abstract of Poirier et al.

> What is the difference between PhaSeal and chemospike?
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.

> Can PhaSeal be used with vials where it states "Do not use Chemopins" (chemospikes)?
The steel cannula of the PhaSeal Protector makes the system compatible with most of the cytotoxic drugs on the market.

> How are the PhaSeal products sterilized?
All products in the PhaSeal system are sterilized using ethylene oxide except for the M20 Infusion Clamp which is non sterile.

> Is it possible to retrieve all of the drug from the vial when using PhaSeal?
Yes, when aspirating the last few mls it is possible to retract the Injector needle in order to minimize the residual drug volume in the vial.