> 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 syringe pumps?
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.

> 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?
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.

> Can vials with the PhaSeal Protector attached be stored in a refrigerator or freezer?
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.

> 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 (N30) fits on to all Luer slip syringes and the Injector Luer Lock (N35) fits on to all Luer lock syringes.

> 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 alcohol, e.g. isopropanol (IPA) pads or swab sticks 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 is equipped with inline 15 µm filters. 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 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.

> Do any of the PhaSeal products contain silicone?
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.

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

> Do all the PhaSeal components come individually packaged?
All sterile 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, PhaSeal is protected by a number of patents.

> 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 Syringe Tray M15, Infusion Clamp M20 and Infusion Clamp M25 which are non sterile.

> > Is it possible to retrieve all of the drug from the vial when using PhaSeal?
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.