Frequently Asked Questions
Technical and practical aspects
What are the dimensions of the PharmaHelp?
What is the weight of the PharmaHelp?
Approximately 500 kg.
Does the PharmaHelp have a storage space for level 2 vials?
The PharmaHelp has a storage space for temporary rest vials.
Does the PharmaHelp have a storage space for IV bags?
No. The PharmaHelp is loaded with the vials and IV bags which are needed for the production of one batch. A batch can consist of a maximum of 16 patient-specific IV bags.
Does the PharmaHelp have the possibility of labelling IV bags?
Can the PharmaHelp handle different vial types?
Can the PharmaHelp handle different vial sizes?
Yes. At the moment, a vial with a diameter of 65mm (incl. ring) is the largest vial which the PharmaHelp can handle.
Can the PharmaHelp handle different IV bag types?
Yes. The PharmaHelp has been validated for FreeFlex IV bags from Fresenius Kabi.
Can the PharmaHelp handle transfusion sets ('IV bag lines')?
Can the PharmaHelp handle multiple vials for one IV bag?
Yes. The contents of at most 16 vials can be injected into one IV bag (same drug).
Which requirements does the cleanroom have to meet in which the PharmaHelp is located?
The cleanroom must be a class B cleanroom for GMP and class C for general use. Its measurements can be standard measurements. No additional cooling of the cleanroom is necessary.
Which technical connections are required?
230 V ~ outlets and network connections.
To what extent is personal support for the use of the PharmaHelp needed?
When the PharmaHelp is running, no personal support is needed.
The educational level of the personnel can be the same as in case of manual preparation.
Releasing orders happens analogously to that when manually preparing.
Are there interfaces with other software, like prescription software, the VTGM guideline, etc.?
In general, interfaces are possible. Up to now, four customer-specific interfaces have been realized.
Is it necessary to work with specific disposables (syringes, IV bags, and the like)?
Yes: the PharmaNeedle, the PharmaVent, and the FreeFlex IV bags from Fresenius Kabi.
How much time does setting and loading the PharmaHelp take?
Generally speaking, the PharmaHelp is loaded with a batch, which contains at most 16 vials and 16 IV bags. It can also be loaded with fewer vials and/or IV bags. Per vial and IV bag separately, 10 to 15 seconds are needed.
Is it necessary that an operator be present at the PharmaHelp when it is running?
No. After having been loaded, the PharmaHelp runs stand-alone, so that the operator can accomplish other tasks; for example, pre- and post-processing.
Can an operator operate more than one PharmaHelp at the same time?
Is technical support in The Netherlands available?
Yes: in Enschede.
How many times have failures happened so far?
As a result of the unique, simple design, the susceptibility to failures is little. Should a failure occur, then it can often be fixed remotely.
Every two to three months on average, there is some maintenance (depending on the produced quantities).
Can the software be linked to the hospital pharmacy ICT system?
So far, this has always been found possible.
Considerations with respect to labour conditions
GMP protocols are available for this.
This is equal to that from a normal workbench. The PharmaHelp itself does not increase the noise generation.
Class B cleanroom.
The PharmaHelp is encased into a validated cytostatics workbench.
How much heat is produced during production?
No more than is the case for a regular workbench. The robot consumes only 200 W; the workbench around 1 kW.
Can cross-contamination be ruled out?
Yes. The PharmaHelp has been validated to demonstrate that there is no risk of cross-contamination.
Have aerosol measurements been taken?
Is the outside of a finished IV bag free of contamination?
Yes. This has been verified by the German IUTA institute.
Considerations with respect to 'Good Manufacturing Practice' (GMP)
Are validation reports available?
The PharmaHelp has been released for GMP production in Germany by the Bavarian authorities.
Are validation reports for scales and software available?
Are PQ data available at the hospital pharmacies concerned?
Which validation protocols are included?
All necessary protocols for IQ, OQ, and PQ which are required for GMP use in Germany.
Which validation protocols can be carried out on-site?
In our opinion, all relevant validation protocols.
Are microbiologic inspections, for instance of IPCs, carried out?
Standard microbiological inspections (Petri dishes, bouillon fillings, ...) can be carried out.
A nozzle for a particle counter is present, which always measures within 200 mm of the puncturing point. Such a counter is to be purchased by the hospital pharmacy itself. The PharmaHelp can usually be connected to a particle counter already present.
Considerations with respect to safety
How is it guaranteed that a product is a correct product?
By means of a camera and/or bar code.
How is it guaranteed that a quantity is a correct quantity?
By gravimetric verification.
Considerations with respect to costs
What are the acquisition costs for the PharmaHelp?
We refer to Fr esenius Kabi for this.
What are the maintenance costs for the PharmaHelp?
We refer to Fr esenius Kabi for this.
What are the validation costs for the PharmaHelp?
This depends on the number of hours which the hospital pharmacy spends to this.
What is the ROI for the PharmaHelp?
We also refer to Fresenius Kabi for this.
What is the service life of the PharmaHelp?
10 years according to expectations.
How high is the power consumption by the PharmaHelp?
It is comparable to that of an ordinary workbench.