Staff shortages and pressure from the Joint Commission on Accreditation of Hospital Organizations (JCAHO) drove Capital Region Pharmacy to validate CytoCare(TM). Senior Scientist Dr. Vagn Handlos said: "We have been through all of the GMP procedures needed to take CytoCare(TM) into action. Regarding microbiological integrity, I have never seen anything better. We conducted tests using settle plates and swabbing the surfaces with growth media; there was no growth of microorganisms in any of the samples. On handling of particulate contamination, the robot gets an excellent score. There is no problem complying with class-A conditions and there is no leakage from the filters. Cross-contamination has also been tested using cyclophosphamide. We were unable to detect cyclophosphamide above a detection limit of one picogram*/ml after having handled multiple cyclophosphamide doses in concentrations of 1g/50ml."
Dr. Alicia Tavella, Oncology Pharmacist at the General Hospital of Bolzano stated: "the results of the validation tests for CytoCare(TM) have all met the required GMP standards. The system efficiently removes particulate and microbiological contamination.
* A picogram [pg] is a metric unit of mass equivalent to one trillionth
(10-12) of 1 gram, or one millionth (10-6) of 1 microgram. Prior to
CytoCare(TM) it was becoming increasingly difficult to recruit staff to
undertake this work, often because of concerns about exposure to carcinogenic
agents and the ever-present risk
|SOURCE Health Robotics SRL|
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