Download PharmaVent - Medical Dispensing Systems

Medical Dispensing Systems B.V.
Kopersteden 24/5
NL-7547 TK ENSCHEDE
 +31 (0)53 450 09 49
 +31 (0)84 224 80 99
[email protected]
www.medicaldispensing.nl
PharmaVent
Through
E-mail
From
Peter Kars
Attn.
To whom it may concern
Date
February 25th, 2014
E-mail
[email protected]
Phone
E-mail
Final product
10 venting needles in a polypropylene holder in a hardblister, which is sealed, stamped, put in a bag in an
outer box (75 hardblisters per box; box dimensions: 60 x 37 x 28 cm), and sterilized.
Our conditions of sale and delivery apply to all our deliveries and can be downloaded from our website: www.medicaldispensing.nl
Medical Dispensing Systems B.V.
Bank: 3133.60.499 – Rabobank Hengelo
VAT ID: NL817123799B01
Chamber of Commerce no: 08100685 – Enschede
IBAN: NL86RABO0313360499; BIC: RABONL2U
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Use
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The PharmaVent is used to ventilate vials during withdrawals.
The PharmaVent is inserted (by hand) in the septum.
After insertion, the PharmaVent stays in the vial and is discarded together with the vial.
Since the PharmaVent stays in the vial, it is not to be reused.
Contraindications / warnings
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The PharmaVent is to be used in combination with the PharmaHelp only.
The PharmaVent is not for human use.
Our conditions of sale and delivery apply to all our deliveries and can be downloaded from our website: www.medicaldispensing.nl
Medical Dispensing Systems B.V.
Bank: 3133.60.499 – Rabobank Hengelo
VAT ID: NL817123799B01
Chamber of Commerce no: 08100685 – Enschede
IBAN: NL86RABO0313360499; BIC: RABONL2U
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Needle
The needles have the dimensions 19 G x 1” and are provided with a polypropylene tip cap.
Filter
The filters have a 1.2 μ pore size and are made of polypropylene.
Holder
The holders are made of polypropylene PPC 10642.
Sterilization method
The sterilization method is γ-irradiation using the VDmax method. A typical dose is 25 kGy.
Bioburden
Needle
The bioburden is of the order of magnitude of 1 to 10, which is very small, thus enabling the VDmax method.
Filter
The bioburden is of the order of magnitude of 1, which is also very small, thus enabling the VDmax method.
Holder
The bioburden – defined as the total of aerobic bacteria, yeast, mould, anaerobic bacteria, and spores – is
equal to 84. This is again small, thus enabling the VDmax method.
Risk management
Not applicable. The employees of hospital pharmacies / compounding centres are already acquainted with
working with (syringe / venting) needles.
Shelf life
3 years from sterilization date, which is December 2013.
Our conditions of sale and delivery apply to all our deliveries and can be downloaded from our website: www.medicaldispensing.nl
Medical Dispensing Systems B.V.
Bank: 3133.60.499 – Rabobank Hengelo
VAT ID: NL817123799B01
Chamber of Commerce no: 08100685 – Enschede
IBAN: NL86RABO0313360499; BIC: RABONL2U
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