Wipes and CE marking

A number of our customers are facing confusion regarding the CE marking of the sterile wipes that they are using in aseptic preparation.

If a product is classified as a medical device as specified in the medical devices directive 93/42/EEC, then it must be CE marked.

SteriClean wipes are not classified as a medical device and therefore should not and cannot be CE marked.

With reference to the guide ‘Quality assurance of Aseptic Preparation Services’ fourth edition, P57 chapter 13, 13.2.1, sterile wipes are classified as a component and should be supplied with a documented from of approval, which in this case will be a sterility certificate.

I hope this clarifies the issue and for more information and samples of our SteriClean range of wipes please call 0800 0328 428

http://www.mhra.gov.uk/home/groups/es-era/documents/publication/con057319.pdf

Are infection control challenging your cleaning products?

Some hospitals are having problems with growth of coliform bacteria in their aseptic units and isolator cabinets.

Helapet take pride in supplying quality products that are both effective and validated. The results of the SteriClean Bio + I and Bio + II against european Standard EN 1276 including Escherichia coli (E. Coli) are proven to be excellent.

Units that have moved over to using the SteriClean range of cleaning and disinfection products have seen a significant fall in levels of contamination not only after cleaning, but in general background levels.

Why not try SteriClean in your unit for FREE and see the results for yourselves, call
0800 0328 428.

Study Day date

The last in the 3rd series of free study days 'Managing the risks in the preparation of aseptic products' takes place on 17th June 2010 at Crewe Hall Hotel in Cheshire.

For more information and to book your place please call 0800 0328 428
http://www.helapet.net/

The next series starts in September with the agenda and venues still to be finalised.

SteriClean Bio I and Bio II proven consistently effective

SteriClean Bio I and Bio II have been proved extremely effective for cleaning benches and floors in Central Production Units.

Results show that over a 3 week period, the number of colony forming units produced after cleaning with SteriClean biocidal sprays was consistently reduced to zero.

In addition the number of colony forming units present before the weekly clean had been significantly reduced.

SteriClean Bio I and Bio II have now been proven to have more effective control against microbial contamination commonly found in cleanrooms than other leading brands.

Introducing Alcorub Hand Sanitiser

Helapet are delighted to announce that new Alcorub Sanitising Gel has been added to the SteriClean range of cleaning and disinfection products.

Alcorub has been specifically formulated for the aseptic Cleanroom and pharmaceutical markets. The alcohol blend controls microbial contamination commonly found in Cleanroom environments and evaporates quickly leaving no sticky residues.

Tested to BS EN 1500:1997, alcorub contains lanolin free emollients that leave hands feeling soft and nourished making sore and dry hands a thing of the past even after repeated use.

Try some samples for FREE by calling 0800 0328 428


http://www.helapet.com/acatalog/Hand_Sanitising_Gel.html

Avoid fungal contamination in your isolator

The careful and time consuming cleaning and disinfecting of sharps bins and trays before taking into controlled aseptic areas and isolators is not a guarantee that those items will be free from microbial contamination. The crevices and rims of containers are difficult to clean effectively and could harbour harmful organisms.

Helapet sharps bins and trays are supplied individually wrapped and are sterilised by gamma irradiation at no less than 25kgy ensuring that the sterility of your isolator is not compromised.

For more information and FREE SAMPLES please call 0800 0328 428

http://www.helapet.com/acatalog/Sterile_Sharps_Bins.html

New coloured filters

Helapet are pleased to announce production capabilities for coloured filters. The new range can be incorporated into your design together with logo and instructions.

Coloured filters are particularly suited for modern design products where colour coordination is a factor and can be used practically to show inlet and outlet sides.

www.filterdevices.co.uk