Our website, Biosite®, is developed and produced by ourselves. Our Biosite® will never become finished. But our offer concerning technical information is certainly kept extended and updated. We understand our website as communication platform with our market. In special our customers are enabled to get and supply information and documents needed independently of Bios working hours.
Do you like our Biosite®? Please let us know, but also we are interested to learn, if you have comments. Please do not hesitate to keep us informed. Bios will try to implement your good suggestions – as far as possible with our technical know-how.
Bios does not use Google and similar to make itself known.
Bios does not publish in such media. And Bios is aware that such media nevertheless use Bios publications to fill their pages. Bios will not try to hinder Google and Co. living from outside data. No!
But Bios does not take care for content Google and Co. publish about Bios: Bios went bankrupt, Bios has been bought out by xy, or similar.
Please turn to Bios directly, in case of any question. Thank you for your understanding.
Once more we like to explain to you important issues addressed in § 6 of the Terms and Conditions of Bios GmbH Labordiagnostik
06/2017
Maintaining the cold chain during transit of our products from our refrigerators to our customers' refrigerators and until their use in the customers’ laboratory.
Once customers receive our shipment it is their responsibility to ascertain and document accordingly that the cold chain remained uninterrupted during transit of the products (refer to the temperature-sensitive blue Bios package sticker) and that the required temperature range for our products is being maintained during their entire storage period in the customer’s laboratory until used.
Any deviations from the required temperature range/interruptions in the cold chain must be fully documented, e.g. refrigerator breaks down, leaving goods accidentally (too long) outside the refrigerator, etc. This documentation also must include a trouble shooting protocol describing how was the problem dealt with, what was done with the affected goods?
Storage of Bios reagents in the customer’s laboratory
All Bios reagents that require refrigeration (refer to temperature information on the product label) contain water. The water structure changes significantly at 4°C, regardless of whether water is heated or cooled down. If a refrigerator reaches or falls below 4°C when cooling down, the water structure in these reagents changes twice per cooling cycle, which gradually destroys the activity of substrate slides, positive controls and conjugates, etc. Bios therefore specifies a storage temperature of 8°C, which we have tried and tested over many years. Using a data logger we confirmed if the fridge temperature is set to 8°C, it will neither reach the critical temperature of 4°C nor will it drop below 4°C during the cooling down cycle.
For our customers this means that the long storage lives of our products are applicable only if the reagents/IVDs are stored at 8°C as specified on the product label. In case of any dispute in regard to our product performance we request proof from our customers about correct product storage. We would like our customers to provide data logger evidence that shows the cooling cycles in their fridge did not reach or fell below 4°C.
To be on the safe side, we encourage our customers to carefully plan their expected product needs from Bios GmbH Labordiagnostik for no longer than a three-month period. To help you manage your Bios product orders appropriately and thus also comply with the FIFO rule, you can find the respective delivery date on our product labels.
Important additional information
All other provisions for avoiding any impaired product performance through users’ inappropriate product handling (do not freeze bios reagents/IVDs, do not subdivide, do not change the product in any way such as dilution, post-fixation, extending the shelf-life, etc.)) can be found on our Biosite® in our parameter-specific Instructions for Use.
(www.bios-world.com: Customer's Club/Technical information/III. Information and directions for use of BIOS products)
All of these provisions should be incorporated in your internal laboratory guidelines and should be documented for each performed test.
Last modification: 12.4.2024
top |
