We like to encourage all of our customers to trial Enzyme Indicators for decontamination validation alongside Biological Indicators when first considering this revolutionary technology. It’s vital that pharmaceutical companies have trust in the product and a clear indication of the benefits EI’s can bring versus the traditional biological indicators.
Read on to see how Howorth Air Technology are reaping the benefits of their EI vs BI head to head trial and their views as to the future use of Enzyme Indicators.
I’m writing to give an overview of our recent trials and comparative study of Enzyme Indicators vs Biological Indicators. We have now completed our first complete gassing cycle development on three pieces of equipment and used EI’s initially alongside BI’s and then relied upon EI’s to develop cycles. From the very first cycle it became clear that Enzyme Indicator technology offers a huge advantage. The ability to read EI’s instantly enabled us to understand the gassing cycles at a new level, creating a new dimension in terms of data that really helped us to save time and tailor the cycles very quickly. We were able to see the least penetrative locations immediately and this in turn allowed us to save many days waiting for BI’s results.
Being able to instantly see a log reduction reading this enabled us to increase cycle parameters instantly and run back to back cycles until we achieved a log 6+ reduction in all areas, this would typically take two – three weeks using BI’s to collect the data in all three chambers, using EI’s we was able to collect the data over a two day period, this will be significant improvement going forward potentially saving up to four weeks on each project.
For information, we found that another clear advantage of using EI’s alongside BI’s for final cycle development helped nullify some issues we had with the actual BI’s themselves. Having a stable and repeatable indication from the EI’s supported us and the cycle development very well and we will certainly be using EI’s into the future.
Best regards, Shane Stevenson,
BioGen product development manager.
Howorth Air Technology
- Tim Coles & Dr Helen Hale Article – Taming the Tyrannosaurus of Validation - 6th February 2018
- Exclusive ISPE Decontamination & Validation ½ Day Workshop and Focus Group - 18th January 2018
- The Shortfalls Of Biological Indicators For HPV Decontamination Validation - 7th September 2017
- Protak Features In Clean Air & Containment Review - 1st August 2017
- Protak Scientific At Pharma Integrates 2017 In November As Sponsor & Panelist - 1st July 2017
- Enzyme Indicators Proven As Viable Alternative For HPV Decontamination Validation - 20th June 2017
- Protak Scientific At The ISPE UK Summer Conference: Containment & Decontamination – 14/6 - 6th June 2017
- Howorth Air Technology Trials Enzyme Indicators Successfully - 26th May 2017
- Clean Air & Containment Review – “EI’s Will Eventually Take Over BI’s” - 5th May 2017
- Protak Scientific Announce Appointment of Netsteril As Distributor for Spain To Supply Revolutionary Alternative To Biological Indicators - 15th February 2017