So where can the use of Enzyme Indicators for decontamination validation bring real value? Here we discuss some key areas where this new science will revolutionise current processes…
EI’s with pharmaceutical isolators or spaces that use VHP or HPV for decontamination
EI’s start bringing value in the very early days for equipment manufacturers when developing new products. When a new product is being manufactured, it is imperative for the product developer to understand VHP penetration and efficacy. Until the introduction of EI’s this process could be really hit and miss. Simply no technology existed that allowed localised data to be easily captured from the very first development cycle that could be presented instantly and immediately post cycle.
Typically a manufacturer would run 100’s if not 1000’s of BI’s, usually in triplicate to give allowance for rogue BI’s. They would have “some initial ideas” about concentration but the process is much more complex than for instance using a generalised PPM H?O? counter for a general idea. The VHP process needs to stand the scrutiny of a validated >Log? reduction to the BI Geobacillus Stearothermophilus.
Rogue BIs can be a thing of the past
As all manufacturers know, the very first cycles are based on previous example data and experience and a picture is built up over time. One of the problems with this process is that BI’s have a high failure rate, known as Rogue BI’s. These BI’s for a range of reasons, always incubate successfully, showing a “false positive”. It is well known in the industry and a real headache, causing as you can imagine, no end of issues for a Gassing Cycle Developer. Did I mention that we have no rogue syndrome with an EI?
So – what does an EI bring to the table? A lot.
Using an Enzyme Indicator as a supporting tool for cycle development immediately maps performance to a data scale. This effectively enables isolators, equipment or pretty much anything that uses H?O? as a decontamination tool to be fully mapped on the first cycle. The data is collected immediately, taking just 3 seconds per test to collate. From the first cycle, typically within less than an hour in total, the GCD process is clearly mapped out, least penetrative spots are located and positive action can be taken.
This is verses a BI model where at this point you would still be putting the BI’s into broth and preparing to incubate. You would then wait days – up to seven to collate assured data. Even when you have that data all you would know is that you did or didn’t achieve a >Log? reduction. You would have no real idea about how close of far from this goal you really are.
IQ/ PQ / FAT / SAT just became a lot quicker and easier. Using EI’s gives confidence in cycle. This ensures that when processing with end users and developing a cycle, as a manufacturer you already know the outcome of your cycle and can then easily demonstrate the performance of your system to customers with complete confidence. Using EI’s alongside a BI also gives immediate assurance that you are not suffering Rogue syndrome too. EI’s offer a direct correlation to the performance of BI Geobacillus Stearothermophilus using a developed standard curve.
Enzyme Indicators take away all the frustration and wasted time associated with Gassing Cycle Development. Enzyme Indicators are never fully denatured so are always able to provide a true measure of cycle performance. That alone is a massive boost to the process but the fact that data is captured immediately and enables multiple cycles per day and immediate action. That is where the true value lies.
Read more about EI’s versus BIs here.
- Bye Bye BI -
- VHP (Vapour Hydrogen Peroxide) Fragility -
- Using Enzyme Indicators to validate decontamination measurement -
- Global Healthcare and Pharmaceutical Magazine Feature – Phillip Godden -
- Phillip Godden voted Pharmaceutical CEO of the Year 2018 -
- Protak Scientific win Healthcare and Life Sciences 2018 award -
- Protak Scientific & the MHRA form an Enzymatic Indicator and Decontamination Validation Industry focus group -
- Protak Scientific invest in new purpose designed and built premises -
- Tim Coles & Dr Helen Hale Article – Taming the Tyrannosaurus of Validation -
- Exclusive ISPE Decontamination & Validation ½ Day Workshop and Focus Group -