The new Annex 1 draws a distinction between cleaning and disinfection with a clear statement that for the disinfectant to be effective it must follow a cleaning stage. Delta is a neutral detergent which has been developed for use within cleanrooms alongside our existing rotational disinfectants Alpha and Beta.
Delta Trigger Spray 950ml (Sterile)
Neutral Detergent 950ml trigger spray, Sterile.
• Available in sterile version
• Safe to use on any surface and is colourless and odourless
• Pre-mixed solution ensures homogenous distribution
• Manufactured with WFI
• pH 6.5 - 7.5
Hard surface cleaning agent
• Trigger spray with spray / off settings
• Trigger designed for low actuation force
• Tamper resistant neck fastening
• HDPE bottle
The product is filled and capped in ISO 14644-1 Class 5 (in use) unidirectional airflow cabinets. Packaging is performed within an ISO 14644-1 Class 7 (in use) cleanroom.
The Neutral Detergent is filtered through a 0.2 micron filter at the point of fill.
Primary packaging: natural HDPE bottle with tamper resistant trigger spray.
Secondary packaging: double bagged in polythene bags in ISO 14644.
15 double-bagged bottles in the box.
Gamma Irradiation (minimum 25kGy).
Product supplied under BS EN ISO 9001:2015 registered systems.
2 years from date of manufacture.
Store in a dry, well-ventilated area in ambient conditions.
Q1: Is there a regulatory driver for using a Neutral Detergent?
The current draft of the new Annex 1 for GMP states that “The disinfection of cleanrooms is particularly important. They should be cleaned and disinfected thoroughly in accordance with a written programme. For disinfection to be effective, prior cleaning to remove surface contamination should be performed."
In our view the best solution to use for prior cleanroom cleaning is a neutral detergent.
Q2: So, what does the neutral detergent do?
A pharmaceutical quality neutral detergent will have been designed for use in a cleanroom environment alongside a rotational disinfection routine and will remove dirt and contaminants without reducing the effectiveness of the disinfectants.
Q3: How often should I use Delta?
As cleaning with Delta preserves the effectiveness of the disinfectant we would recommend that you use Delta every time before you disinfect.
Q4: How do I know if a detergent is compatible with my existing disinfectants?
At Micronclean our Delta (Neutral Detergent) product has been developed for use with and rigorously tested alongside our existing Alpha and Beta rotational disinfectant products to ensure complete compatibility.
Q5: If I don’t use your disinfectants can I still use Delta?
Our Delta product has been developed to be fully compatible with other disinfectant regimes by having the following key features:
• Low foaming formulation - this reduces the risk of streaks and staining when in use which could affect the subsequent disinfectant effectiveness
• Neutral (pH 6.5-7.5) - to ensure that it is non-corrosive and will not damage hard surfaces
• Supplied Pre-mixed - to ensure a homogeneous distribution of the active ingredient
• Manufactured with WFI - to ensure maximum cleanroom compatibility with cleanroom environment
• Gamma Irradiated - to give a sterile product with a two-year shelf life.
Q6: Is Delta the same as the detergent you pre-saturated your mops with before?
Delta it is not the same detergent as the detergent we used before. Delta it is Neutral Detergent pH 6.5-7.5, whereas the previous detergent was a High Alkaline Detergent with a pH in the range 9-10.
Q7: Have you performed any direct comparisons between the two detergents?
Because of the marked difference in pH, we haven’t performed any comparison testing.
Q8: So, what else should I be aware of?
Delta should always be used as part of a documented cleaning and disinfectant regime with the cleanroom that does not “overstretch” the chemicals. In addition, it is important that these instructions are always followed as it is possible for all detergent solutions to become contaminated with bacteria if not changed frequently which results in the cleaning process actually spreading these pathogens around the environment instead of removing them.
Q9: What product forms does Delta currently come in?
Delta is currently available in the following product forms:
• Delta Reusable Laundered Mops (Sterile)
• Delta 950ml Trigger Sprays (Sterile)
• Delta 5L RFU (Sterile)
• Delta Microfibre Disposable Mops (Sterile)
Q10: What other products forms are you working on for Delta?
We are always keen to work with our customers to work on new product forms but in the short term we are working on:
• Delta Pre-Saturated Wipes (Sterile)