What are the main Annex 1 Updates regarding cleaning and disinfection?
Why is it so important with a residue removal step in a disinfection regime?
How do I implement a residue removal step in my disinfection regime?
Is cleaning and disinfection the same thing?
Treating cleaning and disinfection as two different steps is crucial for comprehensive cleanroom maintenance. Cleaning removes physical contaminants, while disinfection eliminates microbial contamination.
How do I implement a cleaning and disinfection strategy?
Clean First: Always start with cleaning to remove physical debris. Then choose suitable Disinfectants that are appropriate for your cleanroom's specific needs based on your facility’s risk assessment. Ensure that all personnel are trained regularly in both cleaning and disinfecting procedures.
Why do I have to rotate between different disinfectants?
A disinfectant rotation is critical for effective cleanroom maintenance. Because it ensures efficacy against different organisms, and it provides different modes of action for various organisms including bacteria and fungi. And using a sporicidal agent regularly ensures that you have protected your cleanroom against spores.
Does it matter if I choose a concentrated biocide or a ready to use solution?
As the stringency for use of filters and water increases, and proof of sterility and performance in use regarding the disinfectants, the risk of blending a concentrate by yourself increases significantly. Therefore, a ready to use solution is a safer choice and in the long term also more cost effective.
Which air flow rate is ideal for my application?
25 l/m for continuous monitoring for up to three hours per plate/head.100 l/m the traditional flow. And also, when sampling in compressed air/gas.200 l/m to reduce 50% of the cycle time.
Is the air sampler CF21 11 validated?
YES, in combination with the BAS SW (test for free under a month)*
*Not valid for TRIO.BAS mini
Is the sampler easily sanitized and disinfected?
It can be sterilised with alcohol or VHP.
Is the aspirating head sterilisable?
It can be sterilised by autoclaving.
Is a sterilised daily used aspirating head available?
The Daily aspirating heads are available, both for Petri and Contact.
Is Physical and biological efficiency validated?
YES
Is the air sampler easily handled?
It is light and balanced and with an intuitive interface in the software's menu.
Is the air sampler usable for compressed gas?
YES, in combination with TRIO.GAS (100L/min), Flugas (100/200L /min) or Verigas (100L/min) system (Airflow speed options in respective gas system).
Is the exhaust air filtered?
Can the pictures of the culture plate after incubation be recorded?
YES, in combination with the BAS SW and the CFU Photo Camera*
*Not valid for TRIO.BAS mini.
Is the laminar flow affected?
NO
What sterile glove can be used in cleanrooms?
The first and most important thing to understand is the difference between sterile surgical gloves and sterile cleanroom gloves. While both types have been sterilised and offer a similar sterility assurance level, they differ on pretty much all other aspects, particularly the cleanliness level.
Sterile cleanroom gloves are washed more extensively and have a lower particle count than sterile surgical gloves. Also, sterile cleanroom gloves are triple-packed in ultraclean plastic packaging, while sterile surgical gloves are typically only double-packed in paper-based pouches. For these reasons, and more, only sterile cleanroom gloves can be used in aseptic cleanrooms. The offer of sterile cleanroom gloves is vast, with different product attributes bringing advantages for different applications. There is no “one fits all” solution. Nitrile is preferably used in cleanrooms, as it removes the risk of allergies associated with latex, provides a comfort level similar to latex, and a generally better chemical protection (particularly to isopropanol, which is very commonly used in cleanrooms, even more so in aseptic cleanrooms). Accelerator-free nitrile gloves bring the additional advantage of reducing the risk of Type IV allergies.
How do I put on and take off sterile cleanroom gloves?
To put on and take off Halyard's sterile cleanroom gloves, we recommend that you follow the steps in this pdf
How do I put on and take off Halyard's non-sterile cleanroom gloves?
To put on and take off Halyard's non-sterile cleanroom gloves, we recommend that you follow the steps in this pdf
How do I put on and take off Halyards Exam Gloves?
To put on and take off Halyard's Exam Gloves, we recommend that you follow the steps in this pdf
What is AQL?
AQL stands for Acceptance Quality Limit and is usually defined as the “worst tolerable process average that is still considered acceptable”. The AQL determines the maximum number of defective units, out of a sample population, for the lot to be accepted. The smaller the AQL number, the less tolerance for defects. The AQL number itself is a rough approximation of the accepted percentage of defects in the lot.
While any product attribute (dimensions, colour, etc) can be inspected and have its own AQL, the AQL printed on the packaging and documentation of disposable gloves refer to the pinhole test, also known as the watertight test, where gloves are filled with water and checked for leaks.
The Halyard PUREZERO* gloves have an AQL of 1.0, which is better than the industry standard of 1.5 and gives sufficient assurance as to the wearer’s protection, particularly when double-gloving.
What is PureZero*?
PUREZERO* is Halyard’s brand for laboratory and cleanroom products. It currently encompasses cleanroom gloves and facemasks, as well as laboratory gloves.
What are the benefits of sterile disposable cleanroom garments?
There are several advantages when using sterile disposable cleanroom clothing: