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 are the benefits of sterile disposable cleanroom garments?
There are several advantages when using sterile disposable cleanroom clothing:
What do I have to wear before I enter an aseptic gowning area?
In general, aseptic gowning areas may only be entered after you have washed and disinfected your hands. You must wear a head cover, a beard cover when relevant, a cleanroom undergarment, clean socks and cleanroom footwear (shoes or clogs). Outdoor clothing may not be brought into EU-GMP grade A/B and C areas.
How should I disinfect the step-over bench?
Before you put the required materials on the step-over bench you should disinfect the top surface. The step-over bench can be disinfected by spraying the surface with sterile 70% alcohol. Normally a contact time of 1 minute is sufficient to kill the low numbers of microorganisms present, effectively. The surface should be dry before you sit on it during donning your boot covers. Alternatively, the step-over bench can be wiped with a wetted cleanroom wipe. Wiping should also result in a contact time which is sufficient to kill
How contaminated is the packaging of the sterile cleanroom garment and the other accessories such as goggles, face mask and gloves?
The exterior surface of the packed sterile materials present in the personnel air lock should have a very low bioburden, i.e. a maximum of a few microorganisms present on the surface. These sterile materials should be double or triple packed before they are transferred into an aseptic manufacturing facility. During each transfer step to an area of a higher classification, e.g. from EU-GMP grade C to grade A/B, a layer of packaging must be removed or if not present cleaned (=wiped) and disinfected adequately. The materials should be transferred into the personnel air lock using aseptic techniques, which means that the last secondary packaging should be removed without touching the primary packaging of the material. The person doing this should wear a head cover, sterile gloves and a face mask. The cabinet or rack in which the materials are stored should be (kept) clean and disinfected.
When should I disinfect my gloves during gowning?
There is always a low risk that your gloves will become contaminated after touching surfaces (e.g. packaging, step-over bench) in the personnel air lock. Therefore, as a preventative measure, gloves must be disinfected before you start gowning and after each step during gowning, i.e. each step where there is a low risk for contaminating your gloves. Also disinfect the second pair of sterile gloves before you enter the production area.
What is the correct order for gowning?
After you have washed and disinfected your hands, you must don sterile cleanroom gloves. Then, disinfect the required materials. Subsequently, the face mask should be put on to prevent contamination by fluids and aerosols from the mouth and nose during gowning. Then, the hood is don. It is okay to put on the goggles immediately after donning the hood. However, when putting on goggles at this stage, there is a high risk for glasses of the goggles to become foggy, which is undesirable. Therefore, goggles are mostly put on after donning the coverall. After donning the hood, the coverall is don and goggles are put on. Then, the boot covers are put on. Finally, the second pair of sterile gloves is don. Be sure to disinfect the gloves after each step during gowning.
May I touch the outside of the garment?
During all steps of gowning you wear sterile disinfected gloves. Gloves must be disinfected after each step of the gowning procedure, in order to kill microorganisms (normally very low numbers) that might have contaminated the gloves during gowning. Touching the outside of the garment should be very limited, and should only be done if touching the inside is posing a greater contamination hazard. In many cases, touching the inside of the garment during gowning means that you will probably touch a surface that has been in contact with your skin, undergarment, socks or head cover. This will absolutely lead to contaminated gloves, and will thereby increase the risk for contaminating the garment during gowning. Therefore, gloves must be disinfected after each step during gowning.
Do I have to put both my arms simultaneously in the sleeves of the garment?
No. You may also put your arms in the sleeves one by one. However, doing so has a disadvantage. The shoulder part of the coverall may then roll with the outside over your undergarment, which will lead to contamination of the back part of the coverall.
Do I have to disinfect my gloves before closing the zipper?
Yes. You may have touched your undergarment slightly during donning the coverall. Therefore, the gloves should be disinfected before closing the zipper.
How do I put on and take off cleanroom garments?
Learning how to properly put on and take off cleanroom garments is very important to maintain a contamination-free environment. Below you will find two videos: one demonstrating the gowning procedure one demonstrating the degowning procedure for cleanroom environments.
If you have any questions, please don’t hesitate to contact us at Miclev!
Gowning procedure for A/B Grade cleanroom with Tyvek® IsoClean® IC 193
Degowning procedure for A/B Grade cleanroom with Tyvek® IsoClean® IC 193
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 should I disinfect my hands?
It is important to distribute the hand disinfectant gently over the whole surface of the hands, wrists and between the fingers. For an effective disinfection the surface should be moist for at least 20 to 30 seconds. Do not rub your hands. Rubbing will release skin flakes and large numbers of microorganisms. In addition, as a result of rubbing the disinfectant will evaporate faster and the contact time will be shortened. Disinfect your hands after you have washed your hands before entering the gowning area and before you don sterile gloves.
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.