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Cleaning & Disinfection

Annex 1

What are the main Annex 1 Updates regarding cleaning and disinfection?

  • Cleaning and disinfection should be treated as 2 different steps
  • Periodic use of a sporicide
  • Sterile products in GMP garde C/D based on QRM principles
  • Control residues
  • Validation of disinfectants in the manner which they are used
  • Higher control regarding transfer disinfection

Why is it so important with a residue removal step in a disinfection regime?

  • It prevents Contamination: Residues, if left unchecked, can harbor harmful microorganisms and particulate matter.
  • It enhances Efficacy of Disinfectants because clean surfaces ensure that disinfectants can work more effectively.
  • It provides a safer environment: Residues on floors can be slippery and lead to personnel falls and injuries.

How do I implement a residue removal step in my disinfection regime?

  1. Select a cleaning agent: Choose cleaners, such as WFI or a neutral detergent, that can be used regularly and are designed for cleanroom use.
  2. Use Proper Techniques: Employ wiping and mopping techniques to encourage overlapping strokes and cleaning irregular surfaces.
  3. Regular Monitoring: Regular testing for residues ensures that the cleaning protocols are effective.

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.

Air Samplers

How to select an air sampler from Orum

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?


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?



Cleanroom Gloves

Choose the right cleanroom gloves

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 to use

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.

Cleanroom Garments

Choose the right cleanroom garments

What are the benefits of sterile disposable cleanroom garments?

There are several advantages when using sterile disposable cleanroom clothing:

  • Because disposable garments are not used, washed and sterilized more than once, the fabric barrier and its strength are consistent. This is in contrast to reusable cleanroom clothing which is used, washed, dried and sterilized over and over again. The performance of reusable clothing is significantly degraded by repeated washing and sterilization.
  • Qualification and quality review is easier for disposable garment users as test data and certifications are available from one place. Reusable cleanroom clothing involves multiple suppliers in the value chain, such as manufacturers and laundries. Qualification and subsequent quality reviews are therefore significantly easier for disposable clothing.
  • Greater flexibility: You can order the number of disposable clothes you need and your stock can be regulated according to production needs. You can order the number of disposables that you will use, which can be adjusted as your needs change. Inventory management is also easier for disposable garments, as you don't have to deal with a system of reusable garments with all the washing, disinfection, wash cycles, replacement and repair of garments.
  • Recycling: Many disposable garments - for example those made of Tyvek® fabric - can also be recycled, provided they have not come into contact with hazardous substances.

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