What to consider when selecting cleanroom disinfectants
Cleanroom disinfectants are essential for maintaining the cleanliness and sterility of controlled environments such as pharmaceutical manufacturing facilities, biotechnology labs, and hospitals. Cleanrooms can be subject to different environments and activities that have a profound effect on the way cleanrooms are operated and how they perform. Selecting the right disinfectant is critical for ensuring the safety and efficacy of products, protecting personnel, and complying with regulatory requirements.
Why disinfectants are important?
Without suitable disinfectants, even the most high-tech cleanrooms with robust hygiene procedures and working practices may eventually fail. Disinfectants are a diverse group of chemicals that reduce the number of micro-organisms present within any given area. Disinfectants vary in their spectrum of activity, modes of action and efficacy. For example, some disinfectants are effective against vegetative Gram-positive and Gram-negative micro-organisms only, while some are effective against fungi.
Cleanrooms are crucial environments in the pharmaceutical, healthcare, and biotech industries. These spaces require a high degree of cleanliness to ensure that products are manufactured in a controlled and sterile environment. One of the key components of maintaining a cleanroom is the use of disinfectants. However, selecting the right disinfectant for your cleanroom can be challenging. In this article, we will discuss some factors that you should consider when selecting cleanroom disinfectants.
1. Regulatory Compliance
One of the most important factors to consider when selecting a cleanroom disinfectant is regulatory compliance. The disinfectant you choose should be approved by regulatory agencies such as the Environmental Protection Agency (EPA) and the Food and Drug Administration (FDA). These agencies have specific requirements for disinfectants used in cleanrooms. You should also ensure that the disinfectant is registered with the appropriate governing bodies in your region.
2. Compatibility with Cleanroom Surfaces
Another important factor to consider when selecting a cleanroom disinfectant is compatibility with cleanroom surfaces. Disinfectants can react with surfaces, causing damage or leaving behind residue. It is important to choose a disinfectant that is compatible with the surfaces in your cleanroom. For example, some disinfectants may be effective on stainless steel but not on plastics or other materials. It is also important to consider the impact of the disinfectant on the integrity of the surfaces in your cleanroom, such as seals, gaskets, and coatings.
3. Spectrum of Activity
The spectrum of activity is the range of microorganisms that a disinfectant is effective against. When selecting a cleanroom disinfectant, it is important to consider the spectrum of activity. The disinfectant should be effective against a broad range of microorganisms, including bacteria, viruses, and fungi. You should also consider the disinfectant's efficacy against specific types of microorganisms that are commonly found in your cleanroom.
4. Mode of Action
The mode of action is the mechanism by which a disinfectant kills microorganisms. Some disinfectants work by disrupting the cell membrane, while others work by denaturing proteins. It is important to choose a disinfectant that has a mode of action that is effective against the types of microorganisms that are present in your cleanroom. Additionally, you should consider the potential for resistance to the disinfectant and the risk of developing superbugs.
5. Safety and Toxicity
The safety and toxicity of a disinfectant are important considerations when selecting a cleanroom disinfectant. Disinfectants can be hazardous to human health and the environment. You should choose a disinfectant that has low toxicity and is safe for use in your cleanroom. You should also consider the safety precautions that need to be taken when handling and using the disinfectant, such as the use of personal protective equipment.
6. Residue and Residual Activity
Residue and residual activity are important considerations when selecting a cleanroom disinfectant. Residue can impact the cleanliness of your cleanroom, and residual activity can help to maintain a sterile environment. You should choose a disinfectant that leaves little or no residue and has residual activity that is effective against microorganisms.
7. Ease of Use
The ease of use of a disinfectant is an important consideration when selecting a cleanroom disinfectant. Disinfectants should be easy to prepare, apply, and dispose of. You should choose a disinfectant that is easy to apply and requires minimal preparation. You should also consider the environmental impact of the disinfectant and choose a product that is easy to dispose of and has minimal impact on the environment.
Disinfection validation
It is essential for cleanroom hygiene that validated disinfectants are used. Disinfectants including biocides and sporicides can be tested to recognised standards to determine product efficacy against bacteria, fungi and spores. A sterile disinfectant should be selected that demonstrates performance against the following standards:
• EN1276 – Chemical Disinfectants Bacterial Activity Test
• EN1650 – Quantitative Suspension Test for the Evaluation of Fungicidal Activity of Chemical Disinfectants
• EN13697 – Quantitative Surface Test for the Evaluation of Bactericidal or Fungicidal Activity
• EN13704 – Quantitative Suspension Test for the Evaluation of Sporicidal Activity of Chemical Disinfectants
Selecting the right rotation
In cleanroom environments, the control of contamination is critical to ensure the safety and efficacy of products being manufactured. Disinfectants are an essential tool for controlling microbial contamination in these environments. However, over-reliance on a single disinfectant can lead to the development of microbial resistance, making it crucial to rotate disinfectants regularly.
Disinfectant rotation involves the use of different disinfectants with varying modes of action and chemical properties to control microbial contamination. By rotating disinfectants, the potential for microbial resistance development is minimized, and the efficacy of the disinfectants is maintained. Furthermore, rotating disinfectants can help identify any gaps in the disinfection process and enhance the overall cleaning and disinfection program.
There are several factors to consider when developing a disinfectant rotation program. The first is the selection of disinfectants that are compatible with the cleanroom environment, equipment, and surfaces. Additionally, the disinfectants should have varying modes of action to prevent the development of microbial resistance. It is also important to consider the frequency and duration of use of each disinfectant to ensure maximum efficacy and minimal risk of exposure to personnel.
A well-designed disinfectant rotation program should include a combination of sporicidal, virucidal, and bactericidal disinfectants to target a broad range of microbial contaminants. Furthermore, the program should take into account the frequency and intensity of cleaning required based on the cleanroom classification and manufacturing processes. For example, aseptic manufacturing requires more stringent cleaning and disinfection protocols than non-sterile manufacturing.
Regular monitoring and validation of the disinfectant rotation program are essential to ensure its effectiveness. Environmental monitoring and microbial testing can help identify any gaps or weaknesses in the disinfection program and enable corrective actions to be taken promptly.
In conclusion, disinfectant rotation is a critical consideration in cleanroom environments. A well-designed disinfectant rotation program can minimize the potential for microbial resistance development, enhance the efficacy of the disinfectants, and identify any gaps or weaknesses in the cleaning and disinfection process. Regular monitoring and validation of the program are essential to ensure its effectiveness in controlling microbial contamination and maintaining a safe and controlled environment.
Spray or wipe?
Micro-organisms that are exposed to the disinfectants for the recommended contact time will be killed. Redditch Medical recently studied microbial activity assessing wiping performance in real practice conditions following the guidance of EN16615. This study demonstrates that contamination control can be improved by spraying and wiping surfaces to mechanically lift and remove surface contaminants.
InSpec is designed to offer complete cleanroom contamination control.
Detergents, sporicides, alcohols and aqueous biocides
The technical team at Redditch Medical can assist with all cleanroom contamination control requirements, designing working practices and making recommendations to meet the unique needs of every cleanroom.
Controlling any cleanroom is a fine balance; just like choosing a disinfectant, it is a balance between safety, modes of action, efficacy, contact times, corrosion, residue, shelf-life and in-use shelf-life, not to mention convenience of use and cost.
As cleanroom users, the designers behind InSpec understand regulators’ expectations – including robust validation programmes demonstrating reasoned selection, challenge of site isolates and in-use efficacy that keeps the cleanroom micro-organisms in control.
The contamination control division at Redditch Medical recently developed an innovative burstable pouch system
Sporicidal wipes and mops are somewhat rare in the cleanroom industry. The contamination control division at Redditch Medical recently developed an innovative burstable pouch system now available in the InSpec range as a wipe or mop system. This unique concept preserves the integrity and efficacy of both the physical wipes and the sporicide or biocide solution until the pouch is activated at the point of use.
The innovative burstable pouch system preserves the integrity and efficacy of both the physical wipes and the sporicide or biocide solution until the pouch is activated at the point of use