Written by Domhnall Mc Gowan M.Sc.
To maintain your cleanroom classification and protect the quality of your product it is important to develop an appropriate cleaning strategy for your facility. You must take into consideration the room classifications that you must maintain, the appropriate cleaning frequencies for your different areas and the correct type of cleaning agents that you will use.
To understand the different classifications that a cleanroom and support areas can be classified as check out our article on Cleanroom Classifications.
When developing your cleaning strategy, you should consider the 5 questions posed in our article The Importance of Cleaning Practices for your Cleanroom.
In this article we will be looking at how you determine cleaning frequencies, how to pick your cleaning agents and how to properly document your cleaning operations.
It is common to stratify your cleaning frequencies using a risk-based approach based on the classification of the space and level of use of the area. Higher classification areas and high use areas should be cleaned more frequently than lower class areas and areas which are rarely used by personnel.
Common frequencies, or cleaning levels, are: Daily, Weekly, Monthly, Quarterly and Annual.
When defining the aspects of each level it is common to use a stacking approach i.e., the areas cleaned in Daily are also cleaned during Weekly and the areas cleaned during Weekly are also cleaned during Monthly and so on. This strategy means that you are continuously cleaning your most critical areas while you clean the less critical areas.
There are 3 classes of cleaning agent: detergents, disinfectants and sporicides or sterilants. Disinfectants (also termed biocides) can be further classified as low-level disinfectants (LLD) and high-level disinfectants (HDL). Sporicides or sterilants can also be classified as disinfectants however as they have the ability to eliminate all levels of microorganisms as defined by the disinfection hierarchy.
Detergents are cleaning agents with remove residues or soilant from surfaces. There are 3 categories of detergents but all work to solubilize and remove build up from surfaces. Some detergents possess biocidal actions which can compliment your disinfectant use. Detergents should be used regularly to remove build up and residue from surfaces for two main reasons – 1. To remove films in which microorganisms could grow and 2. To allow disinfectants to reach the surface and act effectively. Residue build up can be a contributor to ineffective disinfection.
Disinfectants are cleaning agents which possess biocidal actions and work to eliminate bioburden from treated surfaces. Disinfectants are your main line of defense against microorganisms. They can be categorized into Low-Level Disinfectants and High-Level Disinfectants. LLD should be used daily to disinfect critical work areas such as the internal surfaces of your Grade A or ISO 5 space. HLD should be used at a minimum on a weekly basis to treat critical work surfaces and high use surfaces such as floors. An example of a LLD is isopropyl alcohol (IPA). An example of a HLD is accelerated hydrogen peroxide (AHP).
Sporicides are cleaning agents which are effective at eliminating spore forming bacteria by inactivating or lysing the spore coating. Sporicides can have negative effects on equipment and construction materials so their use should be closely managed. As part of normal cleaning strategies sporicides should be used on a quarterly frequency and in emergency situations where environmental monitoring identifies spore forming bacteria in the environment. For further information on sporicides read our article. [insert hyperlink to Manual sporicide v iHP]
Common frequencies for different cleaning agents
Now that we have discussed cleaning frequencies and the different types of cleaning agents we need to understand when to deploy each agent and how frequently to use them. See Table 1 for an outline of an example cleaning strategy.
Table 1: Example of cleaning strategy for an ISO 5/7 manufacturing cleanroom
“If it’s not documented, it didn’t happen”
As true as this statement is for your production/manufacturing operations, it also holds true for your cleaning operations. Under GMP you must document all activities which can have an impact on your manufacturing, and cleaning is one of those activities. Your cleaning documentation can be used in internal investigations and can be requested during regulatory or customers audits, so it is important to ensure that you are documenting all critical steps of your cleaning and ensuring principles of good documentation practices (GDP) are being followed.
When designing cleaning documentation there are no rules as to what structure or format should be implemented. Some organizations build out batch record type documents with step-by-step instructions with multiple sign off steps, while others design simpler documentation and rely more heavily on SOPs for step-by-step instructions which all personnel must exhibit knowledge on before executing an cleaning process. At a minimum your cleaning documentation should include sections for:
- Date, time and, area being cleaning
- High level instructions
- Identification of cleaning personnel
- Documentation of cleaning agents used
- Sign off and review by supervisors and/or quality representatives.
Vibraclean are experts in designing cleaning strategies and creating appropriate cleaning documentation. Vibraclean possess extensive experience and knowledge of cleaning agents and a network of trusted suppliers from working in the industry for over 30 years. Vibraclean can help customers develop excellent cleaning strategies to ensure that cleanroom environments and facilities are maintained correctly, and critical products are protected.