Written by: Domhnall Mc Gowan M.Sc.
What is A Cleanroom?
A cleanroom is defined as:
A room designed, maintained, and controlled to prevent particle and microbiological contamination of drug products. Such a room is assigned and reproducibly meets an appropriate air cleanliness classification.” FDA: Guidance for Industry – Sterile Drug Products Produced by Aseptic Processing.
From this definition we see that it really is in the name – a room in which a specified level of cleanliness is met and is maintained so that sensitive products can be manufactured free from adulteration by particles and microbes that would compromise the quality of the product.
Hence, when operating a cleanroom or cleanroom facility, employing good and proper cleaning practices is critical to maintaining your cleanroom in a fit, operational, state.
Good Cleaning Practices
While your cleanroom design and construction are integral for keeping non-viable particle counts low and within specifications, cleaning and sanitization practices are used to remove bioburden (viable particles) from your cleanroom area. (Check out our Cleanroom Classification article for an in-depth look at what specifications must be met when classifying your cleanroom.)
There is no set of defined “Good Cleaning Practices” as prescribed by any regulatory body, however it is stated that all facilities and equipment that are used in the production of a product must be maintained in a fit state to manufacture said product safely. In essence “Good Cleaning Practices” are built into Good Manufacturing Practices (GMPs), but their design and implementation are left up to the manufacturing organization.
However, if an organization neglects to maintain the cleanliness of their cleanroom by appropriate practices and to an appropriate level they can be cited by their regulatory body and production can be shut down.
Employing good cleaning practices can be seen as practicing good risk management. Bioburden and particle generation pose risks to your cleanroom and product so spending time to consider your cleaning practices is necessary for any organization which works under a quality system and looks to reduce risk to their operations.
Some high-level components that you must consider when creating your cleaning practices are:
The cleanroom specification you must maintain
Are you classifying your cleanroom as ISO 7 or ISO 5, or does your organization work with European or WHO standards and you have Grade A/B/C rooms?
How often do you have to clean your cleanrooms to maintain the correct level of cleanliness? Within your cleanroom space how often will you clean different areas such as floors or ceilings. High traffic or heavily used areas should be cleaned more frequently than lower use areas.
Furthermore, what will your frequency of changing your cleaning chemicals be? Using the same cleaning chemical repeatedly without any change can increase the likelihood of microbial resistance evolving within your facility’s normal flora.
Training and Personnel
A major but sometimes overlooked aspect of good cleaning practices is the training program you enact and what personnel you employ to execute cleaning.
If you do not train your personnel in the correct methods for cleaning and the correct use of the cleaning materials, then mistakes will be made which can ultimately invalidate your whole program. Additionally, will you add cleaning as a responsibility to you own cleanroom personnel, employ specific cleaning personnel, or contract out your cleaning requirements to a specialized third party.
Choosing the correct cleaning chemicals for your facility and for your product is crucial. Employing the proper balance between detergents and disinfectants with broad spectrum abilities and specialized sporicides for emergency use. See our article of choosing your cleaning chemicals for more information
Do you have the ability to integrate a sterilization step into your cleaning program such as using ionized hydrogen peroxide (iHP) or UV light? Building in the ability to deploy a sterilization agent can greatly increase your confidence in your cleaning program.
Have you designed a good monitoring program which will allow you to monitor the levels of particles, both viable and non-viable, that will allow you to assess the efficacy of your cleaning program and identify any risks to your cleanroom and the assigned classification?
Vibraclean are experts in cleanroom and facility cleaning. Vibraclean have over 30 years’ experience in providing third part cleaning services and are used by some of the biggest pharmaceutical and biopharmaceutical companies in Canada to manage their cleaning and ensure that their cleanrooms are kept in an operational state.